80 FR 16804 - 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 60 (March 30, 2015)

Page Range		16804-16921
FR Document		2015-06612

This notice of proposed rulemaking introduces a new edition of certification criteria (the 2015 Edition health IT certification criteria or ``2015 Edition''), proposes a new 2015 Edition Base EHR definition, and proposes to modify the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition would also establish the capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.

Federal Register, Volume 80 Issue 60 (Monday, March 30, 2015)

[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)]
[Proposed Rules]
[Pages 16804-16921]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-06612]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 170

RIN 0991-AB93

2015 Edition Health Information Technology (Health IT)
Certification Criteria, 2015 Edition Base Electronic Health Record
(EHR) Definition, and ONC Health IT Certification Program Modifications

AGENCY: Office of the National Coordinator for Health Information
Technology (ONC), Department of Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking with comment period.

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SUMMARY: This notice of proposed rulemaking introduces a new edition of
certification criteria (the 2015 Edition health IT certification
criteria or ``2015 Edition''), proposes a new 2015 Edition Base EHR
definition, and proposes to modify the ONC Health IT Certification
Program to make it open and accessible to more types of health IT and
health IT that supports various care and practice settings. The 2015
Edition would also establish the capabilities and specify the related
standards and implementation specifications that Certified Electronic
Health Record (EHR) Technology (CEHRT) would need to include to, at a
minimum, support the achievement of meaningful use by eligible
professionals (EPs), eligible hospitals, and critical access hospitals
(CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR
Incentive Programs) when such edition is required for use under these
programs.

DATES: To be assured consideration, written or electronic comments must
be received at one of the addresses provided below, no later than 5
p.m. on May 29, 2015.

ADDRESSES: You may submit comments, identified by RIN 0991-AB93, by any
of the following methods (please do not submit duplicate comments).
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Federal eRulemaking Portal: Follow the instructions for
submitting comments. Attachments should be in Microsoft Word, Microsoft
Excel, or Adobe PDF; however, we prefer Microsoft Word. http://www.regulations.gov.
Regular, Express, or Overnight Mail: Department of Health
and Human Services, Office of the National Coordinator for Health
Information Technology, Attention: 2015 Edition Health IT Certification
Criteria Proposed Rule, Hubert H. Humphrey Building, Suite 729D, 200
Independence Ave SW., Washington, DC 20201. Please submit one original
and two copies.
Hand Delivery or Courier: Office of the National
Coordinator for Health Information Technology, Attention: 2015 Edition
Health IT Certification Criteria Proposed Rule, Hubert H. Humphrey
Building, Suite 729D, 200 Independence Ave SW., Washington, DC 20201.
Please submit one original and two copies. (Because access to the
interior of the Hubert H. Humphrey Building is not readily available to
persons without federal government identification, commenters are
encouraged to leave their comments in the mail drop slots located in
the main lobby of the building.)
Enhancing the Public Comment Experience: To facilitate public
comment on this proposed rule, a copy will be made available in
Microsoft Word format. We believe this version will make it easier for
commenters to access and copy portions of the proposed rule for use in
their individual comments. Additionally, a separate document will be
made available for the public to use to provide comments on the
proposed rule. This document is meant to provide the public with a
simple and organized way to submit comments on the certification
criteria, associated standards and implementation specifications, and
respond to specific questions posed in the preamble of the proposed
rule. While use of this document is entirely voluntary, we encourage
commenters to consider using the document in lieu of unstructured
comments or to use it as an addendum to narrative cover pages. Roughly
30% of the public comments submitted to our past two editions of
certification criteria proposed rules used the provided template, which
greatly assisted in our ability to rapidly process and more accurately
categorize public comments. Because of the technical nature of this
proposed rule, we believe that use of the document may facilitate our
review and understanding of the comments received. The Microsoft Word
version of the proposed rule and the document that can be used for
providing comments can be found at http://www.regulations.gov as part
of this proposed rule's docket and on ONC's Web site (http://www.healthit.gov).
Inspection of Public Comments: All comments received before the
close of the comment period will be available for public inspection,
including any personally identifiable or confidential business
information that is included in a comment. Please do not include
anything in your comment submission that you do not wish to share with
the general public. Such information includes, but is not limited to: a
person's social security number; date of birth; driver's license
number; state identification number or foreign country equivalent;
passport number; financial account number; credit or debit card number;
any personal health information; or any business information that could
be considered proprietary. We will post all comments that are received
before the close of the comment period at http://www.regulations.gov.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the Department
of Health and Human Services, Office of the National Coordinator for
Health Information Technology, Hubert H. Humphrey Building, Suite 729D,
200 Independence Ave SW., Washington,

[[Page 16805]]

DC 20201 (call ahead to the contact listed below to arrange for
inspection).

FOR FURTHER INFORMATION CONTACT: Michael Lipinski, Office of Policy,
Office of the National Coordinator for Health Information Technology,
202-690-7151.

SUPPLEMENTARY INFORMATION:

Commonly Used Acronyms

API Application Programming Interface
CAH Critical Access Hospital
CDA Clinical Document Architecture
CDC Centers for Disease Control and Prevention
CDS Clinical Decision Support
CEHRT Certified Electronic Health Record Technology
CFR Code of Federal Regulations
CHPL Certified Health IT Product List
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare & Medicaid Services
CQM Clinical Quality Measure
EHR Electronic Health Record
HHS Department of Health and Human Services
HISP Health Information Service Providers
HIT Health Information Technology
HITPC HIT Policy Committee
HITSC HIT Standards Committee
HL7 Health Level Seven
IG Implementation Guide
LOINC[supreg] Logical Observation Identifiers Names and Codes
ONC Office of the National Coordinator for Health Information
Technology
SNOMED CT[supreg] Systematized Nomenclature of Medicine Clinical
Terms

Table of Contents

I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
1. Overview of the 2015 Edition Health IT Certification Criteria
2. Base EHR Definition and Certified EHR Technology Definition
3. The ONC Health IT Certification Program and Health IT Module
C. Costs and Benefits
II. Background
A. Statutory Basis
1. Standards, Implementation Specifications, and Certification
Criteria
2. HIT Certification Programs
B. Regulatory History
1. Standards, Implementation Specifications, and Certification
Criteria Rules
2. Medicare and Medicaid EHR Incentive Programs Rules
3. ONC Health IT Certification Programs Rules
III. Provisions of the Proposed Rule Affecting Standards,
Implementation Specifications, Certification Criteria, and
Definitions
A. 2015 Edition Health IT Certification Criteria
1. Applicability
2. Standards and Implementation Specifications
3. Certification Criteria
4. 2015 Edition Gap Certification Eligibility Table
5. Pharmacogenomics Data--Request for Comment
B. Definitions
1. Base EHR Definitions
2. Certified EHR Technology Definition
3. Common Clinical Data Set Definition
4. Cross-Referenced FDA Definitions
IV. Provisions of the Proposed Rule Affecting the ONC Health IT
Certification Program
A. Subpart E--ONC Health IT Certification Program
B. Modifications to the ONC Health IT Certification Program
1. Health IT Modules
2. ``Removal'' of Meaningful Use Measurement Certification
Requirements
3. Types of Care and Practice Settings
4. Referencing the ONC Health IT Certification Program
C. Health IT Module Certification Requirements
1. Privacy and Security
2. Design and Performance (Sec. 170.315(g))
D. Principles of Proper Conduct for ONC-ACBs
1. ``In-the-Field'' Surveillance and Maintenance of
Certification
2. Transparency and Disclosure Requirements
3. Open Data Certified Health IT Product List (CHPL)
4. Records Retention
5. Complaints Reporting
6. Adaptations and Updates of Certified Health IT
E. ``Decertification'' of Health IT--Request for Comment
V. Response to Comments
VI. Incorporation by Reference
VII. Collection of Information Requirements
VIII. Regulatory Impact Statement
A. Statement of Need
B. Overall Impact
1. Executive Orders 12866 and 13563--Regulatory Planning and
Review Analysis
2. Regulatory Flexibility Act
3. Executive Order 13132--Federalism
4. Unfunded Mandates Reform Act of 1995

I. Executive Summary

A. Purpose of Regulatory Action

Building on past rulemakings, this proposed rule further identifies
how health IT certification can support the establishment of an
interoperable nationwide health information infrastructure. It reflects
stakeholder feedback received through various outreach initiatives,
including the regulatory process, and is designed to broadly support
the health care continuum through the use of certified health IT. To
achieve this goal, this rule proposes to:
Improve interoperability for specific purposes by adopting
new and updated vocabulary and content standards for the structured
recording and exchange of health information, including a Common
Clinical Data Set composed primarily of data expressed using adopted
standards; and rigorously testing an identified content exchange
standard (Consolidated Clinical Document Architecture (C-CDA));
Facilitate the accessibility and exchange of data by
including enhanced data portability, transitions of care, and
application programming interface (API) capabilities in the 2015
Edition Base EHR definition;
Establish a framework that makes the ONC Health IT
Certification Program open and accessible to more types of health IT,
health IT that supports a variety of care and practice settings,
various HHS programs, and public and private interests;
Support the Medicare and Medicaid EHR Incentive Programs
(EHR Incentive Programs) through the adoption of a set of certification
criteria that align with proposals for Stage 3;
Address health disparities by providing certification: To
standards for the collection of social, psychological, and behavioral
data; for the exchange of sensitive health information (Data
Segmentation for Privacy); and for the accessibility of health IT;
Ensure all health IT presented for certification possess
the relevant privacy and security capabilities;
Improve patient safety by: Applying enhanced user-center
design principles to health IT, enhancing patient matching, requiring
relevant patient information to be exchanged (e.g., Unique Device
Identifiers), improving the surveillance of certified health IT, and
making more information about certified products publicly available and
accessible;
Increase the reliability and transparency of certified
health IT through surveillance and disclosure requirements; and
Provide health IT developers with more flexibility and
opportunities for certification that support both interoperability and
innovation.

B. Summary of Major Provisions

1. Overview of the 2015 Edition Health IT Certification Criteria
The 2015 Edition health IT certification criteria (``2015
Edition'') would facilitate greater interoperability for several
clinical health information purposes and enable health information
exchange through new and enhanced certification criteria, standards,
and implementation specifications. It incorporates changes that are
designed to spur innovation, open new market opportunities, and provide
more choices to providers when it comes to electronic

[[Page 16806]]

health information exchange. To achieve these goals, we propose a new
``Application Access to Common Clinical Data Set'' certification
criterion that would require the demonstration of an API that responds
to data requests for any one of the data referenced in the Common
Clinical Data Set as well as for all of the data referenced in the
Common Clinical Data Set. To further validate the continued
interoperability of certified health IT and the ability to exchange
health information, we propose a new certification criterion that would
rigorously assess a product's C-CDA creation performance (for both C-
CDA version 1.1 and 2.0) when presented for certification for such
capabilities.
2. Definitions
a. Base EHR Definitions
We propose to adopt a Base EHR definition specific to the 2015
Edition (i.e., a 2015 Edition Base EHR definition) at Sec. 170.102 and
rename the current Base EHR definition at Sec. 170.102 as the 2014
Edition Base EHR definition. For the proposed 2015 Edition Base EHR
definition, it would differ from the 2014 Edition Base EHR definition
in the following ways:
It does not include privacy and security capabilities and
certification criteria. We believe privacy and security capabilities
would be more appropriately addressed through our new proposed approach
for the privacy and security certification of Health IT Modules to the
2015 Edition, as discussed under ``Privacy and Security'' in section
IV.C.1 of the preamble. Our new privacy and security approach would
eliminate eligible professionals (EPs)', eligible hospitals', and
critical access hospitals (CAHs)' responsibilities to ensure that they
have technology certified to all the necessary privacy and security
criteria. Rather, as part of certification, health IT developers would
need to meet applicable privacy and security certification criteria.
It only includes the capability to record and export CQM
data (Sec. 170.315(c)(1)). To note, the capabilities to import,
calculate and report CQM data are not included in the proposed 2015
Edition Base EHR definition or any other CQM-related requirements.
Please refer to the ``Clinical Quality Measures'' section (III.A.3)
later in the preamble for a more detailed discussion of the CQM
certification criteria. Please also see the EHR Incentive Programs
Stage 3 proposed rule published elsewhere in this issue of the Federal
Register for proposals related to CQMs, including the CEHRT definition
proposal.
It includes the 2015 Edition ``smoking status,''
``implantable device list,'' and ``application access to Common
Clinical Data Set'' certification criteria. For a detailed discussion
of these certification criteria, please refer to section III.A.3 of the
preamble.
It includes the proposed 2015 Edition certification
criteria that correspond to the remaining 2014 Edition certification
criteria referenced in the ``2014 Edition'' Base EHR definition (i.e.,
Computerized Provider Order Entry (CPOE), demographics, problem list,
medication list, medication allergy list, clinical decision support
(CDS), transitions of care, data portability, and relevant transport
certification criteria). On the inclusion of transport certification
criteria, we propose to include the ``Direct Project'' criterion (Sec.
170.315(h)(1)) as well as the ``Direct Project, Edge Protocol and XDR/
XDM'' \1\ criterion (Sec. 170.315(h)(2)) as equivalent alternative
means for meeting the 2015 Edition Base EHR definition for the reasons
discussed under ``Transport Methods and Other Protocols'' in section
III.A.3 of the preamble.
---------------------------------------------------------------------------

\1\ XDR stands for Cross-Enterprise Document Reliable
Interchange. XDM stands for Cross-Enterprise Document Media
Interchange.
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We refer readers to section III.B.1 for a more detailed discussion
of the proposed 2015 Edition Base EHR definition.
b. CEHRT Definition
We propose to remove the Certified EHR Technology (CEHRT)
definition from Sec. 170.102 for the following reasons. The CEHRT
definition has always been defined in a manner that supports the EHR
Incentive Programs. As such, the CEHRT definition would more
appropriately reside solely within the EHR Incentive Programs
regulations. This would also be consistent with our approach in this
proposed rule to make the ONC Health IT Certification Program more open
and accessible to other types of health IT beyond EHR technology and
for health IT that supports care and practice settings beyond those
included in the EHR Incentive Programs. Further, this approach should
add administrative simplicity in that regulatory provisions, which EHR
Incentive Programs participants must meet (e.g., the CEHRT definition),
would be defined within the context of rulemakings for those programs.
We understand that the CEHRT definition proposed by CMS would continue
to include the Base EHR definition(s) defined by ONC, including the
2015 Edition Base EHR definition proposed in this proposed rule. We
also refer readers to Table 2 (``2015 Edition Proposed Certification
Criteria Associated with the EHR Incentive Programs Stage 3'') found in
section III.A.3 of this preamble. Table 2 crosswalks proposed 2015
Edition certification criteria with the proposed CEHRT definition and
proposed EHR Incentive Programs Stage 3 objectives.
c. Common Clinical Data Set
We propose to revise the ``Common MU Data Set'' definition in Sec.
170.102. We propose to change the name to ``Common Clinical Data Set,''
which aligns with our approach throughout this proposed rule to make
the ONC Health IT Certification Program more open and accessible to
other types of health IT beyond EHR technology and for health IT that
supports care and practice settings beyond those included in the EHR
Incentive Programs. We also propose to change references to the
``Common MU Data Set'' in the 2014 Edition (Sec. 170.314) to ``Common
Clinical Data Set.''
We propose to revise the definition to account for the new and
updated standards and code sets we propose to adopt in this proposed
rule that would improve and advance interoperability through the
exchange of the Common Clinical Data Set. We also propose to revise the
definition to support patient safety through clearly referenced data
elements and the inclusion of new patient data. These proposed
revisions would not change the standards, codes sets, and data
requirements specified in the Common Clinical Data Set for 2014 Edition
certification. They would only apply to health IT certified to the 2015
Edition Health IT certification criteria that reference the Common
Clinical Data Set.
3. The ONC Health IT Certification Program and Health IT Module
We propose to change the name of the ONC HIT Certification Program
to the ``ONC Health IT Certification Program'' (referred to as the
``ONC Health IT Certification Program'' throughout this proposed rule).
We also propose to modify the ONC Health IT Certification Program in
ways that would further open access to other types of health IT beyond
EHR technology and for health IT that supports care and practice
settings beyond the ambulatory and inpatient settings. These
modifications would also serve to support other public and private
programs that may reference the use of health IT certified under the
ONC Health IT Certification Program. When we established the
certification

[[Page 16807]]

program (76 FR 1294), we stated our initial focus would be on EHR
technology and supporting the EHR Incentive Programs, which focus on
the ambulatory setting and inpatient setting. Our proposals in this
proposed rule would permit other types of health IT (e.g., laboratory
information systems (LISs)), and technology implemented by health
information service providers (HISPs) and health information exchanges
(HIEs)) to receive appropriate attribution and not be referenced by a
certificate with ``EHR'' in it. Our proposals also support health IT
certification for other care and practice settings such as long-term
post-acute care (LTPAC), behavioral health, and pediatrics. Further,
the proposals in this rule would make it simpler for certification
criteria and certified health IT to be referenced by other HHS programs
(e.g., Medicaid and Medicare payment programs and various grant
programs), other public programs, and private entities and
associations.
As part of our approach to evolve the ONC Health IT Certification
Program, we have replaced prior rulemaking use of ``EHR'' and ``EHR
technology'' with ``health IT.'' The term health IT is reflective of
the scope of ONC's authority under the Public Health Service Act (Sec.
3000(5) as ``health information technology'' is so defined), and
represents a broad range of technology, including EHR technology. It
also more properly represents some of the technology, as noted above,
that has been previously certified to editions of certification
criteria under the ONC Health IT Certification Program and may be
certified to the proposed 2015 Edition in the future. Similarly, to
make the ONC Health IT Certification Program more open and accessible,
we propose to rename the EHR Module as ``Health IT Module'' and will
use this term throughout the proposed rule.
We propose not to require ONC-Authorized Certification Bodies
(ACBs) to certify all Health IT Modules to the 2015 Edition
``meaningful use measurement'' certification criteria (Sec.
170.315(g)(1) ``automated numerator recording'' and Sec. 170.315(g)(2)
``automated measure calculation''). We note that CMS has proposed to
include the 2015 Edition ``meaningful use measurement'' certification
criteria in the CEHRT definition as a unique program requirement for
the EHR Incentive Programs.
We propose a new, simpler, straight-forward approach to privacy and
security certification requirements for Health IT Modules certified to
the 2015 Edition. In essence, we identify the privacy and security
certification criteria that would be applicable to a Health IT Module
presented for certification based on the other capabilities included in
the Health IT Module and for which certification is sought. Under the
proposed approach, a health IT developer would know exactly what it
needed to do in order to get its Health IT Module certified and a
purchaser of a Health IT Module would know exactly what privacy and
security functionality against which the Health IT Module had to be
tested in order to be certified.
We propose new and revised principles of proper conduct (PoPC) for
ONC-ACBs. We propose to require ONC-ACBs to report an expanded set of
information to ONC for inclusion in the open data file that would make
up the Certified Health IT Product List (CHPL). We propose to revise
the PoPC in order to provide for more meaningful disclosure of certain
types of costs and limitations that could interfere with the ability of
users to implement certified health IT in a manner consistent with its
certification. We propose that ONC-ACBs retain records longer and
consistent with industry standards. We propose to require that ONC-ACBs
obtain a record of all adaptations and updates, including changes to
user-facing aspects, made to certified health IT, on a monthly basis
each calendar year. We propose to require that ONC-ACBs report to the
National Coordinator complaints received on certified health IT. We
propose to adopt new requirements for ``in-the-field'' surveillance
under the ONC Health IT Certification Program that would build on ONC-
ACBs' existing surveillance responsibilities by specifying requirements
and procedures for in-the-field surveillance. We believe these proposed
new and revised PoPC would promote greater transparency and
accountability for the ONC Health IT Certification Program. We also
include a request for comment on the potential ``decertification'' of
health IT that proactively blocks the sharing of information.

C. Costs and Benefits

Our estimates indicate that this proposed rule is an economically
significant rule as its overall costs for health IT developers may be
greater than $100 million in at least one year. We have, therefore,
projected the costs and benefits of the proposed rule. The estimated
costs expected to be incurred by health IT developers to develop and
prepare health IT to be tested and certified in accordance with the
2015 Edition health IT certification criteria (and the standards and
implementation specifications they include) are represented in monetary
terms in Table 1 below. We note that this proposed rule does not impose
the costs cited as compliance costs, but rather as investments which
health IT developers voluntarily take on and expect to recover with an
appropriate rate of return.
The dollar amounts expressed in Table 1 are expressed in 2013
dollars.

Table 1--Distributed Total Development and Preparation Costs for Health IT Developers (4-Year Period)--Totals
Rounded
----------------------------------------------------------------------------------------------------------------
Total high Total average
Year Ratio (%) Total low cost cost estimate cost estimate
estimate ($M) ($M) ($M)
----------------------------------------------------------------------------------------------------------------
2015............................................ 25 49.36 101.80 75.58
2016............................................ 30 59.23 122.16 90.70
2017............................................ 30 59.23 122.16 90.70
2018............................................ 15 29.61 61.08 45.35
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4-Year Totals............................... .............. 197.43 407.20 302.32
----------------------------------------------------------------------------------------------------------------

We believe that there will be several significant benefits that may
arise from this proposed rule for patients, health care providers, and
health IT developers. The 2015 Edition continues to improve health IT
interoperability through the adoption of new and updated standards and
implementation specifications. For example, many

[[Page 16808]]

proposed certification criteria include standards and implementation
specifications for interoperability that directly support the EHR
Incentive Programs, which include objectives and measures for the
interoperable exchange of health information and for providing patients
electronic access to their health information in structured formats. In
addition, proposed certification criteria that support the collection
of patient data that could be used to address health disparities would
not only benefit patients, but the entire health care delivery system
through improved quality of care. The 2015 Edition also supports
usability and patient safety through new and enhanced certification
requirements for health IT.
Our proposals to make the ONC Health IT Certification Program open
and accessible to more types of health IT and for health IT that
supports a variety of care and practice settings should benefit health
IT developers, providers practicing in other care/practice settings,
and consumers through the availability and use of certified health IT
that includes capabilities that promote interoperability and enhanced
functionality.

II. Background

A. Statutory Basis

The Health Information Technology for Economic and Clinical Health
(HITECH) Act, Title XIII of Division A and Title IV of Division B of
the American Recovery and Reinvestment Act of 2009 (the Recovery Act)
(Pub. L. 111-5), was enacted on February 17, 2009. The HITECH Act
amended the Public Health Service Act (PHSA) and created ``Title XXX--
Health Information Technology and Quality'' (Title XXX) to improve
health care quality, safety, and efficiency through the promotion of
HIT and electronic health information exchange.
1. Standards, Implementation Specifications, and Certification Criteria
The HITECH Act established two new federal advisory committees, the
Health IT Policy Committee (HITPC) and the Health IT Standards
Committee (HITSC) (sections 3002 and 3003 of the PHSA, respectively).
Each is responsible for advising the National Coordinator for Health
Information Technology (National Coordinator) on different aspects of
standards, implementation specifications, and certification criteria.
The HITPC is responsible for, among other duties, recommending
priorities for the development, harmonization, and recognition of
standards, implementation specifications, and certification criteria.
Main responsibilities of the HITSC include recommending standards,
implementation specifications, and certification criteria for adoption
by the Secretary under section 3004 of the PHSA, consistent with the
ONC-coordinated Federal Health IT Strategic Plan.
Section 3004 of the PHSA identifies a process for the adoption of
health IT standards, implementation specifications, and certification
criteria and authorizes the Secretary to adopt such standards,
implementation specifications, and certification criteria. As specified
in section 3004(a)(1), the Secretary is required, in consultation with
representatives of other relevant federal agencies, to jointly review
standards, implementation specifications, and certification criteria
endorsed by the National Coordinator under section 3001(c) and
subsequently determine whether to propose the adoption of any grouping
of such standards, implementation specifications, or certification
criteria. The Secretary is required to publish all determinations in
the Federal Register.
Section 3004(b)(3) of the PHSA titled, Subsequent Standards
Activity, provides that the Secretary shall adopt additional standards,
implementation specifications, and certification criteria as necessary
and consistent with the schedule published by the HITSC. We consider
this provision in the broader context of the HITECH Act to grant the
Secretary the authority and discretion to adopt standards,
implementation specifications, and certification criteria that have
been recommended by the HITSC and endorsed by the National Coordinator,
as well as other appropriate and necessary health IT standards,
implementation specifications, and certification criteria. Throughout
this process, the Secretary intends to continue to seek the insights
and recommendations of the HITSC.
2. Health IT Certification Programs
Section 3001(c)(5) of the PHSA provides the National Coordinator
with the authority to establish a certification program or programs for
the voluntary certification of health IT. Specifically, section
3001(c)(5)(A) specifies that the National Coordinator, in consultation
with the Director of the National Institute of Standards and
Technology, shall keep or recognize a program or programs for the
voluntary certification of health information technology as being in
compliance with applicable certification criteria adopted under this
subtitle (i.e., certification criteria adopted by the Secretary under
section 3004 of the PHSA).
The certification program(s) must also include, as appropriate,
testing of the technology in accordance with section 13201(b) of the
[HITECH] Act. Overall, section 13201(b) of the HITECH Act requires that
with respect to the development of standards and implementation
specifications, the Director of the National Institute of Standards and
Technology (NIST), in coordination with the HITSC, shall support the
establishment of a conformance testing infrastructure, including the
development of technical test beds. The HITECH Act also indicates that
the development of this conformance testing infrastructure may include
a program to accredit independent, non-Federal laboratories to perform
testing.

B. Regulatory History

1. Standards, Implementation Specifications, and Certification Criteria
Rules
The Secretary issued an interim final rule with request for
comments titled, ``Health Information Technology: Initial Set of
Standards, Implementation Specifications, and Certification Criteria
for Electronic Health Record Technology'' (75 FR 2014, Jan. 13, 2010)
(the ``S&CC January 2010 interim final rule''), which adopted an
initial set of standards, implementation specifications, and
certification criteria. After consideration of the public comments
received on the S&CC January 2010 interim final rule, a final rule was
issued to complete the adoption of the initial set of standards,
implementation specifications, and certification criteria and realign
them with the final objectives and measures established for the EHR
Incentive Programs Stage 1 (formally titled: Health Information
Technology: Initial Set of Standards, Implementation Specifications,
and Certification Criteria for Electronic Health Record Technology;
Final Rule, (75 FR 44590, July 28, 2010) and referred to as the ``2011
Edition final rule''). The 2011 Edition final rule also established the
first version of the Certified EHR Technology (CEHRT) definition.
Subsequent to the 2011 Edition final rule (October 13, 2010), we issued
an interim final rule with a request for comment to remove certain
implementation specifications related to public health surveillance
that had been previously adopted in the 2011 Edition final rule (75 FR
62686).
The standards, implementation specifications, and certification
criteria

[[Page 16809]]

adopted by the Secretary in the 2011 Edition final rule established the
capabilities that CEHRT must include in order to, at a minimum, support
the achievement of EHR Incentive Programs Stage 1 by EPs, eligible
hospitals, and CAHs under the EHR Incentive Programs Stage 1 final rule
(the ``EHR Incentive Programs Stage 1 final rule'') (see 75 FR 44314
for more information about meaningful use and the Stage 1
requirements).
The Secretary issued a proposed rule with request for comments
titled ``Health Information Technology: Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record
Technology, 2014 Edition; Revisions to the Permanent Certification
Program for Health Information Technology'' (77 FR 13832, March 7,
2012) (the ``2014 Edition proposed rule''), which proposed new and
revised standards, implementation specifications, and certification
criteria. After consideration of the public comments received on the
2014 Edition proposed rule, a final rule was issued to adopt the 2014
Edition set of standards, implementation specifications, and
certification criteria and realign them with the final objectives and
measures established for the EHR Incentive Programs Stage 2 as well as
Stage 1 revisions (Health Information Technology: Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology (77
FR 54163, Sept. 4, 2012) (the ``2014 Edition final rule''). The
standards, implementation specifications, and certification criteria
adopted by the Secretary in the 2014 Edition final rule established the
capabilities that CEHRT must include in order to, at a minimum, support
the achievement of the EHR Incentive Programs Stage 2 by EPs, eligible
hospitals, and CAHs under the EHR Incentive Programs Stage 2 final rule
(the ``EHR Incentive Programs Stage 2 final rule'') (see 77 FR 53968
for more information about the EHR Incentive Programs Stage 2
requirements).
On December 7, 2012, an interim final rule with a request for
comment was jointly issued and published by ONC and CMS to update
certain standards that had been previously adopted in the 2014 Edition
final rule. The interim final rule also revised the EHR Incentive
Programs by adding an alternative measure for the Stage 2 objective for
hospitals to provide structured electronic laboratory results to
ambulatory providers, corrected the regulation text for the measures
associated with the objective for hospitals to provide patients the
ability to view online, download, and transmit information about a
hospital admission, and made the case number threshold exemption policy
for clinical quality measure (CQM) reporting applicable for eligible
hospitals and CAHs beginning with FY 2013. The rule also provided
notice of CMS's intent to issue technical corrections to the electronic
specifications for CQMs released on October 25, 2012 (77 FR 72985). On
September 4, 2014, a final rule (Medicare and Medicaid Programs;
Modifications to the Medicare and Medicaid Electronic Health Record
(EHR) Incentive Program for 2014 and Other Changes to the EHR Incentive
Program; and Health Information Technology: Revisions to the Certified
EHR Technology Definition and EHR Certification Changes Related to
Standards; Final Rule) (79 FR 52910) was published adopting these
proposals.
On November 4, 2013, the Secretary published an interim final rule
with a request for comment, 2014 Edition Electronic Health Record
Certification Criteria: Revision to the Definition of ``Common
Meaningful Use (MU) Data Set'' (78 FR 65884), to make a minor revision
to the Common MU Data Set definition. This revision was intended to
allow more flexibility with respect to the representation of dental
procedures data for EHR technology testing and certification.
On February 26, 2014, the Secretary published a proposed rule
titled ``Voluntary 2015 Edition Electronic Health Record (EHR)
Certification Criteria; Interoperability Updates and Regulatory
Improvements'' (79 FR 10880) (``Voluntary Edition proposed rule''). The
proposed rule proposed a voluntary edition of certification criteria
that was designed to enhance interoperability, promote innovation, and
incorporate ``bug fixes'' to improve upon the 2014 Edition. A
correction notice was published for the Voluntary Edition proposed rule
on March 19, 2014, entitled ``Voluntary 2015 Edition Electronic Health
Record (EHR) Certification Criteria; Interoperability Updates and
Regulatory Improvements; Correction'' (79 FR 15282). This correction
notice corrected the preamble text and gap certification table for four
certification criteria that were omitted from the list of certification
criteria eligible for gap certification for the 2015 Edition EHR
certification criteria. On September 11, 2014, a final rule was
published titled ``2014 Edition Release 2 Electronic Health Record
(EHR) Certification Criteria and the ONC HIT Certification Program;
Regulatory Flexibilities, Improvements, and Enhanced Health Information
Exchange'' (79 FR 54430) (``2014 Edition Release 2 final rule''). The
final rule adopted a small subset of the original proposals in the
Voluntary Edition proposed rule as optional and revised 2014 Edition
EHR certification criteria that provide flexibility, clarity, and
enhance health information exchange. It also finalized administrative
proposals (i.e., removal of regulatory text from the Code of Federal
Regulations (CFR)) and proposals for the ONC HIT Certification Program
that provide improvements.
On May 23, 2014, CMS and ONC jointly published the ``Medicare and
Medicaid Programs; Modifications to the Medicare and Medicaid
Electronic Health Record Incentive Programs for 2014; and Health
Information Technology: Revisions to the Certified EHR Technology
Definition'' proposed rule (79 FR 29732). The rule proposed to update
the EHR Incentive Programs Stage 2 and Stage 3 participation timeline.
It proposed to revise the CEHRT definition to permit the use of EHR
technology certified to the 2011 Edition to meet the CEHRT definition
for FY/CY 2014. It also proposed to allow EPs, eligible hospitals, and
CAHs that could not fully implement EHR technology certified to the
2014 Edition for an EHR reporting period in 2014 due to delays in the
availability of such technology to continue to use EHR technology
certified to the 2011 Edition or a combination of EHR technology
certified to the 2011 Edition and 2014 Edition for the EHR reporting
periods in CY 2014 and FY 2014. On September 4, 2014, a final rule
(``CEHRT Flexibility final rule'') was published (79 FR 52910) adopting
these proposals.
2. Medicare and Medicaid EHR Incentive Programs Rules
On January 13, 2010, CMS published the EHR Incentive Programs Stage
1 proposed rule (75 FR 1844). The rule proposed the criteria for Stage
1 of the EHR Incentive Programs and regulations associated with the
incentive payments made available under Division B, Title IV of the
HITECH Act. Subsequently, CMS published a final rule (75 FR 44314) for
Stage 1 and the EHR Incentive Programs on July 28, 2010, simultaneously
with the publication of the 2011 Edition final rule. The EHR Incentive
Programs Stage 1 final rule established the objectives, associated
measures, and other requirements that EPs, eligible hospitals, and CAHs
must satisfy to meet Stage 1.
On March 7, 2012, CMS published the EHR Incentive Programs Stage 2

[[Page 16810]]

proposed rule (77 FR 13698). Subsequently, CMS published a final rule
(77 FR 53968) for the EHR Incentive Programs on Sept. 4, 2012,
simultaneously with the publication of the 2014 Edition final rule. The
EHR Incentive Programs Stage 2 final rule established the objectives,
associated measures, and other requirements that EPs, eligible
hospitals, and CAHs must satisfy to meet Stage 2 as well as revised
some Stage 1 requirements.
As described above in Section II.B.1, ONC and CMS jointly issued an
interim final rule with a request for comment that was published on
December 7, 2012 and a final rule that published on September 4, 2014.
Also, as described above in Section II.B.1, ONC and CMS jointly issued
proposed and final rules that were published on May 23, 2014 and
September 4, 2014, respectively.
3. ONC Health IT Certification Program Rules
On March 10, 2010, ONC published a proposed rule (75 FR 11328)
titled, ``Proposed Establishment of Certification Programs for Health
Information Technology'' (the ``Certification Programs proposed
rule''). The rule proposed both a temporary and permanent certification
program for the purposes of testing and certifying HIT. It also
specified the processes the National Coordinator would follow to
authorize organizations to perform the certification of HIT. A final
rule establishing the temporary certification program was published on
June 24, 2010 (75 FR 36158) (``Temporary Certification Program final
rule'') and a final rule establishing the permanent certification
program was published on January 7, 2011 (76 FR 1262) (``the Permanent
Certification Program final rule'').
On May 31, 2011, ONC published a proposed rule (76 FR 31272) titled
``Permanent Certification Program for Health Information Technology;
Revisions to ONC-Approved Accreditor Processes.'' The rule proposed a
process for addressing instances where the ONC-Approved Accreditor
(ONC-AA) engaged in improper conduct or did not perform its
responsibilities under the permanent certification program, addressed
the status of ONC-Authorized Certification Bodies in instances where
there may be a change in the accreditation organization serving as the
ONC-AA, and clarified the responsibilities of the new ONC-AA. All these
proposals were finalized in a final rule published on November 25, 2011
(76 FR 72636).
The 2014 Edition final rule made changes to the permanent
certification program. The final rule adopted a proposal to change the
Permanent Certification Program's name to the ``ONC HIT Certification
Program,'' revised the process for permitting the use of newer versions
of ``minimum standard'' code sets, modified the certification processes
ONC-ACBs need to follow for certifying EHR Modules in a manner that
provides clear implementation direction and compliance with the new
certification criteria, and eliminated the certification requirement
that every EHR Module be certified to all the mandatory ``privacy and
security'' certification criteria.
The Voluntary Edition proposed rule included proposals that focused
on improving regulatory clarity, simplifying the certification of EHR
Modules that are designed for purposes other than meeting Meaningful
Use requirements, and discontinuing the use of the Complete EHR
definition. As noted above, we issued the 2014 Edition Release 2 final
rule to complete the rulemaking for the Voluntary Edition proposed
rule. The 2014 Edition Release 2 final rule discontinued the ``Complete
EHR'' certification concept beginning with the proposed 2015 Edition,
adopted an updated standard (ISO/IEC 17065) for the accreditation of
ONC-ACBs, and adopted the ``ONC Certified HIT'' certification and
design mark for required use by ONC-ACBs under the ONC Health IT
Certification Program.

III. Provisions of the Proposed Rule Affecting Standards,
Implementation Specifications, and Certification Criteria

A. 2015 Edition Health IT Certification Criteria

This rule proposes new, revised, and unchanged certification
criteria that would establish the capabilities and related standards
and implementation specifications for the certification of health IT,
including EHR technology. We refer to these new, revised, and unchanged
certification criteria as the ``2015 Edition health IT certification
criteria'' and propose to add this term and its definition to Sec.
170.102. As noted in the Executive Summary, we also refer to these
criteria as the ``2015 Edition'' in this preamble. We propose to codify
the 2015 Edition in Sec. 170.315 to set them apart from other editions
of certification criteria and make it easier for stakeholders to
quickly determine the certification criteria the 2015 Edition includes.
Health IT certified to these proposed certification criteria and
associated standards and implementation specifications could be
implemented as part of an EP's, eligible hospital's, or CAH's CEHRT and
used to demonstrate meaningful use (as identified in Table 2 below). We
note that Table 2 does not identify certification criteria that are
included in conditional certification requirements, such as privacy and
security, safety-enhanced design, and quality management system
certification criteria. We do, however, classify these types of
certification criteria as ``associated'' with the EHR Incentives
Programs Stage 3 for the purposes of the regulatory impact analysis we
performed for this proposed rule (see section VIII.B.1).
Health IT certified to the proposed certification criteria and
associated standards and implementation specifications could also be
used to meet other HHS program requirements (e.g., grant and contract
requirements) or referenced by private sector associations and
entities.

Table 2--2015 Edition Proposed Certification Criteria Associated With the EHR Incentive Programs Stage 3
----------------------------------------------------------------------------------------------------------------
Relationship to the
proposed CEHRT \2\
Proposed CFR citation Certification Proposed inclusion in 2015 definition and
criterion edition base EHR definition proposed stage 3
objectives
----------------------------------------------------------------------------------------------------------------
Sec. 170.315(a)(1)............... Computerized Provider Included \3\............... Objective 4.
Order Entry (CPOE)--
medications.
Sec. 170.315(a)(2)............... CPOE--laboratory...... Included \4\............... Objective 4.
Sec. 170.315(a)(3)............... CPOE--diagnostic Included \5\............... Objective 4.
imaging.

[[Page 16811]]

Sec. 170.315(a)(4)............... Drug-drug, Drug- Not included............... Objective 3.
allergy Interaction
Checks for CPOE.
Sec. 170.315(a)(5)............... Demographics.......... Included................... No additional
relationship beyond
the Base EHR
definition.
Sec. 170.315(a)(7)............... Problem List.......... Included................... No additional
relationship beyond
the Base EHR
definition.
Sec. 170.315(a)(8)............... Medication List....... Included................... No additional
relationship beyond
the Base EHR
definition.
Sec. 170.315(a)(9)............... Medication Allergy Included................... No additional
List. relationship beyond
the Base EHR
definition.
Sec. 170.315(a)(10).............. Clinical Decision Included................... Objective 3.
Support.
Sec. 170.315(a)(11).............. Drug-formulary and Not included............... Objective 2.
Preferred Drug List
Checks.
Sec. 170.315(a)(12).............. Smoking Status........ Included................... No additional
relationship beyond
the Base EHR
definition.
Sec. 170.315(a)(14).............. Family Health History. Not included............... CEHRT \6\.
Sec. 170.315(a)(15).............. Family Health History-- Not included............... CEHRT \7\.
pedigree.
Sec. 170.315(a)(17).............. Patient-specific Not included............... Objective 5.
Education Resources.
Sec. 170.315(a)(19).............. Patient Health Not included............... CEHRT
Information Capture. Objective 6.
Sec. 170.315(a)(20).............. Implantable Device Included................... No additional
List. relationship beyond
the Base EHR
definition.
Sec. 170.315(b)(1)............... Transitions of Care... Included................... Objective 7.
Sec. 170.315(b)(2)............... Clinical Information Not included............... Objective 7.
Reconciliation and
Incorporation.
Sec. 170.315(b)(3)............... Electronic Prescribing Not included............... Objective 2.
Sec. 170.315(b)(6)............... Data Portability...... Included................... No additional
relationship beyond
the Base EHR
definition.
Sec. 170.315(c)(1) \8\........... Clinical Quality Included................... CEHRT.
Measures--record and
export.
Sec. 170.315(e)(1)............... View, Download, and Not included............... Objective 5
Transmit to Third Objective 6.
Party.
Sec. 170.315(e)(2)............... Secure Messaging...... Not included............... Objective 6.
Sec. 170.315(f)(1)............... Transmission to Not included............... Objective 8.\9\
Immunization
Registries.
Sec. 170.315(f)(2)............... Transmission to Public Not included............... Objective 8.
Health Agencies--
syndromic
surveillance.
Sec. 170.315(f)(3)............... Transmission to Public Not included............... Objective 8.
Health Agencies--
reportable laboratory
tests and values/
results.
Sec. 170.315(f)(4)............... Transmission to Cancer Not included............... Objective 8.
Registries.
Sec. 170.315(f)(5)............... Transmission to Public Not included............... Objective 8.
Health Agencies--case
reporting.
Sec. 170.315(f)(6)............... Transmission to Public Not included............... Objective 8.
Health Agencies--
antimicrobial use and
resistance reporting.
Sec. 170.315(f)(7)............... Transmission to Public Not included............... Objective 8.
Health Agencies--
health care surveys.
Sec. 170.315(g)(1)............... Automated Numerator Not included............... CEHRT.
Recording.
Sec. 170.315(g)(2)............... Automated Measure Not included............... CEHRT.
Calculation.
Sec. 170.315(g)(7)............... Application Access to Included................... Objective 5
Common Clinical Data Objective 6.
Set.
Sec. 170.315(h)(1)............... Direct Project........ Included \10\.............. No additional
relationship beyond
the Base EHR
definition.
Sec. 170.315(h)(2)............... Direct Project, Edge Included \11\.............. No additional
Protocol, and XDR/XDM. relationship beyond
the Base EHR
definition.
----------------------------------------------------------------------------------------------------------------
\2\ CMS' CEHRT definition would include the criteria adopted in the Base EHR definition. For more details on the
CEHRT definition, please see the CMS EHR Incentive Programs proposed rule published elsewhere in this issue of
the Federal Register.
\3\ Technology needs to be certified to Sec. 170.315(a)(1), (a)(2), or (a)(3).
\4\ Technology needs to be certified to Sec. 170.315(a)(1), (a)(2), or (a)(3).
\5\ Technology needs to be certified to Sec. 170.315(a)(1), (a)(2), or (a)(3).
\6\ Technology needs to be certified to Sec. 170.315(a)(14) or (a)(15).
\7\ Technology needs to be certified to Sec. 170.315(a)(14) or (a)(15).
\8\ As discussed in the preamble for the ``clinical quality measures--report'' criterion, additional CQM
certification policy may be proposed in or with CMS payment rules in CY15. As such, additional CQM
certification criteria may be proposed for the Base EHR and/or CEHRT definitions.
\9\ For the public health certification criteria in Sec. 170.315(f), technology would only need to be
certified to those criteria that are required to meet the options the provider intends to report in order to
meet the proposed Objective 8: Public Health and Clinical Data Registry Reporting.
\10\ Technology needs to be certified to Sec. 170.315(h)(1) or (h)(2) to meet the proposed Base EHR
definition.
\11\ Technology needs to be certified to Sec. 170.315(h)(1) or (h)(2) to meet the proposed Base EHR
definition.

[[Page 16812]]

1. Applicability
Section 170.300 establishes the applicability of subpart C--
Certification Criteria for Health Information Technology. We propose to
revise paragraph (d) of Sec. 170.300 to add in a reference to Sec.
170.315 and revise the parenthetical in the paragraph to say ``i.e.,
apply to any health care setting'' instead of ``i.e., apply to both
ambulatory and inpatient settings.'' These proposed revisions would
clarify which specific capabilities within a certification criterion
included in Sec. 170.315 have general applicability (i.e., apply to
any health care setting) or apply only to an inpatient setting or an
ambulatory setting. The proposed revision to change the language of the
parenthetical aligns with our proposed approach to make the ONC Health
IT Certification Program more agnostic to health care settings and
accessible to health IT that supports care and practice settings beyond
the ambulatory and inpatient settings. We refer readers to section IV.B
of this preamble for a detailed discussion of our proposals to modify
the ONC Health IT Certification Program.
We note that, with the proposed 2015 Edition, we no longer label
certification criteria as either optional or ambulatory/inpatient (at
the second paragraph level). For example, the proposed 2015 Edition
certification criterion for electronic medication administration record
is simply ``electronic medication administration record'' instead of
``inpatient setting only--electronic medication administration
record.'' Similarly, the proposed 2015 Edition certification criterion
for ``accounting of disclosures'' is simply ``accounting of
disclosures'' instead of ``optional--accounting of disclosures.'' These
simplifications are possible given that, beginning with the 2015
Edition health IT certification criteria, ``Complete EHR''
certifications will no longer be issued (see 79 FR 54443-45).
Therefore, there is no longer a need to designate an entire
certification criterion in this manner. Again, this approach supports
our goal to make the ONC Health IT Certification Program more agnostic
to health care settings and accessible to health IT that supports care
and practice settings beyond the ambulatory and inpatient settings.
We propose to replace the term ``EHR technology'' in paragraphs
(d)(1) and (d)(2) with ``health IT'' to align with our proposed
approach to make the ONC Health IT Certification Program more clearly
open to the certification of all types of health IT. Again, we refer
readers to section IV.B of this preamble for a detail discussion of our
proposals to modify the ONC Health IT Certification Program.
2. Standards and Implementation Specifications
a. National Technology Transfer and Advancement Act
The National Technology Transfer and Advancement Act (NTTAA) of
1995 (15 U.S.C. Sec. 3701 et. seq.) and the Office of Management and
Budget (OMB) Circular A-119 \12\ require the use of, wherever
practical, technical standards that are developed or adopted by
voluntary consensus standards bodies to carry out policy objectives or
activities, with certain exceptions. The NTTAA and OMB Circular A-119
provide exceptions to selecting only standards developed or adopted by
voluntary consensus standards bodies, namely when doing so would be
inconsistent with applicable law or otherwise impractical. In this
proposed rule, we refer to voluntary consensus standards, except for:
---------------------------------------------------------------------------

\12\ http://www.whitehouse.gov/omb/circulars_a119.
---------------------------------------------------------------------------

The standards adopted in Sec. 170.202. (These standards
were developed by groups of industry stakeholders committed to
advancing the Direct Project,\13\ which included initiatives under the
Standards and Interoperability (S&I) Framework.\14\ These groups used
consensus processes similar to those used by other industry
stakeholders and voluntary consensus standards bodies.);
---------------------------------------------------------------------------

\13\ http://www.healthit.gov/policy-researchers-implementers/direct-project.
\14\ http://www.healthit.gov/policy-researchers-implementers/standards-interoperability-si-framework.
---------------------------------------------------------------------------

The standards we propose to adopt at Sec.
170.205(a)(5)(iii) and (iv) for electronic submission medical
documentation (esMD) (These standards were developed by groups of
industry stakeholders committed to advancing esMD,\15\ which included
initiatives under the Standards and Interoperability (S&I)
Framework.\16\ These groups used consensus processes similar to those
used by other industry stakeholders and voluntary consensus standards
bodies.);
---------------------------------------------------------------------------

\15\ http://wiki.siframework.org/esMD+-+Author+of+Record and
http://wiki.siframework.org/esMD+-+Provider+Profiles+Authentication.
\16\ http://www.healthit.gov/policy-researchers-implementers/standards-interoperability-si-framework.
---------------------------------------------------------------------------

The standards we propose to adopt at Sec. 170.205(d)(4)
and (e)(4) for reporting of syndromic surveillance and immunization
information to public health agencies, respectively (These standards go
through a process similar within the public health community to those
used by other industry stakeholders and voluntary consensus standards
bodies.);
The standard we propose to adopt at Sec. 170.207(f)(2)
for race and ethnicity; and
Certain standards related to the protection of electronic
health information adopted in Sec. 170.210.
We are aware of no voluntary consensus standard that would serve as
an alternative to these standards for the purposes that we have
identified in this proposed rule.
b. Compliance With Adopted Standards and Implementation Specifications
In accordance with Office of the Federal Register regulations
related to ``incorporation by reference,'' 1 CFR part 51, which we
follow when we adopt proposed standards and/or implementation
specifications in any subsequent final rule, the entire standard or
implementation specification document is deemed published in the
Federal Register when incorporated by reference therein with the
approval of the Director of the Federal Register. Once published,
compliance with the standard and implementation specification includes
the entire document unless we specify otherwise. For example, if we
adopted the HL7 Laboratory Orders Interface (LOI) implementation guide
(IG) proposed in this proposed rule, health IT certified to
certification criteria referencing this IG would need to demonstrate
compliance with all mandatory elements and requirements of the IG. If
an element of the IG is optional or permissive in any way, it would
remain that way for testing and certification unless we specified
otherwise in regulation. In such cases, the regulatory text would
preempt the permissiveness of the IG.
c. ``Reasonably Available'' to Interested Parties
The Office of the Federal Register has established new requirements
for materials (e.g., standards and implementation specifications) that
agencies propose to incorporate by reference in the Federal Register
(79 FR 66267; 1 CFR 51.5(a)). To comply with these requirements, in
section VI (``Incorporation by Reference'') of this preamble, we
provide summaries of, and uniform resource locators (URLs) to, the
standards and implementation specifications we propose to adopt and
subsequently incorporate by reference in the Federal Register. To note,
we also provide relevant information about

[[Page 16813]]

these standards and implementation specifications throughout this
section of the preamble (section III), including URLs.
d. ``Minimum Standards'' Code Sets
We propose to adopt newer versions of four previously adopted
minimum standards code sets in this proposed rule for the 2015 Edition.
These code sets are the September 2014 Release of the U.S. Edition of
SNOMED CT[supreg], LOINC[supreg] version 2.50, the February 2, 2015
monthly version of RxNorm, and the February 2, 2015 version of the CVX
code set. We also propose to adopt two new minimum standards code sets
(the National Drug Codes (NDC)--Vaccine Codes, updates through January
15, 2015 and the ``Race & Ethnicity--CDC'' code system in the PHIN
Vocabulary Access and Distribution System (VADS) Release 3.3.9 (June
17, 2011)). As we have previously articulated (77 FR 54170), the
adoption of newer versions improve interoperability and health IT
implementation, while creating little additional burden through the
inclusion of new codes. As many of these minimum standards code sets
are updated frequently throughout the year, we will consider whether it
may be more appropriate to adopt a version of a minimum standards code
set that is issued before we publish a final rule for this proposed
rule. In making such determination, as we have done with these proposed
versions of minimum standards code sets, we will give consideration to
whether it includes any new substantive requirements and its effect on
interoperability. If adopted, a newer version of a minimum standards
code set would serve as the baseline for certification. As with all
adopted minimum standards code sets, health IT can be certified to
newer versions of the adopted baseline version minimum standards code
sets for purposes of certification, unless the Secretary specifically
prohibits the use of a newer version (see Sec. 170.555 and 77 FR
54268).
e. Object Identifiers (OIDs) for Certain Code Systems
We are providing the following table of OIDs for certain code
systems to assist health IT developers in the proper identification and
exchange of health information coded to the vocabulary standards
proposed in this proposed rule.

------------------------------------------------------------------------
Code system OID Code system name
------------------------------------------------------------------------
2.16.840.1.113883.6.96................. IHTSDO SNOMED CT.[supreg]
2.16.840.1.113883.6.1.................. LOINC.[supreg]
2.16.840.1.113883.6.88................. RxNorm.
2.16.840.1.113883.12.292............... HL7 Standard Code Set CVX-
Vaccines Administered.
2.16.840.1.113883.6.69................. National Drug Code Directory.
2.16.840.1.113883.6.8.................. Unified Code of Units of
Measure (UCUM \17\).
2.16.840.1.113883.6.13................. Code on Dental Procedures and
Nomenclature (CDT).
2.16.840.1.113883.6.4.................. International Classification of
Diseases, 10th Revision,
Procedure Coding System (ICD-
10-PCS).
2.16.840.1.113883.6.238................ Race & Ethnicity--Centers for
Disease Control and Prevention
(CDC).
2.16.840.1.113883.6.316................ Tags for Identifying Languages--
Request for Comment (RFC) 5646
(preferred language).
------------------------------------------------------------------------

f. Subpart B--Standards and Implementation Specifications for Health
Information Technology
In Sec. 170.200, we propose to remove term ``EHR Modules'' and add
in its place ``Health IT Modules.'' In Sec. 170.210, we propose to
remove the term ``EHR technology'' and add in its place ``health IT.''
These proposals are consistent with our overall approach to this
rulemaking as discussed in the Executive Summary.
---------------------------------------------------------------------------

\17\ Copyright (copyright) 1998-2013, Regenstrief Institute,
Inc. and the UCUM Organization. All rights reserved.
---------------------------------------------------------------------------

3. Certification Criteria
We discuss the certification criteria that we propose to adopt as
the 2015 Edition below. In a header for each criterion, we specify
where the proposed certification criteria would be included in Sec.
170.315. We discuss each certification criterion in the chronological
order in which it would appear in the CFR. In other words, the preamble
that follows will discuss the proposed certification criteria in Sec.
170.315(a) first, then Sec. 170.315(b), and so on.
We identify the certification criteria as new, revised, or
unchanged in comparison to the 2014 Edition. In the 2014 Edition final
rule we gave meaning to the terms ``new,'' ``revised,'' and
``unchanged'' to both describe the differences between the 2014 Edition
certification criteria and the 2011 Edition certification criteria as
well as establish what certification criteria in the 2014 Edition were
eligible for gap certification (see 77 FR 54171, 54202, and 54248).
Given that beginning with the 2015 Edition ``Complete EHR''
certifications will no longer be issued (see also 79 FR 54443-45) and
that our proposals in this proposed rule to make the ONC Health IT
Certification Program more open and accessible to other health care/
practice settings, we propose to give new meaning to these terms for
the purpose of a gap certification analysis.
``New'' certification criteria are those that as a whole
only include capabilities never referenced in previously adopted
certification criteria editions and to which a Health IT Module
presented for certification to the 2015 Edition could have never
previously been certified. As a counter example, the splitting of a
2014 Edition certification criterion into two criteria as part of the
2015 Edition would not make those certification criteria ``new'' for
the purposes of a gap certification eligibility analysis.
``Revised'' certification criteria are those that include
within them capabilities referenced in a previously adopted edition of
certification criteria as well as changed or additional new
capabilities; and to which a Health IT Module presented for
certification to the 2015 Edition could not have been previously
certified to all of the included capabilities.
``Unchanged'' certification criteria would be
certification criteria that include the same capabilities as compared
to prior certification criteria of adopted editions; and to which a
Health IT Module presented for certification to the 2015 Edition could
have been previously certified to all of the included capabilities.
We explain the proposed certification criteria and provide
accompanying rationale for the proposed certification criteria,
including citing the recommendations of the HITPC and HITSC, where
appropriate. For 2015 Edition health IT certification criteria

[[Page 16814]]

that have been revised in comparison to their 2014 Edition
counterparts, we focus the discussion on any revisions and
clarifications in comparison to the 2014 Edition version of the
criteria. A revised 2015 Edition certification criterion would also
include all the other capabilities that were included in the 2014
Edition version. For example, we propose to adopt a 2015 Edition
``drug-drug, drug-allergy interaction checks for CPOE'' certification
criterion (Sec. 170.315(a)(4)) that is revised in comparison to the
2014 Edition ``drug-drug, drug-allergy interaction checks'' criterion
(Sec. 170.314(a)(2)). We only discuss clarifications (e.g., the
criterion name change) and revisions we propose as part of the 2015
Edition ``drug-drug, drug-allergy interaction checks for CPOE''
certification criterion. However, the 2015 Edition criterion also
includes all the other capabilities of the 2014 Edition ``drug-drug,
drug allergy interaction checks'' criterion. We refer readers to Sec.
170.315 of the proposed regulation text near the end of this document,
which specifies all the capabilities included in each proposed 2015
Edition certification criterion.
We include an appendix (Appendix A) to this proposed rule, which
provides a table with the following data for each proposed 2015 Edition
certification criterion, as applicable: (1) Proposed CFR citation; (2)
estimated development hours; (3) proposed privacy and security
certification requirements (approach 1); \18\ (4) conditional
certification requirements (Sec. 170.550); (5) gap certification
eligibility; (6) proposed inclusion in the 2015 Edition Base EHR
definition; and (7) relationship to proposed Stage 3 of the EHR
Incentive Programs, including the CEHRT definition.
---------------------------------------------------------------------------

\18\ Please see section IV.C.1 (``Privacy and Security'') for a
detailed discussion of approach 1.
---------------------------------------------------------------------------

We propose, and readers should interpret, that the following terms
used in the proposed 2015 Edition have the same meanings we adopted in
the 2014 Edition final rule (77 FR 54168-54169), in response to public
comment: ``user,'' ``record,'' ``change,'' ``access,'' ``incorporate,''
``create,'' and ``transmit,'' but apply to all health IT not just ``EHR
technology.'' For the term ``incorporate,'' we also direct readers to
the additional explanation we provided under the ``transitions of
care'' certification criterion (77 FR 54218) in the 2014 Edition final
rule and in the Voluntary Edition proposed rule (79 FR 10898). We
propose that the scope of a 2015 Edition certification criterion is the
same as the scope previously assigned to a 2014 Edition certification
criterion (for further explanation, see the discussion at 77 FR 54168).
That is, certification to proposed 2015 Edition health IT certification
criteria at Sec. 170.315 would occur at the second paragraph level of
the regulatory section and encompass all paragraph levels below the
second paragraph level. We also propose to continue to use the same
specific descriptions for the different types of ``data summaries''
established in the 2014 Edition final rule (77 FR 54170-54171) for the
proposed 2015 Edition health IT certification criteria (i.e., ``export
summary,'' ``transition of care/referral summary,'' ``ambulatory
summary,'' and ``inpatient summary.'')
As with the adoption of the 2011 and 2014 editions of certification
criteria (see the introductory text to Sec. Sec. 170.302, 170.304,
170.306, and 170.314), all capabilities mentioned in certification
criteria are expected to be performed electronically, unless otherwise
noted. Therefore, we no longer include ``electronically'' in
conjunction with each capability included in a certification criterion
proposed under Sec. 170.315 because the proposed introductory text to
Sec. 170.315 (which covers all the certification criteria included in
the section) clearly states that health IT must be able to
electronically perform the following capabilities in accordance with
all applicable standards and implementation specifications adopted in
the part.
Computerized Provider Order Entry
In the 2014 Edition Release 2 final rule, we adopted separate
computerized provider order entry (CPOE) certification criteria based
on the clinical purpose (i.e., medications, laboratory, and diagnostic
imaging) (79 FR 54435-36). We propose to take the same approach for the
2015 Edition and propose to adopt three certification criteria for
CPOE, as compared to a single criterion that would include combined
functionality for all three clinical purposes (e.g., Sec.
170.314(a)(1)).
We request comment on whether we should specify, for the purposes
of testing and certification to the 2015 Edition CPOE criteria, certain
data elements that a Health IT Module must be able to include in a
transmitted order. In particular, we request comment on whether a
Health IT Module should be able to include any or all of the following
data elements: secondary diagnosis codes; reason for order; and comment
fields entered by the ordering provider, if they are provided to the
ordering provider in their order entry screen. We also request comment
on whether there are any other data elements that a Health IT Module
should be able to include as part of an order for the purposes of
testing and certification. We clarify, however, that any specific data
requirements for a transmitted order that may be adopted in a final
rule would only apply in the absence of a standard for testing and
certification. As discussed below, we propose a laboratory order
standard for the ambulatory setting. If we were to adopt this standard
in a final rule, any potential required data elements for a transmitted
order adopted in response to this proposal would not be made applicable
to the ambulatory setting for the ``CPOE--laboratory'' certification
criterion.
Computerized Provider Order Entry--Medications

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(1) (Computerized provider order entry--medications)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition CPOE certification criterion
specific to medication ordering. This proposed criterion does not
reference any standards or implementation specifications and is
unchanged in comparison to the 2014 Edition CPOE--medications criterion
adopted at Sec. 170.314(a)(18).
Computerized Provider Order Entry--Laboratory

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(2) (Computerized provider order entry--laboratory)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition CPOE certification criterion
specific to laboratory ordering that is revised in comparison to the
CPOE--laboratory criterion adopted at Sec. 170.314(a)(19) as well as
Sec. 170.314(a)(1).
We propose to adopt and include in this criterion, for the
ambulatory setting, the HL7 Version 2.5.1 Implementation Guide: S&I
Framework Laboratory Orders (LOI) from EHR, Draft Standard for Trial
Use, Release 2--US Realm (``Release 2'').\19\ Due to the absence of a
consensus standard for the purpose of sending laboratory orders from
EHRs to laboratories, this standard was developed in conjunction with
laboratories representative of the industry, health IT developers, and

[[Page 16815]]

provider stakeholders through an open consensus-based process under the
Standards and Interoperability Framework (S&I Framework). Release 1 of
the standard was balloted and approved through HL7, a standards
developing organization. Release 2 is currently under ballot
reconciliation with HL7 and should be published in the next few months.
Release 2 would:
---------------------------------------------------------------------------

\19\ http://www.hl7.org/special/committees/projman/searchableprojectindex.cfm?action=edit&ProjectNumber=922 and http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember.
Access to the current draft of the LOI Release 2 IG is freely
available for review during the public comment period by
establishing an HL7 user account.
---------------------------------------------------------------------------

Implement common formats across US Realm IGs for
consistent reader experience (e.g., sequence of sections, formatting,
layout, and terminology);
Adopt HL7 version 2.8 fields developed to fill gaps
identified in the development of Release 1;
Include harmonized data type ``flavors'' for use across
the US Realm Lab IGs;
Introduce initial requirements for error reporting
conditions and severity (hard/soft errors) and system/application
acknowledgements;
Harmonize data element usage and cardinality requirements
with LOI Release 1, and the electronic Directory of Services (eDOS) IG;
Incorporate US Lab Realm value sets developed for clarity
and consistency across all laboratory IGs; and
Use a new publication method for value sets that allows
for precision usage at point of use and provides ``at a glance''
comprehensive usage at the field and component-level across all
laboratory IGs; and synced with value set activities (HL7, VSAC, etc.).
Overall, we propose to adopt Release 2 of the standard because it
addresses errors and ambiguities found in Release 1 and harmonizes
requirements with other laboratory standards we propose to adopt in
this proposed rule. Release 2 would also make implementation of the LOI
IG clearer and more consistent for health IT developers and
laboratories, as well as improve interoperability. We propose to adopt
Release 2 at Sec. 170.205(l)(1).
Commenters on the Voluntary Edition proposed rule noted that for
optimal interoperability we need to also adopt the most recent version
of the HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory
Test Compendium Framework, Release 2, (also referred to as the
``electronic Directory of Services (eDOS) IG''), as it is the companion
IG to the LOI IG. We agree with the commenters' assessment and propose
to include the most recent version of the eDOS IG in this criterion for
certification to all health care settings (i.e., not confining it to
only the ambulatory setting) and adopt it at Sec. 170.205(l)(2). The
most recent version of the eDOS IG will be Release 2, Version 1.2,
which is scheduled to publish in the next few months. Release 2,
Version 1.2 is currently under ballot reconciliation.\20\ In general,
the eDOS IG provides requirements and guidance for the delivery of an
electronic Directory of Services (test compendium) from a laboratory
(compendium producer) to an EHR or other system (compendium consumer)
where it is used to produce electronic orders (LOI-conformant messages)
for laboratory tests. Version 1.2 of the eDOS IG addresses errors and
ambiguities in the prior version as well as harmonizes with Release 2
of the LOI IG.
---------------------------------------------------------------------------

\20\ http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. Access to the current draft
of the eDOS IG, Release 2, Version 1.2 is freely available for
review during the public comment period by establishing an HL7 user
account.
---------------------------------------------------------------------------

We also propose, for the purposes of certification, to require a
Health IT Module to be able to use, at a minimum, the version of
Logical Observation Identifiers Names and Codes (LOINC[supreg]) adopted
at Sec. 170.207(c)(3) (version 2.50) as the vocabulary standard for
laboratory orders. This is the most recent version of LOINC[supreg]. We
refer readers to section III.A.2.d (``Minimum Standards'' Code Sets)
for further discussion of our adoption of LOINC[supreg] as a minimum
standards code set and our proposal to adopt version 2.50, or
potentially a newer version if released before a subsequent final rule,
as the baseline for certification to the 2015 Edition.
We note that the LOI Release 2 IG requires the information for a
test requisition as specified in the Clinical Laboratory Improvement
Amendments (CLIA), 42 CFR 493.1241(c)(1) through (c)(8), to be included
in the content message. Therefore, inclusion of this standard for
certification may also facilitate laboratory compliance with CLIA.
Computerized Provider Order Entry--Diagnostic Imaging

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(3) (Computerized provider order entry--diagnostic
imaging)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition CPOE certification criterion
specific to diagnostic imaging. This proposed criterion does not
reference any standards or implementation specifications, and is
unchanged in comparison to the 2014 Edition CPOE--diagnostic imaging
criterion adopted at Sec. 170.314(a)(20). To note, we also propose to
adopt the title of ``diagnostic imaging,'' which is the title we gave
to the 2014 Edition version of this certification criterion in the 2014
Edition Release 2 final rule (79 FR 54436).
Drug-Drug, Drug-Allergy Interaction Checks for CPOE

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(4) (Drug-drug, drug-allergy interaction checks for
CPOE)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``drug-drug, drug-allergy
interaction checks for CPOE'' certification criterion that is revised
in comparison to the 2014 Edition ``drug-drug, drug-allergy interaction
checks'' criterion (Sec. 170.314(a)(2)). We propose to clarify that
the capabilities included in this criterion are focused on CPOE by
including ``for CPOE'' in the title of this criterion.
We also propose to include in this criterion the capabilities to
record user actions for drug-drug, drug-allergy interaction (DD/DAI)
interventions and to enable a user to view the actions taken for DD/DAI
interventions (also referred to as ``checks''). Specifically, we
propose that a Health IT Module must be able to record at least one
action taken and by whom in response to drug-drug or drug-allergy
interaction checks. To be certified to this criterion, a Health IT
Module (at a user's request) must also be able to generate either a
human readable display or human readable report of actions taken and by
whom in response to drug-drug or drug-allergy interaction checks.
We solicited comment in the Voluntary Edition proposed rule on
whether health IT should be able to track (which means ``record'' and
will be referred to as ``record'' throughout this preamble) provider
(referred to as ``user'' for the purposes of this proposed
certification criterion) actions for DD/DAI interventions, including
recording if and when the user viewed, accepted, declined, ignored,
overrode, or otherwise commented on the DD/DAI interventions. We
received comments that supported recording user actions for DD/DAI
interventions (79 FR 54449). We also received comments recommending
that we consider including recording user actions in response to CDS
interventions. We discuss those comments under the CDS certification
criterion in this section (III.A.3) of the preamble.
We believe that recording user actions for DD/DAI interventions
could assist with quality improvement and patient safety. While some
commenters expressed concern that functionality for recording user
actions would be

[[Page 16816]]

burdensome to develop, we believe the potential benefits of improved
care and reduced adverse events that can come from using such
functionality and being able to subsequently analyze user actions for
DD/DAI interventions outweighs the development burden. To provide
health IT developers with flexibility and the opportunity to innovate,
we have explicitly not specified the types of actions a Health IT
Module must be able to record to meet this criterion. Health IT
developers would need to simply demonstrate that their Health IT Module
can record at least one user action for DD/DAI checks. For example, a
Health IT Module could include the capability to record whether the
user viewed, accepted, declined, ignored, overrode, provided a
rationale or explanation for the action taken, took some other type of
action not listed here or otherwise commented on the DD/DAI check. We
solicit comment on whether we should focus this proposed requirement to
record at least one user action taken for DD/DAI interventions on a
subset of DD/DAI interventions, such as those of highest patient safety
concern, and what sources we should consider for defining this subset.
We note, however, that we do not intend with this proposed
requirement to infer a specific workflow or user interface in order to
achieve conformance to this criterion. While appropriate documentation
in accordance with clinical, safety, and system design best practices
for these DD/DAI interventions is beyond the scope of certification for
this criterion, we would encourage health IT developers to consider
these best practices in developing this functionality and attempt to
not interrupt a provider's workflow unnecessarily to meet this
criterion. This criterion also does not propose to establish the uses
for the ``user action'' information, whom should be able to view the
information, or who could adjust the capability. Further, based on
stakeholder feedback, there does not appear to be a consensus method or
standard for characterizing the severity of patient DD/DAI reactions.
Therefore, until the stakeholder community determines if there should
be a set of methods, standards, or clinical guidelines for determining
the severity of a patient DD/DAI reaction, we believe that users should
determine these definitions for their organization and/or setting.
While this proposed certification criterion focuses on DD/DAI
checking at the point when a user enters a computerized order, we
believe that there are instances when a user should be aware of a
patient's DD/DAI when new medications or medication allergies are
entered into the patient record. Therefore, we strongly encourage
health IT developers to build in functionality, including but not
limited to clinical decision support, that would inform a user of new
or updated DD/DAI when the medication or medication allergy lists are
updated. We also seek comment on whether we should include this
functionality in certification and whether this functionality should be
included in an existing certification criterion (e.g., medication list,
medication allergy list, clinical decision support) or a standalone
criterion.
Demographics

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(5) (Demographics)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``demographics'' certification
criterion that is revised as described below in comparison to the 2014
Edition certification criterion (Sec. 170.314(a)(3)).
Sex
We propose that, for certification (and testing) to this criterion,
health IT must be capable of recording sex in accordance with HL7
Version 3 (``AdministrativeGender'') and a nullFlavor value attributed
as follows: male (M); female (F); and unknown (UNK). This proposal
serves as another means of improving interoperability through the use
of consistent standards.
We propose in a later section of this rule that using HL7 Version 3
for recording sex would be required under the ``Common Clinical Data
Set'' definition for certification to the 2015 Edition. Please see
section III.B.3 ``Common Clinical Data Set'' of this preamble for
further discussion of this associated proposal.
Race and Ethnicity
We propose that, for certification (and testing) to this criterion,
a Health IT Module must be capable of recording each one of a patient's
races and ethnicities in accordance with, at a minimum, the ``Race &
Ethnicity--CDC'' code system in the PHIN Vocabulary Access and
Distribution System (VADS), Release 3.3.9.\21\ We also propose that a
Health IT Module must be able to aggregate each one of a patient's
races and ethnicities to the categories in the OMB standard for race
and ethnicity, which we previously adopted for the 2011 Edition and
2014 Edition ``demographics'' certification criteria.
---------------------------------------------------------------------------

\21\ https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.113883.6.238#.
---------------------------------------------------------------------------

As discussed in the 2014 Edition final rule (77 FR 54208), the OMB
standard for the classification of data on race and ethnicity requires
that the option for selecting one or more racial designations be
provided. The standard also permits the use of more than the minimum
standard categories for race and ethnicity, but requires that the data
can be ``rolled up'' or mapped to the minimum standard categories as
well as aggregated. The ``Race & Ethnicity--CDC'' code system in PHIN
VADS (at a minimum, Release 3.3.9) permits a much more granular
structured recording of a patient's race and ethnicity with its
inclusion of over 900 concepts for race and ethnicity. The recording
and exchange of patient race and ethnicity at such a granular level can
facilitate the accurate identification and analysis of health
disparities based on race and ethnicity. Further, the ``Race &
Ethnicity--CDC'' code system has a hierarchy that rolls up to the OMB
minimum categories for race and ethnicity and, thus, supports
aggregation and reporting using the OMB standard. Accordingly, we
propose the adoption and inclusion of both these standards in this
certification criterion as described.
For the purposes of testing and certification to this
``demographics'' criterion, we would test that a Health IT Module can
record each one of a patient's races and ethnicities using any of the
900 plus concepts in the ``Race & Ethnicity--CDC'' code system. We
would not, however, expect the user interface to include a drop-down
menu of all 900 plus ``Race & Ethnicity--CDC'' code system concepts for
race and ethnicity, as we believe doing so could have negative workflow
effects. Rather, we expect that health IT developers and health care
providers would work together to establish the appropriate
implementation given the care setting.
We refer readers to section III.A.2.d (``Minimum Standards'' Code
Sets) for further discussion of our proposal to adopt ``Race &
Ethnicity--CDC'' code system in PHIN VADS as a minimum standards code
set and Release 3.3.9, or potentially a newer version if released
before a subsequent final rule, as the baseline for certification to
the 2015 Edition.
We propose in a later section of this proposed rule that the ``Race
& Ethnicity--CDC'' code system in PHIN VADS (at a minimum, Release
3.3.9) and the OMB standard would become the race and ethnicity
standards under the ``Common Clinical Data Set'' definition for
certification to the 2015

[[Page 16817]]

Edition. Please see section III.B.3 ``Common Clinical Data Set'' of
this preamble for further discussion of this associated proposal.
Preferred Language
Based on specific HITSC recommendations from 2011, we adopted ISO
639-2 constrained by ISO 639-1 for recording preferred language in the
2014 Edition ``demographics'' certification criterion (77 FR
54208).\22\ More specifically, this means that technology is required
to be capable of using the alpha-3 codes of ISO 639-2 to represent the
corresponding alpha-2 code in ISO-639-1. To provide further clarity, we
issued FAQ 27 \23\ in which we stated that where both a bibliographic
code and terminology code are present for a required ISO 639-2
language, technology is expected to be capable of representing the
language in accordance with the (T) terminology codes (ISO 639-2/T) for
the purposes of certification. After we issued FAQ 27, we issued FAQ 43
\24\ in which we acknowledge that our constrained approach to the use
of ISO 639-2 unintentionally excluded multiple languages that are
currently in use, such as sign language and Hmong. Additionally, ISO
639-2 is meant to support written languages, which may not be the
language with which patients instinctively respond when asked for their
preferred language.
---------------------------------------------------------------------------

\22\ http://www.loc.gov/standards/iso639-2/php/code_list.php.
\23\ http://www.healthit.gov/policy-researchers-implementers/27-question-10-12-027.
\24\ http://www.healthit.gov/policy-researchers-implementers/43-question-11-13-043.
---------------------------------------------------------------------------

To improve the situation described above, we propose to adopt the
Internet Engineering Task Force (IETF) Request for Comments (RFC) 5646
\25\ standard for preferred language. RFC 5646 entitled ``Tags for
Identifying Languages, September 2009'' is the coding system that is
commonly used to encode languages on the web and is the most current
RFC for this purpose and listed as a ``best current practice.'' \26\
The first part of the code relies on the shortest ISO-639 code for the
language. That means a 2-character code if the language is specified in
ISO 639-1 or a 3-character code from ISO 639-2 or -3, if the language
is only listed in one of those two ISO standards. We are also aware
that RFC 5646 supports dialects.
---------------------------------------------------------------------------

\25\ http://www.rfc-editor.org/info/rfc5646.
\26\ http://www.rfc-editor.org/info/rfc5646.
---------------------------------------------------------------------------

After consideration of comments we received on the Voluntary
Edition proposed rule (79 FR 54450) and further research, we believe
that RFC 5646 is the most appropriate standard to support preferred
language interoperability. It is our understanding that this standard
is compatible with the C-CDA Release 2.0 and that other preferred
language standards in use today can be efficiently mapped to it, such
as ISO 639-1, 639-2, and 639-3. Therefore, for the purposes of testing
and certification to this ``demographics'' criterion, we would test
that a Health IT Module can record a patient's preferred language using
any of the codes in RFC 5646.
We emphasize that this requirement would apply to a Health IT
Module presented for certification and not health care providers. In
other words, a Health IT Module certified to this criterion would need
to support the recording of preferred language in RFC 5646 and should
in no way be interpreted or imply the way in which health care
providers use the capability to record preferred language or the
preferred language values they are presented with to select a patient's
preferred language. For example, we would not expect the user interface
to include a drop-down menu of all RFC 5646 codes for language, as we
believe doing so could have negative workflow effects. Rather, we
expect that health IT developers and health care providers would work
together to establish the appropriate implementation given the care
setting.
We propose in a later section of this proposed rule that RFC 5646
would also become the preferred language standard under the ``Common
Clinical Data Set'' definition for certification to the 2015 Edition.
Please see section III.B.3 (``Common Clinical Data Set'') of this
preamble for further discussion of this associated proposal.
Preliminary Cause of Death and Date of Death
We propose to include in the 2015 Edition the capability to enable
a user to electronically record, change, and access the ``date of
death'' as a required capability that EHR technology designed for the
inpatient setting must demonstrate. We previously included this
capability as part of the 2011 Edition ``demographics'' certification
criterion and inadvertently omitted it from the 2014 Edition. While we
heard from commenters in response to the Voluntary Edition proposed
rule that they were unaware of any developer removing this capability,
we believe it is appropriate to specifically include this capability in
the 2015 Edition criterion for testing and certification purposes and
to align with the data required by the Meaningful Use criteria of the
EHR Incentive Programs. To note, this functionality would be in
addition to the inclusion in the 2015 Edition ``demographics''
certification criterion of the same capability to enable a user to
electronically record, change, and access ``preliminary cause of
death'' in case of mortality, as is included in the 2014 Edition
``demographics'' certification criterion.
Vital Signs, Body Mass Index (BMI), and Growth Charts

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(6) (Vital signs, body mass index, and growth charts)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``vital signs, BMI, and growth
charts'' certification criterion that is revised in comparison to the
2014 Edition ``vital signs, BMI, and growth charts'' criterion (Sec.
170.314(a)(4)). Specifically, we propose to: 1) Expand the types of
vital signs for recording; 2) require that each type of vital sign have
a specific LOINC[supreg] code attributed to it; 3) that The Unified
Code of Units of Measure, Revision 1.9, October 23, 2013 (``UCUM
Version 1.9'') \27\ be used to record vital sign measurements; and 4)
that certain metadata accompany each vital sign, including date, time,
and measuring- or authoring-type source.
---------------------------------------------------------------------------

\27\ http://unitsofmeasure.org/trac/.
---------------------------------------------------------------------------

Proposed Approach for Vital Signs
In the Voluntary Edition proposed rule (79 FR 10889-10890), we
solicited comment on whether we should require health IT to record
vital signs in standardized vocabularies. We solicited comments on
whether we should require that vital signs be recorded in standardized
vocabularies natively within the health IT system or only during
transmission. We also solicited comment on whether we should require
vital signs be recorded with specific metadata for contextual purposes.
Many commenters recommended that the industry should standardize
how vital signs are represented and collected. To this end, we are
aware that several stakeholder groups are working to define unique,
unambiguous representations/definitions for clinical concepts along
with structured metadata that together provide improved context for the
system to interpret information, including vital signs. This approach
can help increase data standardization at a granular level so that
clinical elements and associated values/findings can be consistently
represented and exchanged. For example, blood pressure is represented
in current systems using a variety of formats, which creates

[[Page 16818]]

significant challenges to aggregate, compare, and exchange data across
systems. This occurs despite the numeric nature of blood pressure,
resulting in costly and time-consuming manual translation to integrate
this data across systems.
Some commenters supported requiring standardized vocabularies for
vital signs during data exchange rather than natively within the health
IT system. While we agree that data should be exchanged in a standard
way, we also believe that the granularity necessary to unambiguously
represent this data should be implemented within health IT systems so
that data is captured with the same level of specificity to enable
consistent and reliable interpretation by other data users and
receivers without requiring mapping. Thus, we propose that health IT
demonstrate it is able to record vital signs data natively as specified
below. Overall, these proposals reflect our interest in ensuring that
the data a user enters into a health IT system is semantically and
syntactically identical to the information coming out of the system and
being exchanged. We believe this would increase the confidence that the
data exchanged is what the provider intended.
The 2014 Edition ``vital signs'' certification criterion requires
health IT to enable a user to electronically record, change, and access
a patient's height/length, weight, and blood pressure. We propose to
include BMI, heart rate, respiratory rate, temperature, oxygen
saturation in arterial blood by pulse oximetry, and mean blood pressure
as we understand that these vital signs are commonly captured or
calculated (i.e., BMI) in the routine course of clinical encounters
across a wide variety of both inpatient and ambulatory settings. We
also propose to further specify that health IT would need to be able to
record diastolic and systolic blood pressure as separate vital signs
rather than ``blood pressure'' (unspecified) as a single vital sign. We
clarify that this list of vital signs is not intended to be
comprehensive. Rather, these listed vital signs indicate our interest
in a more specific approach to recording and exchanging vital signs
data that could promote unambiguous interpretation. These vital sign
concepts derive from the C-CDA standard and the Public Health
Information Network Vocabulary Access and Distribution System value set
for vital sign result types \28\ (2.16.840.1.113883.3.88.12.80.62),
which was developed by the Health IT Standards Panel.\29\ Therefore, we
believe the health care community has experience with collecting these
vital sign concepts because they have been defined for some time as
part of previous collaborative stakeholder work.
---------------------------------------------------------------------------

\28\ https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.113883.3.88.12.80.62.
\29\ The Health IT Standards Panel was established in 2005 as a
strategic public-private partnership in contract with the U.S.
Department of Health and Human Services to achieve a widely accepted
and useful set of standards to enable and support widespread
interoperability among healthcare software applications. The Health
IT Standards Panel's contract with HHS concluded on April 30, 2010.
http://www.hitsp.org/.
---------------------------------------------------------------------------

We propose to require that a Health IT Module be able to attribute
a specific LOINC[supreg] code to each type of vital sign using the
following identifiers:
``Systolic blood pressure'' with LOINC[supreg] code 8480-
6;
``Diastolic blood pressure'' with LOINC[supreg] code 8462-
4;
``Body height'' with LOINC[supreg] code 8302-2;
``Body weight measured'' with LOINC[supreg] code 3141-9;
``Heart rate'' with LOINC[supreg] code 8867-4;
``Respiratory rate'' with LOINC[supreg] code 9279-1;
``Body temperature'' with LOINC[supreg] code 8310-5;
``Oxygen saturation in arterial blood by pulse oximetry''
with LOINC[supreg] code 59408-5;
``Body mass index (BMI) [Ratio]'' with LOINC[supreg] code
39156-5; and
``Mean blood pressure'' with LOINC[supreg] code 8478-0.
We understand that the industry is commonly identifying these vital
signs using LOINC[supreg] codes today.
We also propose to require that a Health IT Module enable a user to
record these vital signs with at least the following metadata:
date and time of vital sign measurement or end time of
vital sign measurement with optional certification in accordance with
the clock synchronization standard adopted at Sec. 170.210(g); and
the measuring- or authoring-type source of the vital sign
measurement (such as the user who documented the vital sign or the
medical device that was used to measure the vital sign).
In some cases, the provider documenting the vital sign may record
the date and time of vital sign measurement manually and enter the data
into a health IT system at a later time; therefore, it would not be
necessary to use the clock synchronization standard. However, use of
the clock synchronization standard may be useful for situations where
the vital sign data comes from a device and should be synchronized with
the health IT system.
For ``oxygen saturation in arterial blood by pulse oximetry,'' we
propose that a Health IT Module enable a user to record ``inhaled
oxygen concentration'' with LOINC[supreg] code 3150-0 as metadata
associated with the vital sign. We understand that ``inhaled oxygen
concentration'' is frequently provided to assist with interpretation of
the ``oxygen saturation in arterial blood by pulse oximetry'' value.
For all units of measure associated with a vital sign value, we
propose to require that health IT be able to record an applicable unit
of measure in accordance with UCUM Version 1.9 (e.g., the UCUM unit
``mm[Hg]'' for systolic blood pressure; e.g., the UCUM unit
``[lb_av],'' ``g,'' ``kg,'' or ``[oz_av]'' for body weight). We note
that LOINC provides a translation table \30\ that enumerates the UCUM
syntax for a subset of UCUM codes that are commonly used in health IT
that may be a useful reference for stakeholders.
---------------------------------------------------------------------------

\30\ https://loinc.org/downloads/usage/units.
---------------------------------------------------------------------------

Proposed ``Optional'' Pediatric Vital Signs
We propose to offer optional certification for health IT to be able
to electronically record, change, and access:
Body mass index (BMI) [Percentile] per age and sex (with
LOINC[supreg] code 59576-9) for youth 2-20 years of age; and
Weight for length per age and sex (with LOINC[supreg] code
to be established in a newer version of LOINC[supreg] prior to the
publication of a subsequent final rule) and/or Head occipital-frontal
circumference by tape measure (with LOINC[supreg] code 8287-5) for
infants less than 3 years of age.
We propose to require that a Health IT Module enable each optional
vital sign to be recorded with an applicable unit of measure in
accordance with UCUM Version 1.9. CDC recommends the collection of
these anthropomorphic indices for youth 2-20 years of age and infants
less than 3 years of age, respectively, as part of best care
practices.\31\
---------------------------------------------------------------------------

\31\ http://www.cdc.gov/growthcharts/clinical_charts.htm#Set1
and http://www.cdc.gov/growthcharts/clinical_charts.htm#Set2.
---------------------------------------------------------------------------

A Health IT Module certified to the ``BMI percentile per age and
sex,'' ``weight for length per age and sex,'' or ``head occipital-
frontal circumference by tape measure'' vital signs would also need to
record metadata for the date and time or end time of vital sign

[[Page 16819]]

measurement, the measuring- or authoring-type source of the vital sign
measurement, the patient's date of birth, and the patient's sex in
accordance with the standard we propose to adopt at Sec.
170.207(n)(1). We believe offering optional certification to these
three vital signs can provide value in settings where pediatric and
adolescent patients are provided care.
Request for Comments on Vital Signs Proposal
We intend that the LOINC[supreg] codes proposed for attribution to
the vital signs in the list above are neutral to, and therefore can
encompass, any clinically reasonable method of measurement that is
commonly used in obtaining vital signs in the course of clinical
encounters in a wide variety of contexts, including but not limited to,
primary-care office/clinic visits, emergency department visits, and
routine inpatient admissions processes. For example, this would mean
the system would attribute ``body height'' to LOINC[supreg] code 8302-2
for the measurement of how tall or long the patient is. This
measurement is collected as part of routine vital signs observation
regardless of whether this clinical observation was made by measuring a
standing or supine adult/child, or a supine infant, or by estimating
through clinically reasonable methods the height/length of an adult or
child who cannot be measured in a standing or fully supine position.
Likewise, we propose to attribute a specific LOINC[supreg] code for
body temperature regardless of whether the temperature was measured by
a liquid-filled, digital/electronic, or infrared (non-contact)
thermometer. The choice of UCUM unit code will indicate whether the
measurement was taken in English or metric units. The metadata
describing the source of the measurement would provide the context of
the device that was used to perform the measurement. We reiterate that
the intent behind this ``vital signs'' proposal is to ensure that the
data a user enters into a health IT system is semantically and
syntactically identical to the information coming out of the system and
being exchanged, allowing other users to unambiguously and consistently
interpret the information. We anticipate that stakeholders may want to
expand the list of metadata beyond the date, time, and source of vital
sign measurement. We welcome comment on additional vital sign metadata
that we should consider for inclusion and the best available standards
for representing the metadata (e.g., LOINC[supreg] or a similar
standard).
Health IT users may currently capture vital signs in more granular
LOINC[supreg] codes that specify the method of measurement. We
therefore solicit comment on the feasibility and implementation
considerations for our proposals that rely on less granular
LOINC[supreg] codes for attribution to vital sign measurements and the
inclusion of accompanying metadata. Additionally, we solicit comment on
the following issues:
Support for or against the proposal to require attribution
of vital sign values using specific LOINC[supreg] codes and associated
metadata;
whether our proposal will accomplish the stated goal of
ensuring that the vital signs data a user enters into a health IT
system is semantically and syntactically identical to the information
coming out of the system and being exchanged;
whether the LOINC[supreg] codes proposed above are the
correct ones for representing the vital sign concepts broadly,
including any method of measurement; and
standards for recording the source of the vital sign
measurement.
We also solicit comment on whether we should require a Health IT
Module to be able to record metadata specific to particular vital signs
results/findings. This could provide additional contextual information
(e.g., position for diastolic and systolic blood pressure, whether the
patient is breathing supplemental oxygen, the site of the temperature
such as oral or rectal, pregnancy status for BMI, and whether the vital
sign was measured or self-reported). Because the LOINC[supreg] code
associated with some vital sign concepts we are proposing may include
whether the vital sign was measured or self-reported (e.g., body weight
measured), we also request comment on which specific vital signs should
include metadata on whether it was measured or self-reported. If we
were to require a Health IT Module to be able to record metadata
specific to particular vital signs, we solicit comment on what
additional metadata should be required for certification and what
standards (e.g., LOINC[supreg] or a similar standard) we should
consider for representing that data.
We note, with respect to arterial oxygen saturation, that we are
proposing here the type of measurement that we understand to be
commonly performed as part of vital signs observation across a wide
variety of clinical settings. We are aware that in some clinical
circumstances oxygen saturation in arterial blood by pulse oximetry is
not a sufficiently precise measurement to support sound clinical
decisions. We therefore invite comment as to whether we should consider
defining the arterial blood oxygen saturation vital sign in a more
method-agnostic way, and whether we should also require capture and
exchange of more robust metadata to ensure technology could reliably
identify to clinicians seeking to use the value whether it was measured
by pulse oximetry or a more precise but more invasive and, in most
clinical contexts, less commonly performed arterial blood gas (ABG)
test.
We propose in a later section of this proposed rule that vital
signs be represented in same manner for the ``Common Clinical Data
Set'' definition as it applies to the certification of health IT to the
2015 Edition. Note that the optional portions of the proposed vital
signs criterion would not be required for the ``Common Clinical Data
Set'' (i.e., BMI percentile per age and sex for youth, weight for
length for infants, head occipital-frontal circumference by tape
measure, calculating BMI, and plotting and displaying growth charts.)
Please see section III.B.3 (``Common Clinical Data Set'') of this
preamble for further discussion of this associated proposal.
Problem List

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(7) (Problem list)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``problem list'' certification
criterion that is revised in one way as compared to the 2014 Edition
``problem list'' certification criterion (Sec. 170.314(a)(5)). We
propose to include the September 2014 Release of the U.S. Edition of
SNOMED CT[supreg] in the 2015 Edition ``problem list'' certification
criterion as the baseline version permitted for certification to this
criterion. The 2014 Edition ``problem list'' criterion included the
July 2012 Release of SNOMED CT[supreg] (International Release and the
U.S. Extension) as the baseline version permitted for certification. We
also refer readers to section III.A.2.d (``Minimum Standards'' Code
Sets) for further discussion of our adoption of SNOMED CT[supreg] as a
minimum standards code set and our proposal to adopt the September 2014
Release (U.S. Edition), or potentially a newer version if released
before a subsequent final rule, as the baseline for certification to
the 2015 Edition.
Medication List

[[Page 16820]]

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(8) (Medication list)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``medication list''
certification criterion that is unchanged as compared to the 2014
Edition ``medication list'' certification criterion (Sec.
170.314(a)(6)). To note, this proposed criterion does not reference any
standards or implementation specifications.
Medication Allergy List

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(9) (Medication allergy list)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``medication allergy list''
certification criterion that is unchanged as compared to the 2014
Edition ``medication allergy list'' certification criterion (Sec.
170.314(a)(7)).
We received comments in response to the Voluntary Edition proposed
rule suggesting that a ``medication allergy list'' criterion should
include also other types of allergies and intolerances, such as food
and environmental allergies (79 FR 54451-52). We are aware of a number
of vocabularies and code sets that could support food and environmental
allergies as well as medications, but believe that the industry is
working on identifying ways that multiple vocabularies and code sets
can be used together in an interoperable way to support coding of
allergies. Therefore, at this time, there is no ready solution for
using multiple vocabularies to code allergies that could be adopted for
the purposes of certification.
Clinical Decision Support

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(10) (Clinical decision support)
------------------------------------------------------------------------

Health IT is key component of advanced health models and delivery
system reform. CDS is a primary means of supporting the implementation
of best evidence and new knowledge at the point of care and in real
time (see our definition of ``CDS intervention'' discussed at 77 FR
13847). When effective decision support is presented in a useful
manner, it enhances usability and helps providers and patients avoid
medical errors. Therefore, we believe that clinical decision support is
a crucial feature of certified health IT.
We propose to adopt a 2015 Edition ``clinical decision support''
certification criterion that is revised in comparison to the 2014
Edition ``CDS'' criterion (Sec. 170.314(a)(8)). We propose to adopt
and include an updated ``Infobutton'' \32\ standard and two updated
associated IGs. We propose to require certification only to the
Infobutton standard (and an associated IG) for identifying diagnostic
or therapeutic reference information. We propose to require that a
Health IT Module presented for certification to this criterion be able
to record users' actions in response to CDS interventions. Last, we
have revised the regulation text in comparison to the 2014 Edition CDS
criterion to provide more clarity for certification to this proposed
criterion as well as guidance for certification to the 2014 Edition CDS
criterion.
---------------------------------------------------------------------------

\32\ Infobutton'' is typically the shorthand name used to refer
to the formal standard's name: HL7 Version 3 Standard: Context-Aware
Retrieval Application (Infobutton)
---------------------------------------------------------------------------

Infobutton Standard and IGs
We propose to adopt and include the updated Infobutton standard
(Release 2, June 2014) \33\ in the proposed 2015 Edition CDS criterion.
Infobutton provides a standard mechanism for health IT systems to
request context-specific clinical or health knowledge from online
resources. We propose to adopt and include the HL7 Implementation
Guide: Service-Oriented Architecture Implementations of the Context-
aware Knowledge Retrieval (Infobutton) Domain, Release 1, August 2013
(``SOA Release 1 IG'') \34\ in the CDS criterion. The SOA Release 1 IG
includes additional conformance criteria, redesigns extensions, revises
possible values, and includes support for an additional format for
representing knowledge responses. We also propose to adopt and include
in the proposed 2015 Edition CDS criterion the updated Infobutton URL-
based IG (HL7 Version 3 Implementation Guide: Context-Aware Knowledge
Retrieval (Infobutton), Release 4, June 2014) (``URL-based Release 4
IG'').\35\ The IG provides a standard mechanism for health IT to submit
knowledge requests to knowledge resources over the HTTP protocol using
a standard URL format.
---------------------------------------------------------------------------

\33\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=208.
\34\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=283.
\35\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=22.
---------------------------------------------------------------------------

We propose to adopt the updated Infobutton standard with the SOA
Release 1 IG at Sec. 170.204(b)(3). We propose to adopt the updated
Infobutton standard with the URL-based Release 4 IG at Sec.
170.204(b)(4). We clarify that as proposed, a Health IT Module
presented for certification would need to demonstrate the ability to
electronically identify for a user diagnostic and therapeutic reference
information in accordance with Sec. 170.204(b)(3) or (b)(4) (i.e.,
Infobutton and the SOA Release 1 IG or Infobutton and the URL-based
Release 4 IG).
For certification to the 2014 Edition CDS criterion, we permit a
health IT to be certified if it can electronically identify for a user
diagnostic and therapeutic reference information using the Infobutton
standard or another method (Sec. 170.314(a)(8)(ii)). For the 2015
Edition CDS criterion, we propose to require that a Health IT Module
must be able to identify linked referential CDS information using the
Infobutton standard only, as we believe this is the best consensus-
based standard available to support this use case. We have taken this
approach because certification focuses on the capabilities health IT
can demonstrate (where applicable, according to specific standards) and
not on how it is subsequently used. Thus, with this focus we believe we
can refrain from continuing a regulatory requirement (i.e., requiring
``another method'' for certification) from the 2014 Edition to the 2015
Edition.
For the proposed 2015 Edition ``patient-specific education
resources'' certification criterion discussed later in this section of
the preamble, we propose, for the purposes of certification, to require
that a Health IT Module be able to request patient-specific education
resources based on a patient's preferred language. We believe this
capability would assist providers in addressing and mitigating certain
health disparities. We solicit comment on whether we should require
this functionality as part of the CDS certification criterion for
reference materials identified using the Infobutton standards,
including examples of use cases for which this functionality would be
appropriate. We note that if should require a Health IT Module to be
able to request patient-specific education resources based on a
patient's preferred language as part of the CDS criterion, the
availability of resources in a patient's preferred language depends on
the material supported by the content provider. Therefore, to clarify,
testing and certification would focus on the ability of the Health IT
Module to make the request using a preferred language and Infobutton.
CDS Intervention Response Documentation
We solicited comment in the Voluntary Edition proposed rule on
whether a Health IT Module should be able to record users' responses to
the DD/DAI checks that are performed,

[[Page 16821]]

including if and when the user viewed, accepted, declined, ignored,
overrode, or otherwise commented on the product of a DD/DAI check. We
also received comments recommending we broaden our consideration to
include functionality for recording user responses for all CDS
interventions. We believe that this functionality could be valuable for
all CDS interventions, not solely DD/DAI checks, because it could
assist with enhancing CDS intervention design and implementation,
quality improvement, and patient safety.
As such, we propose that the CDS criterion include functionality at
Sec. 170.315(a)(10)(vi) that would require a Health IT Module to be
able to record at least one action taken and by whom when a CDS
intervention is provided to a user (e.g., whether the user viewed,
accepted, declined, ignored, overrode, provided a rationale or
explanation for the action taken, took some other type of action not
listed here, or otherwise commented on the CDS intervention). We also
propose that a Health IT Module be able to generate either a human
readable display or human readable report of the responses and actions
taken and by whom when a CDS intervention is provided.
We note that we do not believe that a Health IT Module's ability to
record user responses should increase provider burden in order to just
meet this criterion. For example, we would not encourage
implementations that would unnecessarily (e.g., for a non-clinical or
safety-related reason) interrupt a provider's workflow and require the
provider to document the reason just to meet this criterion. Rather, we
encourage health IT developers to leverage current best practices for
presenting, documenting, and facilitating the safest and most
appropriate clinical options in response to CDS interventions.
Clarifying ``Automatically'' and ``Triggered'' Regulatory Text
CDS can include a broad range of decision support interventions and
are not solely limited to alerts. Our 2014 Edition ``CDS'' criterion
uses the terms ``automatically'' and ``triggered'' when referencing
interventions. The use of ``trigger'' and ``automatic'' can be
associated with CDS rules or alerts, but may not encompass all kinds of
CDS interventions. For example, CDS could be seamlessly presented in
the user interface (e.g., a dashboard display) or selected by the user
within the workflow (e.g., Infobutton or documentation flowsheets). The
use of ``automatically'' and ``trigger'' as related to CDS
interventions in the 2014 Edition ``CDS'' caused confusion as to what
types of CDS interventions were permitted. To clarify, our intent is to
encompass all types of CDS interventions without being prescriptive on
how the interventions are deployed (e.g., automatic, triggered,
selected, seamless, or queried). As such, we are not using the terms
``automatically'' and ``trigger'' as related to CDS interventions in
the regulatory text for this 2015 Edition certification criterion.
However, we do not propose to change the regulatory text language in
the 2014 Edition ``CDS'' certification criterion as current testing and
certification under the ONC Health IT Certification Program permits the
other types of interventions we have described above.
2014 Edition ``Clinical Decision Support'' Certification Criterion--
Corrections
We propose to revise the cross-reference in Sec.
170.314(a)(8)(iii)(B)(2) (CDS configuration) to more specifically
cross-reference the 2014 ToC criterion (Sec. 170.314(b)(1)(iii)(B)).
This more specific cross reference aligns with the our other proposed
revision to this criterion, which is to add a cross-reference to Sec.
170.314(b)(9)(ii)(D). We inadvertently omitted the cross-reference to
Sec. 170.314(b)(9)(ii)(D) in the 2014 Edition Release 2 final rule.
These revised cross-references would more clearly indicate that health
IT certified to the 2014 Edition CDS criterion would need to enable CDS
interventions when a patient's medications, medication allergies, and
problems are incorporated from a transition of care/care referral
summary.
Drug Formulary and Preferred Drug List Checks

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(11) (Drug-formulary and preferred drug list checks)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``drug formulary checks and
preferred drug list'' certification criterion that is revised in
comparison to the 2014 Edition ``drug formulary checks'' certification
criterion (Sec. 170.314(a)(10)). We propose a criterion that is split
based on drug formularies and preferred drug lists. For drug
formularies, we propose that a Health IT Module must (1) automatically
check whether a drug formulary exists for a given patient and
medication and (2) receive and incorporate a formulary and benefit file
according to the NCPDP Formulary and Benefit Standard v3.0 (``v3.0'').
We propose to adopt v3.0 at Sec. 170.205(n)(1), but also solicit
comment on more recent versions of the NCPDP Formulary and Benefit
Standard. For preferred drug lists, we propose that a Health IT Module
must automatically check whether a preferred drug list exists for a
given patient and medication. This situation applies where the health
IT system does not use external drug formularies, such as in a hospital
health IT system. We also propose, for both drug formularies and
preferred drug lists, that a Health IT Module be capable of indicating
the last update of a drug formulary or preferred drug list as part of
certification to this criterion. We believe that health IT should
indicate the last update of the drug formulary or preferred drug list
so the provider knows how recently the information was last updated. We
also solicit comment on the best standard for individual-level, real-
time formulary benefit checking to address the patient co-pay use case,
and whether we should offer health IT certification to the standard for
this use case.
As described in more detail in the Voluntary Edition proposed rule
(79 FR 10892), CMS finalized a proposal to recognize NCPDP Formulary
and Benefit Standard v3.0 as a backwards compatible version of NCPDP
Formulary and Benefit Standard 1.0 for the period of July 1, 2014
through February 28, 2015, and to retire version 1.0 and adopt version
3.0 as the official Part D e-Prescribing standard on March 1, 2015 (78
FR 74787-74789). In response to the Voluntary Edition proposed rule, we
received comments supporting adoption of the NCPDP Formulary and
Benefit Standard v3.0 (``v3.0'') for this edition of certification
criteria. Those commenters in support of adopting v3.0 noted the
potential to reduce file sizes, which is beneficial when checking
thousands of drug formularies on a daily basis. We agree with those
commenters that v3.0 is the best available option for standardizing the
implementation of drug-formulary checks in health IT and for its
potential to reduce file sizes. As noted above, the adoption of v3.0
would also align with CMS' adoption of version 3.0 as the official Part
D e-Prescribing standard beginning March 1, 2015.
We are aware that more recent versions of the NCPDP Formulary and
Benefit Standard. Versions 4.0 (``v4.0'') (January 2013), 4.1
(``v4.1'') (October 2013), and 42 (October 2014) (``v42'') \36\ have
been published and are available for industry use. At the time of this

[[Page 16822]]

proposed rule, we understand that the NCPDP is currently developing and
balloting Version 43 (``v43''). Version 4.0 has minor changes compared
to v3.0, including removal of values from an unused diagnosis code,
typographical corrections, and a change to the standard length of the
name field. Version 4.1 removes files to support electronic prior
authorization (ePA) transactions since these have been added to the
NCPDP SCRIPT Standard Implementation Guide v2013011 (January 2013) and
later versions, makes typographical corrections, adds a new coverage
type for ePA routing, and adds an RxNorm qualifier to some data
elements. V42 includes changes to reduce the file size. Stakeholder
feedback has indicated that v4.0, v4.1, and v42 are backwards
compatible with v3.0 for the elements that are the same as compared to
v3.0.
---------------------------------------------------------------------------

\36\ Please note a change to the naming convention to Version 42
and Version 43, as NCPDP accepted a change request to remove the
period in version numbering.
---------------------------------------------------------------------------

We received mixed comments in response to the Voluntary Edition
proposed rule on whether it is more appropriate to adopt v4.0 instead
of v3.0 (79 FR 54454). Some commenters were concerned about known
problems with v3.0 and indicated v4.0 could fix these known problems.
Conversely, other commenters stated that v4.0 was too unstable and new
for an edition of certification criteria that was anticipated to be
adopted and in use in 2014. With these comments in mind, we solicit
comment on whether we should adopt v4.0, v4.1, or v42 of the NCPDP Drug
and Formulary Benefit Standard instead of v.3.0 for the proposed 2015
Edition ``drug formulary checks and preferred drug list'' criterion and
what unintended impacts this could have on the industry given the Part
D requirements.
We believe there is value in certifying that health IT is able to
receive and incorporate a formulary and benefit file in accordance with
the NCPDP Formulary and Benefit Standard v3.0. Systems would be able to
incorporate more updated or complete formulary and benefit files to
inform providers as they make determinations about which medications to
prescribe their patients. We seek to understand the potential system
burden in incorporating formulary and benefit files and, therefore,
seek comment on this issue.
In the Voluntary Edition proposed rule, we noted that the NCPDP
Formulary and Benefit Standard v3.0 did not address individual-level,
real-time formulary benefit checking. Comments in response to the
Voluntary Edition proposed rule noted that the ASC X12 270/271 Health
Care Eligibility Benefit Inquiry and Response standard could perform
individual-level, real-time formulary benefit checking in addition to
the NCPDP Telecommunication Standard. Commenters also noted that e-
prescribing networks could provide this service to customers within
proprietary networks. We are aware of a recently established NCPDP task
group that is defining potential use cases and business requirements
for real-time benefit checking.
We continue to believe in the value of providers and patients
knowing what the patient's cost sharing responsibilities are at the
point of care for a given medication to inform discussions about a
patient's care. Therefore, for this use case, we ask commenters to
identify the best standard(s) for individual-level, real-time (at the
point of care) formulary benefit checking and describe how the standard
addresses this use case. We also solicit comment on whether we should
offer certification for this use case using the appropriate standard
for individual-level, real-time formulary benefit checking and whether
it should be part of the 2015 Edition ``drug formulary and preferred
drug list checks'' certification criterion or a standalone
certification criterion.
Smoking Status

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(12) (Smoking status)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``smoking status'' certification
criterion that is revised in comparison to the 2014 Edition ``smoking
status'' criterion (Sec. 170.314(a)(11)). We propose that a Health IT
Module must be able to record, change, and access smoking status in any
of the available codes for smoking status in, at a minimum, the
September 2014 Release of the U.S. Edition of SNOMED CT[supreg].\37\ We
have taken this more flexible approach because there is no longer a
proposed meaningful use objective and measure associated with this
requirement and, thus, no specific requirement for certain codes to be
used toward numerator calculation.
---------------------------------------------------------------------------

\37\ We refer readers to section III.A.2.d (``Minimum
Standards'' Code Sets) for further discussion of our adoption of
SNOMED CT[supreg] as a minimum standards code set and our proposal
to adopt the September 2014 Release (U.S. Edition), or potentially a
newer version if released before a subsequent final rule, as the
baseline for certification to the 2015 Edition.
---------------------------------------------------------------------------

We note, however, that the 8 smoking status SNOMED CT[supreg] codes
identified in Sec. 170.207(h) \38\ remain the same codes as identified
for the 2014 Edition. They are also the value set included in the
Common Clinical Data Set for the 2015 Edition and the only codes
permitted for representing smoking status for electronic transmission
in a summary care record for the purposes of certification. Therefore,
a Health IT Module certified to certification criteria that reference
the Common Clinical Data Set (i.e., the ToC, data portability, VDT,
Consolidated CDA creation performance, and application access to the
Common Clinical Data Set certification criteria) would need to be able
to code smoking status in only the 8 smoking status codes, which may
mean mapping other smoking status codes to the 8 codes.
---------------------------------------------------------------------------

\38\ These 8 codes are: Current every day smoker, 449868002;
current some day smoker, 428041000124106; former smoker, 8517006;
never smoker, 266919005; smoker--current status unknown, 77176002;
unknown if ever smoked, 266927001; heavy tobacco smoker,
428071000124103; and light tobacco smoker, 428061000124105.
---------------------------------------------------------------------------

We also note that we would not expect the user interface to include
a drop-down menu of all available SNOMED CT[supreg] smoking status
codes, as we believe doing so could have negative workflow effects.
Rather, we expect that health IT developers and health care providers
would work together to establish the appropriate implementation given
the care setting.
We propose to include the 2015 Edition ``smoking status''
certification criterion in the 2015 Edition Base EHR definition. Please
see section III.B.1 of this preamble for further discussion of this
associated proposal.
Image Results

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(13) (Image results)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``image results'' certification
criterion that is unchanged in comparison to the 2014 Edition ``image
results'' criterion (Sec. 170.314(a)(12)).
Family Health History

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(14) (Family health history)
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(15) (Family health history--pedigree)
------------------------------------------------------------------------

We propose to adopt two 2015 Edition ``family health history''
(FHH) certification criteria. Both proposed criteria are revised in
comparison to the 2014 Edition FHH certification criterion (Sec.
170.314(a)(13)). The proposed 2015 Edition FHH certification criterion
at Sec. 170.315(a)(14) would require

[[Page 16823]]

technology to enable a user to record, change, and access a patient's
FHH electronically according to, at a minimum, the concepts or
expressions for familial conditions included in the September 2014
Release of the U.S. Edition of SNOMED CT[supreg]. We refer readers to
section III.A.2.d (``Minimum Standards'' Code Sets) for further
discussion of our adoption of SNOMED CT[supreg] as a minimum standards
code set and our proposal to adopt the September 2014 Release (U.S.
Edition), or potentially a newer version if released before a
subsequent final rule, as the baseline for certification to the 2015
Edition.
The proposed 2015 Edition FHH--pedigree certification criterion at
Sec. 170.315(a)(15) would require technology to enable a user to
create and incorporate a patient's FHH according to HL7 Pedigree
standard and the HL7 Pedigree IG, HL7 Version 3 Implementation Guide:
Family History/Pedigree Interoperability, Release 1.\39\ We believe
that this approach gives the most flexibility to health IT developers
and providers to develop, adopt, and implement technology that supports
their clinical documentation needs, while still enabling
interoperability. For example, some providers may only need technology
that supports FHH coding in SNOMED CT[supreg]. Other providers may also
want technology that supports genomic coding, which HL7 Pedigree can
support. The adoption of two separate criteria can more effectively
support different use cases and clearly identify the capabilities to
which health IT has been certified.
---------------------------------------------------------------------------

\39\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=301.
---------------------------------------------------------------------------

As part of the 2014 Edition final rule, we incorrectly assigned the
HL7 Pedigree standard to Sec. 170.207 where we adopt ``vocabulary''
standards. Accordingly, for the 2015 Edition, we have placed the HL7
Pedigree standard and its IG in Sec. 170.205(m)(1) to more accurately
place it in the ``content'' exchange standards section of the CFR.
Patient List Creation

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(16) (Patient list creation)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``patient list creation''
certification criterion that is unchanged in comparison to the 2014
Edition ``patient list creation'' criterion (Sec. 170.314(a)(14)). We
propose to incorporate our guidance provided in FAQ 39 \40\ into the
2015 Edition ``patient list creation'' criterion. Specifically, the
text of the 2015 Edition ``patient list creation'' certification
criterion provides that a Health IT Module must demonstrate its
capability to use at least one of the more specific data categories
included in the ``demographics'' certification criterion (Sec.
170.315(a)(5)) (e.g., sex or date of birth).
---------------------------------------------------------------------------

\40\ http://www.healthit.gov/policy-researchers-implementers/39-question-04-13-039.
---------------------------------------------------------------------------

Patient-Specific Education Resources

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(17) (Patient-specific education resources)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``patient-specific education
resources'' certification criterion that is revised in comparison to
the 2014 Edition ``patient-specific education resources'' certification
criterion (Sec. 170.314(a)(15)). We propose that certification would
only focus on the use of Infobutton for this certification criterion
instead of Infobutton and any means other than Infobutton as required
by the 2014 Edition criterion. We have reviewed the regulatory burden
posed by the 2014 Edition criterion and determined that there is
diminished value in continuing to frame the 2015 Edition certification
criterion in this way. We continue to believe, however, that the
Infobutton capability is important to be available to providers to have
and use to identify patient-specific education resources.
We propose to adopt the updated Infobutton standard (Release 2 and
the associated updated IGs (SOA-based IG and URL-based IG)). These are
discussed in more detail under the ``CDS'' certification criterion
earlier in this section of the preamble. We also note that we no longer
include a requirement that health IT be capable of electronically
identifying patient-specific education resources based on ``laboratory
values/results.'' We understand from stakeholder feedback on the 2014
Edition version of this criterion and our own research that the
Infobutton standard cannot fully support this level of data
specificity. For example, Infobutton could likely provide something
useful for results that are a concept like ``E.coli,'' but not
necessarily a numerical laboratory result.
We also propose that a Health IT Module be able to request patient-
specific education resources based on a patient's preferred language as
this would assist providers in addressing and mitigating certain health
disparities. More specifically, we propose that a Health IT Module must
be able to request that patient-specific education resources be
identified (using Infobutton) in accordance with RFC 5646. We are
aware, however, that Infobutton only supports a value set of ISO 639-1
for preferred language and, therefore, testing and certification of
preferred language for this certification criterion would not go beyond
the value set of ISO 639-1. To note, we also understand that the
language of patient education resources returned through Infobutton is
dependent on what the source can support. Thus, we reiterate that
testing and certification would focus on the ability of the Health IT
Module to make the request using a preferred language and Infobutton.
Electronic Medication Administration Record

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(18) (Electronic medication administration record)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition electronic medication
administration record (eMAR) certification criterion that is unchanged
in comparison to the 2014 Edition ``eMAR'' criterion (Sec.
170.314(a)(16)).
Patient Health Information Capture

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(19) (Patient health information capture)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition ``patient health information
capture'' certification criterion that would ``replace'' the 2014
Edition ``advance directives'' certification criterion (Sec.
170.314(a)(17)) for the purposes of certification to the 2015 Edition.
The HITPC recommended, as part of their EHR Incentive Programs Stage 3
recommendations, that we adopt a certification criterion for ``advance
directives'' that would require a Health IT Module to be capable of
storing an advance directive and/or including more information about
the advance directive, such as a link to the advance directive or
instructions regarding where to find the advance directive or more
information about it.\41\ We agree with this recommendation in that
more functionality should be demonstrated for certification as it
relates to advance directives. Further, we believe that the
functionality described by the HITPC can be more broadly applicable
and, thus, have named this certification criterion to reflect
functionality that can be applied to various patient health information
documents. For example,

[[Page 16824]]

we believe such capabilities could be applicable to birth plans as well
as advance directives.
---------------------------------------------------------------------------

\41\ http://www.healthit.gov/facas/sites/faca/files/HITPC_MUWG_Stage3_Recs_2014-04-01.pdf.
---------------------------------------------------------------------------

For certification to this criterion, we propose that a Health IT
Module would need to properly identify health information documents for
users (e.g., label health information documents as advance directives
and birth plans). A Health IT Module would also need to be able to
demonstrate that it could enable a user to record (capture and store)
and access (ability to examine or review) health information documents.
We further propose that a Health IT Module would need to be able to
reference health information documents, which means providing narrative
information on where to locate a specific health information document.
A Health IT Module would also need to demonstrate that it can link to
patient health information documents. ``Linking'' would require a
Health IT Module to demonstrate it could link to an internet site
storing a health information document. While an intranet link to a
health information document might suffice for provider use, a Health IT
Module would still need to demonstrate the ability to link to an
external site via the internet for the purposes of certification.
We also propose that a Health IT Module would be required to
demonstrate that it could enable a user to record and access
information directly and electronically shared by a patient. This could
come from multiple sources, including patient information provided
directly from a mobile device. To note, we have not proposed any
specific standards for this criterion related to receiving and
accepting information directly and electronically shared by a patient.
We clarify that these capabilities may not be applicable to every
patient health information document, but a Health IT Module would need
to be able to perform all of these capabilities electronically for
certification to this criterion.
Implantable Device List

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(20) (Implantable device list)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition certification criterion
focused on the ability of a Health IT Module to record, change, and
access a list of unique device identifiers (UDIs) \42\ corresponding to
a patient's implantable devices (``implantable device list''), parse
certain data from a UDI, retrieve the ``Device Description'' attribute
associated with a UDI in the Global Unique Device Identification
Database (GUDID), and make accessible to a user both the parsed and
retrieved data. The proposed criterion represents a first step towards
enabling health IT to facilitate the widespread availability and use of
unique device identifiers to prevent device-related adverse events,
enhance clinical decision-making related to devices, improve the
ability of clinicians to respond to device recalls and device-related
safety information, and achieve other important benefits, consistent
with the fundamental aims of the HITECH Act \43\ and the HHS Health IT
Patient Safety Action and Surveillance Plan.\44\
---------------------------------------------------------------------------

\42\ A UDI is a unique numeric or alphanumeric code that
consists of two parts: (1) a device identifier (DI), a mandatory,
fixed portion of a UDI that identifies the labeler and the specific
version or model of a device, and (2) a production identifier (PI),
a conditional, variable portion of a UDI that identifies one or more
of the following when included on the label of a device: the lot or
batch number within which a device was manufactured; the serial
number of a specific device; the expiration date of a specific
device; the date a specific device was manufactured; the distinct
identification code required by 21 CFR 1271.290(c) for a human cell,
tissue, or cellular and tissue-based product (HCT/P) regulated as a
device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/.
\43\ Specifically, the certification criterion supports the
National Coordinator's responsibility under the HITECH Act to ensure
that the nation's health IT infrastructure supports activities that
reduce medical errors, improve health care quality, improve public
health activities, and facilitate the early identification and rapid
response to public health threats and emergencies. 42 U.S.C. 300jj-
11(b)(2) & (7).
\44\ ONC, HHS Health IT Patient Safety Action and Surveillance
Plan (July 2013), http://www.healthit.gov/policy-researchers-implementers/health-it-and-patient-safety (hereinafter ``Health IT
Safety Plan''). The first objective of the Health IT Safety Plan is
to use health IT to make care safer. See id. at 7. The Plan
specifically contemplates that ONC will update its standards and
certification criteria to improve safety-related capabilities and
add new capabilities that enhance patient safety.
---------------------------------------------------------------------------

FDA issued the Unique Device Identification System final rule on
September 24, 2013.\45\ The rule implements a statutory directive to
establish a ``unique device identification system'' for medical devices
that will enable adequate identification of devices through
distribution and use.\46\ It accomplishes this objective by requiring
device labelers (usually the device manufacturer) to include a UDI on
the label and packages of most medical devices subject to FDA
jurisdiction. In addition, for each device with a UDI, the labeler must
submit a standard set of identifying data elements to the FDA-
administered GUDID, which will be publicly accessible.\47\ Full
implementation of the UDI system for devices that are implantable,
life-saving, and life-sustaining is required by September 2015.\48\
---------------------------------------------------------------------------

\45\ 78 FR 58786.
\46\ 21 U.S.C. 360i(f).
\47\ See FDA, Global Unique Device Identification Database
(GUDID) Guidance for Industry and Food and Drug Administration Staff
(June 27, 2014), available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf.
\48\ Pursuant to 21 U.S.C. 360i(f), FDA must implement the
Unique Device Identification System Final Rule with respect to
devices that are implantable, life-saving, and life sustaining not
later than 2 years after the rule was finalized. Other
implementation and compliance dates are detailed in the final rule.
Compliance dates for UDI implementation will be phased in based on
the existing risk-based classification of medical devices: September
2014 for devices classified by FDA at the highest risk level (Class
III); September 2015 for implantable, life-supporting or life-
sustaining devices; September 2016 for moderate risk (Class II)
devices; and September 2018 for low risk (Class I) devices.
---------------------------------------------------------------------------

We first proposed to adopt a certification criterion for
implantable devices in the Voluntary Edition proposed rule (79 FR
10894). We received a large volume of comments on our proposal, many of
which supported the adoption of a UDI-related certification criterion
focused on implantable device list functionality. Some supporters of
our proposal suggested that we wait to adopt it in our next rulemaking
cycle in order to allow relevant standards and use cases to mature.
Other commenters, mostly health IT developers, suggested that the
proposed criterion would be applicable only to health IT systems
designed for surgical or specific inpatient settings in which devices
are implanted, and therefore suggested that we reduce the scope of the
criterion to those settings.\49\ For the reasons stated in the 2014
Edition Release 2 final rule,\50\ we finalized only a small subset of
the criteria we had originally proposed in the Voluntary Edition
proposed rule. These criteria focused on adding flexibility and making
improvements to the 2014 Edition. Consistent with this reduced scope,
we did not finalize an implantable device list criterion at that time,
stating instead our intention to propose such a criterion in our next
rulemaking that would provide additional detail and clarity, as well as
respond to concerns raised by commenters.
---------------------------------------------------------------------------

\49\ For a detailed summary of the comments we received on our
earlier implantable device list proposal, see the 2014 Edition,
Release 2, final rule (79 FR 54458).
\50\ 79 FR 54458.
---------------------------------------------------------------------------

We continue to believe that incorporating UDIs in health IT is
important and necessary to realize the significant promise of UDIs and
FDA's

[[Page 16825]]

Unique Device Identification System to protect patient safety and
improve health care quality and efficiency. Crucially, recording and
exchanging UDIs in patients' electronic health records would enable
this information to travel with patients as they move among providers
and throughout the health care system. With access to this information
at the point of care, clinicians can accurately identify a patient's
implantable devices and prevent adverse events resulting from
misidentification or non-identification of the device and its
associated safety characteristics (such as MRI compatibility and latex
content). Health IT could also be leveraged in conjunction with
automated identification and data capture (AIDC) or other technologies
to streamline the capture and exchange of UDIs and associated data for
patients' devices. As UDIs become ubiquitous, UDI capabilities in
health IT could facilitate better post-market surveillance of devices,
better and more accurate reporting of device-related events, and more
effective corrective and preventative action in response to device
recalls and alerts.
Fully implementing UDIs will take time and require addressing a
number of challenges. A key challenge is that UDIs may initially be
captured in any of a variety of clinical, inventory, registry, or other
IT systems. Robust adoption and use of UDIs will require bridging these
different components and changing IT and administrative processes to,
among other things, ensure that UDIs are properly captured and
associated with patients' electronic health records.
In December 2014, the Brookings Institution with collaboration from
FDA published a detailed roadmap for effective UDI implementation.\51\
Significantly, the roadmap's recommendations stated that ``while the
path to full implementation is complex, there are relatively
straightforward steps that can be done now'' to begin realizing the
benefits of UDI implementation across the health care system. The
roadmap's recommendations specifically urged ONC to support the
incorporation of UDIs into certification criteria for health IT.
---------------------------------------------------------------------------

\51\ The Brookings Institution, Unique Device Identifiers
(UDIs): A Roadmap for Effective Implementation (December 2014)
(available at http://www.brookings.http://www.brookings.edu/~/media/
research/files/papers/2014/12/
05%20medical%20device%20tracking%20system/udi%20final%2012052014).
---------------------------------------------------------------------------

We agree that a key initial step towards solving these challenges
is incorporating UDIs in certified health IT. We believe now is the
appropriate time to take that first step. Major efforts have been
underway for some time to harmonize and pilot health IT standards and
specifications in support of a variety of UDI use cases, and
substantial progress has been achieved to standardize the electronic
exchange of UDIs.\52\ In addition, FDA plans to implement the GUDID in
early 2015 and require UDIs for all implantable devices by September
2015.\53\ In light of this progress on technical standards and FDA's
timeline for UDI implementation, we believe it is feasible for health
IT developers to begin implementing the baseline functionality
necessary to use and exchange UDIs, and in particular for UDIs
associated with patient's implantable devices. Once implanted, these
devices cannot be inspected with the naked eye and are therefore more
susceptible to misidentification and resulting patient harm.
---------------------------------------------------------------------------

\52\ For example, the Brookings Institution and FDA convened a
UDI Implementation Work Group comprising device manufacturers,
payers, health IT developers, academics, clinicians, and other
stakeholders to explore opportunities and challenges associated with
capturing UDIs in claims, identifying steps for implementation and
integration of UDIs within EHRs and other health care IT
infrastructure, and utilizing UDIs as a tool for improved patient
and provider connectivity. http://www.brookings.edu/about/centers/health/projects/development-and-use-of-medical-devices/udi. The Work
Group held a series of expert workshops and in December 2014
published a detailed roadmap for effective UDI implementation. The
Brookings Institution, Unique Device Identifiers (UDIs): A Roadmap
for Effective Implementation (December 2014) (available at http://www.brookings.http://www.brookings.edu/~/media/research/files/
papers/2014/12/05%20medical%20device%20tracking%20system/
udi%20final%2012052014). Concurrently, the HL7 Technical Steering
Committee has established a UDI Task Force to ensure that UDI is
implemented in a consistent and interoperable manner across the
suite of HL7 standards. See http://hl7tsc.org/wiki/index.php?title=TSC_Minutes_and_Agendas. And through an S&I
Framework Structured Data Capture Initiative, ONC, AHRQ, FDA, and
NLM are collaborating with industry stakeholders to include UDI data
for devices in health IT adverse event reporting. See http://wiki.siframework.org/Structured+Data+Capture+Initiative. AHRQ has
already incorporated UDI and associated data attributes in its
Common Formats for adverse event reporting. See AHRQ Data
Dictionary, Common Formats Hospital Version 1.2, at 87, available at
https://www.psoppc.org/c/document_library/get_file?p_l_id=375680&folderId=431263&name=DLFE-15061.pdf.
\53\ http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm427496.htm; see also 21 U.S.C. 360i(f).
---------------------------------------------------------------------------

To meet this criterion, a Health IT Module would have to enable a
user to record, change, and access a patient's implantable device list,
which would consist solely of one or more UDIs associated with a
patient's implantable devices. The Health IT Module would also have to
be able to parse the following data elements from a UDI:
Device Identifier;
Batch/lot number;
Expiration date;
Production date; and
Serial number.
In addition to parsing the UDI, a Health IT Module presented for
certification would have to be able to retrieve the optional ``device
description'' data element associated with the Device Identifier in the
GUDID, if the data element has been populated. This could be
accomplished using the GUDID's web interface, web services,
downloadable module, or any other method of retrieval permitted under
FDA's GUDID guidance.
For each UDI in a patient's implantable device list, a Health IT
Module presented for certification would have to enable a user to
access the UDI and the data elements identified above (including the
``device description,'' if it exists). Also, in addition to enabling a
user to record and access UDIs for a patient's implantable devices and
as noted above, a Health IT Module would be required to provide the
capability to change UDIs from a patient's implantable device list in
order to meet this criterion. This functionality would allow a user to
delete erroneous or duplicative entries from a patient's implantable
device list and update the list in the event that a device were removed
from the patient. We seek comment on whether such functionality is
necessary and whether there is a safer or more effective way to
maintain the accuracy of this information.
We believe that, in addition to capturing UDIs, health IT should
facilitate the exchange of UDIs in order to increase the overall
availability and reliability of information about patients' implantable
and other devices. Therefore, we propose in a later section of this
rule to include the 2015 Edition ``implantable device list''
certification criterion in the 2015 Edition Base EHR definition and
propose to include a patient's unique device identifier(s) as data
within the Common Clinical Data Set definition for certification to the
2015 Edition. Please see section III.B of this preamble for further
discussion of these associated proposals.
We have also proposed to modify Sec. 170.102 to include new
definitions for ``Device Identifier,'' ``Implantable Device,'' ``Global
Unique Device Identification Database (GUDID),'' ``Production
Identifier,'' and ``Unique Device Identifier.'' This will prevent any
ambiguity in interpretation and ensure that each term's specific
meaning reflects the same meaning given to them in the Unique Device
Identification System final rule and in 21 CFR 801.3. Capitalization
was purposefully applied

[[Page 16826]]

to each word in these defined phrases in order to signal to readers
that they have specific meanings. Please see section III.B of this
preamble for further discussion of these associated proposals.
In several respects the scope of this proposed implantable device
list criterion is narrower than the criterion we proposed in the
Voluntary Edition proposed rule. We received comments in response to
the Voluntary Edition proposed rule recommending clear standards and
use cases for an ``implantable device list'' criterion. With
consideration of these comments, unlike in the Voluntary Edition
proposed rule, we do not propose that health IT certified to the 2015
Edition ``implantable device list'' criterion be required to exchange
or display contextual information (such as a procedure note) associated
with a UDI because we believe additional standards and use case
development will be needed to support these capabilities. We request
comment on whether we have overlooked the need for or feasibility of
requiring this functionality.
We also do not propose any requirements on health IT to facilitate
the ``capture'' of UDIs at the point of care. As discussed above, UDIs
may initially be captured in any of a variety of clinical and non-
clinical contexts, many of which are beyond the current scope of health
IT certified under the ONC Health IT Certification Program. Prescribing
a requirement for capturing UDIs in certified health IT would also be
complicated by the range of data capture tools permitted under the UDI
final rule, including several different types of AIDC technology.
Moreover, as several commenters pointed out in response to our proposal
in the Voluntary Edition proposed rule, only a subset of certified
health IT users--generally surgeons or other clinicians who perform or
assist with operations involving implantable devices--would have a need
for such data capture functionality, and presumably health IT
developers who specialize in health IT for these settings can develop
appropriate solutions for these users.
Given the scope of our program and the current state of UDI
adoption, we do not believe that it would be useful to address these
``upstream'' issues at this time through rulemaking. Hence our proposal
focuses on: (1) Ensuring that certified health IT can record and
exchange UDIs for implantable devices as part of a patient's core
electronic health record using appropriate standards for
interoperability and exchange so that regardless of how UDIs are
captured, they can be readily integrated with patients' electronic
health records; (2) providing all users of certified health IT with the
ability to access basic information about patients' implantable
devices, thereby promoting greater awareness of and stimulating
additional demand for UDIs and UDI-related capabilities in health IT;
and (3) encouraging health IT developers to begin implementing GUDID
functionality. We believe that focusing on these three areas of
baseline UDI functionality will provide the greatest value to our
stakeholders and efforts to promote adoption of UDIs and realize the
significant benefits of UDIs and FDA's Unique Device Identification
System described in this proposal.
Social, Psychological, and Behavioral Data

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(21) (Social, psychological, and behavioral data)
------------------------------------------------------------------------

We propose a new 2015 Edition ``social, psychological, and
behavioral data'' certification criterion that would require a Health
IT Module to be capable of enabling a user to record, change, and
access a patient's social, psychological, and behavioral data based on
SNOMED CT[supreg] and LOINC[supreg] codes. This would include the
ability to record a patient's decision not to provide the information.
An individual's health is shaped largely by life circumstances that
fall outside the traditional health care system and include social,
psychological, and behavioral factors. These factors include, but are
not limited to, family support systems, stress, housing, nutrition,
income, and education. This proposed certification criterion to further
the collection and use of such patient data is not intended to be
comprehensive; rather, it reflects efforts to further HHS priorities to
transform health delivery, to reduce health disparities, and to achieve
the overarching goals of the National Quality Strategy. In particular,
the proposed certification criterion supports efforts to reduce
disparities and efforts to collect patient social, psychological, and
behavioral data for improved health care, such as by aligning with
recommendations from HHS and the Institute of Medicine.\54\
---------------------------------------------------------------------------

\54\ U.S. Department of Health and Human Services, Office of
Minority Health, 2011, HHS Action Plan to Reduce Racial and Ethnic
Disparities: A Nation Free of Disparities in Health and Health Care
(available at: http://www.minorityhealth.hhs.gov/npa/files/Plans/HHS/HHS_Plan_complete.pdf); U.S. Department of Health and Human
Services, Office of the Assistant Secretary for Planning and
Evaluation, 2011, Implementation Guidance on Data Collection
Standards for Race, Ethnicity, Sex, Primary Language, and Disability
Status (available at: http://aspe.hhs.gov/datacncl/standards/ACA/4302/index.pdf); and Institute of Medicine (IOM), November 2014,
Washington, DC, The National Academies Press, 2014, Capturing Social
and Behavioral Domains and Measures in Electronic Health Records:
Phase 2 (available at: http://iom.edu/Reports/2014/EHRdomains2.aspx).
---------------------------------------------------------------------------

We believe that offering certification that would require a Health
IT Module to enable a user to record, change, and access a patient's
social, psychological, and behavioral data would assist a wide array of
stakeholders (e.g., providers, consumers, payors, community-based
organizations, and state and local governments) in better understanding
how this data may adversely affect health. Ultimately, this can lead to
better health outcomes for these populations through improved patient
care, quality improvement, health equity, and clinical decision support
based on individual factors.
We also believe the self-reporting of information by individuals in
response to the questions included in these social, psychological, and
behavioral measures (i.e., the question and answer sets below) could be
utilized for the EHR Incentive Programs Stage 3 which proposes an
objective on patient engagement, including patient-generated health
data. For more information, please refer to the EHR Incentive Programs
Stage 3 proposed rule published elsewhere in this issue of the Federal
Register.
We have heard from many stakeholders recommending that we
prioritize the use of available measures and instruments for the
structured recording of social, psychological, and behavioral data, and
have followed those recommendations here. The measures (questions and
answers sets below) will have LOINC[supreg] codes (or in the case of
sexual orientation and gender identity, SNOMED CT[supreg] codes for the
answers--but no specific questions) used to identify them. Therefore,
we propose, for certification to this criterion, that social,
psychological, and behavioral data be coded in accordance with, at a
minimum, version 2.50 of LOINC[supreg] as attributed in the table
below.\55\ Please note that some question-answer sets for specific
domains do not currently have a LOINC[supreg] code in place; in these
instances it is expected that LOINC[supreg] codes will be established
in a newer version of LOINC[supreg] prior to the

[[Page 16827]]

publication of a subsequent final rule. Please further note that we
propose to include sexual orientation and gender identity within this
certification criterion as described after this table.
---------------------------------------------------------------------------

\55\ We refer readers to section III.A.2.d (``Minimum
Standards'' Code Sets) for further discussion of our adoption of
LOINC[supreg] as a minimum standards code set and our proposal to
adopt version 2.50, or potentially a newer version if released
before a subsequent final rule, as the baseline for certification to
the 2015 Edition.

----------------------------------------------------------------------------------------------------------------
LOINC[supreg]
Question(s) Answer(s) Codes for question- LOINC[supreg]
Domain [LOINC[supreg] [LOINC[supreg] answer list Answer list ID
name] answer code] combination
----------------------------------------------------------------------------------------------------------------
Financial Resource Strain How hard is it for For example: Very LOINC[supreg] code LOINC[supreg] code
(Overall financial resource you to pay for hard, Somewhat pending. pending.
strain from CARDIA). the very basics hard, Not hard,
like food, at all.\56\
housing, medical
care, and
heating? Would
you say it is . .
.
Education (Educational What is the [0] Never attended/ 63504-5........... LL1069-5.
attainment). highest level of kindergarten only.
school you have [1] 1st grade.....
completed or the [2] 2nd grade.....
highest degree [3] 3rd grade.....
you have [4] 4th grade.....
received? \57\ [5] 5th grade.....
[6] 6th grade.....
[7] 7th grade.....
[8] 8th grade.....
[9] 9th grade.....
[10] 10th grade...
[11] 11th grade...
[12] 12th grade,
no diploma.
[13] High school
graduate.
[14] GED or
equivalent.
[15] Some college,
no degree.
[16] Associate
degree:
occupational,
technical, or
vocational
program.
[17] Associate
degree; academic
program.
[18] Bachelor's
degree (e.g., BA,
AB, BS).
[19] Master's
degree (e.g., MA,
MS, MEng, MEd,
MSW, MBA).
[20] Professional
school degree
(example: MD,
DDS, DVM, JD).
[21] Doctoral
degree (example:
PhD, EdD).
[77] Refused......
[99] Don't know...
Stress (from Elo et al) \58\.... Stress means a For example: LOINC[supreg] code LOINC[supreg] code
situation in Likert scale pending. pending.
which a person ranging from 1--
feels tense, indicating not at
restless, all, 2--a little
nervous, or bit, 3--somewhat,
anxious, or is 4--quite a bit,
unable to sleep to 5--indicating
at night because very much.
his/her mind is
troubled all the
time. Do you feel
this kind of
stress these
days?
Depression (PHQ-2).............. [Patient Health N/A............... 55757-9........... N/A.
Questionnaire 2
item (PHQ-2)
[Reported]].
Little interest or [0] Not at all, 44250-9........... LL358-3.
pleasure in doing [1] Several days,
things in last 2 [2] More than
weeks half the days,
[Reported.PHQ]. [3] Nearly every
day.
Feeling down, [0] Not at all, 44255-8........... LL358-3.
depressed or [1] Several days,
hopeless in last [2] More than
2 weeks half the days,
[Reported.PHQ]. [3] Nearly every
day.
[Patient Health For example: 0-6.. 5578-7............ Answer is in UCUM
Questionnaire 2 units.\59\
item (PHQ-2)
total score
[Reported]].
Physical Activity (Exercise How many days of For example: 68515-6........... Answer is in UCUM
Vital Signs). moderate to 1,2,3,4,5,6,7, units.\60\
strenuous etc.
exercise, like a
brisk walk, did
you do in the
last 7 days?
[SAMHSA].
On those days that For example: 10, 68516-4........... Answer is in UCUM
you engage in 20, etc. units.
moderate to
strenuous
exercise, how
many minutes, on
average, do you
exercise?
[SAMHSA].
Alcohol Use (AUDIT-C)........... [Alcohol Use N/A............... 72109-2........... N/A.
Disorder
Identification
Test--Consumption
[AUDIT-C].

[[Page 16828]]

How often do you [a] Never......... 68518-0........... LL2179-1.
have a drink [b] Monthly or
containing less.
alcohol? [SAMHSA]. [c] 2-4 times a
month.
[d] 2-3 times a
week.
[e] 4 or more
times a week.
How many standard [a] 1 or 2........ 68519-8........... LL2180-9.
drinks containing [b] 3 or 4........
alcohol do you [c] 5 or 6........
have on a typical [d] 7 to 9........
day? [SAMHSA]. [e] 10 or more....
How often do you [a] Never......... 68520-6........... LL2181-7.
have six or more [b] Less than
drinks on one monthly.
occasion? [c] Monthly.......
[SAMHSA]. [d] Weekly........
[e] Daily or
almost daily.
[Total score N/A \61\.......... .................. N/A.
[AUDIT-C]].
Social Connection and Isolation Are you married or For example, these LOINC[supreg] code LOINC[supreg] code
(NHANES III). living together categories form pending. pending.
with someone in a an ordinal scale
partnership at assessing the
the time of number of types
questioning? of social
In a typical week, relationships on
how many times do which a person is
you talk on the connected and not
telephone with isolated, and has
family, friends, standard scoring.
or neighbors?. Individuals
How often do you receive one point
get together with for each of the
friends or following: Being
relatives?. married or living
How often do you together with
attend church or someone in a
religious partnership at
services?. the time of
How often do you questioning,
attend meetings averaging three
of the clubs or or more social
organizations you interactions per
belong to?. week (assessed
with questions
one and two,
above), reporting
attending church
or other
religious
services more
than four times
per year
(assessed with
question three,
above), and
reporting that
they belong to a
club or
organization
(assess with
question four,
above). A score
of 0 represents
the highest level
of social
isolation and a
score of 4
represents the
lowest level of
social isolation.
\62\
Exposure to violence: Intimate Within the last Pending........... LOINC[supreg] code LOINC[supreg] code
partner violence (HARK 4Q). year, have you pending. pending.
been humiliated
or emotionally
abused in other
ways by your
partner or ex-
partner?
Within the last ..................
year, have you
been afraid of
your partner or
ex-partner?
Within the last ..................
year, have you
been raped or
forced to have
any kind of
sexual activity
by your partner
or ex-partner?
Within the last ..................
year, have you
been kicked, hit,
slapped, or
otherwise
physically hurt
by your partner
or ex-partner?
----------------------------------------------------------------------------------------------------------------

We propose to require that a Health IT Module enable a user to
record, change, and access a patient's sexual orientation and gender
identity as part of this certification criterion. We propose that
sexual orientation be coded in accordance with, at a minimum, the
September 2014 Release of the U.S. Edition of SNOMED CT[supreg] \63\
and HL7 Version 3 attributed as follows:
---------------------------------------------------------------------------

\56\ The answer is then scored from a scale of 1 (very hard) to
3 (not at all), and unknown answers are scored as a negative number.
\57\ LOINC[supreg] Component used for the table.
\58\ Elo, A.-L., A. Lepp[auml]nen, and A. Jahkola. 2003.
Validity of a single-item measure of stress symptoms. Scandanavian
Journal of Work, Environment & Health 29(6):444-451.
\59\ Note that LOINC[supreg] provides a translation table at
https://loinc.org/downloads/usage/units that enumerates the UCUM
syntax for a subset of UCUM codes that are commonly used in health
IT that may be a useful reference for stakeholders.
\60\ Note that LOINC[supreg] provides a translation table at
https://loinc.org/downloads/usage/units that enumerates the UCUM
syntax for a subset of UCUM codes that are commonly used in health
IT that may be a useful reference for stakeholders.
\61\ The Alcohol Use Disorders Identification Test C (AUDIT-C)
is scored on a scale of 0 to 12. Each of the three AUDIT-C questions
has 5 answer choices with points ranging from 0 to 4. A screen is
considered positive for unhealthy alcohol use or hazardous drinking
if the AUDIT-C score is 4 or more points for men or 3 or more points
for women.
\62\ Pantell et al., 2013.

[[Page 16829]]

------------------------------------------------------------------------
Sexual orientation Code
------------------------------------------------------------------------
Homosexual................................ SNOMED CT[supreg] 38628009.
Heterosexual.............................. SNOMED CT[supreg] 20430005.
Bisexual.................................. SNOMED CT[supreg] 42035005.
Other..................................... HL7 V3
nullFlavor OTH.
Asked but unknown......................... HL7 V3
nullFlavor ASKU.
Unknown................................... HL7 V3
nullFlavor UNK.
------------------------------------------------------------------------

We propose that gender identity be coded in accordance with, at a
minimum, the September 2014 Release of the U.S. Edition of SNOMED
CT[supreg] \64\ and HL7 Version 3 attributed as follows:
---------------------------------------------------------------------------

\63\ We refer readers to section III.A.2.d (``Minimum
Standards'' Code Sets) for further discussion of our adoption of
SNOMED CT[supreg] as a minimum standards code set and our proposal
to adopt the September 2014 Release (U.S. Edition), or potentially a
newer version if released before a subsequent final rule, as the
baseline for certification to the 2015 Edition.
\64\ We refer readers to section III.A.2.d (``Minimum
Standards'' Code Sets) for further discussion of our adoption of
SNOMED CT[supreg] as a minimum standards code set and our proposal
to adopt the September 2014 Release (U.S. Edition), or potentially a
newer version if released before a subsequent final rule, as the
baseline for certification to the 2015 Edition.

------------------------------------------------------------------------
Gender identity Code
------------------------------------------------------------------------
Identifies as male gender................. SNOMED CT[supreg]
446151000124109.*
Identifies as female gender............... SNOMED CT[supreg]
446141000124107.*
Female-to-male transsexual................ SNOMED CT[supreg] 407377005.
Male-to-female transsexual................ SNOMED CT[supreg] 407376001.
Identifies as non-conforming gender....... SNOMED CT[supreg]
446131000124102.*
Other..................................... HL7 V3
nullFlavor OTH.
Asked but unknown......................... HL7 V3
nullFlavor ASKU
------------------------------------------------------------------------
* These new concepts will appear in the March 2015 release of the U.S.
Edition of SNOMED CT[supreg] and are now viewable at https://uscrs.nlm.nih.gov/main.xhtml.

We note that the functionality under consideration to record the
data discussed above has no bearing on whether a patient chooses to
provide this information or whether a health care provider chooses to
record the information or would be required to do so through the EHR
Incentive Programs or other programs. However, we believe the
structured recording of these types of data as described is the best
available method for reliably capturing and maintaining accurate
reflections of this information. For this proposed certification
criterion, we seek comment on whether:
The appropriate measures have been included for the listed
social, psychological, and behavioral data;
There should be standardized questions associated with the
collection of sexual orientation and gender identity data (and if so,
what vocabulary standard would be best suited for coded these
standardized questions);
We should set a minimum number of data measures for
certification (e.g., at a minimum: One, 3, or all); and
These measures should be part of one certification
criterion or separate certification criteria. We note that our proposal
for an ``Open Data Certified Health IT Products List,'' as discussed in
section IV.D.3 of this preamble, would result in more granular
identification of certified health IT. Specific to this criterion, the
CHPL would include information regarding each of the data measures
(e.g., education, depression, and sexual orientation) that were
certified as part of a Health IT Module's certification to this
criterion.
Work Information--Industry/Occupation Data
The Institute of Medicine identified patients' work information as
valuable data that could be recorded by health IT and used by both
health care providers and public health agencies.\65\ Similarly, the
2012 HHS Environmental Justice Strategy and Implementation Plan echoed
the potential benefits of having work information in EHR
technology.\66\ The combination of industry and occupation (I/O)
information provides opportunities for health care providers to improve
patient health outcomes--for health issues wholly or partially caused
by work and for health conditions whose management is affected by work.
For example, ``Usual'' (longest-held) I/O information can be key for
health care improvement and population-based health investigations, and
is already a required data element for cancer reporting.\67\ Health
care providers also can use current I/O information to assess symptoms
in the context of work activities and environments, inform patients of
risks, obtain information to assist in return-to-work determinations,
and evaluate the health and informational needs of groups of patients.
---------------------------------------------------------------------------

\65\ IOM (Institute of Medicine). 2011. ``Incorporating
Occupational Information in Electronic Health Records: A Letter
Report''. Available at: http://www.nap.edu/catalog.php?record_id=13207.
\66\ U.S. Department of Health and Human Services. February,
2012. 2012 HHS Environmental Justice Strategy and Implementation
Plan. Available at: http://www.hhs.gov/environmentaljustice/strategy.html.
\67\ CDC (2) (Centers for Disease Control and Prevention). 2012.
Implementation Guide for Ambulatory Healthcare Provider Reporting to
Central Cancer Registries, HL7 Clinical Document Architecture (CDA)
Release 1.0, August 2012. Available at: http://www.cdc.gov/phin/library/guides/Implementation_Guide_for_Ambulatory_Healthcare_Provider_Reporting_to_Central_Cancer_Registries_August_2012.pdf.
---------------------------------------------------------------------------

Since publication of the Voluntary Edition proposed rule (79 FR
10924) in which we requested comment on I/O information for the
purposes of certification, we have considered health IT developer
feedback on the need to adopt consensus standards for capturing I/O
information in health IT and continue to work with the National
Institute for Occupational Health and Safety (NIOSH) to explore avenues
to record I/O data in health IT. NIOSH also continues to work with
various industry stakeholders and health IT developers to assess the
incorporation of patient I/O fields into commercial EHRs, develop
occupationally related CDS, and to investigate practices and systems to
achieve accurate, automated coding of I/O information. Given the value
of I/O information as noted above and the progress being made by NIOSH
and others, we are making a refined request for comments as part of a
future edition of certification criteria. We invite commenters to
consider what additional support might be needed for health IT
developers, implementers, and users to effectively include a
certification criterion that would require health IT to enable a user
to record, change, and access (all electronically) the following data
elements in structured format:
Patients' employment status and primary activities (e.g.,
volunteer work);
Patients' current I/O, linked to one another and with
time-stamp, including start date;
Patients' usual I/O, linked to one another and with time-
stamp, including start year and duration in years; and
Patients' history of occupation with a time and date stamp
for when the history was collected (to note, this is focused on the
capability to record a history, not a requirement that a history must
be recorded or that a patient history be recorded for a certain
historical period of time).
We solicit public comment on the experience health IT developers
and health care providers have had in recording, coding, and using I/O
data. This would include any innovation that is making I/O data more
useful for providers.
To better understand the health care needs associated with work
data, we specifically solicit public comment from health care
providers, provider

[[Page 16830]]

organizations, and patients on the following:
The usefulness for providers to be able to access current
and usual I/O and related data in the EHR, including whether additional
data elements, such as work schedule, are useful.
The usefulness of a history of positions provided as
current I/O, with data from each position time-stamped, linked,
retained, and accessible as part of the longitudinal patient care
(medical) record.
Narrative text (vs. codes) for both current and usual I/O.
CDC_Census codes for both current and usual I/O; available
through PHIN VADS at https://phinvads.cdc.gov/vads/SearchVocab.action.
SNOMED CT[supreg] codes for occupation (current codes or
potentially developed codes).
Other standards and codes that may be in use by the health
IT industry for both current and usual I/O.
U.S. Uniformed/Military Service Data
In the Voluntary Edition proposed rule (79 FR 10924), we outlined
rationale for a potential certification criterion that would assess the
capability of health IT to enable a user to record, change, and access
U.S. military service or all uniformed service (including commissioned
officers of the U.S. Public Health Service (USPHS) and the National
Oceanographic and Atmospheric Administration (NOAA) as they too are
eligible for military health services, veterans benefits, and related
services). We reiterate the rationale here as we continue to believe it
is persuasive for adopting such a certification criterion. In recent
years, U.S. Military service members have been returning from service
in Iraq and Afghanistan and other various combat duty stations. A
portion of these service members are returning with traumatic brain
injuries, major limb injuries, and diagnoses of post-traumatic stress
disorder as reported by the Department of Defense and Department of
Veterans Affairs. We believe recording U.S. uniformed/military service
information can have many benefits. It can help in identifying
epidemiological risks for patients such as those noted above. It can
assist in ensuring that a patient receives all the health care benefits
he or she is entitled to by alerting medical professionals to the
patient's service history, which can facilitate the coordination of
benefits. This information can also increase the ability to assemble a
longitudinal record of care for a U.S. service member, such as by
requesting or merging of a patient's electronic health record stored by
the Department of Defense, Veteran's Health Administration, and/or
another health care provider.
In response to the request for comment on a ``U.S. uniformed/
military service'' certification criterion in the Voluntary Edition
proposed rule, commenters indicated that vocabulary standards for
capturing such history may not be mature enough yet. Specifically,
commenters noted that SNOMED CT [supreg] currently has relevant codes,
such as ``history relating to military service,'' and ``duration of
military service,'' but not codes to cover all potential military
service statuses, capture military service in an unambiguous way (e.g.,
capturing current employed as well as history of military service) and
military service in foreign locales. To improve coding of military and
all uniformed history, we believe a promising path forward would be to
add codes to the U.S. Extension of SNOMED-CT [supreg]. Therefore, we
request comment on the following:
Whether a potential certification criterion should be
focused solely on U.S. military service or all uniformed service
members (e.g., commissioned officers of the USPHS and NOAA);
Whether the U.S. Extension of SNOMED-CT [supreg] is the
most appropriate vocabulary code set or whether other vocabulary code
sets may be appropriate; and
The concepts/values we should use to capture U.S. military
service or all uniformed service status. We ask commenters to consider
the work of NIOSH on I/O information as it relates to capturing
military service.
Other Social, Psychological, and Behavioral Data
We seek comment on whether there are additional social,
psychological, and behavioral data that we should include for
certification as well as the best available standards for representing
such data.
Decision Support--Knowledge Artifact

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(22) (Decision support--knowledge artifact)
------------------------------------------------------------------------

We propose a new ``decision support--knowledge artifact''
certification criterion in the 2015 Edition for technology to
electronically send and receive clinical decision support knowledge
artifacts in accordance with a Health eDecisions (HeD) standard.
A previous ONC-sponsored S&I initiative, HeD, defined two use cases
(UC) with the goals of expressing CDS interventions in a standardized
format for sharing (UC 1) and requesting/receiving knowledge artifacts
from a CDS service provider (UC 2). We discuss UC 2 further in the
proposal for a 2015 Edition ``decision support--service'' certification
criterion in this section of the preamble. HeD UC 1 defined the
functional requirements needed to build a standard schema for the
contents of three ``CDS Knowledge Artifact'' \68\ types: event
condition action (ECA) rules, order sets, and documentation
templates.\69\ UC 1 was based on the scenario of a ``CDS Knowledge
Artifact supplier'' making a computable CDS Knowledge Artifact
available to a ``CDS Artifact integrator.'' For example, in accordance
with the HeD standard, health IT could automatically integrate
medication order sets based on best practice clinical guidelines in a
machine-readable format without the need for human interpretation.
---------------------------------------------------------------------------

\68\ A CDS Knowledge Artifact is the encoding of structured CDS
content as a rule to support clinical decision making in many areas
of the health care system, including quality and utilization
measures, disease outbreaks, comparative effectiveness analysis,
efficacy of drug treatments, and monitoring health trends.
\69\ HL7 Implementation Guide: Clinical Decision Support
Knowledge Artifact Implementation Guide, Release 1 (January 2013)
(``HeD standard'').
---------------------------------------------------------------------------

In the Voluntary Edition proposed rule, we proposed to adopt the
HL7 Implementation Guide: Clinical Decision Support Knowledge Artifact
Implementation Guide, Release 1 (January 2013) (``HeD standard'').\70\
We stated that the HeD standard would greatly assist the industry in
producing and sharing machine-readable files for representations of
clinical guidance. We did not adopt the HeD standard as we agreed with
commenters that more clarity is needed regarding the HeD proposals (79
FR 54453).
---------------------------------------------------------------------------

\70\ http://wiki.siframework.org/file/detail/implementation_guide_working_final_042413_lse_uploaded-1.docx.
---------------------------------------------------------------------------

As the HeD initiative has completed, a new S&I initiative has
launched, the Clinical Quality Framework (CQF), which builds on the HeD
work and expands the scope to harmonize both CDS and electronic
clinical quality measurement (eCQM) standards. The CQF initiative has
created an updated and more modular HeD implementation guide for
sharing CDS artifacts, HL7 Version 3 Standard: Clinical Decision
Support Knowledge Artifact Specification, Release 1.2 DSTU (July
2014).\71\ The modularity allows for portions of the HeD standard
Release 1.2 to be updated without requiring updates

[[Page 16831]]

to the entire standard. As the CQF work continues, this more recent
standard will be leveraged heavily to produce a harmonized clinical
quality expression language for both CDS and eCQMs.
---------------------------------------------------------------------------

\71\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=337.
---------------------------------------------------------------------------

We continue to believe that the HeD standard would greatly assist
the industry in producing and sharing machine readable files for
representations of clinical guidance. We therefore propose to adopt the
HL7 Version 3 Standard: Clinical Decision Support Knowledge Artifact
Specification, Release 1.2 DSTU (July 2014) (``HeD standard Release
1.2'') at Sec. 170.204(d)(1) and offer testing and certification for
health IT demonstrate it can electronically send and receive a CDS
artifact formatted in the HeD standard Release 1.2.
We solicited comment in the Voluntary Edition proposed rule on what
we should test and certify to when it comes to testing and
certification for acceptance and incorporation of CDS Knowledge
Artifacts (79 FR 54453). Commenters suggested that we focus testing on
a few types of CDS Knowledge Artifacts, but not on all possible types
included in the HeD standard. We note that HHS is developing publicly
available CDS interventions in HL7 draft standard formats,\72\
including the HeD standard Release 1.2, that will be available at
www.ushik.org. We welcome comment on specific types of CDS Knowledge
Artifacts on which we should focus testing and certification to the HeD
standard Release 1.2. We also invite comments on versions of standards
we should consider as alternative options, or for future versions of
this certification criterion, given the ongoing work to harmonize CDS
and quality measurement standards as discussed under the ``CQM--record
and export'' certification criterion later in this section of the
preamble.
---------------------------------------------------------------------------

\72\ This site may also include CDS interventions formatted to
the Quality Improvement and Clinical Knowledge Model (QUICK)
standard which we discuss in the preamble for the ``Clinical quality
measures--record and export'' certification criterion.
---------------------------------------------------------------------------

Decision Support--Service

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(a)(23) (Decision support--service)
------------------------------------------------------------------------

We propose a new ``decision support--service'' certification
criterion in the 2015 Edition for technology to electronically make an
information request with patient data and receive in return electronic
clinical guidance in accordance with the standard in accordance with an
HeD standard.
A previous ONC-sponsored S&I initiative, HeD, defined two use cases
(UC) with the goals of expressing CDS interventions in a standardized
format for sharing (HeD UC 1) and requesting/receiving knowledge
artifacts from a CDS service provider (HeD UC 2). We discuss HeD UC 1
further in the proposal for a 2015 Edition ``decision support--
knowledge artifact'' certification criterion above. HeD UC 2 defines
the interface requirements needed to send patient data and receive CDS
guidance based on one scenario: a request for clinical guidance made to
a CDS guidance supplier. The HeD S&I initiative considered the
following interactions with a CDS guidance supplier: Drug dosing
calculation; immunization forecasting; disease management; quality
measure evaluation; transition of care support; test appropriateness
scores (e.g., radiology tests); prediction rule evaluation (e.g.,
APACHE score, AHRQ Pneumonia Severity Index); and severity of illness
assessment (e.g., Charlson Index). The HeD initiative created the HL7
Implementation Guide: Decision Support Service, Release 1--US Realm
DSTU (January 2014) (``Decision Support Service IG''),\73\ which
defines SOAP and REST web service interfaces for CDS guidance services.
---------------------------------------------------------------------------

\73\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=334.
---------------------------------------------------------------------------

We proposed to adopt the Decision Support Service IG in the
Voluntary Edition proposed rule because the implementation of this IG
would promote systems whereby a health care provider can send a query
about a patient to a CDS guidance supplier and receive CDS guidance
back in near real-time. Although we received general support for
adopting the Decision Support Service IG, we did not adopt it because
the 2014 Edition Release 2 final rule focused on the adoption and
revision of a small number of 2014 Edition certification criteria that
add flexibility and make improvements to the existing set of 2014
Edition certification criteria.
We are aware of a more recent release of the Decision Support
Service IG, HL7 Implementation Guide: Decision Support Service, Release
1.1 (March 2014), US Realm DSTU Specification (``Release 1.1'').\74\
Release 1.1 utilizes the latest available version of the HL7 Virtual
Medical Record specification. Given the general support we received in
the Voluntary Edition proposed rule, we propose to adopt the HL7
Implementation Guide: Decision Support Service, Release 1.1 (March
2014), US Realm DSTU Specification at Sec. 170.204(e)(1) and offer
testing and certification for health IT to demonstrate the ability to
send and receive electronic clinical guidance according to the
interface requirements defined in Release 1.1. We also invite comments
on versions of standards we could consider as alternative options, or
for future versions of this certification criterion, given the ongoing
work to harmonize CDS and quality measurement standards as discussed
under the ``CQM--record and export'' certification criterion later in
this section of the preamble.
---------------------------------------------------------------------------

\74\ http://www.hl7.org/documentcenter/public/standards/dstu/HL7_DSS_IG%20_R1_1_2014MAR.zip.
---------------------------------------------------------------------------

Transitions of Care

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(1) (Transitions of care)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition certification criterion for
``transitions of care'' (ToC) that is a continuation and extension of
the ToC certification criterion adopted as part of the 2014 Edition
Release 2 final rule at Sec. 170.314(b)(8). This proposed criterion
also reflects the corresponding structural and clarifying changes that
we adopted in the 2014 Edition Release 2 final rule that correspond to
``clinical information reconciliation and incorporation'' certification
criterion also adopted as part of the 2014 Edition final rule.
Accordingly, the 2015 Edition ToC certification criterion we
propose to adopt would include many of the same capabilities adopted at
Sec. 170.314(b)(8) with the exception of the following revisions and
additions.
Updated C-CDA Standard
As expressed in the 2014 Edition final rule, the C-CDA standard is
now the single standard permitted for certification and the
representation of summary care records. It is also referenced in other
proposed 2015 Edition certification criteria. Industry stakeholders
have continued to work to improve and refine the C-CDA standard since
the 2014 Edition final rule, including publishing additional guidance
for its consistent implementation.\75\ An updated version, HL7
Implementation Guide for CDA[supreg] Release 2: Consolidated CDA
Templates for Clinical Notes (US Realm), Draft

[[Page 16832]]

Standard for Trial Use, Release 2.0,\76\ which was balloted through
2014, includes the following changes, which we believe provide
important clarifications and enhancements:
---------------------------------------------------------------------------

\75\ http://wiki.siframework.org/Companion+Guide+to+Consolidated+CDA+for+MU2.
\76\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=379. Access to the IG is freely
available for review during the public comment period by
establishing an HL7 user account.
---------------------------------------------------------------------------

Addition of new structural elements: new document sections
and data entry templates:
[cir] New Document Templates for: Care Plan; Referral Note;
Transfer Summary.
[cir] New Sections for: Goals; Health Concerns; Health Status
Evaluation/Outcomes; Mental Status; Nutrition; Physical Findings of
Skin.
[cir] New organizers and many new entries (e.g. Wound Observation).
Some sections/entries were deprecated (i.e., should no
longer be used).
Updates to (versioning of) template/section/entry object
identifiers (OIDs).
[cir] This includes a new chapter describing HL7's approach to
template versioning.
Tighter data constraints/requirements.
[cir] For example, some data elements with a ``MAY'' requirement
now have a ``SHOULD'' requirement. Likewise, some with a ``SHOULD''
requirement now have a ``MUST'' requirement.
Updated Vocabulary/Value Set constraints.
[cir] For example: two SNOMED CT [supreg] codes were added to the
Current Smoking Status value set and the Tobacco Use value set to
support the 2014 Edition vocabulary requirements for patient smoking
status.
[cir] NLM's Value Set Authority Center (VSAC) was named as
reference for Value Sets used in C-CDA.
In the Voluntary Edition proposed rule, we proposed to adopt the C-
CDA Release 2.0 standard and reference its use in the other
certification criteria in which this standard would have also been
applicable. At the time of that proposal, the C-CDA Release 2.0 had not
yet completed its balloting cycle within HL7 and stakeholder comments
on the Voluntary Edition proposed rule expressed concern related to the
C-CDA Release 2.0 standard's stability. Given that the C-CDA Release
2.0 has completed balloting and is now published as the next C-CDA
version, we believe that the continued attention it received through
HL7 balloting has resulted in a standard that is the best available for
adoption in this proposed rule and for future implementation in the
coming years. Thus, we propose to adopt C-CDA Release 2.0 at Sec.
170.205(a)(4) as part of this certification criterion. We note that
compliance with the C-CDA Release 2 cannot include the use of the
``unstructured document'' document-level template for certification to
this criterion.
To address a technical implementation challenge sometimes referred
to as ``bilateral asynchronous cutover,'' (which is meant to convey the
complexity of continued interoperability among exchange partners as
each upgrades their health IT at different times and with different
standards capabilities), we propose that the 2015 Edition ToC
certification criterion reference both the C-CDA Release 1.1 and
Release 2.0 standards. In other words, a Health IT Module presented for
certification to this criterion would need to demonstrate its
conformance and capability to create and parse both versions (Release
1.1 and 2.0) of the C-CDA standards. Under this proposal, the sending
Health IT Module would send two documents (one conforming to C-CDA R1.1
and other conforming to C-CDA R2.0) and the receiving Health IT Module
would receive both versions of the documents and choose the appropriate
version for downstream processing.
While we recognize that this proposal is not ideal, we have
proposed this more conservative approach as a way to mitigate the
potential that there would be interoperability challenges for ToC as
different health care providers adopt Health IT Modules certified to
the 2015 Edition criterion at different times that include C-CDA
Release 2.0 capabilities. However, we request public comment,
especially from health IT developers with experience implementing the
C-CDA, on an alternative approach related to the creation of C-CDA-
formatted documents. The alternative approach would be focused on C-CDA
creation and receipt capabilities related to whether the health IT
system could produce one, ``dually compliant,'' C-CDA that addresses
both C-CDA versions at once. We understand that this approach is
possible, may be preferred from an implementation perspective, and
could help prevent potential data duplication errors that could result
if a Health IT Module is required to be able to produce two separate C-
CDA files (one in each version) as part of certification.
Our proposal to adopt C-CDA Release 2.0 is applicable to all of the
other certification criteria in which the C-CDA is referenced.
Similarly, unless C-CDA Release 2.0 is explicitly indicated as the sole
standard in a certification criterion, we propose to reference both C-
CDA versions in each of these criteria for the reasons just discussed.
Valid/Invalid C-CDA System Performance
As we considered stakeholder feedback and reviewed the additional
public dialogue surrounding the variability of CEHRT in recognizing
valid/invalid documents formatted according to the C-CDA 1.1 standard,
including structured content by different health IT developers,\77\ we
recognized that an expanded ToC certification criterion with a specific
capability focused principally on health IT system behavior and
performance related to recognizing valid/invalid C-CDAs would be
beneficial. Thus, we propose to include within the 2015 Edition ToC
certification criterion a specific focus on this technical system
behavior. We believe this type of error checking and resilience is an
important and necessary technical prerequisite in order to ensure that
as data in the system is parsed from a C-CDA for incorporation as part
of the ``clinical information reconciliation and incorporation''
certification criterion the user can be assured that the system has
appropriately interpreted the C-CDA it received. Further, we believe
this level of rigorous testing will better enable Health IT Modules to
properly recognize C-CDA-based documents and prepare the necessary
information for reconciliation and other workflow needs.
---------------------------------------------------------------------------

\77\ D'Amore JD, et al. J Am Med Inform Assoc 2014;21:1060-1068.
---------------------------------------------------------------------------

We propose that this specific aspect of the certification criterion
would focus on and require the following technical outcomes be met. The
Health IT Module would need to demonstrate the ability to detect valid
and invalid C-CDA documents, including document, section, and entry
level templates for data elements specified in 2014 and 2015 edition.
Specifically, this would include:
The ability of the Health IT Module to detect invalid C-
CDA documents. Thus, any data in the submitted C-CDA document that does
not conform to either the C-CDA 1.1 or 2.0 standard (in addition to
data coding requirements specified by this regulation) would be
considered invalid;
The ability to identify valid C-CDA document templates
(e.g., CCD, Discharge Summary, Progress Note) and process the required
data elements, section and entries, specific to the document templates
and this regulation.
The ability to detect invalid vocabularies and codes not
specified in

[[Page 16833]]

either the C-CDA 1.1 or 2.0 standard or required by this regulation
(e.g., using a SNOMED CT [supreg] code where a LOINC [supreg] code is
required or using a code which does not exist in the specified value
set).
The ability to correctly interpret empty sections and
nullFlavor combinations per the C-CDA 1.1 or 2.0 standard. For example,
we anticipate testing could assess a Health IT Module's ability to
continue to process a C-CDA when a nullFlavor is used at the section
template level.
We expect these capabilities would be tested by providing several
C-CDA documents with valid and invalid data. We do not expect Health IT
Modules presented for certification to have a common C-CDA handling
process, however, we do expect that they would have a baseline
capability to identify valid and invalid C-CDA documents and prepare
the necessary data for clinical information reconciliation and
incorporation. Further, we expect that Health IT Modules will have some
mechanism to track errors encountered when assessing received C-CDA's
and we have proposed that health IT be able to track the errors
encountered and allow for a user to be notified of errors or review the
errors produced. The Health IT Module would not need to support both
and how this technical outcome is accomplished is entirely up to the
health IT developer.
We direct readers to the proposed ``Consolidated CDA creation
performance'' certification criterion (Sec. 170.315(g)(6)) under which
we seek comment on a potential requirement for this certification
criterion or the ``Consolidated CDA creation performance''
certification criterion that would evaluate the completeness of the
data included in a C-CDA in order to ensure that the data recorded by
health IT is equivalent to the data included in a created C-CDA.
XDM Package Processing
As indicated in the earlier paragraphs, a Health IT Module
presented for certification to this certification criterion will need
to support one of the edge protocols referenced in the Edge IG version
1.1 (i.e., the ``IHE XDR profile for Limited Metadata Document
Sources'' edge protocol or an SMTP-focused edge protocol (SMTP alone or
SMTP in combination with either IMAP4 or POP3)). However industry
feedback has indicated that the use of XDM packages has grown within
the stakeholder community using Direct, which most often happens when
Edge System A using XDR sends content and metadata to its HISP-A, who
in turn packages that content and metadata into an XDM ZIP and sends it
within a Direct message to HISP-B, which then ultimately sends the
message containing the XDM package to Edge System B using an SMTP-based
edge.
Therefore, if Edge System B does not support XDM package
processing, interoperability could be impacted when HISP-B forwards XDM
packages to Edge System B via the SMTP protocol. To mitigate this
potential incompatibility, we propose to include a specific capability
in this certification criterion that would require a Health IT Module
presented for certification that is also being certified to the SMTP-
based edge to demonstrate its ability to accept and process an XDM
package it receives, which would include extracting relevant metadata
and document(s). That is, this additional requirement only applies to a
Health IT Module presented for certification with an SMTP-based edge
implementation and not an XDR edge implementation). Additionally,
because we expect XDM packaging to be created in accordance with the
specifications included in IHE IT Infrastructure Technical Framework
Volume 2b (ITI TF-2b),\78\ we propose to adopt this as the standard (at
Sec. 170.205(p)(1)) for assessing whether the XDM package was
successfully processed.
---------------------------------------------------------------------------

\78\ http://www.ihe.net/Technical_Framework/upload/IHE_ITI_TF_Rev7-0_Vol2b_FT_2010-08-10.pdf.
---------------------------------------------------------------------------

Common Clinical Data Set
We propose to include an updated Common Clinical Data Set for the
2015 Edition that includes references to new and updated vocabulary
standards code sets. Please also see the Common Clinical Data Set
definition proposal in section III.B.3 of this preamble.
Encounter Diagnoses
For encounter diagnoses, we are carrying over the requirement from
the 2014 Edition ``ToC'' certification criterion that a Health IT
Module must enable a user to create a transition of care/referral
summary that also includes encounter diagnoses using either SNOMED CT
[supreg] (September 2014 Release of the U.S. Edition as a baseline for
the 2015 Edition) or ICD-10 codes.
``Create'' and Patient Matching Data Quality
In 2011, both the HITPC and HITSC made recommendations to ONC on
patient matching. The HITPC made recommendations in the following five
categories: Standardized formats for demographic data fields;
internally evaluating matching accuracy; accountability; developing,
promoting and disseminating best practices; and supporting the role of
the individual/patient.\79\ The HITSC made the following four
recommendations: Detailing patient attributes that could be used for
matching (in order to understand the standards that are needed); data
quality; formats for these data elements; and what data are returned
from a match request.\80\ The standards recommended by the HITSC are as
follows:
---------------------------------------------------------------------------

\79\ http://www.healthit.gov/sites/default/files/hitpc-transmittal-letter-priv-sectigerteam-020211.pdf.
\80\ http://www.healthit.gov/FACAS/sites/default/files/standards-certification/8_17_2011Transmittal_HITSC_Patient_Matching.pdf.
---------------------------------------------------------------------------

Basic Attributes: Given Name; Last Name; Date of Birth;
Administrative Gender.\81\
---------------------------------------------------------------------------

\81\ Despite its inclusion of the word ``gender,''
``Administrative Gender'' is generally used in standards to
represent a patient's ``sex,'' such as male or female. See: http://ushik.ahrq.gov/ViewItemDetails?system=hitsp&itemKey=83680000.
---------------------------------------------------------------------------

Other Attributes: Insurance Policy Number; Medical Record
Number; Social Security Number (or last 4 digits); Street Address;
Telephone Number; Zip Code.
Potential Attributes: Email Address; Voluntary
Identifiers; Facial Images; Other Biometrics.
In July 2013, ONC launched an initiative to reinvigorate public
discussion around patient matching, to perform a more detailed analysis
of patient matching practices, and to identify the standards, services,
and policies that would be needed to implement the HITPC and HITSC's
recommendations. The initiative's first phase focused on a common set
of patient attributes that could be leveraged from current data and
standards referenced in our certification criteria. Given the initial
findings, we proposed to include a limited set of standardized data as
a part of the ``Create'' portion of the ToC criterion in the Voluntary
Edition proposed rule to improve the quality of the data included in
outbound summary care records. Overall, the vast majority of commenters
supported the proposed policy that standardized patient attributes
should be required for use in as part of the transitions of care
certification criterion. Commenters overwhelmingly supported the
inclusion of the proposed constrained specifications for last name/
family name, maiden name, suffix, first/given name, middle/second name,
maiden name, date of birth, current address and historical address,
phone number, and sex in support of patient matching. However, given
our approach in the 2014 Edition Release 2 final rule

[[Page 16834]]

to only adopt a small subset of the proposed certification criteria to
provide flexibility, clarity, and enhance health information exchange,
we decided not adopted this proposal.
We again propose to include a limited set of standardized data as a
part of the ``Create'' portion of the ToC criterion in the 2015 Edition
to improve the quality of the data included in outbound summary care
records. To be clear, this proposal does not require a Health IT Module
to capture the data upon data entry, but rather at the point when the
data is exchanged (an approach commonly used for matching in HL7
transactions, IHE specifications,\82\ C-CDA specification, and the
eHealth Exchange). The proposed standardized data include: first name,
last name, middle name (including middle initial), suffix, date of
birth, place of birth, maiden name, phone number, and sex. In the
bulleted list below, we identify more constrained specifications for
some of the standardized data we propose. Based on our own research, we
do not believe that the proposed constraints to these data conflict
with the C-CDA. That being said, some proposed constraints may further
restrict the variability as permitted by existing specifications and
others may create new restrictions that do not currently exist within
the C-CDA. We propose that:
---------------------------------------------------------------------------

\82\ http://www.ihe.net/Technical_Frameworks/.
---------------------------------------------------------------------------

For ``last name/family name'' the CAQH Phase II Core 258:
Eligibility and Benefits 270/271 Normalizing Patient Last Name Rule
version 2.1.0 \83\ (which addresses whether suffix is included in the
last name field) be followed.
---------------------------------------------------------------------------

\83\ http://www.caqh.org/pdf/CLEAN5010/258-v5010.pdf.
---------------------------------------------------------------------------

For ``suffix,'' that the suffix should follow the CAQH
Phase II Core 258: Eligibility and Benefits 270/271 Normalizing Patient
Last Name Rule version 2.1.0 (JR, SR, I, II, III, IV, V, RN, MD, Ph.D.,
ESQ) \84\ and that if no suffix exists, the field should be marked as
null.
---------------------------------------------------------------------------

\84\ http://www.caqh.org/pdf/CLEAN5010/258-v5010.pdf.
---------------------------------------------------------------------------

For ``date of birth,'' that the year, month and date of
birth should be required fields while hour, minute and second should be
optional fields. If hour, minute and second are provided then either
time zone offset should be included unless place of birth (city,
region, country) is provided; in the latter local time is assumed. If
date of birth is unknown, the field should be marked as null.
For ``phone numbers,'' the ITU format specified in ITU-T
E.123 \85\ and ITU-T E.164 \86\ be followed and that the capture of
home, business, and cell phone numbers be allowed.\87\ Further, that if
multiple phone numbers are present in the patient's record, all should
be included in the C-CDA and transmitted.
---------------------------------------------------------------------------

\85\ http://www.itu.int/rec/T-REC-E.123-200102-I/e.
\86\ http://www.itu.int/rec/T-REC-E.164-201011-I/en.
\87\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=186.
---------------------------------------------------------------------------

For ``sex'' we propose to require developers to follow the
HL7 Version 3 Value Set for Administrative Gender and a nullFlavor
value attributed as follows: M (Male), F (Female), and UNK (Unknown).
While the Patient Matching Initiative's recommendations included
standardizing current and historical address, we have not included a
specific standardized constraint for that data at this time due to a
lack of consensus around the proper standard. In response to the
Voluntary Edition proposed rule, commenters also suggested that we
delay support for international standards for address until future
editions of certification criteria. To reiterate, the data we propose
for patient matching would establish a foundation based on leveraging
current data and standards in certification criteria. We welcome
comments on this approach and encourage health IT developers to
consider and support the use other patient data that would improve
patient matching for clinical care and many types of clinical research.
Direct Best Practices
In the past couple of years we have heard feedback from
stakeholders regarding health IT developers limiting the transmission
or receipt of different file types via Direct. We wish to remind all
stakeholders of the following best practices for the sharing of
information and enabling the broadest participation in information
exchange with Direct: http://wiki.directproject.org/Best+Practices+for+Content+and+Workflow.
Certification Criterion for C-CDA and Common Clinical Data Set
Certification
We note that no proposed 2015 Edition health IT certification
criteria includes just the C-CDA Release 2.0 and/or the Common Clinical
Data Set, particularly with the 2015 Edition not including a proposed
``clinical summary'' certification criterion as discussed later on in
this preamble. Health IT certified to simply the C-CDA Release 2.0 with
or without certification to the Common Clinical Data Set may be
beneficial for other purposes, including participation in HHS payment
programs. We request comment on whether we should adopt a separate 2015
Edition health IT certification criterion for the voluntary testing and
certification of health IT to the capability to create a summary record
formatted to the C-CDA Release 2.0 with or without the ability to meet
the requirements of the Common Clinical Data Set definition.
C-CDA Data Provenance Request for Comment
As the exchange of health data increases, so does the demand to
track the provenance of this data over time and with each exchange
instance. Confidence in the authenticity, trustworthiness, and
reliability of the data being shared is fundamental to robust privacy,
safety, and security enhanced health information exchange. The term
``provenance'' in the context of health IT refers to evidence and
attributes describing the origin of electronic health information as it
is captured in a health system and subsequently persisted in a way that
supports its lifespan. As described in the President's Council of
Advisors on Science and Technology (PCAST) Report ``Realizing the Full
Potential of Health Information Technology to Improve Healthcare for
Americans'' \88\, provenance includes information about the data's
source and the processing that the data has undergone. The report
refers to ``tagged data elements'' as units of data accompanied by a
``metadata tag'' that describes the attributes, provenance, and
required security protections of the data.
---------------------------------------------------------------------------

\88\ PCAST Report to the President: Realizing the Full Potential
of Health Information Technology to Improve Healthcare for
Americans: The Path Forward, http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdf.
---------------------------------------------------------------------------

In April 2014, ONC launched the Data Provenance Initiative within
the Standards and Interoperability (S&I) Framework to identify the
standards necessary to capture and exchange provenance data, including
provenance at time of creation, modification, and time of exchange.\89\
The stakeholder community represented a wide variety of organizations
including health IT developers; federal, state, and local agencies;
healthcare professionals; research organizations; payers; labs; and
individuals within academia. In the fall of 2014, the HL7 IG for CDA
Release 2: Data Provenance, Release 1 (US Realm) (DSTU) \90\ was
published. This IG

[[Page 16835]]

clarifies existing content from various standards within HL7 \91\ and
describes how provenance information for a CDA document in a health IT
system should be applied, and what vocabulary should be used for the
metadata. This includes provenance metadata in the CDA at the header,
section and entry levels. We seek comment on the maturity and
appropriateness of this IG for the tagging of health information with
provenance metadata in connection with the C-CDA. Additionally, we seek
comment on the usefulness of this IG in connection with certification
criteria, such as ToC and VDT certification criteria.
---------------------------------------------------------------------------

\89\ http://wiki.siframework.org/Data+Provenance+Initiative.
\90\ http://wiki.hl7.org/index.php?title=HL7_Data_Provenance_Project_Space and http://gforge.hl7.org/gf/project/cbcc/frs/?action=FrsReleaseBrowse&frs_package_id=240.
\91\ Standards including HL7 Clinical Documentation Architecture
Release 2 (CDA R2), HL7 Implementation Guide: Data Segmentation for
Privacy (DS4P), Release 1, and HL7 Version 2 Vocabulary &
Terminology Standards (all are normative standards).
---------------------------------------------------------------------------

Clinical Information Reconciliation and Incorporation

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(2) (Clinical information reconciliation and
incorporation)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``clinical information
reconciliation and incorporation'' certification criterion that is a
revised (but largely similar to the 2014 Edition Release 2) version of
the ``clinical information reconciliation and incorporation'' criterion
adopted at Sec. 170.314(b)(9).
Incorporation System Performance
As we considered public comments made after the 2014 Edition final
rule and reviewed the additional public dialogue surrounding the
variability of certified health IT in incorporating C-CDAs including
structured content by different health IT developers \92\, we
recognized the need to expand the existing ``clinical information
reconciliation and incorporation'' certification criterion to focus on
health IT system behavior and performance related to incorporating C-
CDAs including structured content. We believe that testing a Health IT
Module's capability to reconcile and incorporate, at a minimum:
problems, medications, and medication allergies from multiple C-CDAs
will improve the overall clinical effectiveness.
---------------------------------------------------------------------------

\92\ D'Amore JD, et al. J Am Med Inform Assoc 2014; 21:1060-
1068.
---------------------------------------------------------------------------

We expect that testing for this specific system performance would
include the ability to incorporate valid C-CDAs with variations of data
elements to be reconciled (e.g., documents with no medications,
documents having variations of medication timing data). In addition we
believe we can further strengthen this certification criterion by
proposing to require that a C-CDA be created based on the
reconciliation and incorporation process in order to validate the
incorporation results. We anticipate that the generated C-CDA would be
verified using test tools for conformance and can be checked against
the information that was provided to incorporate.
Accordingly, we propose that the following technical system
behavior and performance also be addressed as part of the clinical
information reconciliation and incorporation certification criterion:
The Health IT Module must demonstrate the ability to reconcile problem,
medication, and medication allergy data from valid C-CDAs (both Release
1.1. and 2.0) with variations of data elements to be reconciled and
then generate a conformant C-CDA document based on the reconciled
information. For example, a test could include assessing a Health IT
Module's capability to reconcile and incorporate medication information
with different timing information.
Electronic Prescribing (e-Prescribing)

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(3) (Electronic prescribing)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition certification criterion for e-
prescribing that is revised in comparison to the 2014 Edition ``e-
prescribing'' criterion (Sec. 170.314(b)(3)). First, for the purposes
of certification, we propose to require a Health IT Module to be able
to receive and respond to additional NCPDP SCRIPT Standard
Implementation Guide Version 10.6 (v10.6) transactions or segments,
namely Change Prescription, Refill Prescription, Cancel Prescription,
Fill Status, and Medication History. Second, for the purposes of
certification, we propose to require that a Health IT Module
demonstrate that directions for medication use transmitted as e-
prescriptions are codified in a structured format. Third, for the
purposes of certification, we propose to require a Health IT Module be
able to limit a user to e-prescribing all medications in the metric
unit standard only, follow NCPDP-recommended conventions for use of
leading zeroes before a decimal, and avoid use of trailing zeroes after
a decimal when e-prescribed.
e-Prescribing Transactions or Segments
For 2014 Edition testing and certification to this criterion, a
Health IT Module presented for certification must demonstrate that it
can create a new prescription according to the NCPDP SCRIPT v10.6 New
Prescription transaction (NEWRX). Stakeholders have recommended we
consider expanding testing to a greater number of NCPDP SCRIPT v10.6
transactions and segments in order to better facilitate prescriber and
pharmacist communications to provide better care for patients.
Stakeholders have indicated that there is variable uptake and
inconsistent implementation of the transactions in the NCPDP SCRIPT
Standard v10.6 despite their added value for patient safety and
improved communication between prescribers and pharmacists. In
consideration of stakeholder input, we propose to include additional
NCPDP SCRIPT v10.6 transactions in addition to the New Prescription
transaction for health IT testing and certification. We propose that
testing and certification would require a Health IT Module to
demonstrate the ability to send and receive end-to-end prescriber-to-
receiver/sender-to-prescriber transactions (bidirectional
transactions). The transactions and reasons for inclusion for testing
and certification are outlined in Table 3 below.

[[Page 16836]]

Table 3--Proposed Additional \93\ NCPDP SCRIPT v10.6 Transactions for Testing and Certification to e-Prescribing
Certification Criterion
----------------------------------------------------------------------------------------------------------------
NCPDP SCRIPT v10.6 transaction or Problem addressed/value in
segment Use case(s) testing for certification
----------------------------------------------------------------------------------------------------------------
Change Prescription (RXCHG, CHGRES).. Allows a pharmacist to request a Facilitates more efficient,
change of a new prescription or a standardized electronic
``fillable'' prescription. communication between
Allows a prescriber to respond to prescribers and pharmacists
pharmacy requests to change a for changing prescriptions.
prescription.
Cancel Prescription (CANRX, CANRES).. Notifies the pharmacist that a Facilitates more efficient,
previously sent prescription should be standardized electronic
canceled and not filled. communication between
prescribers and pharmacists
for cancelling
prescriptions.
Sends the prescriber
the results of a
prescription cancellation
request.
Refill Prescription (REFREQ, REFRES). Allows the pharmacist to request Facilitates more efficient,
approval for additional refills of a standardized electronic
prescription beyond those originally communication between
prescribed. prescribers and pharmacists
for refilling prescriptions.
Allows the prescriber to grant
the pharmacist permission to provide a
patient additional refills or decline to
do so.
Fill Status (RXFILL)................. Allows the pharmacist to notify the Allows the prescriber to know
prescriber about the status of a whether a patient has picked
prescription in three cases: 1) to notify up a prescription, and if
of a dispensed prescription, 2) to notify so, whether in full or in
of a partially dispensed prescription, 3) part. This information can
to notify of a prescription not inform assessments of
dispensed. medication adherence.
Medication History (RXHREQ, RXHRES).. Allows a requesting entity to Allows a requesting entity to
generate a patient-specific medication receive the medication
history request. history of a patient. A
The responding entity can respond prescriber may use this
with a patient's medication history, information to perform
including source, fill number, follow-up medication utilization
contact, date range, as information is review, medication
available. reconciliation, or other
medication management to
promote patient safety.
----------------------------------------------------------------------------------------------------------------

We solicit comment on including the proposed transactions and
segments for testing and certification to this certification criterion
as outlined in Table 3, and on the problems addressed/value in testing
for certification. We also solicit comment on the following issues:
---------------------------------------------------------------------------

\93\ We are proposing to keep the ``New Prescription''
transaction for testing and certification.
---------------------------------------------------------------------------

Other NCPDP SCRIPT v10.6 transactions that should be
considered for testing and certification, and for what use cases/value;
What factors we should consider for end-to-end prescriber-
to-receiver testing.
We also propose to adopt and include the February 2, 2015 monthly
version of RxNorm in this criterion as the baseline version minimum
standards code set for coding medications (see section III.A.2.d
(``Minimum Standards'' Code Sets) of this preamble).
Structured and Codified ``Sig''
Medications can be e-prescribed using a free text format, and
typically the instructions include the medication name, dose, route of
administration, frequency of administration, and other special
instructions. This set of prescribing instructions is referred to as
the ``Sig.'' In a free text format, non-standard or conflicting
language may be used that is not understood by the pharmacist filling
the prescription. Where systems do facilitate creation of the Sig, some
systems may auto-concatenate the field length and thus the tail end of
the Sig is lost. This has implications for communication between
prescribers and pharmacists as well as for patient safety. Prescribers
and pharmacists may have to engage in back-and-forth communication to
clarify what is intended in the Sig instructions. Therefore, there is
an opportunity to streamline prescriber-pharmacist communication, allow
more time for direct activities of patient care, and reduce confusion
during the pharmacy verification and dispensing processes.
We are aware that the NCPDP SCRIPT v10.6 standard includes
structured Sig segments that are used to codify the prescribing
directions in a structured format.\94\ Providing Sig instructions in a
structured format promotes accurate, consistent, and clear
communication of the prescribing information as intended by the
prescriber.
---------------------------------------------------------------------------

\94\ NCPDP's Structured and Codified Sig Format Implementation
Guide v1.2 is adopted within SCRIPT v10.6.
---------------------------------------------------------------------------

In one study of the structured and codified Sig within NCPDP SCRIPT
v10.5, the Sig format fully represented 95% of ambulatory prescriptions
tested.\95\ While we believe that the results of this study give an
indication of the scope of the structured and codified Sig within NCPDP
SCRIPT v10.5, we note that the Sig standard was tested in the lab
environment and not with live end-users. Stakeholders have also
indicated the limitations of the structured and codified Sig within
NCPDP SCRIPT v10.6 to represent all Sig instructions, particularly
complex Sigs requiring multi-step directions. For example, stakeholders
have noted that the Sig segment within the NCPDP SCRIPT v10.6 standard
limits the field length to 140 characters whereas later versions of the
NCPDP SCRIPT standard (from v201311 onward) have expanded the character
length to 1000. Despite these potential limitations, we see
standardizing and codifying the majority of routine prescriptions as a
means to promote patient safety as well as reduce disruptions to
prescriber workflow through a reduction in pharmacy call-backs.
---------------------------------------------------------------------------

\95\ Liu H, Burkhart Q and Bell DS. Evaluation of the NCPDP
Structured and Codified Sig Format for e-prescriptions. J Am Med
Inform Assoc. 2011 Sep-Oct;18(5):645-51.
---------------------------------------------------------------------------

We note the flexibility to create complex unstructured Sigs remains
through use of existing e-prescribing workflow and appropriate use of
the free text field. There is, however, low uptake of structured Sig
according to the NCPDP SCRIPT v10.6 standard, which includes a
combination of mandatory and conditional structured Sig segments.
We believe that medication Sig instructions should be codified in a

[[Page 16837]]

structured format for the benefits outlined above. Therefore, we
propose to require that a Health IT Module enable a user to enter,
receive, and transmit codified Sig instructions in a structured format
in accordance with NCPDP Structured and Codified Sig Format
Implementation Guide v1.2 which is embedded within NCPDP SCRIPT v10.6
for certification to the e-prescribing criterion in the 2015
Edition.\96\ We propose that this requirement apply to the New
Prescription, Change Prescription, Refill Prescription, Cancel
Prescription, Fill Status, and Medication History prescription
transactions or segments as we understand that the NCPDP Structured and
Codified Sig Format can be used for all NCPDP SCRIPT v10.6 prescription
transactions that include the medication field. We also propose to
require that a Health IT Module include all structured Sig segment
components enumerated in NCPDP SCRIPT v10.6 (i.e., Repeating Sig, Code
System, Sig Free Text String, Dose, Dose Calculation, Vehicle, Route of
Administration, Site of Administration, Sig Timing, Duration, Maximum
Dose Restriction, Indication and Stop composites).
---------------------------------------------------------------------------

\96\ NCPDP's Structured and Codified Sig Format Implementation
Guide v1.2 is within the NCPDP SCRIPT v10.6 standard.
---------------------------------------------------------------------------

We are aware that NCPDP has recently published recommendations for
implementation of the structured and Codified Sig format for a subset
of component composites that represent the most common Sig segments in
the NCPDP SCRIPT Implementation Recommendations Version 1.29.\97\ We
therefore welcome comment on this proposal, including whether we should
require testing and certification to a subset of the structured and
codified Sig format component composites that represent the most common
Sig instructions rather than the full NCPDP Structured and Codified Sig
Format Implementation Guide v1.2. As previously noted, prescribers
would still be able to be able to create unstructured Sigs through the
use of the free text field, and our proposal only discusses the
capability of technology to enable a user to enter, receive, and
transmit codified Sig instructions using the NCPDP Structured and
Codified Sig Format.
---------------------------------------------------------------------------

\97\ http://www.ncpdp.org/NCPDP/media/pdf/SCRIPTImplementationRecommendationsV1-29.pdf.
---------------------------------------------------------------------------

Medication Dosing
In the Voluntary Edition proposed rule, we solicited comment on
whether we should propose health IT certification for oral liquid
medication dosing to the metric standard (e.g., mL or milliliters) for
patient safety reasons (79 FR 10926-10927). Use of the metric standard
offers more precision in medication dose than the Imperial standard
(e.g., teaspoons), which can decrease preventable adverse drug events.
A number of health care and standards developing organizations,
including the AAP \98\ and NCPDP,\99\ support the use of the metric
standard for dosing volumetric medications. Additionally, the FDA's
Safe Use Initiative is working with CDC, NCPDP, and other stakeholders
to encourage adoption of the NCPDP's recommendations for standardizing
dosing designations on prescription container labels of oral liquid
medications.\100\ Recent research has demonstrated that parents who
used milliliter-only dosing instruments were less likely to make dosing
errors than parents who used teaspoons or tablespoon units.\101\
---------------------------------------------------------------------------

\98\ AAP Council on Clinical Information Technology Executive
Committee, 2011-2012. Policy Statement--Electronic Prescribing in
Pediatrics: Toward Safer and More Effective Medication Management.
Pediatrics 2013; 131;824.
\99\ http://www.ncpdp.org/NCPDP/media/pdf/wp/DosingDesignations-OralLiquid-MedicationLabels.pdf.
\100\ http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm188762.htm#overdoses.
\101\ Unit of Measurement Used and Parent Medication Dosing
Errors. Pediatrics 134:2 August 1, 2014. Pp. e354-e361.
---------------------------------------------------------------------------

We received a number of comments to the comment solicitation. Many
commenters noted that the structured Sig segment of the NCPDP SCRIPT
Standard v10.6 supports use of the metric standard for liquid
medication dosing. One ONC-ACB commented that in their experience,
vendors have struggled to properly codify medication dosing information
within the C-CDA in terms of consistency across all health IT systems.
Many provider organizations and patient advocacy organizations were in
support of requiring use of the metric standard for oral liquid
medication dosing. Additionally, many commenters were in favor of
providing the metric standard as one option to record liquid medication
doses. We also received comments recommending the proper use of leading
and trailing zeroes in dosing designations. NCPDP has recommended that
dose amounts should always use leading zeroes before the decimal point
for amounts less than one, and should not use trailing zeroes after a
decimal point for oral liquid medications.\102\
---------------------------------------------------------------------------

\102\ http://www.ncpdp.org/NCPDP/media/pdf/wp/DosingDesignations-OralLiquid-MedicationLabels.pdf.
---------------------------------------------------------------------------

Our intent is for health IT to be able to more precisely dose
prescriptions in order to reduce dosing errors and improve patient
safety. We also believe that use of the metric standard could improve
patient safety and potentially reduce dosing errors for all medications
in addition to oral liquid medications. We therefore propose, for
certification to this criterion, that a Health IT Module be capable of
limiting a user's ability to electronically prescribe all medications
in only the metric standard. Prescription labels contain the dosing
instructions specified by the prescriber. Thus, if the prescriber doses
using the metric standard, the label will contain dosing instructions
in the metric standard and potentially reduce dosing errors during
administration. We also propose to require that a Health IT Module be
capable of always inserting leading zeroes before the decimal point for
amounts less than one when a user electronically prescribes medications
as well as not allow trailing zeroes after a decimal point. We welcome
comment on these proposals, including the feasibility of implementing
the metric standard for e-prescribing all medications.
Incorporate Laboratory Tests and Values/Results

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(4) (Incorporate laboratory tests and values/results)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``incorporate laboratory tests
and values/results'' certification criterion that is revised in
comparison to the 2014 Edition ``incorporate laboratory tests and
values/results'' criterion (Sec. 170.314(b)(5)). We propose to adopt
and include the HL7 Version 2.5.1 Implementation Guide: S&I Framework
Lab Results Interface, Draft Standard for Trial Use, Release 2, US
Realm (``LRI Release 2'') in the proposed 2015 Edition ``transmission
of laboratory test reports'' criterion for the ambulatory setting. LRI
Release 2 is currently under ballot reconciliation with HL7 and should
be published in the next few months.\103\ LRI Release 2 would:
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\103\ http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. Access to the current draft
of the LRI Release 2 IG is freely available for review during the
public comment period by establishing an HL7 user account.
---------------------------------------------------------------------------

Implement common formats across US Realm IGs for
consistent reader

[[Page 16838]]

experience (e.g., sequence of sections, formatting, layout, and
terminology);
Incorporates all previous errata, LRI Release 1 DSTU
comments and change requests;
Adopt HL7 version 2.8 fields developed to fill gaps
identified in the development of Release 1;
Include harmonized data type ``flavors'' for use across
the US Realm Lab IGs;
Introduce initial requirements for error reporting
conditions and severity (hard/soft errors) and system/application
acknowledgements;
Harmonize data element usage and cardinality requirements
with LOI Release 1, and the electronic Directory of Services (eDOS) IG;
Incorporate US Lab Realm value sets developed for clarity
and consistency across all laboratory IGs; and
Use a new publication method for value sets that allows
for precision usage at point of use and provides ``at a glance''
comprehensive usage at the field and component-level across all
laboratory IGs; and synced with value set activities (HL7, VSAC, etc.).
Overall, we propose to adopt LRI Release 2 because it addresses
errors and ambiguities found in LRI Release 1 and harmonizes
interoperability requirements with other laboratory standards we
propose to adopt in this proposed rule (e.g., the HL7 Version 2.5.1
Implementation Guide: S&I Framework Laboratory Orders from EHR, DSTU
Release 2, US Realm, 2013 \104\).
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\104\ We have proposed to adopt this implementation guide for
the 2015 Edition ``CPOE for laboratory orders'' certification
criterion.
---------------------------------------------------------------------------

As compared to the 2014 Edition certification criterion, we also
propose more specific requirements for how a Health IT Module must be
capable of electronically displaying the information included in a test
report. This specificity would improve the consistency with how
laboratory tests and values/results are displayed, which would also
assist with laboratory compliance with CLIA. To meet this criterion, a
Health IT Module would be required to display the following information
included in laboratory test reports it receives: (1) the information
for a test report as specified in 42 CFR 493.1291(a)(1) through (a)(3)
and (c)(1) through (c)(7); the information related to reference
intervals or normal values as specified in 42 CFR 493.1291(d); the
information for alerts and delays as specified in 42 CFR 493.1291(g)
and (h); and the information for corrected reports as specified in 42
CFR 493.1291(k)(2).
We also propose, for the purposes of certification, to require a
Health IT Module to be able to use, at a minimum, the version of
Logical Observation Identifiers Names and Codes (LOINC[supreg]) adopted
at Sec. 170.207(c)(3) (version 2.50) as the vocabulary standard for
laboratory orders. This is the most recent version of LOINC[supreg]. We
refer readers to section III.A.2.d (``Minimum Standards'' Code Sets)
for further discussion of our adoption of LOINC[supreg] as a minimum
standards code set and our proposal to adopt version 2.50, or
potentially a newer version if released before a subsequent final rule,
as the baseline for certification to the 2015 Edition.
We propose to adopt the updated LRI Release 2 at Sec.
170.205(j)(2), which requires the modification of the regulatory text
hierarchy in Sec. 170.205(j) to designate the standard referenced by
the 2014 Edition version of this certification criterion at Sec.
170.205(j) to be at Sec. 170.205(j)(1). This regulatory structuring of
the IGs would make the CFR easier for readers to follow.
EHR-S Functional Requirements LRI IG/Testing and Certification
Requirements
We seek comment on the HL7 EHR-S Functional Requirements for the
V2.5.1 Implementation Guide: S&I Framework Lab Results Interface R2,
Release 1, US Realm, Draft Standard for Trial Use, Release 1 (``EHR-S
IG''). The EHR-S IG is currently under ballot reconciliation with
HL7.\105\ The focus of the EHR-S IG is the definition of EHR system
functional requirements related to the receipt of laboratory results
that are compliant with the LRI Release 2. The EHR-S IG also includes
additional requirements as set forth in CLIA as well as clinical best
practices beyond the scope of LRI Release 2.
---------------------------------------------------------------------------

\105\ http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. Access to the current draft
of the EHR-S IG is freely available for review during the public
comment period by establishing an HL7 user account.
---------------------------------------------------------------------------

We specifically seek comment on the clarity and completeness of the
EHR-S IG in describing the requirements related to the receipt and
incorporation of laboratory results for measuring conformance of a
Health IT Module to LRI Release 2. In addition, we seek comment on how
a Health IT Module should be tested and certified consistently and
uniformly for the incorporation of laboratory results data. For
example, should testing and certification require the Health IT Module
to demonstration the ability to associate the laboratory result with an
order or patient, to recall the result for display or for submission to
another technology, and/or to use the result for automated clinical
decision support interventions? Further, what, if any, specific
capabilities currently included in the EHR-S IG should be part of
testing and certification for this criterion?
Transmission of Laboratory Test Reports

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(5) (Transmission of laboratory test reports)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``transmission of laboratory
test reports'' certification criterion that is revised in comparison to
the 2014 Edition ``transmission of electronic laboratory tests and
values/results to ambulatory providers'' criterion (Sec.
170.314(b)(6)). We have renamed this criterion to more clearly indicate
its availability for the certification of health IT used by any
laboratory. We propose to adopt and include the HL7 Version 2.5.1
Implementation Guide: S&I Framework Lab Results Interface, Draft
Standard for Trial Use, Release 2, US Realm (``LRI Release 2'') in the
proposed 2015 Edition ``transmission of laboratory test reports''
criterion. LRI Release 2 is currently under ballot reconciliation with
HL7 and should be published in the next few months.\106\ We propose to
adopt this standard for the same reasons discussed in the 2015 Edition
``incorporate laboratory tests and values/results'' above. We refer
readers to the description of the LRI Release 2 IG and our rationale
for its adoption discussed in that criterion.
---------------------------------------------------------------------------

\106\ Access to the current draft of the LRI Release 2 IG is
freely available for review during the public comment period by
establishing an HL7 user account.
---------------------------------------------------------------------------

As also discussed in the 2015 Edition ``incorporate laboratory
tests and values/results'' above, the LRI Release 2 IG requires the
information for a test report as specified at 42 CFR 493.1291(a)(1)
through (3), (c)(1) through (c)(7), (d), (g), (h) and (k)(2) to be
included in the content message. Therefore, inclusion of this standard
for certification should not only facilitate improved interoperability
of electronically sent laboratory test reports (as discussed in more
detail in the 2015 Edition ``incorporate laboratory tests and values/
results'' criterion), but also facilitate laboratory compliance with
CLIA as it relates to the incorporation and display of test results in
a receiving system.
We also propose, for the purposes of certification, to require a
Health IT

[[Page 16839]]

Module to be able to use, at a minimum, the version of Logical
Observation Identifiers Names and Codes (LOINC[supreg]) adopted at
Sec. 170.207(c)(3) (version 2.50) as the vocabulary standard for
laboratory orders. This is the most recent version of LOINC[supreg]. We
refer readers to section III.A.2.d (``Minimum Standards'' Code Sets)
for further discussion of our adoption of LOINC[supreg] as a minimum
standards code set and our proposal to adopt version 2.50, or
potentially a newer version if released before a subsequent final rule,
as the baseline for certification to the 2015 Edition.
We propose to adopt the updated LRI Release 2 at Sec.
170.205(j)(2), which requires the modification of the regulatory text
hierarchy in Sec. 170.205(j) to designate the standard referenced by
the 2014 Edition version of this certification criterion at Sec.
170.205(j) to be at Sec. 170.205(j)(1). This regulatory structuring of
the IGs would make the CFR easier for readers to follow.
Data Portability

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(6) (Data portability)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``data portability''
certification criterion that is revised in comparison to the 2014
Edition ``data portability'' certification criterion (Sec.
170.314(b)(7)). Similar to the 2014 Edition version, we propose to
include the 2015 Edition ``data portability'' criterion in the Base EHR
definition (i.e., the 2015 Base EHR definition).
For the 2014 Edition ``data portability'' criterion, we expressed
that the criterion was intended to enable an EP, eligible hospital, or
CAH to create a set of export summaries for all patients in EHR
technology formatted according to the C-CDA that includes each
patient's most recent clinical information. (77 FR 54193). We also
included this criterion in the Base EHR definition as a way to ensure
that the capability was delivered to EPs, eligible hospitals, or CAHs.
By including the criterion in the Base EHR definition, an EP, eligible
hospital, or CAH must have EHR technology certified to this criterion
in order to possess EHR technology that meets the CEHRT definition.
In the years since the 2014 Edition final rule was issued
(September 2012) and the subsequent implementation and use of this
capability by EPs, eligible hospitals, and CAHs, we have received two
types of feedback. From health IT developers, we have received requests
for clarification about this certification criterion's scope. For
example, requests for clarifications about the data that must be
produced and from how far back in time the data must be produced.
Whereas from providers (and the implementation professionals and third
party developers with which they work), we have generally received more
substantive critiques about the overall usefulness of the capability
and the ways in which health IT developers met the certification
criterion's requirements but did not necessarily deliver on its intent.
Such ``user'' comments conveyed that some health IT developers provided
a capability that was difficult or non-intuitive to use, difficult to
find to even use (e.g., ``hidden''), and in some cases either required
developer personnel to assist the provider in executing the capability
or limited its execution to only being done by the developer at the
provider's request. We have also received feedback that the scope of
testing has not rigorously assessed the ability of health IT to create
large quantities of export summaries. As a result, some providers have
reported challenges and poor performance associated with this
capability.
We believe that this feedback from CEHRT users indicates that the
data portability certification criterion adopted in the 2014 Edition
has not provided the data accessibility to providers we believed would
occur as a result of its adoption. It also indicates that some health
IT developers have (intentionally or unintentionally) obstructed the
certification criterion's true intent--to give providers easy access
and an easy ability to export clinical data about their patients for
use in a different EHR technology or even a third party system for the
purpose of their choosing.
To address provider critiques as well as to provide additional
developer requested clarity, we propose a revised 2015 Edition ``data
portability'' certification criterion as compared to the 2014 Edition
version. The proposed data portability certification criterion at Sec.
170.315(b)(6) approaches data portability from a slightly different
angle than the 2014 Edition version and focuses on the following
specific capabilities.
1. As a general rule, we emphasize that this capability would need
to be user-focused and user driven. A user must be able to set the
configuration options included within the more detailed aspects of the
criterion and a user must be able to execute these capabilities at any
time the user chooses and without subsequent developer assistance to
operate. We expect that testing of a Health IT Module presented for
certification to this criterion would include a demonstration that the
Health IT Module enables a user to independently execute this
capability without assistance from the health IT developer beyond
normal orientation/training.
2. The criterion would require that a user be able to configure the
Health IT Module to create an export summary for a given patient or set
of export summaries for as many patients selected. It would also
require that these export summaries be able to be created according to
any of the following document-template types included in the C-CDA R2.0
(also proposed as the content standard in this criterion): CCD;
Consultation Note; History and Physical; Progress Note; Care Plan;
Transfer Summary; and Referral Note. We also propose that the Discharge
Summary document template be included for a Health IT Module developed
for the inpatient setting.
3. From a data perspective, we propose that the minimum data that a
Health IT Module must be capable of including in an export summary are:
the data represented by the Common Clinical Data Set and:
Encounter diagnoses (according to the standard specified
in Sec. 170.207(i) (ICD-10-CM) or, at a minimum, the version of the
standard at Sec. 170.207(a)(4) (September 2014 Release of the U.S.
Edition of SNOMED CT[supreg]) \107\;
---------------------------------------------------------------------------

\107\ We refer readers to section III.A.2.d (``Minimum
Standards'' Code Sets) for further discussion of our adoption of
SNOMED CT[supreg] as a minimum standards code set and our proposal
to adopt the September 2014 Release (U.S. Edition), or potentially a
newer version if released before a subsequent final rule, as the
baseline for certification to the 2015 Edition.
---------------------------------------------------------------------------

Cognitive status;
Functional status;
For the ambulatory setting only. The reason for referral;
and referring or transitioning provider's name and office contact
information; and
For the inpatient setting only. Discharge instructions.
4. We propose that a user would need to be able to be able to
configure the technology to set the time period within which data would
be used to create the export summary or summaries. And that this must
include the ability to enter in a start and end date range as well as
the ability to set a date at least three years into the past from the
current date.
5. We propose that a user would need to be able to configure the
technology to create an export summary or summaries based on the
following user selected events:
A relative date or time (e.g., the first of every month);

[[Page 16840]]

A specific date or time (e.g., on 10/24/2015); and
When a user signs a note or an order.
6. We propose that a user would need to able to configure and set
the storage location to which the export summary or export summaries
are intended to be saved.
Again, we emphasize that all these capabilities would need to be
able to be configured and executed by a user without the aid of
additional health IT developer personnel and without the need to
request developer action. Further, we also reiterate that we have
expanded the nature and focus of this criterion to more precisely
address provided critiques as well as to expand the anticipated and
potential uses providers can deploy based on this more configuration
focused criterion.
Data Segmentation for Privacy
We propose to adopt two new certification criteria that would focus
on the capability to separately track (``segment'') individually
identifiable health information that is protected by rules that are
more privacy-restrictive than the HIPAA Privacy Rule. This type of
health information is sometimes referred to as sensitive health
information. The HIPAA Privacy Rule serves as the federal baseline for
health information privacy protections. It also generally permits the
use or disclosure of protected health information (PHI) for limited
specific purposes (such as treatment and payment) without a patient's
permission.\108\
---------------------------------------------------------------------------

\108\ http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/.
---------------------------------------------------------------------------

The HIPAA Privacy Rule does not override (or preempt) more privacy-
protective federal and state privacy laws. A number of federal and
state health information privacy laws and regulations are more privacy-
protective than the HIPAA Privacy Rule. Typically, these rules require
a patient's permission (often referred to as ``consent'' in these
rules) in writing in order for the individually identifiable health
information regulated by those laws to be shared. One example is the
Federal Confidentiality of Alcohol and Drug Abuse Patient Records
regulations (42 CFR part 2) (``part 2'') that apply to information
about treatment for substance abuse from federally funded
programs.\109\ There are also federal laws protecting certain types of
health information coming from covered U.S. Department of Veterans
Affairs facilities and programs (38 U.S.C. 7332). These laws and
comparable state laws were established, in part, to address the social
stigma associated with certain medical conditions by encouraging people
to get treatment and providing them a higher degree of control over how
their health information may be shared. These laws place certain
responsibilities on providers to maintain the confidentiality of such
information. More restrictive state laws also protect certain
categories of individually identifiable health information, such as
information regarding minors or teenagers, intimate partner/sexual
violence, genetic information, and HIV-related information.\110\ These
laws and regulations remain in effect and changes to these laws and
regulations are not within the scope of this proposed rule.\111\
However, with these laws in mind, the proposals that follow seek to
encourage the development and use of a technical capability that
permits users to comply with these existing laws and regulations. These
proposals are also in line with the Connecting Health and Care for the
Nation: A Shared Nationwide Interoperability Roadmap Version 1.0.\112\
HHS is committed to encouraging the development and use of policy and
technology to advance patients' rights to access, to amend, and to make
choices for the disclosure of their electronic individually
identifiable health information. HHS also noted support for the
development of standards and technology to facilitate patients' ability
to control the disclosure of specific information that is considered by
many to be sensitive in nature (such as information related to
substance abuse treatment, reproductive health, mental health, or HIV)
in an electronic environment.\113\
---------------------------------------------------------------------------

\109\ http://www.healthit.gov/sites/default/files/privacy-security/gwu-data-segmentation-final-cover-letter.pdf.
\110\ http://www.healthit.gov/providers-professionals/patient-consent-electronic-health-information-exchange/health-information-privacy-law-policy.
\111\ For a policy discussion, see Substance Abuse and Mental
Health Services Administration (SAMHSA)'s recent public listening
session pertaining to the federal confidentiality of regulations:
https://www.federalregister.gov/articles/2014/05/12/2014-10913/confidentiality-of-alcohol-and-drug-abuse-patient-records.
\112\ http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf.
\113\ http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf.
---------------------------------------------------------------------------

Technological advances are creating opportunities to share data and
allow patient preferences to electronically persist in health IT. In
2012, ONC launched the Data Segmentation for Privacy (DS4P) initiative
through ONC's Standards and Interoperability (S&I) Framework.\114\ The
DS4P initiative aimed to provide technical solutions and pilot
implementations to help meet existing legal requirements in an
increasingly electronic environment.\115\ The DS4P initiative worked to
enable the implementation and management of varying disclosure policies
in an electronic health information environment in an interoperable
manner. Overall, the DS4P initiative and its subsequent pilots focused
on the exchange of health information in the context of 42 CFR part 2
and sought to develop technical standards that would enable a provider
to adopt health IT that could segment electronic sensitive health
information regulated by more restrictive laws and make compliance with
laws like Part 2 more efficient. Since the sunset of the DS4P
initiative in April 2014, there have been live implementations and
public testimony regarding the success and practical application of the
DS4P standard. Organizations including the Substance Abuse and Mental
Health Services Administration (SAMHSA), the U.S. Department of
Veterans Affairs (VA), and private companies that participated in the
initiative have moved to production use of DS4P. For example, a
stakeholder who implemented the DS4P part 2 solution noted that the
DS4P technical capability implemented in parts of Florida has saved
some hospitals millions of dollars associated with the cost of care
because the patients they treat with substance use issues or behavioral
health issues were able to send an electronic referral and get a
discharge performed earlier in the process.\116\ Another technology
stakeholder incorporated the DS4P technical functionality into its
behavioral health and general hospital health IT solutions released
this year. Most recently, SAMHSA developed an open source technology
for patient consent management that uses the DS4P standard.\117\ In
September 2014, this technical solution was deployed into a live
environment at a public health department.
---------------------------------------------------------------------------

\114\ http://wiki.siframework.org/Data+Segmentation+for+Privacy+Use+Cases.
\115\ For more information about enabling privacy through data
segmentation technology, see http://www.healthit.gov/providers-professionals/enabling-privacy.
\116\ See Health IT Policy Committee's (HITPC) Privacy and
Security Tiger Team Public Meeting, Transcript, (Apr. 16, 2014), p.
14, http://www.healthit.gov/facas/sites/faca/files/PSTT_Transcript_Final_2014-04-16.pdf.
\117\ http://www.healthit.gov/providers-professionals/ds4p-initiative.
---------------------------------------------------------------------------

The technical specifications are outlined in the HL7 Version 3
Implementation Guide: DS4P, Release 1

[[Page 16841]]

(DS4P IG), Part 1: CDA R2 and Privacy Metadata.\118\ The DS4P IG
describes the technical means of applying security labels (privacy
metadata) which can be used to enact any security or privacy law,
regulation, or policy so that the appropriate access control decisions
will be made regarding downstream use, access or disclosure for
specially protected data so that appropriate metadata tags are applied.
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\118\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=354. Completed Normative Ballot in
January 2014 and was successfully reconciled in February 2014. HL7
approved the final standard for publication and ANSI approved in May
2014.
---------------------------------------------------------------------------

Conceptually, the DS4P approach utilizes metadata applied in layers
(e.g. metadata applied to the header, section, or entry levels of a C-
CDA document). The DS4P technical approach defaults to privacy metadata
tagging at the document level. If an organization chooses to apply
additional privacy metadata tagging within a document, that optional
technical capability is also described within the IG for CDA. If a
receiving system is unable to process section or entry level privacy
metadata, the default is tagging at the document level. The approach
relies on certain electronic actions being taken by both the sending
system and the receiving system. The sending system must:
1. Identify information that requires enhanced protection or is
subject to further restrictions;
2. Verify that the patient's privacy consent decision allows for
the disclosure of health information; \119\ and
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\119\ http://www.healthit.gov/providers-professionals/patient-consent-electronic-health-information-exchange.
---------------------------------------------------------------------------

3. Add privacy metadata to the health information being disclosed.
In turn, the receiving system must:
1. Be able to process the privacy metadata associated with the
received health information; and
2. Verify the patient's consent before re-disclosure, if the
receiving system has a need to re-disclose the information.
Data segmentation technology emerged to enable health care
providers' use of technology to comply with existing privacy laws,
regulations, and policies. The term ``data segmentation'' is often used
to describe the electronic labeling or tagging of a patient's health
information in a way that allows patients or providers to
electronically share parts,\120\ but not all, of a patient record. For
example, data segmentation technology can be applied to the sharing of
electronic sensitive health information, because that information is
afforded greater protections under various state and federal laws,\121\
as is discussed above. In this proposed rule, we propose to offer two
certification criteria that would allow for health IT to be presented
for testing and certification to the DS4P standard. We view the
proposed offering of certification to these criteria as an initial step
on technical standards towards the ability of an interoperable health
care system to compute and persist the applicable permitted access, use
or disclosure; whether regulated by state or federal laws regarding
sensitive health information or by an individual's documented choices
about downstream access to, or use or disclosure to others of, the
identifiable individual's health information. The application of the
DS4P standard at the document level is an initial step. We understand
and acknowledge additional challenges surrounding the prevalence of
unstructured data, sensitive images, and potential issues around use of
sensitive health information by CDS systems. The adoption of document
level data segmentation for structured documents will not solve these
issues, but will help move technology in the direction where these
issues can be addressed.
---------------------------------------------------------------------------

\120\ The HL7 approved standard does allow for tagging at the
data element level, but this proposed rule is suggesting just
applying the DS4P to the document level.
\121\ http://www.healthit.gov/providers-professionals/patient-consent-electronic-health-information-exchange/health-information-privacy-law-policy.
---------------------------------------------------------------------------

For example, today, electronic sensitive health information is not
typically kept in the same repository as non-sensitive data. If
security labels were applied to C-CDA documents at the time they are
created (see ``data segmentation for privacy--send'' certification
criterion), the receiving system would have more choices about how to
store and use that sensitive information. If the receiving system had
the capability to grant access to the tagged documents by using the
security labels as part of the access control decision, then co-
mingling the tagged, sensitive health information with the non-
sensitive data becomes more achievable.
In July 2014, the HITPC provided recommendations on the use of DS4P
technology to enable the electronic implementation and management of
disclosure policies that originate from the patient, the law, or an
organization, in an interoperable manner, so that electronic sensitive
health information may be appropriately shared.\122\ The HITPC noted a
clear need to provide coordinated care for individuals with mental
health and/or behavioral health issues. The HITPC recognized that the
ability of patients to withhold consent to disclose information remains
a concern for providers. In particular, providers want to provide the
best care for patients, but they have concerns about incomplete records
due to both professional obligation and liability considerations. While
the need for providers to act on incomplete information is not
necessarily new, the use of health IT may create an expectation of more
complete information.\123\ In recognition of the consumer, business,
clinical, and technical complexities, the HITPC suggested a framework
of two glide paths for the exchange of 42 CFR part 2-protected data,
based on whether the subject is sending or receiving information.\124\
As a first step in the glide path, the HITPC recommended that we
include Level 1 (document level tagging) send and receive
functionality.\125\ Document level is the most basic level of privacy
metadata tagging described in the DS4P standard. The following two
proposals would implement the HITPC's recommendations.
---------------------------------------------------------------------------

\122\ See Health IT Policy Committee (HITPC) Recommendation
Letter to ONC, July 2014, http://www.healthit.gov/facas/sites/faca/files/PSTT_DS4P_Transmittal%20Letter_2014-07-03.pdf; see also
HITPC's Privacy and Security Tiger Team Public Meeting, Transcript,
May 12, 2014, http://www.healthit.gov/facas/sites/faca/files/PSTT_Transcript_Final_2014-05-12.pdf; Public Meeting, Transcript,
May 27, 2014, http://www.healthit.gov/facas/sites/faca/files/PSTT_Transcript_Final_2014-05-27.pdf.
\123\ Id.
\124\ For more details on the two glide paths for part 2-
protected data, see http://www.healthit.gov/facas/sites/faca/files/PSTT_DS4P_Transmittal%20Letter_2014-07-03.pdf.
\125\ Id. See also, related HITPC recommendations pertaining to
data segmentation submitted to ONC in September 2010: http://www.healthit.gov/sites/faca/files/hitpc_transmittal_p_s_tt_9_1_10_0.pdf.
---------------------------------------------------------------------------

Data Segmentation for Privacy--Send

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(7) (Data segmentation for privacy--send)
------------------------------------------------------------------------

A provider currently cannot send sensitive patient information
electronically without some technical capability to indicate
information is subject to restrictions, such as a prohibition on re-
disclosure without consent, consistent with 42 CFR part 2. The sending
provider also must have confidence that the receiver can properly
handle electronically sent 42 CFR part 2-covered data. Because neither
of these functionalities are currently supported in certification,
sensitive health information such as 42 CFR part 2-covered data is
often only

[[Page 16842]]

shared via paper and fax. We propose, consistent with the HITPC
recommendations, that for certification to this criterion, a Health IT
Module must be able to send documents using document level tagging
(Level 1) in accordance with the DS4P IG. Document level tagging
enables health IT to send the 42 CFR part 2-covered data along with the
appropriate privacy metadata tagging and keep it sequestered from other
data. The DS4P IG, which includes Level 1 functionality, provides
guidance to allow, with proper authorization, a system to send a C-CDA
with tags indicating any restrictions (such as a prohibition on re-
disclosure without consent). While the DS4P IG specifies the technical
means for applying privacy metadata tagging to C-CDA documents, it also
optionally supports use of privacy metadata tagging within the document
(at the section and entry levels). We only propose to require the
document level functionality for sending as part of certification to
this criterion.
Data Segmentation for Privacy--Receive

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(8) (Data segmentation for privacy--receive)
------------------------------------------------------------------------

In general, 42 CFR part 2-covered data is not currently provided
electronically to healthcare providers through electronic exchange.
Instead, the status quo remains to share 42 CFR part 2-covered data via
paper and fax. In line with the HITPC recommendations, we propose a
certification criterion that would require a Health IT Module to be
able to receive 42 CFR part 2-covered data in accordance with the DS4P
IG. DS4P at the document level (Level 1) of the recommendations allows
recipient health IT to receive, recognize, and view documents with
privacy metadata tagging indicating certain restrictions from 42 CFR
part 2 providers with the document sequestered from other health IT
data. A recipient provider could use document level tagging to
sequester the document from other documents received and help prevent
unauthorized re-disclosure, while allowing the sensitive data to flow
more freely to authorized recipients. Thus, consistent with the HITPC
recommendations, we propose that a Health IT Module be able to receive
documents tagged with privacy metadata tagging (Level 1).
Care Plan

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(b)(9) (Care plan)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition certification criterion that
would reflect a Health IT Module's ability to enable a user to record,
change, access, create and receive care plan information in accordance
with the ``Care Plan document template'' in the C-CDA Release 2.0
standard.
The S&I Framework Longitudinal Coordination of Care (LCC)
Longitudinal Care Plan Sub-Work Group defined a ``care plan'' as ``the
synthesis and reconciliation of the multiple plans of care produced by
each provider to address specific health concerns. It serves as the
blueprint shared by all participants to guide the individual's care. As
such, it provides the structure required to coordinate care across
multiple sites, providers, and episodes of care.'' \126\ The care plan
helps multiple providers and caregivers align and coordinate care,
which is especially valuable for patients living with chronic
conditions and/or disabilities. It also provides a structure to promote
the consideration of a patient's future goals and expectations in
addition to managing their currently active health issues.
---------------------------------------------------------------------------

\126\ http://wiki.siframework.org/file/view/Care%20Plan%20Glossary_v25.doc/404538528/Care%20Plan%20Glossary_v25.doc.
---------------------------------------------------------------------------

The C-CDA Release 2.0 contains a Care Plan document template that
reflects these principles and provides a structured format for
documenting information such as the goals, health concerns, health
status evaluations and outcomes, and interventions. Note that the Care
Plan document template is distinct from the ``Plan of Care Section'' in
previous versions of the C-CDA. The Care Plan document template
represents the synthesis of multiple plans of care (for treatment) for
a patient, whereas the Plan of Care Section represented one provider's
plan of care (for treatment). To make this distinction clear, the C-CDA
Release 2.0 has renamed the previous ``Plan of Care Section'' as the
``Plan of Treatment Section (V2).''
Given the value for improved coordination of care, we propose a new
2015 Edition certification criterion for ``care plan'' that would
require a Health IT Module to enable a user to record, change, access,
create, and receive care plan information in accordance with the ``Care
Plan document template'' in the HL7 Implementation Guide for
CDA[supreg] Release 2: Consolidated CDA Templates for Clinical
Notes.\127\ The IG provides guidance for implementing CDA documents,
including the Care Plan document template. The ``transitions of care''
certification criterion proposed elsewhere in this section of the
preamble would require a Health IT Module enable a user to send and
receive transitions of care/referral summaries according to the C-CDA
Release 2.0, which would include the Care Plan document template.
Therefore, this criterion would focus only on a Health IT Module's
ability to enable a user to record, change, access, create, and receive
care plan information. We welcome comment on our proposal, including
whether we should require certain ``Sections'' that are currently
deemed optional as part of the Care Plan document template for
certification to this criterion. For example, we invite comment on
whether we should require the optional ``Health Status Evaluations and
Outcomes Section'' and ``Interventions Section (V2)'' as part of
certification to this criterion, and if so, for what value/use case.
---------------------------------------------------------------------------

\127\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=379.
---------------------------------------------------------------------------

Clinical Quality Measures--Record and Export

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(c)(1) (Clinical quality measures--record and export)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition certification criterion for
``clinical quality measures (CQM)--record and export'' that is revised
in comparison to the 2014 Edition ``CQM--capture and export''
certification criterion (Sec. 170.314(c)(1)). In order to align with
our use of the term ``record'' used in other 2014 and 2015 Edition
certification criteria, we propose to call this certification criterion
``CQM--record and export.'' We explain the term ``record'' in the 2014
Edition final rule at 77 FR 54168.\128\ We propose to require that a
system user be able to export CQM data at any time the user chooses and
without subsequent developer assistance to operate. We also propose to
require that this certification criterion be part of the set of
criteria necessary to satisfy the ``2015 Edition Base EHR'' definition
(see also section III.B.1 of this preamble for a discussion of the
proposed 2015 Edition Base EHR definition). Last, we solicit comment on
the version of standards we should adopt for this certification
criterion.
---------------------------------------------------------------------------

\128\ ``Record'' is used to mean the ability to capture and
store information in technology.
---------------------------------------------------------------------------

Standards for Clinical Quality Measures
In the 2014 Edition ``CQM--capture and export'' certification
criterion, we require that technology must be able to export a data
file formatted in

[[Page 16843]]

accordance with the HL7 Implementation Guide for CDA Release 2: Quality
Reporting Document Architecture (QRDA), DSTU Release 2 (July 2012)
standard. We understand that the industry is working to harmonize both
clinical quality measurement and CDS standards through initiatives such
as the Clinical Quality Framework (CQF) S&I initiative. CDS guides a
clinician to follow a standard plan of care, while CQMs measure
adherence to a standard plan of care. Thus, these two areas are closely
related and would benefit from standard ways to reference patient data
within health IT as well as common logic to define a sub-population.
The CQF S&I initiative is working to define a shared format,
terminology, and logic between CQMs and CDS for improved efficiency,
cost, and quality of care.
In order to harmonize CQM and CDS standards, the industry is using
pieces of existing CQM standards (e.g., Health Quality Measures Format
(HQMF), QRDA Categories I and III, and the Quality Data Model (QDM))
and CDS standards (e.g., Clinical Decision Support Knowledge Artifact
Specification (also known as HeD Schema) and the Virtual Medical
Record). HL7 issued an errata (September 2014) \129\ that reflects
updates based on an incremental version of the harmonized CQM and CDS
standards (i.e., QDM-based HQMF Release 2.1).\130\ This errata is meant
to be used in conjunction with the July 2012 QRDA IG we adopted in the
2014 Edition. Our understanding is that the fully harmonized CQM and
CDS standards will be based on the Quality Improvement and Clinical
Knowledge (QUICK) data model,\131\ and that the industry expects to
ballot a QUICK FHIR-based DSTU serving the same function as the HQMF
standard at the May 2015 HL7 meeting. Subsequent standards for
electronically processing and reporting CQMs and CDS would then be
expected to be built on the QUICK data model, including a QRDA-like
standard based on the anticipated QUICK FHIR-based DSTU.
---------------------------------------------------------------------------

\129\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=35. Please note that in order to access
the errata, the user should download the ``HL7 Implementation Guide
for CDA Release 2: Quality Reporting Document Architecture--Category
I, DSTU Release 2 (US Realm)'' package.
\130\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=97.
\131\ http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1045.
---------------------------------------------------------------------------

Given the timing of this proposed rule and the expected
deliverables for harmonized CQM and CDS standards as described above,
we solicit comment on the version of QRDA or the QRDA-like standards we
should adopt for this certification criterion. Specifically, we solicit
comment on the following three options:
HL7 Implementation Guide for CDA Release 2: Quality
Reporting Document Architecture (QRDA), DSTU Release 2 (July 2012);
HL7 Implementation Guide for CDA Release 2: Quality
Reporting Document Architecture (QRDA), DSTU Release 2 (July 2012) and
the September 2014 Errata; or
A QRDA-like standard based on the anticipated QUICK FHIR-
based DSTU.CQM standards we should adopt for this certification
criterion.
We anticipate that the QUICK data model will not be available to
review during the public comment period of this NPRM, and welcome
stakeholder input on the usefulness of adopting the current (July 2012)
QRDA standard alone or in conjunction with the September 2014 errata
given that we anticipate there will be harmonized CQM and CDS standards
available in mid-2015. We also seek to understand the tradeoffs
stakeholders perceive in adopting each standard provided that the EHR
Incentive Programs Stage 3 proposed rule is proposing that technology
certified to the 2015 Edition would not be required until January 1,
2018, but that technology certified to the 2015 Edition ``CQM--record
and export'' certification criterion would be needed for EPs, eligible
hospitals, and CAHs participating in the EHR Incentive Programs Stage 3
objectives and measures in 2017. Thus, we welcome input on recommended
QRDA standards for the ``CQM--record and export'' certification
criterion factoring in where the industry may be with adoption of CQM
and CDS standards over the next few years.
User Ability To Export CQM Data
We have received stakeholder feedback that some systems certified
to the 2014 Edition ``CQM--capture and export'' certification criterion
do not provide users with the ability to export data ``on demand'' nor
to export batches of multiple patients simultaneously. Rather, some
users of certified health IT must request this functionality from the
health IT developer. Our intent is that users should be able to export
CQM data formatted to the QRDA standard at any time the user chooses
for one or multiple patients and without additional assistance. Thus,
as proposed, when a Health IT Module is presented for certification to
this criterion, we would expect that testing of the Health IT Module
would include demonstration of a user's ability to export CQM data
without subsequent health IT developer assistance beyond normal
orientation/training.
Clinical Quality Measures--Import and Calculate

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criteria
Sec. 170.315(c)(2) (Clinical quality measures--import and calculate)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition certification criterion for
``clinical quality measures (CQM)--import and calculate'' that is
revised in comparison to the 2014 Edition ``CQM--import and calculate''
certification criterion (Sec. 170.314(c)(2)). We propose to require
that a system user be able to import CQM data at any time the user
chooses and without subsequent health IT developer assistance to
operate. We also no longer include an exemption that would allow a
Health IT Module presented for certification to all three CQM
certification criteria (Sec. Sec. 170.315(c)(1), (c)(2), and (c)(3))
to not have to demonstrate the data import capability. Last, we solicit
comment on our intended direction for testing and certifying health IT
and the version of standards we should adopt for this certification
criterion.
User Ability To Import CQM Data
We have received stakeholder feedback that some systems certified
to the 2014 Edition ``CQM--import and calculate'' certification
criterion do not provide users the ability to import data ``on
demand,'' and rather users must request this functionality from the
system developer or vendor. Our intent is that users should be able to
import CQM data formatted to the QRDA standard for one or multiple
patients at any time the user chooses and without additional
assistance. Thus, when a Health IT Module is presented for
certification to this criterion, we would expect that testing of the
Health IT Module would include demonstration of a user's ability to
import CQM data without subsequent health IT developer assistance
beyond normal orientation/training.
Import of CQM Data
For the 2014 Edition, we do not require systems that certify to
Sec. 170.314(c)(1) (CQM--capture and export), Sec. 170.314(c)(2)
(CQM--import and calculate), and Sec. 170.314(c)(3) (CQM--electronic
submission) to have to demonstrate that they can import data files in
accordance with the QRDA

[[Page 16844]]

standard. In 2012, we adopted this policy because we did not believe
that systems that could perform capture, export, and electronic
submission functions would need to import CQM data as they were in
essence ``self-contained'' (77 FR 54231). However, we have received
stakeholder input recommending that all systems should be able to
import CQM data and that there could be instances were a provider using
one technology to record CQM data could not subsequently import such
data into a different technology. We agree with this feedback.
Therefore, this exemption will no longer carry forward as part of the
proposed 2015 Edition version of this certification criterion. This
means that a Health IT Module presented for certification to this
certification criterion (Sec. 170.315(c)(2)) would need to be able to
demonstrate the ability to import data in order to be certified to this
certification criterion even if they also certify to provide ``record
and export'' and ``electronic submission/report'' functions.
Testing of Import and Calculate Functionalities
The testing procedures for the 2014 Edition ``CQM--import and
calculate'' certification criterion only test that technology can
import a small number of test records and use those for calculation of
CQM results. We have received feedback that technology should be able
to import a larger number of test records and that we should test this
ability to reflect real-world needs for technology. With the import of
a large number of records, technology also needs to be able to de-
duplicate records for accurate calculation of CQM results. Therefore
for testing and certification to the proposed 2015 Edition ``CQM--
import and calculate'' certification criterion, we intend for testing
to include that technology can import a larger number of test records
compared to testing for the 2014 Edition and automatically de-duplicate
them for accurate CQM calculation. We welcome comment on our proposed
intentions to test a larger number of test records compared to the 2014
Edition test procedure and that a Health IT Module could eliminate
duplicate records. We also request comment on the number of test
records we should consider testing a Health IT Module for performing
import and calculate functions.
Standards for Clinical Quality Measures
We describe above in the preamble for the proposed 2015 Edition
``CQM--record and export'' certification criterion our understanding of
the industry's timeline and expected deliverables for harmonized CQM
and CDS standards. Given the discussion above, we also solicit comment
on the QRDA standards we should consider adopting for this 2015 Edition
``CQM--import and calculate'' certification criterion.
Clinical Quality Measures--Report

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criteria
Sec. 170.315(c)(3) [Reserved]
------------------------------------------------------------------------

In the 2014 Edition, we adopted a ``CQM--electronic submission''
certification criterion that requires technology to enable a user to
electronically create a data file for transmission of CQM data in
accordance with QRDA Category I and III standards and ``that can be
electronically accepted by CMS'' (Sec. 170.314(c)(3)). We have
received stakeholder feedback recommending we better align our
certification policy and standards for electronically-specified CQM
(eCQM) reporting with other CMS programs that include eCQMs, such as
the Physician Quality Reporting System (PQRS) and Hospital Inpatient
Quality Reporting (IQR) programs. The PQRS and Hospital IQR programs
update their measure specifications on an annual basis through
rulemaking in the Physician Fee Schedule (PFS) and Inpatient
Prospective Payment Systems (IPPS) rules respectively.
To better align with the reporting requirements of other CMS
programs, we intend to propose certification policy for reporting of
CQMs in or with annual PQRS and/or Hospital IQR program rulemaking. We
anticipate we will propose standards for reporting of CQMs that reflect
CMS' requirements for the ``form and manner'' of CQM reporting (e.g.,
CMS program-specific QRDA standards), allowing for annual updates of
these requirements as necessary. Under this approach, the ``CQM--
report'' certification policy and associated standards for the 2015
Edition that support achieving EHR Incentive Program requirements would
be proposed jointly with the calendar year (CY) 2016 PFS and/or IPPS
proposed rules. We anticipate these proposed and final rules will be
published in CY 2015. We clarify that we anticipate removing
``electronic'' from the name of this certification criterion. As
described in the preamble, we expect that all functions proposed in the
2015 Edition certification criteria are performed or demonstrated
electronically. Thus, it is not necessary to specifically include this
requirement in the title of this certification criterion. We also
anticipate naming this certification criterion ``report'' instead of
``submission'' to better align with the language we use in other
certification criteria that also require demonstration of the same
functionality to submit data.
Clinical Quality Measures--Filter

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(c)(4) (Clinical quality measures--filter)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition certification criterion for
CQM filtering. In the Voluntary Edition proposed rule, we proposed a
new certification criterion that would require health IT to be able to
record structured data for the purposes of being able to filter CQM
results to create different patient population groupings by one or more
of a combination of certain patient characteristics \132\ (79 FR 10903-
04). We proposed this capability to support eCQM reporting where the
reporting entity is not an individual provider but rather a group
practice or an accountable care organization (ACO). We also proposed
certain patient characteristics that would support identification of
health disparities, help providers identify gaps in quality, and
support a provider in delivering more effective care to sub-groups of
their patients. We did not adopt this certification criterion in the
2014 Edition Release 2 final rule as we received comments recommending
we further refine the use cases and perform more analysis of which data
elements are being captured in standardized ways (79 FR 54462).
---------------------------------------------------------------------------

\132\ Practice site and address; Tax Identification Number
(TIN), National Provider Identifier (NPI), and TIN/NPI combination;
diagnosis; primary and secondary health insurance, including
identification of Medicare and Medicaid dual eligible; demographics
including age, sex, preferred language, education level, and
socioeconomic status.
---------------------------------------------------------------------------

CMS offers various options for providers to report quality data as
part of a group instead of individually reporting as individual
providers. For example, the PQRS offers the Group Practice Reporting
Option (GPRO) that allows for assessment and payment (or adjustment)
based on reporting of data on quality measures at the group level.
Similarly, there are group reporting options, including the GRPO under
the PQRS for reporting data used to assess quality for purposes of the
Value Modifier under the Medicare Physician Fee Schedule. Another CMS
group reporting option is the Comprehensive Primary Care (CPC)
initiative. In the CPC initiative, participating primary

[[Page 16845]]

care practices receive care management fees to support enhanced,
coordinated services. In the CPC initiative, each physical site
location is counted as a ``practice.'' A group practice may encompass
several primary care sites, of which some, but not all, are
participating in CPC. Because the unit of analysis in CPC is the
practice site, CMS requires all CPC participants to report CQMs at the
level of the practice rather than at the level of the individual
provider. Each CPC practice's quality results, which include
performance on patient experience and claims measures as well as CQMs,
are tied to the distribution of any Medicare shared savings calculated
and earned at the level of the Medicare population of each region
participating in the initiative.
ACO models and programs, such as the Medicare Shared Savings
Program (MSSP) and CMS Pioneer ACO Model, include groups of doctors,
hospitals, and other health care providers who come together
voluntarily to give coordinated high quality care to their patients. In
ACO models and programs, the providers that participate in the ACO
share responsibility for the care and outcomes of their patients. For
example, MSSP participants are rewarded if the ACO lowers the growth in
its health care costs while meeting performance standards on quality of
care. ACOs are required to internally report on cost and quality
metrics associated with the activities of their practitioners, to
promote the use of evidence-based medicine, and to support the care
coordination activities of their practitioners. Understanding the
practice patterns of individual practitioners for services provided on
behalf of the ACO is therefore important for such organizations.
In some cases, not all providers practicing at a particular
practice site location or in an ACO will be participating in the group
practice or ACO reporting options. The National Provider Identifier
(NPI) is insufficient by itself to attribute a provider's performance
to a particular group practice or ACO, as the provider could practice
in multiple health care organizations. Likewise, a health care
organization may have multiple Tax Identification Numbers (TINs).
Currently, data may be accessed by filtering on either the TIN or the
NPI, but not in combination due, in part, to current CMS reporting
requirements and limitations of health IT being used by providers. The
ability to filter by a combination of NPI/TIN could allow for more
specific and proper attribution of a provider's performance to the
correct organization for aggregating group practice or ACO quality
measure results.
Health IT should support an organization's ability to filter both
individual patient level and aggregate level eCQM results by data that
would support administrative reporting as well as identification of
health disparities and gaps in care for patients being treated at
particular group practice sites or in a given ACO. We, therefore,
propose a new certification criterion for CQM filtering that would
require health IT to be able to record data (according to specified
standards, where applicable) and filter CQM results at both patient and
aggregate levels by each one and any combination of the following data:
TIN;
NPI;
Provider type;
Patient insurance;
Patient age;
Patient sex in accordance with the standard specified in
Sec. 170.207(n)(1) (HL7 Version 3);
Patient race and ethnicity in accordance with the
standards specified in Sec. 170.207(f)(1) (OMB standard) and, at a
minimum, (f)(2) (``Race & Ethnicity--CDC'' code system in the PHIN
VADS);
Patient problem list data in accordance with, at a
minimum, the version of the standard specified in Sec. 170.207(a)(4)
(September 2014 Release of the U.S. Edition of SNOMED CT[supreg]); and
Practice site address.
We clarify that a Health IT Module must be able to filter by any
combination of the proposed data elements (i.e., by any one (e.g.,
provider type) or a combination of any of the data elements (e.g.,
combination of TIN and NPI or combination of all data)). We also note
that this combination requirement is different than other proposed
certification criteria in that it requires all combinations to be
demonstrated for certification and not just one. We anticipate that if
adopted, stakeholders may want to expand the list of data in this
certification criterion and support the reporting needs of additional
programs over time. Our intent with this proposal is to continue to
work with CMS and other stakeholders to ensure that this list of data
represents a common and relatively stable set across program needs in
support of program alignment.
For certain data elements, we have specified vocabulary standards
(as identified above) to maintain consistency in the use of adopted
national standards. As part of the 2014 Edition, technology is
certified to record patient race, ethnicity, and problem lists in
accordance with standards. In this proposed rule, for the
``demographics'' certification criterion and other criteria, we propose
to certify a Health IT Module to record patient sex, race, and
ethnicity in accordance with standards we propose to adopt as part of
the 2015 Edition. We also propose to certify a Health IT Module to the
record patient problem lists in accordance with the latest version of
the SNOMED CT[supreg] standard. Please refer to the proposed
``demographics'' and ``problem list'' certification criteria discussed
earlier in this section of the preamble for a more detailed discussion
about the standards. We are also aware that patient sex, race, and
ethnicity are being collected as supplemental data to the Quality
Reporting Data Architecture (QRDA) Category I and III files for eCQM
reporting to CMS. Collection of patient date of birth is currently
required as part of the 2014 Edition ``demographics'' certification
criterion, and is being proposed for the 2015 Edition ``demographics''
certification criterion. Therefore, we believe there should not be a
large developmental burden to enable a Health IT Module to record these
data because they are already being collected through policy
established in the 2014 Edition and/or are being proposed as part of
2015 Edition certification criteria discussed elsewhere in this
proposed rule.
We are aware that patient insurance can be collected using a payer
value set that denotes whether the patient has Medicare, Medicaid, and/
or another commercial insurance. We solicit comment on other payer
value sets that could be leveraged to support this proposal. We believe
that provider type could also inform quality improvement if there are
differences in quality measure results by different types of providers.
We are aware of the Healthcare Provider Taxonomy Code Set designed to
categorize the type, classification, and/or specialization of health
care providers.\133\ Health care providers applying for an NPI must
select a Healthcare Provider Taxonomy Code or code description during
the application process. We solicit comment on the appropriateness of
this code set for classifying provider types as well as other standards
that could be used classify provider types.
---------------------------------------------------------------------------

\133\ http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/Taxonomy.html
---------------------------------------------------------------------------

In order to support the identification of CQM results for a
particular practice, we propose to include practice site address in the
list of data. We note that

[[Page 16846]]

while this information may not be needed for CQM filtering at the ACO
level, certification would require that health IT enables a user to
record practice site address, but not dictate that a user must include
this information. We believe the industry is aware of the need to
identify a standard way to represent address. While such a standard is
being developed, we believe that to support group or practice
reporting, having the address is one of the key data elements that
would allow a provider using health IT to filter CQM results at the
practice or group level. We solicit comment on standards for collecting
address data that could be leveraged to support this functionality.
We solicit comment on the appropriateness of the proposed data
elements for CQM filtering, including whether they are being captured
in standardized vocabularies. We also solicit comment on additional
data elements that we should consider for inclusion and standardized
vocabularies that might be leveraged for recording this information in
health IT.
Authentication, Access Control, and Authorization

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(1) (Authentication, access control, and authorization)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``authentication, access
control, and authorization'' certification criterion that is unchanged
in comparison to the 2014 Edition ``authentication, access control, and
authorization'' criterion (Sec. 170.314(d)(1)).
Auditable Events and Tamper-Resistance

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(2) (Auditable events and tamper-resistance )
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``auditable events and tamper-
resistance'' certification criterion that is unchanged in comparison to
the 2014 Edition ``auditable events and tamper-resistance'' criterion
(Sec. 170.314(d)(2)). We seek comment, however, on two issues. In
August 2014, the HHS Office of Inspector General (OIG) released a
report entitled ``The Office of the National Coordinator for Health
Information Technology's Oversight of the Testing and Certification of
Electronic Health Records.'' \134\ In that report, the OIG found that
ONC approved test procedures did not address common security issues,
including ``logging emergency access or user privilege changes.'' The
OIG therefore recommended ``. . . that ONC work with NIST to strengthen
EHR test procedure requirements so that the ATCBs [ONC-Authorized
Testing and Certification Bodies] can ensure that EHR vendors
incorporate common security and privacy features into the development
of EHRs.'' \135\
---------------------------------------------------------------------------

\134\ http://oig.hhs.gov/oas/reports/region6/61100063.pdf
\135\ http://oig.hhs.gov/oas/reports/region6/61100063.pdf
---------------------------------------------------------------------------

The standards adopted at Sec. 170.210(e) and referenced by the
2014 Edition ``auditable events and tamper-resistance'' and ``audit
report(s)'' certification criteria require that technology must be able
to record audit log information as specified in sections 7.2 through
7.4, 7.6 and 7.7 of the standard adopted at 45 CFR 170.210(h). The
standard adopted at Sec. 170.210(h) is ASTM E2147.\136\ Section 7.6 of
ASTM E2147 specifies that audit log content needs to include the ``type
of action'' and references six ``actions:'' Additions, deletions,
change, queries, print, and copy. Section 7.7 requires that the audit
log record when patient data is accessed. So while not explicitly
referenced in section 7.6, the action of ``access'' or viewing of a
patient's information is also required to be recorded for
certification. Moreover, we clarify that an ``emergency access'' event
is expected to be recorded (just like any other access) in accordance
with section 7.7.
---------------------------------------------------------------------------

\136\ http://www.astm.org/Standards/E2147.htm. The standard is
also incorporated by reference at 45 CFR 170.299(c)(1) and available
at the Office of the Federal Register.
---------------------------------------------------------------------------

Because it does not appear that the ASTM standard indicates
recording an event when an individual's user privileges are changed, we
seek comment on whether we need to explicitly modify/add to the overall
auditing standard adopted at 170.210(e) to require such information to
be audited or if this type of event is already audited at the point of
authentication (e.g., when a user switches to a role with increased
privileges and authenticates themselves to the system). We also seek
comments on any recommended standards to be used in order to record
those additional data elements.
In a 2013 report entitled ``Not All Recommended Safeguards Have
Been Implemented in Hospital EHR Technology (OEI-01-11-00570),'' \137\
the OIG recommended that ONC should propose a revision to this
certification criterion to require that EHR technology keep the audit
log operational whenever the EHR technology is available for updates or
viewing or, alternatively, CMS could update its meaningful use criteria
to require providers to keep the audit log operational whenever EHR
technology is available for updates or viewing.\138\ As a result of
that report, in the Voluntary Edition proposed rule, we proposed an
``auditable events and tamper resistance'' certification criterion that
would have required technology to prevent all users from being able to
disable an audit log. While several commenters supported the proposal,
an equal share expressed concern, including the HITSC. The HITSC
recommended against implementing this proposal, indicating that the
requirements of the 2014 Edition certification criterion (identifying
only a limited set of users that could disable the audit log and
logging when and by whom an audit log was disabled and enabled)
provided sufficient parameters to determine the accountable party in
the event of a security incident.\139\ Other commenters contended that
including an absolute prohibition would be problematic because there
are valid and important reasons for users to disable the audit log,
including allowing a system administrator to disable the audit log for
performance fixes, stability, disaster recovery, and system updates or
allowing a system administrator to disable it when there is rapid
server space loss which is hindering a provider from accessing needed
clinical information in a timely manner.
---------------------------------------------------------------------------

\137\ https://oig.hhs.gov/oei/reports/oei-01-11-00570.pdf.
\138\ https://oig.hhs.gov/oei/reports/oei-01-11-00570.pdf.
\139\ http://www.healthit.gov/FACAS/sites/faca/files/Baker_PSWG_2015editionnprm_public_comment_V2.pdf.
---------------------------------------------------------------------------

We reiterate our policy first espoused with the adoption of the
2014 Edition ``auditable events and tamper resistance'' certification
criterion in that the ability to disable the audit log must be
restricted to a limited set of users to meet this criterion. The
purpose of this certification criterion is to require health IT to
demonstrate through testing and certification that it has certain
security capabilities built in. As we have evaluated both OIG's input
and that of commenters, we believe our certification criterion is
appropriately framed within the parameters of what our regulation can
reasonably impose as a condition of certification. This regulation
applies to health IT and not to the people who use it. Thus, how an
individual provider or entity chooses to ultimately implement health IT
that has been certified to this or any other certification criterion
does so outside the scope of this regulation.

[[Page 16847]]

We also received feedback to the Voluntary Edition proposed rule
that there may be some events recorded in the audit log that may be
more critical to record than other events. Commenters noted that there
may be a critical subset of events that should remain enabled at all
times, while other events could be turned off during critical times or
for system updates by a subset of users. As noted above, the standards
adopted at Sec. 170.210(e) and referenced by the 2014 Edition
``auditable events and tamper-resistance'' certification criterion
requires that health IT technology must be able to record additions,
deletions, changes, queries, print, copy, access. The 2014 Edition also
required the log to record when the audit log is disabled and by whom
and that such capability must be restricted to a limited set of
identified users. As a result, we again seek comment on whether:
There is any alternative approach that we could or should
consider;
There is a critical subset of those auditable events that
we should require remain enabled at all times, and if so, additional
information regarding which events should be considered critical and
why; and
Any negative consequences may arise from keeping a subset
of audit log functionality enabled at all times.
Audit Report(s)

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(3) (Audit report(s))
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``audit reports(s)''
certification criterion that is unchanged in comparison to the 2014
Edition ``audit reports(s)'' criterion (Sec. 170.314(d)(3)).
Amendments

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(4) (Amendments)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``amendments'' certification
criterion that is unchanged in comparison to the 2014 Edition
``amendments'' criterion (Sec. 170.314(d)(4)). We note that this
certification criterion only partially addresses the amendment of
protected health information (PHI) requirements of 45 CFR 164.526.
Automatic Access Time-Out

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(5) (Automatic access time-out)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``automatic access time-out''
certification criterion that is unchanged (for the purposes of gap
certification) in comparison to the 2014 Edition ``automatic log-off''
criterion (Sec. 170.314(d)(5)). The 2014 Edition ``automatic log-off''
criterion requires a Health IT Module to ``prevent a user from gaining
further access to an electronic session after a predetermined time of
inactivity.'' In June 2014, the Privacy and Security Workgroup (PSWG)
of the HITSC assessed the automatic log-off criterion.\140\ While the
2014 Edition criterion refers to ``sessions,'' the PSWG noted the need
to recognize that many systems are not session-based. Instead, systems
may be stateless, clientless, and/or run on any device. The PSWG
further noted that the risk that this criterion addresses is the
potential that protected health information could be disclosed through
an unattended device. The HITSC recommended that this certification
criterion should not be overly prescriptive so as to inhibit system
architecture flexibility.
---------------------------------------------------------------------------

\140\ http://www.healthit.gov/facas/sites/faca/files/HITSC_PSWG_2015NPRM_Update_2014-06-17.pdf.
---------------------------------------------------------------------------

To clarify this intent and eliminate the reference to ``session,''
the PSWG suggested to the HITSC that this criterion by refined to state
``automatically block access to protected health information after a
predetermined period of inactivity through appropriate means until the
original user re-authenticates or another authorized user
authenticates.'' We agree in substance with the PSWG work and HITSC
recommendations. Accordingly, we propose a 2015 Edition ``automatic
access time-out'' certification criterion that reflects the HITSC
recommendations and the work of the PSWG. Specifically, the criterion
would require a Health IT Module to demonstrate that it can
automatically stop user access to health information after a
predetermined period of inactivity and require user authentication in
order to resume or regain the access that was stopped. We note,
however, that we do not believe this would have any impact on testing
and certification as compared to testing and certification to the 2014
Edition ``automatic log-off'' criterion (i.e., the 2015 ``automatic
access time-out'' criterion would be eligible for gap certification).
We welcome comments on this assessment.
Emergency Access

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(6) (Emergency access)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``emergency access''
certification criterion that is unchanged in comparison to the 2014
Edition ``emergency access'' criterion (Sec. 170.314(d)(6)).
End-User Device Encryption

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(7) (End-user device encryption)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``end-user device encryption''
certification criterion that is unchanged (for the purposes of gap
certification) in comparison to the 2014 Edition ``end-user device
encryption'' criterion (Sec. 170.314(d)(7)). We propose to require
certification to this criterion consistent with the most recent version
of Annex A: Approved Security Functions (Draft, October 8, 2014) for
Federal Information Processing Standards (FIPS) Publication 140-2.\141\
The purpose of this document is to provide a list of the approved
security functions applicable to FIPS PUB 140-2. To maintain and update
our certification requirements to the most recent NIST-approved
security functions, we propose to move to the updated version of Annex
A (Draft, October 8, 2014). We proposed to adopted this updated version
of Annex A at Sec. 170.210(a)(3). We note, however, that we do not
believe that this would have any impact on testing and certification as
compared to testing and certification to the 2014 Edition ``end-user
device encryption'' criterion (i.e., the 2015 ``end-user device
encryption'' criterion would be eligible for gap certification). We
welcome comments on this assessment.
---------------------------------------------------------------------------

\141\ http://csrc.nist.gov/publications/fips/fips140-2/fips1402annexa.pdf.
---------------------------------------------------------------------------

Integrity

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(8) (Integrity)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``integrity'' certification
criterion that is unchanged in comparison to the 2014 Edition
``integrity'' criterion (Sec. 170.314(d)(8)). However, we propose a
change in how a Health IT Module would be tested and certified to this
criterion. The 2011 and 2014 editions of this criterion have been
available for individual testing and certification. We propose that the
2015 Edition ``integrity'' criterion would be tested and certified to
support the context for which it was adopted--upon receipt of a summary
record in order to ensure the integrity of the information exchanged

[[Page 16848]]

(see Sec. 170.315(d)(8)(ii)). Therefore, we expect that this
certification criterion would most frequently be paired with the ToC
certification criterion for testing and certification.
In the 2014 Edition propose rule, we sought comment on whether we
should leave the standard for the 2014 Edition ``integrity''
certification criterion as SHA-1 \142\ or replace it with SHA-2,\143\
as SHA-2 is a much stronger security requirement. In the 2014 Edition
final rule (77 FR 54251), we determined that the SHA-1 standard should
serve as a floor and technology could be certified to the 2014 Edition
``integrity'' certification criterion if it included hashing algorithms
with security strengths equal to or greater than SHA-1. We also noted
that the Direct Project specification requires that SHA-1 and SHA-256
(one type of SHA-2 hash algorithms) be supported, which still remains
the case today.
---------------------------------------------------------------------------

\142\ http://csrc.nist.gov/publications/fips/fips180-4/fips-180-4.pdf.
\143\ http://csrc.nist.gov/publications/fips/fips180-4/fips-180-4.pdf.
---------------------------------------------------------------------------

It is our understanding that many companies, including Microsoft
and Google, plan to sunset (deprecate) SHA-1 no later than January 1,
2017.\144\ While the SHA-1 standard serves as the baseline standard for
certification to the proposed 2015 Edition ``integrity'' certification
criterion and health IT could be certified to a security strength
greater than SHA-1 (e.g., SHA-2), we seek comments on if, and when, we
should set the baseline for certification to the 2015 Edition
``integrity'' certification criterion at SHA-2. For example, we could
adopt and move to SHA-2 as the baseline certification requirement with
the effective date of a subsequent file rule. This would likely be in
late 2015 (considering the start of testing and certification), and
consistent with the current trajectory of the industry in this area.
Alternatively, we could set an effective date within the criterion for
when the baseline for certification would shift from SHA-1 to SHA-2
(e.g., beginning 2017).
---------------------------------------------------------------------------

\144\ http://www.symantec.com/en/au/page.jsp?id=sha2-transition.
---------------------------------------------------------------------------

Accounting of Disclosures

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(d)(9) (Accounting of disclosures)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``accounting of disclosures''
certification criterion that is unchanged in comparison to the 2014
Edition ``accounting of disclosures'' criterion (Sec. 170.314(d)(9)).
We note that the 2015 Edition criterion is no longer designated
``optional'' because such a designation is no longer necessary given
that we have discontinued the Complete EHR definition and Complete EHR
certification beginning with the 2015 Edition health IT certification
criteria.
View, Download, and Transmit to 3rd Party (VDT)

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(e)(1) (View, download, and transmit to 3rd party)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``VDT'' criterion that is
revised in comparison to the 2014 Edition ``VDT'' criterion (Sec.
170.314(e)(1)).
Clarified Introductory Text for 2015 Edition VDT Certification
Criterion
In the Voluntary Edition proposed rule, we proposed to make
clarifying changes to the introductory text at Sec. 170.315(e)(1) to
make it clear that this health IT capability is patient-facing and for
patients to use. Commenters generally supported clarifying the
introductory text of VDT. Commenters stressed the importance of
allowing authorized representatives the ability to perform the VDT
functionality. However, due to our approach to only finalize a subset
of modifications in the 2014 Edition Release 2 final rule, we chose not
to make that revision in the 2014 Edition Release 2 final rule.
Therefore, we again propose to revise the introductory text to lead
with ``Patients (and their authorized representatives) must be able to
use health IT to . . .'' We also propose to use this same phrase at the
beginning of each specific capability for VDT to reinforce this point.
We note that this proposed requirement included in this criterion does
not override an individual's right to access protected health
information (PHI) in a designated record set under 45 CFR 164.524.
Common Clinical Data Set, Updated C-CDA, and Diagnostic Image Reports
We propose to include an updated Common Clinical Data Set for the
2015 Edition that includes references to new and updated vocabulary
standards code sets. Please also see the Common Clinical Data Set
definition proposal in section III.B.3 of this preamble. For the same
reasons discussed in the proposed 2015 Edition ToC certification
criterion, we also propose to reference the updated version of the C-
CDA (Draft Standard for Trial Use, Release 2.0) for this certification
criterion; and note, for the reasons discussed under the 2015 ToC
certification criterion, compliance with Release 2.0 cannot include the
use of the ``unstructured document'' document-level template for
certification to this criterion.
We also propose that a Health IT Module must demonstrate that it
can make diagnostic image reports available to the patient in order to
be certified. A diagnostic imaging report contains a consulting
specialist's interpretation of image data. It is intended to convey the
interpretation to the referring (ordering) physician, and becomes part
of the patient's medical record. We believe it is important to include
this information in a patient's record to improve care. Therefore, we
propose to include diagnostic imaging reports in the certification
criterion as something a Health IT Module must be able to make
accessible to patients. Again, to prevent any misinterpretation, we
reiterate for stakeholders that this proposed rule and proposed
certification criterion apply to a Health IT Module with regard to what
must be demonstrated for the Health IT Module to be certified and does
not govern its use.
We request comment on whether we should require testing and
certification for the availability of additional patient data through
the view, download, transmit, and API (discussed below) capabilities.
For example, should patient data on encounter diagnoses, cognitive
status, functional status, or other information also be made available
to patients (or their authorized representatives) through these
capabilities? Additionally, similar to our proposals for the data
portability certification criterion, we request comment on including
requirements in this criterion to permit patients (or their authorized
representatives) to select their health information for, as applicable,
viewing, downloading, transmitting, or API based on a specific date or
time (e.g., on 10/24/2015), a period of time (e.g., the last 3 years),
or all the information available.
VDT--Application Access to Common Clinical Data Set
To complement the API capabilities in the proposed ``Application
Access to Common Clinical Data Set'' criterion at Sec. 170.315(g)(7),
which are intended to be used by health IT purchasers in the context of
providing application access to the Common Clinical Data Set, we also
propose to require that the same capabilities be met as part of the
2015 Edition VDT certification criterion. While in some respects it
could be argued that repeating these capabilities in the VDT
certification criterion are duplicative, we believe the contexts under
which the capabilities proposed by this criterion and proposed at

[[Page 16849]]

Sec. 170.315(g)(7) would be used and the contexts under which
certification to this criterion would be sought are distinct enough to
warrant this repetition (i.e., in some cases a health IT developer may
seek certification solely to this criterion). In recognition of the
fact that some health IT developers will choose to build a more tightly
integrated system that could rely on the same underlying capabilities
developed to meet Sec. 170.315(g)(7), we clarify that health IT
developers could provide the information necessary to satisfy the
``documentation'' and ``terms of use'' requirements in Sec.
170.315(e)(1)(iii)(D) and (E) of this criterion and Sec.
170.315(g)(7)(iv) and (v) only once so long as the information
addresses any potential technical differences in the application access
capabilities provided (e.g., a RESTful web service for Sec.
170.315(e)(1) versus a SOAP web service for Sec. 170.315(g)(7)). As
proposed as part of certification in conjunction with Sec.
170.315(g)(7), we similarly propose for this criterion to require ONC-
ACBs to submit a hyperlink (as part of a product certification
submission to the CHPL) that would allow any interested party to access
the API's documentation and terms of use. This hyperlink would first
need to be provided by the health IT developer to the ONC-ACB.
Including these capabilities in the VDT certification criterion
could address several aspects that currently pose challenges to
individuals (and their families) accessing their health information
(e.g., multiple ``portals''). Additionally, we have coordinated with
CMS to have the proposed meaningful use measure for VDT revised to
allow for responses to data requests executed by the API functionality
to count in the measure's numerator (please see the EHR Incentive
Programs Stage 3 proposed rule published elsewhere in this issue of the
Federal Register). This combination of technological capability and
measurement flexibility could enhance an individual's ability to
converge their data in the application of their choice. Furthermore, by
including these capabilities in this criterion, we ensure that health
IT developers who seek certification only to this criterion but not
(g)(7) because of their market focus, will equally be required to
include an API available as part of their technology.
We note that readers should also review the proposed ``API''
certification criterion in this section of the preamble for requests
for comments that may impact the finalization of the API proposal
included in this certification criterion. For example, we request
public comment on what additional requirements might be needed to
ensure the fostering of an open ecosystem around APIs so that patients
can share their information with the tools, applications, and platforms
of their own choosing.
Activity History Log
In the Voluntary Edition proposed rule, we proposed to include two
new data elements for the activity history log: transmission status and
addressee. Due to the approach we took with the 2014 Edition Release 2
final rule, we did not finalize either proposal. However, we received
support for our proposal to include the addressee as a data element in
the history log. Therefore, we propose to include ``addressee'' as a
new data element in the 2015 Edition VDT criterion related to the
activity history log. Although the 2014 Edition VDT criterion requires
that the action of ``transmit'' be recorded, we did not specify that
the intended destination be recorded. We believe this transactional
history is important for patients to be able to access, especially if a
patient actively transmits their health information to a 3rd party or
another health care provider.
Patient Access to Laboratory Test Reports
In February 2014, CMS, the CDC, and the Office for Civil Rights
(OCR) issued a final rule that addressed the interplay between the CLIA
rules, state laws governing direct patient access to their laboratory
test reports, and the HIPAA Privacy Rule.\145\ The final rule permits
laboratories to give a patient, a patient's ``personal
representative,'' or a person designated by the patient, as applicable,
access to the patient's completed test reports upon the patient's or
patient's personal representative's request.\146\ The final rule also
eliminated the exception under the HIPAA Privacy Rule to an
individual's right to access his or her protected health information
when it is held by a CLIA-certified or CLIA-exempt laboratory. While
patients can continue to get access to their laboratory test reports
from their doctors, these changes give patients a new option to obtain
their test reports directly from the laboratory while maintaining
strong protections for patients' privacy.
---------------------------------------------------------------------------

\145\ CMS is generally responsible for regulatory laboratory
oversight under CLIA, while CDC provides scientific and technical
advice to CMS related to CLIA and OCR administers the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy
Rule.
\146\ https://www.federalregister.gov/articles/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports.
---------------------------------------------------------------------------

We seek to ensure that the test reports that are delivered by
providers to patients through the VDT capabilities adhere to the CLIA
test reporting requirements and, therefore, propose that a Health IT
Module presented for certification to this criterion must demonstrate
that it can provide patient laboratory test reports that include the
information for a test report specified in 42 CFR 493.1291(c)(1)
through (7); the information related to reference intervals or normal
values as specified in 42 CFR 493.1291(d); and the information for
corrected reports as specified in 42 CFR 493.1291(k)(2).
Web Content Accessibility Guidelines (WCAG)
We reaffirm for stakeholders that the proposed 2015 Edition VDT
criterion includes the WCAG 2.0 Level A (Level A) conformance
requirements for the ``view'' capability. This is the same requirement
we include in the 2014 Edition VDT criterion. We do, however, propose
to modify the regulatory text hierarchy at Sec. 170.204(a) to
designate this standard at Sec. 170.204(a)(1) instead of Sec.
170.204(a). This would also require the 2014 Edition VDT certification
criterion to be revised to correctly reference Sec. 170.204(a)(1). We
also seek comment on whether we should adopt WCAG 2.0 Level AA (Level
AA) conformance requirements for the ``view'' capability included in
the 2015 Edition VDT criterion (instead of Level A).
The most recent set of guidelines (WCAG 2.0) were published in 2008
\147\ and are organized under 4 central principles with testable
success criteria: Perceivable, Operable, Understandable, and Robust.
Each guideline offers 3 levels of conformance: A, AA, and AAA. Level A
conformance corresponds to the most basic requirements for displaying
Web content. Level AA conformance provides for a stronger level of
accessibility by requiring conformance with Level A success criteria as
well as Level AA specific success criteria. WCAG 2.0 Level AAA (Level
AAA) conformance comprises the highest level of accessibility within
the WCAG guidelines and includes all Level A and Level AA success
criteria as well as success criteria unique to Level AAA.
---------------------------------------------------------------------------

\147\ http://www.w3.org/TR/WCAG20/.
---------------------------------------------------------------------------

In the 2014 Edition final rule (77 FR 54179) we considered public
comment and ultimately adopted Level A for accessibility, but indicated
our interest in raising this bar over time. As part of the Voluntary
Edition proposed rule, we again proposed that health IT be compliant
with Level AA for the

[[Page 16850]]

proposed VDT certification criterion. We received a limited and mixed
response to this proposal (79 FR 54465). In particular, some health IT
developers opposed the increased level citing the cost and burden to
reach Level AA, while others supported the move and offered no
concerns. In both cases, health IT developers noted that WCAG
conformance tools are somewhat sparse and that they have had difficulty
finding viable tools.
Level AA provides a stronger level of accessibility and addresses
areas of importance to the disabled community that are not included in
Level A. For example, success criteria unique to Level AA include
specifications of minimum contrast ratios for text and images of text,
and a requirement that text can be resized without assistive technology
up to 200 percent without loss of content or functionality. We
recognize that Level AA is a step up from Level A, but also note that
is has been nearly 3 years since we adopted Level A for the purposes of
certification to the ``view'' capability. Accordingly, we once again
request comment on the appropriateness of moving to Level AA for
certification of the ``view'' capability included in the 2015 Edition
VDT certification criterion.
We understand that there are not separate guidelines for ``mobile
accessibility'' and that mobile is considered by the W3C Web
Accessibility Initiative to be covered by the WCAG 2.0 guidelines.\148\
Further, we would note that in September 2013, the W3C published a
working group note consisting of ``Guidance on Applying WCAG 2.0 to
Non-Web Information and Communications Technologies (WCAG2ICT).'' \149\
We again request public comment (especially from health IT developers
that have sought or considered certification to the 2014 Edition VDT
certification criterion with a ``non-web'' application) on what, if
any, challenges exist or have been encountered when applying the WCAG
2.0 standards.
---------------------------------------------------------------------------

\148\ http://www.w3.org/WAI/mobile/.
\149\ http://www.w3.org/TR/wcag2ict/.
---------------------------------------------------------------------------

``Transmit'' Request for Comment
In the 2014 Edition Release 2 final rule, we modified the
``transmit'' portion of the 2014 Edition VDT certification criterion to
consistently allow for C-CDA ``content'' capabilities to be separately
certified from ``transport'' capabilities using Direct. In so doing, we
modified the transmit portion of the certification criterion to allow
it to be met in one of two ways: (1) Following the Direct Project
specification (for HISPs); or (2) following the Edge Protocol IG. Given
this change to ``transmit'' that we have duplicated in the proposed
2015 Edition VDT certification criterion and our proposal to include an
API capability as part of the proposed 2015 Edition VDT certification
criterion, we request comment on whether stakeholders believe that it
would be beneficial to include the Direct Project's Implementation
Guide for Direct Project Trust Bundle Distribution specification \150\
as part of certification to the first way described above (following
the Direct Project specification (for HISPs)) for the 2015 Edition VDT
certification criterion. This trust bundle specification's focuses on
``guidance on the packaging and distribution of Trust Bundles to
facilitate scalable trust between Security/Trust Agents (STAs).'' As we
understand, including this specification as part of certification could
enable patient-facing technology to be configured to trust externally
hosted bundles of S/MIME certificates. In addition, we have continued
to hear concerns regarding the difficulties related to exchanging
Direct messages across platforms and ``trust communities'' in the
context of patient-directed transmissions. Therefore, we also request
comments on whether any additional requirements are needed to support
scalable trust between STAs as well as ways in which ONC, in
collaboration with other industry stakeholders, could support or help
coordinate a way to bridge any gaps.
---------------------------------------------------------------------------

\150\ http://wiki.directproject.org/file/view/Implementation+Guide+for+Direct+Project+Trust+Bundle+Distribution+v1.0.pdf.
---------------------------------------------------------------------------

C-CDA Creation Capability Request for Comment
We request public comment on a potential means to provide explicit
implementation clarity and consistency as well as to further limit
potential burdens on health IT developers. Specifically, should we
limit the scope of C-CDA creation capability within this certification
criterion to focus solely on the creation of a CCD document template
based on the C-CDA Release 2.0? This approach could also have the
benefit of creating clear expectations and predictability for other
health IT developers who would then know the specific document template
implemented for compliance with this criterion.
C-CDA Data Provenance Request for Comment
We refer readers to the request for comment under the same heading
(``C-CDA Data Provenance Request for Comment'') in the ToC
certification criterion earlier in this section of the preamble
(section III). The request for comment focuses on the maturity of the
HL7 IG for CDA Release 2: Data Provenance, Release 1 (US Realm) (DSTU)
\151\ and its potential use in connection with the C-CDA.
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\151\ http://wiki.hl7.org/index.php?title=HL7_Data_Provenance_Project_Space and http://gforge.hl7.org/gf/project/cbcc/frs/?action=FrsReleaseBrowse&frs_package_id=240.
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Clinical Summary
We note that we are not proposing a 2015 Edition ``clinical
summary'' certification criterion because past versions of this
certification criterion were adopted in direct support of the EHR
Incentive Programs. The proposals found in the EHR Incentive Programs
Stage 3 proposed rule published elsewhere in this issue of the Federal
Register rely on patients being provided with the ability to view,
download, and transmit their health information via online access.
Therefore, we believe the capabilities included in the 2015 Edition
``view, download, and transmit to 3rd party'' certification criterion
appropriately and sufficiently support the proposals of the EHR
Incentive Programs.
Secure Messaging

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(e)(2) (Secure messaging)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``secure messaging''
certification criterion that is unchanged in comparison to the 2014
Edition ``secure messaging'' criterion (Sec. 170.314(e)(3)).
Transmission to Immunization Registries

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(f)(1) (Transmission to immunization registries)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``transmission to immunization
registries'' certification criterion that is revised in comparison to
the 2014 Edition ``transmission to immunization registries'' criterion
(Sec. 170.314(f)(2)). We propose to adopt an updated IG, require
National Drug Codes (NDC) for recording administered vaccines, require
CVX codes for historical vaccines, and require a Health IT Module
presented for certification to

[[Page 16851]]

this criterion to be able to display an immunization history and
forecast from an immunization registry. These proposals are described
in more detail below.
Implementation Guide for Transmission to Immunization Registries
The 2014 Edition certification criterion for transmission to
immunization registries at Sec. 170.314(f)(2) references the following
IG for immunization messaging: HL7 Version 2.5.1: Implementation Guide
for Immunization Messaging, Release 1.4. Since the publication of the
2014 Edition final rule, the CDC has issued an updated IG (HL7 Version
2.5.1: Implementation Guide for Immunization Messaging, Release 1.5)
(October 2014) that promotes greater interoperability between
immunization registries and health IT. Release 1.5 focuses on known
issues from the previous release and revises certain HL7 message
elements to reduce differences between states and jurisdictions for
recording specific data elements. Specifically, Release 1.5: \152\
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\152\ http://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdf.
---------------------------------------------------------------------------

Is organized into profiles, including separate profiles
for VXU and ACK (acknowledgement) messages;
Clarifies and tightens conformance statements;
Corrects ACK (acknowledgment) messages to support improved
messaging back to the EHR about the success/failure of a message; and
Includes query and response changes such as V2.7.1 MSH
user constraints, minimum requirements for a response message, and
corrected profiles for response to errors and no match situations.
We believe these improvements are important to the IG and will
continue to support our ultimate goal for this certification
criterion--bidirectional immunization data exchange. Given the
improvements included in the updated IG, we propose to adopt it at
Sec. 170.205(e)(4) and include it in the 2015 Edition ``transmission
to immunization registries'' certification criterion.
National Drug Codes for Administered Vaccinations
In the Voluntary Edition proposed rule, we solicited comment for
future editions on whether we should replace CVX codes for representing
vaccines with NDC codes,\153\ and on options for recording historical
immunizations (79 FR 10908-9). NDC codes offer a number of benefits
compared to CVX codes because:
---------------------------------------------------------------------------

\153\ http://www.fda.gov/drugs/informationondrugs/ucm142438.htm.
---------------------------------------------------------------------------

They can support pharmaceutical inventory management
within immunization registries and are built into the provider's
workflow;
Are built into 2D barcodes, which have been successfully
piloted for vaccines, and can improve quality and efficiency of data
entry of information such as vaccine lot and expiration date; and
Can improve patient safety with better specificity of
vaccine formulation.
NDC codes also include packaging information as well as support
linking to the unit of use and sale, whereas CVX codes do not provide
this information as efficiently. These data elements are important for
supporting vaccine inventory management.
Immunization registries are tightly linked to inventory management
functions. This is largely due to the administration of the Vaccines
for Children (VFC) program, a federally funded program that provides
vaccines at no cost to children who might not otherwise be vaccinated
because of inability to pay. CDC purchases vaccines at a discount and
distributes them to grantees, which are state health departments and
local and territorial public health agencies. The grantees distribute
the VFC vaccines at no charge to private providers' offices and public
health clinics registered as VFC providers. Because of the way this
program is administered, immunization registries, which are maintained
by public health agencies, have been developed to include vaccine
inventory functions that help the grantees and providers manage their
VFC vaccine stock. Due to the coupling of inventory functions within
registries, many systems that can transmit immunization information to
registries are also able to support these inventory management
functions. NDC codes are used by many immunization registries to order
vaccines and for inventory purposes.
We believe NDC codes for vaccines may be best suited to support
immunization inventory management, as well as for providing the
benefits stated above for 2D barcoding and patient safety. Both the HL7
Version 2.5.1: Implementation Guide for Immunization Messaging, Release
1.5 and the C-CDA Release 2.0 IG support coding of immunizations using
both CVX and NDC codes. CDC also provides a publicly available mapping
of NDC codes for vaccines to CVX codes.\154\
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\154\ http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=ndc. See also: http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp.
---------------------------------------------------------------------------

NDC codes for vaccines include a portion that identifies the
product, and thus cannot be used to code historical vaccinations of
unknown formulation. Historical vaccinations are self-reported
vaccinations given prior to the office visit. Patients can report
historical vaccinations to providers without supporting documentation,
such as a written or electronic vaccination history, and therefore the
provider does not know the manufacturer and/or formulation of the
product. In terms of options for recording historical vaccinations of
unspecified/unknown formulation, we solicited comments on two options
in the Voluntary Edition proposed rule:
Option 1: Continue to use CVX codes for historical
vaccinations only;
Option 2: Use the NDC syntax and create a new value set
for the product portion of the code for vaccines of unspecified formula
(e.g., influenza vaccine of unspecified formula) for historical
vaccinations (resulting in an ``NDC-like'' code).
The majority of commenters were opposed to Option 2 for creating an
``NDC-like'' code. Commenters believed it would add complexity to
coding NDC codes and be burdensome to maintain in the long-term. We
agree with commenters and therefore believe Option 1 is a more viable
solution for recording historical vaccinations. We believe health IT
should be able to record historical vaccinations to provide the most
complete record possible for a provider to use in determining which
vaccines a patient may need.
We received comments that recommended we consider moving to
RxNorm[supreg] codes for immunizations. However, RxNorm[supreg] does
not support inventory management nor does it support recording
historical vaccinations. Therefore, we do not believe RxNorm[supreg] is
the best available option for coding vaccinations at this time.
We also received public comment that, in certain circumstances, NDC
codes can be reused. Commenters expressed concerned about potential
confusion for vaccine products when NDC codes are reused. In
consultation with FDA, we understand that FDA does not intend to allow
reuse of NDC codes for vaccine products going forward. Thus, we do not
believe that reuse of NDC codes will be an issue for vaccine coding.
Given the discussion above on the benefits of NDC codes for coding
vaccinations and in consideration of public comment, we propose to
require for certification that a Health IT Module be able to
electronically create

[[Page 16852]]

immunization information for electronic transmission to immunization
registries using NDC codes for vaccines administered (i.e., the
National Drug Code Directory--Vaccine Codes, updates through January
15, 2015 \155\). For historical vaccines, we propose to continue the
use of CVX codes and propose to adopt the HL7 Standard Code Set CVX--
Vaccines Administered, updates through February 2, 2015,\156\ as the
baseline version for certification to the 2015 Edition. We refer
readers to section III.A.2.d (``Minimum Standards'' Code Sets) for
further discussion of our proposal to adopt the National Drug Code
Directory--Vaccine Codes as a minimum standards code set and the
``January 15, 2015 version,'' or potentially a newer version if
released before a subsequent final rule, as the baseline for
certification to the 2015 Edition. We also refer readers to section
III.A.2.d (``Minimum Standards'' Code Sets) for further discussion of
our adoption of CVX codes as a minimum standards code set and our
proposal to adopt the ``February 2, 2015 version,'' or potentially a
newer version if released before a subsequent final rule, as the
baseline for certification to the 2015 Edition.
---------------------------------------------------------------------------

\155\ http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp.
\156\ http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cvx.
---------------------------------------------------------------------------

In addition to soliciting comments on this proposal, we solicit
comment on whether we should allow use of NDC codes for administered
vaccines as an option for certification, but continue to require CVX
codes for administered vaccines for the 2015 Edition. Allowing for
optional use of NDC codes for administered vaccines could provide
health IT developers and health care providers an implementation period
before we would consider requiring NDC codes for administered vaccines.
We also solicit comment on whether we should require CVX plus the HL7
Standard Code Set MVX--Manufacturers of Vaccines Code Set (October 30,
2014 version) \157\ as an alternative to NDC codes for administered
vaccines. MVX codes identify the manufacturer of a vaccine and support
recording the vaccine at the trade name level when paired with the CVX
code. MVX codes do not, however, independently include the trade name,
package, or unit of use/unit of sale. CVX codes plus MVX codes could
provide more information than CVX codes alone, but not as much
information as NDC codes. As part of this comment solicitation, we also
invite comments on the implementation burden for health IT developers
and health care providers of requiring CVX plus MVX codes versus NDC
codes for administered vaccines.
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\157\ http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=mvx.
---------------------------------------------------------------------------

Immunization History and Forecast
In the Voluntary Edition proposed rule, we solicited comment on the
maturity of bidirectional immunization data exchange activities and
whether we should propose to include bidirectional immunization
exchange in our certification rules. Commenters supported inclusion of
bidirectional immunization data exchange. We understand that the HL7
Version 2.5.1: Implementation Guide for Immunization Messaging, Release
1.5 we are proposing to adopt for this criterion provides improvements
that support bidirectional exchange between health IT and immunization
registries, including segments for querying a registry, receiving
information, and sending a response to the registry. Additionally, we
received comments specifically recommending that immunization forecast
information and CDS guidance provide results in accordance with the
Advisory Committee on Immunization Practice's (ACIP) \158\
recommendations.
---------------------------------------------------------------------------

\158\ http://www.cdc.gov/vaccines/acip/.
---------------------------------------------------------------------------

We believe that bidirectional exchange between health IT and
immunization registries is important for patient safety and improved
care. Immunization registries can provide information on a patient's
immunization history to complement the data in the EHR. Immunization
registries also provide immunization forecasting recommendations
according to the ACIP's recommendations. This information allows for
the provider to access the most complete and up-to-date information on
a patient's immunization history to inform discussions about what
vaccines a patient may need based on nationally recommended
immunization recommendations.
Provided the discussion above, we propose that, for certification
to this criterion, a Health IT Module would need to enable a user to
request, access, and display a patient's immunization history and
forecast from an immunization registry in accordance with the HL7
Version 2.5.1: Implementation Guide for Immunization Messaging, Release
1.5. We welcome comment on this proposal. We also welcome comments on
whether we should include an immunization history information
reconciliation capability in this criterion and the factors we should
consider regarding the reconciliation of immunization history
information.
Exchange of the Common Clinical Data Set--NDC and CVX Codes
For transmission of immunization information across settings using
the C-CDA standard, NDC codes carry more information than CVX codes,
specifically for inventory management and safety functions (e.g., trade
name, package, and unit of use/unit of sale). For quality reporting of
immunization coverage data using the QRDA Category I standard,
inventory management data may not be needed, and therefore a CVX code
is sufficient for submission of quality reporting data. However, ONC is
supportive of moving towards collection of vaccine administration data
within the EHR with the patient's clinical data regardless of the
requirements in the QRDA Category I standard. We believe it is
appropriate to use mapping from NDC codes to CVX codes and a mapping
table is available.\159\ We understand that the C-CDA Release 2.0 can
support NDC codes as a translational data element, but the CVX code is
required to accompany it. The additional information NDC codes contain
could assist with vaccine tracking for clinical trials and adverse
events. Therefore, we propose in a later section of this rule to
include the representation of immunizations in both CVX codes and NDC
codes as part of the ``Common Clinical Data Set'' definition for
certification to the 2015 Edition. Please see section III.B.3 ``Common
Clinical Data Set'' of this preamble for further discussion of this
associated proposal. We note that this means that a Health IT Module
certified to certification criteria that include the Common Clinical
Data Set (e.g., the ToC criterion) must demonstrate the capability to
represent immunizations in CVX codes and NDC codes. This approach
ensures that health IT would be able to support a provider's attempt to
send immunization information that includes NDC information.
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\159\ http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=ndc. See also: http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp.
---------------------------------------------------------------------------

Immunization Information Certification Criterion
In response to the Voluntary Edition proposed rule, we received
comments recommending we discontinue the ``immunization information''
certification criterion for future editions because the necessary data
elements are enumerated in the IG for reporting to immunization
registries required for the

[[Page 16853]]

``transmission to immunization registries'' criterion. These commenters
did not see any additional value in having a standalone certification
criterion for ``immunization information'' as the value lies in being
able to transmit the immunization message. We agree with these
comments. Therefore, we are not proposing an ``immunization
information'' criterion as part of the 2015 Edition. We welcome
comments on this approach.
Transmission to Public Health Agencies--Syndromic
Surveillance

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition EHR Certification Criterion
Sec. 170.315(f)(2) (Transmission to public health agencies--syndromic
surveillance)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition certification criterion for
transmission of syndromic surveillance to public health agencies that
is revised in comparison to the 2014 Edition version (Sec.
170.314(f)(3)) for the inpatient setting. We note, however, that this
proposed certification criterion is unchanged (for the purposes of gap
certification) for the ambulatory setting. As discussed in the 2014
Edition Release 2 final rule, we understand that ambulatory providers
may be using different methods for sending syndromic surveillance
information to public health agencies, including HL7 2.5.1 and query-
based messages (79 FR 54439-54441). It is our understanding that these
methods are still being implemented and refined within the industry and
the public health community. Therefore, given the varied adoption of
methods for transmitting syndromic surveillance information to public
health agencies from ambulatory settings, we propose to continue to
distinguish between ambulatory and emergency department, urgent care,
and inpatient settings.
Emergency Department, Urgent Care, and Inpatient Settings
We propose to adopt the PHIN Messaging Guide for Syndromic
Surveillance: Emergency Department, Urgent, Ambulatory Care, and
Inpatient Settings, Release 2.0, September 2014 (``Release 2.0'').\160\
Release 2.0 provides improvements over previous versions by:
---------------------------------------------------------------------------

\160\ http://www.cdc.gov/phin/library/guides/SyndrSurvMessagGuide2_MessagingGuide_PHN.pdf
---------------------------------------------------------------------------

Re-purposing of the HL7 2.5.1 messaging structure for all
type of messages/trigger events, and combining all specifications in
one profile;
Re-structuring chapters, making them more concise and
placing supporting information into Appendixes;
Adding more implementation comments and better field name
descriptions within segment profile attributes;
Making examples better aligned to the business process;
Adding new conformance statements that simplify testing of
messages;
Making more user-friendly navigation through the document
(adding a more detailed Table of Contents, updating a format of
implementation comments, etc.);
Simplifying collection and management of data by
addressing requests for only using a text format for the ``Chief
Complaint/Reason for Visit'' Data Element; and
Correcting errors that were discovered in Version 1.9.
We believe these improvements are important to the IG and will
continue to support interoperability and data exchange of syndromic
surveillance information. As we adopted Release 1.8 of the IG in 2012
for the 2014 Edition, we believe the industry has had sufficient time
to implement Release 1.8 and could benefit from the updates in Release
2.0. Release 2.0 also updates errors and known issues from Release 1.9
that commenters noted in response to the Voluntary Edition proposed
rule as discussed in the Voluntary Edition final rule (79 FR 54440).
Given the improvements included in Release 2.0 of the IG, we propose to
adopt it at Sec. 170.205(d)(4) and include it in the 2015 Edition
``transmission to public health agencies--syndromic surveillance''
certification criterion for emergency department, urgent care, and
inpatient settings.
Ambulatory Syndromic Surveillance
We propose to permit, for ambulatory setting certification, the use
of any electronic means for sending syndromic surveillance data to
public health agencies as well as optional certification to certain
syndromic surveillance data elements. In the 2014 Edition Release 2
final rule, we adopted a certification criterion for ambulatory
syndromic surveillance at Sec. 170.314(f)(7) that permits use of any
electronic means of sending syndromic surveillance data to public
health agencies for ambulatory settings (79 FR 54440-01). We adopted
this criterion to provide EPs under the EHR Incentive Programs to meet
the Stage 2 syndromic surveillance objective with the use of CEHRT.
Because there were no IGs to support HL7 2.5.1 messaging or query-based
syndromic surveillance for ambulatory settings, we expanded our policy
to provide more flexibility to EPs to meet the syndromic surveillance
objective.
As part of the 2014 Edition criterion, we also provide the option
for technology presented for certification to demonstrate that it can
electronically produce syndromic surveillance information that contains
patient demographics, provider specialty, provider address, problem
list, vital signs, laboratory results, procedures, medications, and
insurance. Public health agencies and stakeholders that piloted query-
based models for transmitting ambulatory syndromic surveillance data
send all of these data elements. We offered this optional list of data
elements for certification to provide clarity and a path forward to
health IT developers on the data elements they should focus on for
creating syndrome-based public health transmissions in support of
query-based models, including any potential certification requirements
introduced through future rulemaking. Due to the continued lack of
mature IGs at this time, we propose to take the same approach for 2015
Edition syndromic surveillance certification for the ambulatory
setting.
Transmission to Public Health Agencies--Reportable
Laboratory Tests and Values/Results

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(f)(3) (Transmission to public health agencies--reportable
laboratory tests and values/results)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition certification criterion that is
revised in comparison to the 2014 Edition ``transmission of reportable
laboratory tests and values/results'' criterion (Sec. 170.314(f)(4)).
We have named this criterion ``transmission to public health agencies--
reportable laboratory tests and values/results'' to clearly convey the
capabilities included in this criterion as they relate to the intended
recipient of the data. We propose to include and adopt an updated IG
for laboratory reporting to public health, an updated version of SNOMED
CT[supreg], and an updated version of LOINC[supreg]. We also propose to
make a technical amendment to the regulation text for the 2014 Edition
criterion in order to have it continue to reference the appropriate
standard and implementation specifications \161\ after we restructure

[[Page 16854]]

the regulatory text hierarchy at Sec. 170.205(g) to accommodate our
2015 Edition proposal.
---------------------------------------------------------------------------

\161\ HL7 2.5.1 and HL7 Version 2.5.1: Implementation Guide:
Electronic Laboratory Reporting to Public Health, Release 1 with
Errata and Clarifications and ELR 2.5.1 Clarification Document for
EHR Technology Certification.
---------------------------------------------------------------------------

CDC worked in conjunction with the HL7 Public Health Emergency
Response Workgroup to develop an updated IG (HL7 Version 2.5.1
Implementation Guide: Electronic Laboratory Reporting to Public Health,
Release 2 (US Realm), DSTU R1.1, 2014 or ``Release 2, DSTU R1.1'') that
address technical corrections and clarifications for interoperability
with laboratory orders and other laboratory domain implementation
guides. Specifically, ``Release 2, DSTU R1.1'': \162\
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\162\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=329.
---------------------------------------------------------------------------

Corrects errata;
Updates Objective Identifiers;
Applies conformance statements from the LRI DSTU;
Provides technical corrections; and
Updates usage for consistent treatment of modifier fields.
As we adopted Release 1 of the IG in 2012 for the 2014 Edition, we
believe the industry has had sufficient time to implement Release 1 and
could benefit from the updates in ``Release 2, DSTU R1.1.'' Given the
improvements included in the updated IG (Release 2, DSTU R1.1), we
propose to adopt it at Sec. 170.205(g)(2) and include it in the 2015
Edition ``transmission of reportable laboratory tests and values/
results'' certification criterion at Sec. 170.315(f)(3). As noted
above, to properly codify this proposal in regulation, we would have to
modify the regulatory text hierarchy in Sec. 170.205(g) to designate
the standard and implementation specifications referenced by the 2014
Edition ``transmission of reportable laboratory tests and values/
results'' certification criterion at Sec. 170.205(g)(1) instead of its
current designation at Sec. 170.205(g).
We propose to include the September 2014 Release of the U.S.
Edition of SNOMED CT[supreg] and LOINC[supreg] version 2.50 in this
criterion. We refer readers to section III.A.2.d (``Minimum Standards''
Code Sets) for further discussion of our adoption of SNOMED CT[supreg]
and LOINC[supreg] as minimum standards code sets and our proposals to
adopt the versions cited above, or potentially newer versions if
released before a subsequent final rule, as the baselines for
certification to the 2015 Edition.
Transmission to Cancer Registries

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(f)(4) (Transmission to cancer registries)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``transmission to cancer
registries'' certification criterion that is revised in comparison to
the 2014 Edition ``transmission to cancer registries'' certification
criterion (Sec. 170.314(f)(6)). We propose to adopt an HL7 version
cancer reporting IG, adopt an updated version of SNOMED CT[supreg], and
adopt an updated version of LOINC[supreg]. We also propose to make a
technical amendment to the regulation text for the 2014 Edition
certification criterion so that it continues to reference the
appropriate standard \163\ in the regulatory text hierarchy at Sec.
170.205(i), while accommodating our 2015 Edition proposal.
Specifically, we propose to modify the 2014 Edition certification
criterion to reference Sec. 170.205(i)(1) to establish the regulatory
text hierarchy necessary to accommodate the standard and IG referenced
by the proposed 2015 Edition certification criterion.
---------------------------------------------------------------------------

\163\ Standard. HL7 Clinical Document Architecture (CDA),
Release 2.0, Normative Edition (incorporated by reference in Sec.
170.299). Implementation specifications. Implementation Guide for
Ambulatory Healthcare Provider Reporting to Central Cancer
Registries, HL7 Clinical Document Architecture (CDA), Release 1.0
(incorporated by reference in Sec. 170.299).
---------------------------------------------------------------------------

The 2014 Edition ``transmission to cancer registries'' criterion at
Sec. 170.314(f)(6) references the following IG for cancer reporting:
Implementation Guide for Ambulatory Healthcare Provider Reporting to
Central Cancer Registries, HL7 Clinical Document Architecture (CDA),
Release 1.0. Since the publication of the 2014 Edition Final Rule, CDC
worked with HL7 to introduce the IG to the standards developing
organization processes. In doing so, an updated IG has been developed
to address technical corrections and clarifications for
interoperability with EHRs and cancer registries (HL7 Implementation
Guide for CDA(copyright) Release 2: Reporting to Public Health Cancer
Registries from Ambulatory Healthcare Providers Release 1 or ``HL7 IG
Release 1''). Specifically, HL7 IG Release 1: \164\
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\164\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=383.
---------------------------------------------------------------------------

Aligns with C-CDA Release 2.0 templates, where possible;
Adds new data elements, including grade, pathologic TNM
stage,\165\ family history of illness, height and weight, discrete
radiation oncology items, planned medications, and planned procedures;
---------------------------------------------------------------------------

\165\ The TNM Classification of Malignant Tumours (TNM) is a
cancer staging system that describes the extent of a person's
cancer.
---------------------------------------------------------------------------

Changes optionality for some data elements in response to
cancer community input and to align with C-CDA Release 2.0 templates;
Improves documentation and aligns conformance statements
with table constraints;
Adds some new vocabulary links and a new reportability
list for ICD-10-CM;
Fixes some within-document references;
Fixes some LOINC[supreg] codes;
Fixes some Code System and Value Set Object Identifiers;
Fixes some conformance verbs;
Improves sample XML snippets;
Fixes some conformance verbs and data element names in
Appendix B ``Ambulatory Healthcare Provider Cancer Event Report--Data
Elements''; and
Fixes a value in the value set.
These improvements will continue to promote interoperability
between health IT and cancer registries for improved cancer case
reporting to public health agencies. As we adopted the non-HL7 Release
1 of the IG in 2012 for the 2014 Edition, we believe the industry has
had sufficient time to implement that IG and could benefit from the
updates in HL7 IG Release 1. Therefore, given the improvements that
will be included in HL7 IG Release 1 as described above, we propose to
adopt it at Sec. 170.205(i)(2) and include it in the proposed 2015
Edition ``transmission to cancer registries'' certification criterion.
We propose to include the September 2014 Release of the U.S.
Edition of SNOMED CT[supreg] and LOINC[supreg] version 2.50 in this
criterion. We refer readers to section III.A.2.d (``Minimum Standards''
Code Sets) for further discussion of our adoption of SNOMED CT[supreg]
and LOINC[supreg] as minimum standards code sets and our proposals to
adopt the versions cited above, or potentially newer versions if
released before a subsequent final rule, as the baselines for
certification to the 2015 Edition.
Cancer Case Information
In response to the Voluntary Edition proposed rule, we received
comments recommending we discontinue proposing and adopting a ``cancer
case information'' certification criterion for future editions because
the necessary data elements are enumerated in the IG for reporting to
cancer registries that we include in editions of ``transmission to
cancer registries'' criteria. We agree with this assessment. Therefore,
we are not proposing a 2015 Edition ``cancer case information''
certification criterion

[[Page 16855]]

similar to the one we adopted for the 2014 Edition. We welcome comments
on this approach.
Transmission to Public Health Agencies--Case Reporting

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(f)(5) (Transmission to public health agencies--case
reporting)
------------------------------------------------------------------------

We propose to adopt a new certification criterion in the 2015
Edition for electronic transmission of case reporting information to
public health agencies.
Health IT standards continue to evolve to address new and emerging
use cases for health care. The utility of health IT for supplemental
purposes has been limited due to a lack of uniformity in the
terminology and definitions of data elements across health IT systems.
This limitation is compounded by the fact that provider workflow often
records patient information in unstructured free-text well after
episodes of care. Linking data in EHR systems with other data in a
uniform and structured way could accelerate quality and safety
improvement, population health, and research.
Toward this end, the S&I Structured Data Capture \166\ (SDC)
initiative is a multi-stakeholder group working on standards-based
architecture so that a set of structured data can be accessed from
health IT and stored for merger with comparable data for other relevant
purposes. The SDC initiative is developing a set of standards that will
enable health IT to capture and store structured data. These standards
will build upon and incorporate existing standards, including the IHE
Retrieve Form for Data Capture (RFD) profile. As part of this work, the
SDC initiative has developed a surveillance case report form for public
health reporting of notifiable diseases as part of the IHE Quality,
Research, and Public Health Technical Framework Supplement, Structured
Data Capture, Trial Implementation (September 5, 2014) standard.\167\
The case report form can be further specified and used to
electronically report vital statistics, vaccine adverse event
reporting, school/camp/daycare physical, early hearing detection and
intervention/newborn hearing screening, and cancer registry reporting,
among other public health reporting data.
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\166\ http://wiki.siframework.org/Structured+Data+Capture+Initiative.
\167\ http://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_SDC.pdf.
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We believe that case reporting from health care providers to public
health agencies could be more real-time, structured, and efficient
through the use of the standard case report form that the SDC
initiative has developed. Therefore, we propose to adopt a
certification criterion for electronic transmission of case reporting
information to public health that would require a Health IT Module to
be able to electronically create case reporting information for
electronic transmission in accordance with the IHE Quality, Research,
and Public Health Technical Framework Supplement, Structured Data
Capture, Trial Implementation (September 5, 2014) standard, which we
propose to adopt at Sec. 170.205(q)(1). As mentioned above, this
standard and our proposal include compliance with other existing
standards. One such standard is the CDA Release 2.0, which is a
foundational standard for use in sending and receiving case reporting
information.
To note, for testing to this criterion, a Health IT Module would
need to demonstrate that it can create and send a constrained
transition of care document to a public health agency, accept a URL in
return, be able to direct end users to the URL, and adhere to the
security requirements for the transmission of this information.
We recognize that the Fast Health Interoperability Resource
(FHIR[supreg]) REST API and FHIR-based standard specifications will
likely play a role in an interoperable health IT architecture. FHIR
resources that implement SDC concepts and support the use of case
reporting to public health would likely play a role in that scenario.
The current HL7 FHIR Implementation Guide: Structure Data Capture
(SDC), Release 1 \168\ is a ``draft for comment'' with a DSTU ballot
planned for mid-2015. Given this trajectory, we solicit comment on
whether we should consider adopting the HL7 FHIR Implementation Guide:
SDC DSTU that will be balloted in mid-2015 in place of, or together
with, the IHE Quality, Research, and Public Health Technical Framework
Supplement. We are aware of a proposed HL7 working group known as the
Healthcare Standards Integration Workgroup that will collaborate on
FHIR resources considered co-owned with the IHE-HL7 Joint Workgroup
\169\ within IHE. The implementation guides created from the S&I SDC
Initiative is part of this joint workgroup's area of responsibility.
Therefore, we intend to work with these coordinated efforts to ensure a
complementary and coordinated approach for case reporting using SDC.
---------------------------------------------------------------------------

\168\ http://hl7.org/implement/standards/FHIR-Develop/sdc.html.
\169\ http://wiki.ihe.net/index.php?title=IHE-HL7_Joint_Workgroup.
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Transmission to Public Health Agencies--Antimicrobial Use
and Resistance Reporting

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(f)(6) (Transmission to public health agencies--
antimicrobial use and resistance reporting)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition certification criterion for
transmission of antimicrobial use and resistance data to public health
agencies that would require a Health IT Module to be able to
electronically create antimicrobial use and resistance reporting
information for electronic transmission in accordance with specific
sections of the HL7 Implementation Guide for CDA [supreg] Release 2--
Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm
(August 2013).
Collection and analysis of data on antimicrobial use and
antimicrobial resistance are important components of antimicrobial
stewardship programs throughout the nation and efforts by health care
organizations and public health agencies aimed at detecting,
preventing, and responding to resistant pathogens. Surveillance
provides vital data for use by health care facilities, local, state,
and federal agencies, research and development teams, policymakers, and
the public. Electronic submission of antimicrobial use and
antimicrobial resistance data to a public health registry can promote
timely, accurate, and complete reporting, particularly if data is
extracted from health IT systems and delivered using well established
data exchange standards to a public health registry. The HL7
Implementation Guide for CDA [supreg] Release 2--Level 3: Healthcare
Associated Infection Reports, Release 1--US Realm--August 2013 \170\
(``HAI IG'') is an ANSI-approved standard for electronic reporting of
antimicrobial use and antimicrobial resistance data to the CDC's
National Healthcare Safety Network (NHSN), the largest health care-
associated infection (HAI) reporting system in the United States with
over 9,000 health care facilities participating. The HAI IG provides
details for reporting from EPs, eligible hospitals, and CAHs.
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\170\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=20.
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We propose to test and certify a Health IT Module for conformance
with the following sections of the IG:

[[Page 16856]]

HAI Antimicrobial Use and Resistance (AUR) Antimicrobial
Resistance Option (ARO) Report (Numerator) specific document template
in Section 2.1.2.1 (pages 69-72);
Antimicrobial Resistance Option (ARO) Summary Report
(Denominator) specific document template in Section 2.1.1.1 (pages 54-
56); and
Antimicrobial Use (AUP) Summary Report (Numerator and
Denominator) specific document template in Section 2.1.1.2 (pages 56-
58).
We propose to adopt these specific sections of the IG in Sec.
170.205(r)(1). Note that the specific document templates referenced
above include conformance to named constraints in other parts of the
IG, and we would expect a Health IT Module presented for certification
to this criterion to conform to all named constraints within the
specified document template.
Transmission to Public Health Agencies--Health Care
Surveys

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(f)(7) (Transmission to public health agencies--health
care surveys)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition certification criterion for
transmission of health care surveys to public health agencies. We
propose to adopt a certification criterion for transmission of health
care survey information to public health agencies that would require a
Health IT Module to be able to create health care survey information
for electronic transmission in accordance with the HL7 Implementation
Guide for CDA [supreg] Release 2: National Health Care Surveys (NHCS),
Release 1--US Realm, Draft Standard for Trial Use (December 2014),\171\
which we propose to adopt at Sec. 170.205(s)(1).
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\171\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=385.
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The National Ambulatory Medical Care Survey (NAMCS) is a national
survey designed to meet the need for objective, reliable information
about the provision and use of ambulatory medical care services in the
U.S. Findings are based on a sample of visits to non-federal employed
office-based physicians who are primarily engaged in direct patient
care.
The National Hospital Ambulatory Medical Care Survey (NHAMCS) is
designed to collect data on the utilization and provision of ambulatory
care services in hospital emergency and outpatient departments.
Findings are based on a national sample of visits to the emergency
departments and outpatient departments of general and short-stay
hospitals.
The kinds of data contained in this survey are:
Patient demographics such as date of birth, sex, race and
ethnicity;
Vital signs such as height, weight and blood pressure;
Reason for visit or chief complaint;
Diagnoses associated with the visit;
Chronic conditions that the patient has at the time of the
visit;
Procedures provided or ordered;
Diagnostic tests ordered or provided;
New or continued medications at the time of the visit; and
Other variables such as tobacco use, whether the provider
is the patient's primary care provider, how many times has the patient
been seen in the practice in the past 12 months, which type of
providers were seen at the visit, amount of time spent with the
provider, and visit disposition.
Automating the survey process using the CDA standard streamlines
the collection of data and increases the sample pool by allowing all
providers who want to participate in the surveys to do so. The HL7
Implementation Guide for CDA [supreg] Release 2: National Health Care
Surveys (NHCS), Release 1--US Realm, Draft Standard for Trial Use
(December 2014) defines the electronic submission of the data to the
CDC. We clarify that the IG is intended for the transmission of survey
data for both the NAMCS (e.g., for ambulatory medical care settings)
and NHAMCS (e.g., for hospital ambulatory settings including emergency
departments and outpatient departments). Templates included in this IG
align with the C-CDA standard. Additionally, the templates in this IG
expand on the scope of the original NAMCS and NHAMCS survey data
elements and do not constrain the data collected to the narrow lists on
the survey instruments; rather they allow any service, procedure or
diagnosis that has been recorded.
Automated Numerator Recording

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(g)(1) (Automated numerator recording)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``automated numerator
recording'' certification criterion that is unchanged in comparison to
the 2014 Edition ``automated numerator recording'' criterion. We note,
however, that the test procedure for this criterion would be different
from the 2014 Edition ``automated numerator recording'' certification
criterion in order to remain consistent with the applicable objectives
and measures required under the EHR Incentive Programs.
Automated Measure Calculation

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(g)(2) (Automated measure calculation)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``automated measure
calculation'' certification criterion that is unchanged in comparison
to the 2014 Edition ``automated measure calculation'' criterion. We
propose to apply the guidance provided for the 2014 Edition ``automated
measure calculation'' certification criterion in the 2014 Edition final
rule in that a Health IT Module must be able to support all CMS-
acceptable approaches for measuring a numerator and denominator in
order for the Health IT Module to meet the proposed 2015 Edition
``automated measure calculation'' certification criterion.\172\ We also
propose that the interpretation of the 2014 Edition ``automated measure
calculation'' certification criterion in FAQ 32 \173\ would apply to
the proposed 2015 Edition ``automated measure calculation''
certification criterion.
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\172\ 77 FR 54244-54245.
\173\ http://www.healthit.gov/policy-researchers-implementers/32-question-11-12-032.
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We note that the test procedure for this criterion would be
different from the 2014 Edition ``automated measure calculation''
certification criterion in order to remain consistent with the
applicable objectives and measures required under the EHR Incentive
Programs.
Safety-Enhanced Design

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(g)(3) (Safety-enhanced design)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``safety-enhanced design'' (SED)
certification criterion that is revised in comparison to the 2014
Edition ``safety-enhanced design'' criterion. We propose to add
certification criteria to this criterion that we believe include
capabilities that pose a risk for patient harm and, therefore, an
opportunity for error prevention. We propose to provide further
compliance clarity for the data elements described in NISTIR 7742 \174\
that are required to be submitted as part of the summative usability
test results and to specifically include these data

[[Page 16857]]

elements as part of the certification criterion.
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\174\ http://www.nist.gov/manuscript-publication-search.cfm?pub_id=907312. NISTIT 7742 is a valid and reliable
publication for user-centered design processes.
---------------------------------------------------------------------------

Certification Criteria Identified in the SED Criterion for UCD
Processes
We propose to include seventeen (17) certification criteria (seven
are new) in the 2015 Edition SED certification criterion, as listed
below (emphasis added for new criteria). For each of the referenced
certification criteria and their corresponding capabilities presented
for certification, user-centered design (UCD) processes must have been
applied in order satisfy this certification criterion.
Sec. 170.315(a)(1) Computerized provider order entry--
medications
Sec. 170.315(a)(2) Computerized provider order entry--
laboratory
Sec. 170.315(a)(3) Computerized provider order entry--
diagnostic imaging
Sec. 170.315(a)(4) Drug-drug, drug-allergy interaction
checks
Sec. 170.315(a)(5) Demographics
Sec. 170.315(a)(6) Vital signs, BMI, and growth charts
Sec. 170.315(a)(7) Problem list
Sec. 170.315(a)(8) Medication list
Sec. 170.315(a)(9) Medication allergy list
Sec. 170.315(a)(10) Clinical decision support
Sec. 170.315(a)(18) Electronic medication administration
record
Sec. 170.315(a)(20) Implantable device list
Sec. 170.315(a)(22) Decision support--knowledge artifact
Sec. 170.315(a)(23) Decision support--service
Sec. 170.315(b)(2) Clinical information reconciliation
and incorporation
Sec. 170.315(b)(3) Electronic prescribing
Sec. 170.315(b)(4) Incorporate laboratory tests/results
The continued submission of summative usability test results
promotes transparency and can foster health IT developer competition,
spur innovation, and enhance patient safety. With this in mind, we also
seek comment on whether there are other certification criteria that we
omitted from this proposed SED criterion that commenters believe should
be included.
NISTIR 7742 Submission Requirements
In the 2014 Edition final rule, we specified that the information
listed below from the NISTIR 7742 ``Customized Common Industry Format
Template for Electronic Health Record Usability Testing'' (NIST 7742)
\175\ was required to be submitted for each and every one of the
criteria specified in the 2014 Edition SED criterion (77 FR 54188). For
the 2015 Edition SED criterion, we propose to include the information
below in the regulation text of the 2015 Edition SED criterion to
provide more clarity and specificity for the information requested to
be provided to demonstrate compliance with this certification
criterion. The findings that would be required to be submitted for each
and every one of the criteria specified in the 2015 Edition SED
criterion (and become part of the test results publicly available on
the Certified Health IT Product List (CHPL)) are:
---------------------------------------------------------------------------

\175\ http://www.nist.gov/manuscript-publication-search.cfm?pub_id=907312.
---------------------------------------------------------------------------

Name and version of the product
Date and location of the test
Test environment
Description of the intended users
Total number of participants
Description of participants as follows:
[ssquf] Sex
[ssquf] Age
[ssquf] Education
[ssquf] Occupation/role
[ssquf] Professional experience
[ssquf] Computer experience
[ssquf] Product experience
Description of the user tasks that were tested and
association of each task to corresponding certification criteria
List of the specific metrics captured during the testing
[ssquf] Task Success (%)
[ssquf] Task Failures (%)
[ssquf] Task Standard Deviations (%)
[ssquf] Task Performance Time
[ssquf] User Satisfaction Rating (Scale with 1 as very difficult
and 5 as very easy)
Test results for each task using metrics listed above
Results and data analysis narrative:
[ssquf] Major test finding
[ssquf] Effectiveness
[ssquf] Efficiency
[ssquf]Satisfaction
[ssquf]Areas for improvement
There are illustrative tables on pages 11 and 20 in NISTIR 7742
that provide examples of the presentation of test participants and test
results data. We specify that all of the data elements and sections
specified above must be completed, including ``major findings'' and
``areas for improvement.'' Pages 18 and 19 of the NISTIR 7742 contain a
table with suggested instructions for data scoring specifically noting
that for task success, a task is counted as successful if the
participant was able to achieve the correct outcome without assistance
and within the time allotted on a per task basis. Likewise, for task
satisfaction a 5 point Likert scale is recommended with scores ranging
from ``1--very difficult'' to ``5--very easy.''
The NISTIR 7742 includes several sections: Executive Summary,
Introduction, Method, and Results. In each of these sections, there are
required data elements--and some of these elements call for the
reporting of the number of study participants, their level of
experience with EHR technology and other pertinent details.
We recommend following NISTIR 7804 \176\ ``Technical Evaluation,
Testing, and Validation of the Usability of Electronic Health Records''
for human factors validation testing of the final product to be
certified. In accordance with this guidance, we recommend a minimum of
15 representative test participants for each category of anticipated
clinical end users who conduct critical tasks where the user interface
design could impact patient safety (e.g., physicians, nurse
practitioners, physician assistants, nurses, etc.). The cohort of users
who are selected as participants will vary with the product and its
intended users; however, the cohort should not include employees of the
developer company. We specify the submission of demographic
characteristics of the test participants comparable to the table on
page 11 of NISTIR 7742 because it is important that the test
participant characteristics reflect the audience of current and future
users. In accordance with NISTIR 7804 (page 8), we recommend that the
test scenarios be based upon an analysis of critical use risks for
patient safety which can be mitigated or eliminated by improvements to
the user interface design.
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\176\ http://www.nist.gov/customcf/get_pdf.cfm?pub_id=909701.
---------------------------------------------------------------------------

In lieu of simply providing guidance on the number of, and user
cohort for, test participants, we request comment on whether we should
establish a minimum number(s) and user cohort(s) for test participants
for the purposes of testing and certification to the 2015 Edition under
the ONC Health IT Certification Program.
New Requirements and Compliance Guidance
As we noted in the 2014 Edition final rule (77 FR 54188), examples
of method(s) that could be employed for UCD include ISO 9241-11, ISO
13407, ISO 16982, ISO/IEC 62366, ISO 9241-210 and NISTIR 7741. The UCD
process selected by a health IT developer need not be listed in the
examples provided in order to be acceptable. We do, however, strongly
advise health IT developers to select an industry standard process
because compliance

[[Page 16858]]

with this certification criterion requires submission of the name,
description, and citation (URL and/or publication citation) of the
process that was selected. In the event that a health IT developer
selects a UCD process that is not an industry standard (that is, not
developed by a voluntary consensus standards organization), but is
based on one or more industry standard processes, the developer may
name the process(es) and provide an outline of the process in addition
to a short description as well as an explanation of the reason(s) why
use of any of the existing UCD standards was impractical.
Health IT developers can perform many iterations of the usability
testing, but the submission that is ultimately provided for summative
usability testing and certification must be an expression of a final
iteration. In addition, we expect the test scenarios used to be
submitted as part of the test results. Last, we note that we do not
expect developers to include trade secrets or proprietary information
in the test results.
Request for Comment on Summative Testing
We understand that some health IT developers are concerned that the
summative testing report may not adequately reflect the design research
that has been performed throughout a product's lifecycle. We request
public comment regarding options that we might consider in addition
to--or as alternatives to--summative testing. For example, if formative
testing reflects a thorough process that has tested and improved the
usability of a product, could a standardized report of the formative
testing be submitted for one or more of the 17 certification criteria
for which summative testing is now required? What would be the
requirements for this formative testing report, and how would
purchasers evaluate these reports?
Retesting and Certification
We believe that ONC-ACB determinations related to the ongoing
applicability of the SED certification criterion to certified health IT
for the purposes of inherited certified status (Sec. 170.550(h)),
adaptations and other updates would be based on the extent of changes
to user-interface aspects of one or more capabilities to which UCD had
previously been applied. We believe that ONC-ACBs should be notified
when applicable changes to user-interface aspects occur. Therefore, we
include these types of changes in our proposal to address adaptations
and updates under the ONC-ACB Principles of Proper Conduct (Sec.
170.523). Please see section IV.D.6 of this preamble for further
discussion of this proposal.
Quality Management System

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(g)(4) (Quality management system)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition ``quality management system''
certification criterion that is revised in comparison to the 2014
Edition ``quality management system'' criterion. We propose to require,
for a Health IT Module presented for certification, the identification
of the Quality Management System (QMS) used in the development,
testing, implementation, and maintenance of capabilities certified
under the ONC Health IT Certification Program. The identified QMS must
be:
Compliant with a quality management system established by
the federal government or a standards developing organization; or
mapped to one or more quality management systems
established by the federal government or standards developing
organization(s).
In the 2014 Edition final rule, we stated that the 2014 Edition QMS
criterion was a first step that could be built on in an incremental
fashion (77 FR 54191). For the 2015 Edition QMS criterion, we are
taking that next step by not permitting health IT to be certified that
has not been subject to a QMS and also requiring health IT developers
to either use a recognized QMS or illustrate how the QMS they used maps
to one or more QMS established by the federal government or a standards
developing organization(s) (SDOs). As identified in the 2014 Edition
final rule (77 FR 54190), QMS established by the federal government and
SDOs include FDA's quality system regulation in 21 CFR part 820, ISO
9001, ISO 14971, ISO 13485, and IEC 62304. We encourage health IT
developers to choose an established QMS, but developers are not
required to do so, and may use either a modified version of an
established QMS, or an entirely ``home grown'' QMS. In cases where a
health IT developer does not use a QMS established by the federal
government or an SDO, the health IT developers must illustrate how
their QMS maps to one or more QMS established by the federal government
or SDO through documentation and explanation that links the components
of their QMS to an established QMS and identifies any gaps in their QMS
as compared to an established QMS. We clarify that we have no
expectation that there will be detailed documentation of historical QMS
or their absence. The documentation of the current status of QMS in a
health IT development organization would be sufficient.
We propose that all Health IT Modules certified to the 2015 Edition
would need to be certified to the 2015 Edition QMS criterion. As such,
we propose to revise Sec. 170.550 to require ONC-ACBs follow this
proposed approach (please see section IV.C.2 of this preamble for this
proposal).
Accessibility Technology Compatibility

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(g)(5) (Accessibility technology compatibility)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition ``accessibility technology
compatibility'' certification criterion that would offer health IT
developers that present a Health IT Module for certification to one or
more certification criteria listed in proposed Sec. 170.315(a), (b),
or (e) the opportunity to have their health IT demonstrate
compatibility with at least one accessibility technology for the user-
facing capabilities included in the referenced criteria.
In response to the Voluntary Edition proposed rule, we received
several comments from health IT users with visual impairments or
disabilities. These commenters raised concerns about the lack of
accessibility in many health IT products certified under the ONC Health
IT Certification Program. Commenters suggested a number of ways in
which the certification program could be leveraged to ensure that
health IT is accessible to visually impaired and disabled individuals.
In particular, many commenters strongly recommended that we require as
a condition of certification that health IT be compatible with popular
text-to-speech (or ``screen reader'') applications and other
accessibility technologies.
Joined by our colleagues in the Administration for Community Living
and Aging Policy and the Office for Civil Rights, we believe that
health IT should be accessible to users regardless of their visual
impairments or disabilities. The lack of accessibility features in
health IT, including the lack of compatibility with third-party
accessibility technologies, can place a significant burden on health IT
users who are visually impaired or disabled. Without these features,
some health IT users may be unable to access the health IT capabilities
they and their patients

[[Page 16859]]

need. Other health IT users may be forced to rely on human
intermediaries, revert to paper-based processes, or employ other
workarounds in order to perform basic clinical tasks and essential
aspects of their jobs. Such limitations and workarounds not only impact
the autonomy, productivity, and employment opportunities of health IT
users, but also jeopardize patient safety, healthcare quality, and
efficiency. For example, without the use of appropriate accessibility
technology, there may be an increased risk of transcription errors,
miscommunication between clinicians, improperly documented patient
health information, and untimely retrieval of patient health
information. For these reasons, we strongly encourage health IT
developers to consider the needs of visually impaired and disabled
users when designing their products, and, where feasible, to integrate
accessibility features directly into health IT. We also encourage them
to seek certification to this proposed certification criterion.
We note that a number of text-to-speech applications exist and are
widely used by many visually impaired or otherwise disabled individuals
in conjunction with a variety of personal computer and mobile
applications that lack built-in accessibility features. Text-to-speech
applications may also be combined with voice control software and other
accessibility technologies and typically provide a scripting language
and/or set of APIs that enable third-party developers to leverage the
accessibility technology's accessibility features in their own software
applications. We have also observed that some health IT is already
compatible with accessibility technology, including the U.S. Department
of Veterans Affairs' Computerized Patient Record System (CPRS). CPRS is
compatible with Job Access With Speech (JAWS), a popular text-to-speech
application that enables a computer to verbally describe the controls
and content of computer applications.
Certification to this proposed criterion would be available (not
required) for Health IT Modules presented for certification to any of
the clinical, care coordination, and patient engagement certification
criteria specified at Sec. 170.315(a), (b), and (e), respectively,
because the use of capabilities associated with these criteria
necessarily requires that a user provide input into, receive feedback
from, or otherwise interact with the Health IT Module. To meet this
proposed certification criterion, for each such ``user-facing''
capability included in certification criteria specified at Sec.
170.315(a), (b), and (e), a Health IT Module would need to demonstrate
that the capability is compatible with at least one accessibility
technology that provides text-to-speech functionality to meet this
criterion. Health IT developers would not be required to license or
provide such accessibility technology to users in order to meet the
criterion. An accessibility technology used to meet this criterion
would also not be ``relied upon'' for purposes of Sec. 170.523(f).
However, it would need to be identified in the issued test report and
would ultimately be made publicly available as part of the information
ONC-ACBs are required to report to ONC for inclusion on the CHPL (in
this case, what was used to demonstrate compliance with this
certification criterion) so that users would be able to identify the
accessibility technology with which the certified Health IT Module
demonstrated its compatibility.
We note that all recipients of federal financial assistance from
HHS are covered by the requirements of Section 504 of the
Rehabilitation Act of 1973 (29 U.S.C. 794) for programs and services
receiving federal financial assistance. We seek comment on the extent
to which certification to this criterion would assist in complying with
this and other applicable federal (e.g., Section 508 of the
Rehabilitation Act of 1973) and state disability laws. We also seek
comment on whether certification to this criterion as proposed would
serve as a valuable market distinction for health IT developers and
consumers (e.g., ``Health IT Module with certified accessibility
features'').
Consolidated CDA Creation Performance

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(g)(6) (Consolidated CDA creation performance)
------------------------------------------------------------------------

In the Voluntary Edition proposed rule (79 FR 10899), we proposed
to adopt as part of the transitions of care certification criterion a
new ``performance standard'' at Sec. 170.212. This performance
standard would have required health IT to be able to receive no less
than 95% of all of the possible variations that could be implemented
under the C-CDA. We summarized in the 2014 Edition Release 2 final rule
(79 FR 54459) that commenters voiced concerns about the testability and
vagueness of this proposed requirement, questioned its likelihood of
success, and noted that the 95% threshold would be impractical, time
consuming, and expensive to implement given the wide variation in C-CDA
implementation. Ultimately, we did not finalize this proposal in the
2014 Edition Release 2 final rule.
As we considered these comments and reviewed the additional public
dialogue surrounding the variability in the C-CDA's implementation by
different health IT developers,\177\ we concluded that a new
certification criterion, focused principally on health IT system
behavior and performance related to C-CDA creation was warranted. Thus,
we propose to adopt a new certification criterion at Sec.
170.315(g)(6) that would rigorously assess a product's C-CDA creation
performance (for both C-CDA Release 1.1 and 2.0) when it is presented
for a Health IT Module certification that includes within its scope any
of the proposed certification criteria that require C-CDA creation
(e.g., Sec. 170.315(b)(2)).
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\177\ D'Amore JD, et al. J Am Med Inform Assoc 2014; 21:1060-
1068.
---------------------------------------------------------------------------

To implement this proposal, we also propose to amend Sec. 170.550
to add a requirement that ONC-ACBs shall not issue a Health IT Module
certification to a product that includes C-CDA creation capabilities
within its scope, unless the product was also tested and satisfied the
certification criteria requirements proposed at Sec. 170.315(g)(6)
(see also section IV.C.2 of this preamble for further discussion of
this proposal). If the scope of certification sought includes multiple
certification criteria that require C-CDA creation, Sec. 170.315(g)(6)
need only be tested in association with one of those certification
criteria and would not be expected or required to be tested for each.
We base this certification efficiency on assumption that passing this
proposed certification criterion for one of the certification criteria
that includes C-CDA creation will cause a health IT developer to apply
these same performance checks to all other capabilities that include C-
CDA creation. However, we request public comment on whether this
proposed efficiency is desirable or would have any adverse
consequences.
We propose that the C-CDA creation performance certification
criterion would focus on and require the following technical outcomes
to be met:
1. Reference C-CDA Match: the Health IT Module must demonstrate
that it can create a C-CDA that matches a gold standard, called a
Reference C-CDA. Reference C-CDAs would include the 2014 and 2015
edition data elements coded according to the HL7 C-CDA standards and
regulatory requirements (the scope of the data would be limited

[[Page 16860]]

to what is proposed for the Common Clinical Data Set definition). As
part of the Reference C-CDA Match, health IT developers would be
provided test data that includes the 2014 and 2015 data elements and
any context specific coding instructions to be used by Health IT Module
to create C-CDA documents. The C-CDA documents created by the Health IT
Module would be validated by comparing it to a Reference C-CDA.
2. Document Template Conformance: the Health IT Module must
demonstrate that it can create C-CDA documents for the following C-CDA
document templates as applicable to the C-CDA 1.1 and C-CDA 2.0
standards: CCD; Consultation Note; History and Physical; Progress Note;
Care Plan; Transfer Summary; Referral Note; and for the inpatient
setting only, Discharge Summary. We do not propose require as part of
this portion of the certification criterion to require testing to the
Diagnostic Imaging Report (DIR); Operative Note; and Procedure Note as
they would not be generally applicable to all products.
3. Vocabulary Conformance: the Health IT Module must demonstrate
that it can create C-CDA documents using the vocabularies and value
sets adopted by the 2014 and 2015 edition. For data elements which do
not require specific vocabularies and value sets in the regulation, the
Health IT Module must use the vocabularies and value sets as specified
in the C-CDA standard.
Additionally, in response to wide stakeholder feedback for
additional publicly available C-CDA samples, we have coordinated with
our colleagues at NIST and understand that NVLAP-Accredited Testing
Laboratories would retain the C-CDA files created under test and
contribute them to an ONC-maintained repository.
Completeness of Data in the C-CDA
Past feedback from providers has indicated that the variability
associated with different functionalities and workflows within health
IT can ultimately affect the completeness of the data included in a
created C-CDA. Thus, in the same context associated with our proposals
in this criterion and the ToC performance certification criterion, we
are considering, and request public comment on, adding to either of
these certification criteria an additional requirement that would
evaluate the completeness of the data included in a C-CDA in order to
ensure that the data recorded by health IT is equivalent to the data
included in a created C-CDA.
Application Access to Common Clinical Data Set

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(g)(7) (Application access to Common Clinical Data Set)
------------------------------------------------------------------------

We propose to adopt a new certification criterion as part of the
proposed 2015 Edition at Sec. 170.315(g)(7) that would focus on the
capability of health IT presented for certification to respond to
requests for patient data from other applications.\178\ We propose that
this certification criterion would require the demonstration of an
application programming interface (API) that responds to data requests
for any one or more of the data referenced in the Common Clinical Data
Set definition (proposed for adoption at Sec. 170.102), including
requests for all of the data referenced in the Common Clinical Data
Set.
---------------------------------------------------------------------------

\178\ We intend for the term ``application'' to generally
encompass any other type of system or software that is not the data
source responding to the requests for data.
---------------------------------------------------------------------------

The expanded access to a common data set from other applications
through APIs (and other techniques) has been referenced in numerous
publications over the past several years.\179\ We have also received
requests from stakeholders to include a certification requirement for
the proposed capability. These stakeholders indicate that such a
requirement would help promote innovation and enhance the ease with
which health care providers could adopt and use third party software
tools along with their core EHR technology to improve patient care.
---------------------------------------------------------------------------

\179\ See: (1) President's Council of Advisors on Science and
Technology (PCAST) ``Realizing the full potential of health
information technology to improve healthcare for Americans: the path
forward (December 2010)'';
(2) JASON: A Robust Health Data Infrastructure (April 2014);
(3) PCAST ``Better health care and lower costs: accelerating
improvement through systems engineering (May 2014); and
(4) ONC ``Connecting Health and Care for the Nation: A 10-Year
Vision to Achieve an Interoperable Health IT Infrastructure (June
2014).
---------------------------------------------------------------------------

For the purposes of this certification criterion, we also propose
to require that this certification criterion be part of the set of
criteria necessary to satisfy the ``2015 Edition Base EHR'' definition
(see also section III.B.1 of this preamble for a discussion of the
proposed 2015 Edition Base EHR definition). This additional proposal,
due to its linkage to the CEHRT definition, would ensure that all EPs,
eligible hospitals, and CAHs would need to adopt a Health IT Module
certified to this criterion in order to have the necessary health IT to
successfully demonstrate meaningful use under the EHR Incentive
Programs.
With limited exceptions, we have broadly specified the technical
outcomes required by this certification criterion. We have taken this
approach in order to allow for a wide array of implementations to meet
the certification criterion. The proposed certification criterion
includes three technical outcomes and a documentation requirement.
(1) Security. The API needs to include a means for the
establishment of a trusted connection with the application that
requests patient data. This would need to include a means for the
requesting application to register with the data source, be authorized
to request data, and log all interactions between the application and
the data source.
(2) Patient Selection. The API would need to include a means for
the application to query for an ID or other token of a patient's record
in order to subsequently execute data requests for that record.
(3) Data requests, response scope, and return format. The API would
need to support two types of data requests and responses: ``by data
category'' and ``all.'' In both cases, while the scope required for
certification is limited to the data specified in the Common Clinical
Data Set, additional data is permitted and encouraged.
For ``data category'' requests, the API would need to
respond to requests for each of the data categories specified in the
Common Clinical Data Set (according to the specified standards, where
applicable) and return the full set of data for that data category. As
the return format, either XML or JSON would need to be produced. For
example, an API function to request ``medications'' from patient 123456
that returns all of a patient's medications in XML or JSON would meet
certification requirements.
For ``all'' requests, the API would need to respond to
requests for all of the data categories specified in the Common
Clinical Data Set at one time (according to the specified standards,
where applicable). As the return format, the C-CDA version 2.0 would
need to be used to produce a patient summary record populated with the
data included in the Common Clinical Data Set. For example, an API
function to request the full common data set ``all'' from patient
567890 would return a patient's fully populated summary record
formatted in accordance with the C-CDA version 2.0.
We believe the proposed approach provides ample flexibility for
health IT developers to implement an API that can best address their
customers' needs. It also leverages current standards that most health
IT developers would

[[Page 16861]]

already need to develop their products to support in order to seek
certification to several other certification criteria. In addition, we
believe that this approach supports future, innovative approaches to be
used. The intent behind this certification criterion is to allow for,
but not require, health IT developers to implement the Fast Health
Interoperability Resource (FHIR[supreg]) REST API and accompanying FHIR
standard specifications.\180\ Therefore, if we have not adequately
specified this certification criterion in a manner that accomplishes
this goal, we solicit public comment on any specific revisions that
would.
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\180\ http://www.hl7.org/implement/standards/ fhir/.
---------------------------------------------------------------------------

This certification criterion would require that the API be
technically well documented and include its terms of use. It would also
require that such technical documentation and the terms of use be
submitted as part of testing for this certification criterion and
subsequently to ONC-ACBs for review prior to issuing a certification.
The technical documentation would need to include, at a minimum: API
syntax, function names, required and optional parameters and their data
types, return variables and their types/structures, exceptions and
exception handling methods and their returns. The terms of use would
need to include information of the API's developer policies and
required developer agreements so that third party developers could
assess these additional requirements before engaging in any development
against the API. Similar to how we approached the submission of
publicly available test results in our past rulemaking, we propose to
require ONC-ACBs to submit a hyperlink (as part of its product
certification submission to the CHPL) that would allow any interested
party to access the API's documentation and terms of use. This
hyperlink would need to be provided by the health IT developer to the
ONC-ACB.
With respect to testing for this certification criterion, we expect
that functional testing would focus primarily on the third capability
we propose. Meaning that for each function call made the health IT
developer would need to demonstrate to/show an Accredited Testing Lab
the response (i.e., output) for each of the data category requests in
JSON or XML and for the ``all'' request, the output according to the
Consolidated CDA. For all other aspects of the certification criterion,
we expect the testing would include attestation, documentation, and
review. Additionally, if these capabilities do not function properly
when implemented in the field, the (at that point) certified Health IT
Module could be subject to surveillance by its ONC-ACB.
The HITPC called for ``well-defined, fairly applied, business and
legal frameworks for using the API.'' \181\ We request public comment
on what additional requirements might be needed to ensure the fostering
of an open ecosystem around APIs so that patients can share their
information with the tools, applications, and platforms of their own
choosing. For instance, should there be any limits expressed on what
can be included in the terms of use? Should the terms be required to
more granularly address security and authorization requirements, for
instance by requiring a certain oAuth profile?
---------------------------------------------------------------------------

\181\ http://www.healthit.gov/sites/faca/files/JTF_Transmittal%20Letter_2014-1-22-15v3.pdf.
---------------------------------------------------------------------------

We also request public comment regarding the feasibility of
additional API capabilities that could be made available to
certification including secure message read/write capability, schedule
read/write capability, ordering/e-prescribing capability, and task list
read/write capability.
C-CDA Creation Capability Request for Comment
We request public comment on a potential means to provide explicit
implementation clarity and consistency as well as to further limit
potential burdens on health IT developers. Specifically, should we
limit the scope of C-CDA creation capability within this certification
criterion to focus solely on the creation of a CCD document template
based on the C-CDA Release 2.0? This approach could also have the
benefit of creating clear expectations and predictability for other
health IT developers who would then know the specific document template
implemented for compliance with this criterion.
Accessibility-Centered Design

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition EHR Certification Criterion
Sec. 170.315(g)(8) (Accessibility-centered design)
------------------------------------------------------------------------

We propose to adopt a new 2015 Edition ``accessibility-centered
design'' certification criterion that would apply to all Health IT
Modules certified to the 2015 Edition. This criterion would require the
identification of user-centered design standard(s) or laws for
accessibility that were applied, or complied with, in the development
of specific capabilities included in a Health IT Module or,
alternatively, the lack of such application or compliance.
This proposed certification criterion would serve to increase
transparency around the application of user-centered design standards
for accessibility to health IT and the compliance of health IT with
accessibility laws. We believe this transparency would be beneficial
for those health care providers, consumers, governments, and other
stakeholders that have an interest in knowing the degree to which heath
IT, particularly certified health IT, meet health IT accessibility
standards and laws. This transparency may also encourage health IT
developers to pursue the application of more accessibility standards
and laws in product development that could lead to improved usability
for health care providers with disabilities and health care outcomes
for patients with disabilities.
We propose to model our approach and this criterion after the 2014
Edition ``quality management system'' criterion (Sec. 170.314(g)(4)
and see 77 FR 54270-54271). Therefore, as a first step, for each
capability that a Health IT Module includes and for which that
capability's certification is sought, the use of a health IT
accessibility-centered design standard or compliance with a health IT
accessibility law in the development, testing, implementation, and
maintenance of that capability must be identified. Working with our
colleagues at NIST, we have identified an initial list of health IT
accessibility-centered design standards and accessibility laws below.
However, health IT developers may choose to use other health IT
accessibility standards or laws in the development, testing,
implementation, and maintenance of capabilities, but must identify
these standards and/or laws for the purposes of certification. As with
the 2014 Edition ``quality management system'' criterion, we propose to
permit a response that ``no health IT accessibility-centered design
standard or law was applied to all applicable capabilities'' as an
acceptable means of satisfy this proposed certification criterion. We
note, however, that whatever method(s) is used to meet this proposed
criterion, it would be reported to the proposed open data CHPL.
We solicit comments on whether the standards and laws identified
below are appropriate examples and whether we should limit the
certification criteria to which this criterion would apply. For
example, limiting it to a Health IT Module certified only to the
certification criteria proposed in Sec. 170.315(a), (b), (c), and (e),
or

[[Page 16862]]

otherwise. To note, we believe that, at a minimum, this criterion would
not apply to the certification criteria in Sec. 170.315(g).
Example health IT accessibility-centered design standards and
accessibility laws:
ETSI ES 202 076--Human Factors (HF); User Interfaces;
Generic spoken command vocabulary for ICT devices and services;
ETSI ETS 300 679--Terminal equipment (TE); Telephony for
the hearing impaired; Electrical coupling of telephone sets to hearing
aids;
ETSI TR 102 068 (2002) Human Factors (HF): Requirements
for assistive technology devices in ICT;
ETSI TS 102 511 (2007) Human Factors (HF): AT commands for
assistive mobile device interfaces;
IEEE 802.11 IEEE standard for Information Technology;
Telecommunications and information: Exchange between systems; local and
metropolitan area network; specific requirements--Part 11: Wireless LAN
Medium Access Control (MAC) and Physical Layer (PHY) Specification;
ISO 13406-1 (1999) Ergonomic requirements for work with
visual displays based on flat panels. Part 1--Introduction;
ISO 13406-2 (2001) Ergonomic requirements for work with
visual displays based on flat panels. Part 2--Ergonomic requirements
for flat panel displays;
IEC 80416-1 (2001) Basic principles for graphical symbols
for use on equipment--Part 1: Creation of symbol originals;
ISO 80416-2 (2002) Basic principles for graphical symbols
for use on equipment--Part 2: Form and use of arrows;
IEC 80416-3 (2002) Basic principles for graphical symbols
for use on equipment--Part 3: Guidelines for the application of
graphical symbols;
ISO 80416-4 (2005) Basic principles for graphical symbols
for use on equipment. Part 4--Guidelines for the adaptation of
graphical symbols for use on screens and displays;
ISO 9241-151 (2008) Ergonomics of human-system
interaction--Part 151: Guidance on World Wide Web user interfaces;
ISO 9355-1 (1999) Ergonomic requirements for the design of
displays and control actuators. Part 1: Human interactions with
displays and control actuators;
ISO 9355-2 (1999) Ergonomic requirements for the design of
displays and control actuators. Part 2: Displays;
ISO 9999 (2007) Assistive products for persons with
disability--Classification and terminology;
ISO/CD 24500 Guidelines for all people, including elderly
persons and persons with disabilities--Auditory signals on consumer
products;
ISO/IEC 15411 (1999) Information technology--Segmented
keyboard layouts;
ISO/IEC 15412 (1999) Information technology--Portable
keyboard layouts;
ISO/IEC 24755 (2007) Information technology--Screen icons
and symbols for personal mobile communication devices;
ISO/IEC CD 24786-1 Information Technology--User
interfaces--Accessible user interface for accessibility setting on
information devices--Part 1: General and methods to start;
ISO/IEC TR 15440 (2005) Information Technology--Future
keyboards and other associated input devices and related entry methods;
ISO/IEC TR 19765 (2007) Information technology--Survey of
icons and symbols that provide access to functions and facilities to
improve the use of IT products by the elderly and persons with
disabilities;
ISO/IEC TR 19766 (2007) Information technology--Guidelines
for the design of icons and symbols accessible to all users, including
the elderly and persons with disabilities;
ITU-T E.902 (1995) Interactive services design guidelines;
ITU-T P.85 (1994) A method for subjective performance
assessment of the quality of speech voice;
Section 504 of the Rehabilitation Act; and
Section 508 of the Rehabilitation Act.
Because we propose that Health IT Modules certified to the 2015
Edition would be required to be certified to the 2015 Edition
Accessibility-centered design criterion, we also propose to revise
Sec. 170.550 to require ONC-ACBs follow this proposed approach (please
see section IV.C.2 of this preamble for this proposal).
Transport Methods and Other Protocols
We propose two ways for providers to meet the 2015 Edition Base EHR
definition using health IT certified to transport methods. These ways
serve to account for transport methods that we understand are being
used to readily exchange electronic health information and ensure that
providers have interoperable ways to exchange electronic health
information. The first way to meet the proposed 2015 Edition Base EHR
definition requirement would be for a provider to have health IT
certified to Sec. 170.315(b)(1) and (h)(1) (Direct Project
specification). This would account for situation where a provider uses
a health IT developer's product that acts as the ``edge'' and the HISP.
The second way would be for a provider to have health IT certified to
Sec. 170.315(b)(1) (ToC criterion) and (h)(2) (Direct Project, Edge
Protocol, and XDR/XDM). This would account for situations where a
provider is using one health IT developer's product that serves as the
``edge'' and another health IT developer's product that serves as a
HISP.\182\ The capabilities included in proposed Sec. 170.315(h)(2)
ensure interoperability by accounting for various electronic health
information exchange options using the Direct Project specification. To
fully implement this approach, we propose to revise Sec. 170.550 to
require an ONC-ACB to ensure that a Health IT Module includes the
certification criterion adopted at Sec. 170.315(b)(1) in its
certification's scope in order to be certified to the certification
criterion proposed for adoption at Sec. 170.315(h)(1). We welcome
comment on these proposed approaches and the transport standards listed
below in Sec. 170.315(h)(1) through (3).
---------------------------------------------------------------------------

\182\ See the 2014 Edition Release 2 final rule for more
discussion on such situations (79 FR 54436-38).
---------------------------------------------------------------------------

Consistent with our proposed title of ``transport methods and other
protocols'' for Sec. 170.315(h), we proposed to revise the heading of
Sec. 170.202 from ``transport standards'' to ``transport standards and
other protocols.''
Direct Project

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(h)(1) (Direct Project)
------------------------------------------------------------------------

We propose to adopt a certification criterion that includes the
capability to send and receive according to the Applicability Statement
for Secure Health Transport (the primary Direct Project specification)
adopted at Sec. 170.202(a). We previously adopted this capability for
the 2014 Edition at Sec. 170.314(b)(1), (b)(2) and (h)(1). We remind
health IT developers that best practices exist for the sharing of
electronic health information and enabling the broadest participation
in electronic health information exchange with Direct.\183\
---------------------------------------------------------------------------

\183\ http://wiki.directproject.org/Best+Practices+for+Content+and+Workflow.
---------------------------------------------------------------------------

We propose to include as an optional capability for certification,
the capability to send and receive according to the Implementation
Guide for Delivery Notification in Direct, Version 1.0, June 29, 2012,
which we propose to

[[Page 16863]]

adopt at Sec. 170.202(e). While this is not a capability we have
previously adopted, we proposed to adopt it as part of the Voluntary
Edition proposed rule (79 FR 10914). The primary Direct Project
specification requires that Security/Trust Agents (STAs) must issue a
Message Disposition Notification (MDN, RFC3798) with a disposition of
processed upon successful receipt, decryption, and trust validation of
a Direct message. By sending this MDN, the receiving STA is taking
custodianship of the message and is indicating that it will deliver the
message to its destination. While the primary Direct Project
specification indicates that additional MDNs may be sent to indicate
further processing progress of the message, they are not required. The
primary Direct Project specification, however, does not provide
guidance in regards to the actions that should be taken by the sending
STA in the event an MDN processed message is not received or if the
receiving STA cannot deliver the message to its destination after
sending the initial MDN processed message. Due to the lack of
specifications and guidance in the primary Direct Project specification
regarding deviations from normal message flow, STAs implementing only
requirements denoted as ``must'' in Section 3 of the primary Direct
Project specification may not be able to provide a high level of
assurance that a message has arrived at its destination. The Delivery
Notification IG provides implementation guidance enabling STAs to
provide a high level of assurance that a message has arrived at its
destination and outlines the various exception flows that result in
compromised message delivery and the mitigation actions that should be
taken by STAs to provide success and failure notifications to the
sending system.
Based on CMS guidance, the use of the Delivery Notification IG can
be used to provide the necessary level of assurance that sent
laboratory results are received by a provider.\184\ Additionally, we
note that the Delivery Notification IG could be generally useful for
any transmission that requires a high level of assurance.
---------------------------------------------------------------------------

\184\ See CMS CLIA guidance on the use of Direct with the
Delivery Notification IG: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-05.html?DLPage=1&DLFilter=2014&DLSort=3&DLSortDir=ascending.
---------------------------------------------------------------------------

Direct Project, Edge Protocol, and XDR/XDM

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(h)(2) (Direct Project, Edge Protocol, and XDR/XDM)
------------------------------------------------------------------------

We propose to include three distinct capabilities in this
criterion. The first capability is the capability to send and receive
according to the Applicability Statement for Secure Health Transport
(the primary Direct Project specification) adopted at Sec. 170.202(a).
The second capability is to send and receive according to both Edge
Protocol methods specified by the standard adopted at Sec. 170.202(d).
The third capability is to send and receive according to the XDR and
XDM for Direct Messaging Specification adopted at Sec. 170.202(b).
These three capabilities were previously adopted as part the 2014
Edition, including through the 2014 Edition and 2014 Edition Release 2
final rules. We remind health IT developers that best practices exist
for the sharing of information and enabling the broadest participation
in information exchange with Direct.\185\
---------------------------------------------------------------------------

\185\ http://wiki.directproject.org/Best+Practices+for+Content+and+Workflow.
---------------------------------------------------------------------------

SOAP Transport and Security Specification and XDR/XDM for
Direct Messaging

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(h)(3) (SOAP Transport and Security Specification and XDR/
XDM for Direct Messaging)
------------------------------------------------------------------------

We propose to adopt a 2015 Edition certification criterion for
electronic transmission that would include the capability to send and
receive according to the Transport and Security Specification (also
referred to as the SOAP-Based Secure Transport RTM adopted at Sec.
170.202(c)) and its companion specification XDR and XDM for Direct
Messaging Specification adopted at Sec. 170.202(b) We previously
adopted this capability for the 2014 Edition at Sec. 170.314(b)(1),
(b)(2) and (h)(3).
Healthcare Provider Directory--Query Request

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(h)(4) (Healthcare Provider Directory--query request)
------------------------------------------------------------------------

In June 2011, the HITPC recommended \186\ that we consider the
adoption of provider directory capabilities for the ONC Health IT
Certification Program as well as work to address many of the issues
they raised. To address the HITPC's recommendations, ONC launched a
number of initiatives to define a single provider directory standard
and to pilot its use.
---------------------------------------------------------------------------

\186\ http://www.healthit.gov/sites/default/files/pdf/HITPC_transmit_InfoExchWG_May2011-finalsigned.pdf.
---------------------------------------------------------------------------

ONC worked with implementers and subject matter experts in the
field to hone in on the specific types of capabilities that should be
included in a provider directory criterion. Stakeholders voiced a
desire for technology to have the ability to be able to query
individual directory sources and directory sources federated by third
parties such as HIOs, RHIOs, HISPs etc. This is also known as
``federated querying.'' However, there were only a few implementations
of federated querying across the country and many were unique due to
the lack of a single standard. Given this challenge, and its potential
to inhibit exchange, ONC launched an open source project called
``Modular Specification Provider Directories (MSPD).'' \187\
---------------------------------------------------------------------------

\187\ http://modularspecs.siframework.org/Provider+Directories+Homepage.
---------------------------------------------------------------------------

During the MSPD project, stakeholders collaborated to identify
requirements for an updated version of the ``Healthcare Provider
Directory (HPD)'' profile in order to provide a unified vendor-neutral
platform for implementation of provider directories that supports both
federated and non-federated architectures. The project resulted in
implementable, testable specifications, and high quality test cases
that verify conformance to the ``test implementation'' and it is now
part of an approved IHE HPD profile Change Proposal \188\. In addition,
ONC awarded a grant to the EHR [verbar] HIE Interoperability
Workgroup \189\ to pilot provider directory standards with multiple
states.
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\188\ ftp://ftp.ihe.net/IT_Infrastructure/TF_Maintenance-2015/CPs/3_FinalText/from_Ballot_24/CP-ITI-792-05.doc.
\189\ http://www.interopwg.org/.
---------------------------------------------------------------------------

The original HPD profile created by Integrating the Healthcare
Enterprise (IHE) \190\ addresses transactions between the client and a
single provider directory with a single data source. While the standard
can be used for federation, it does not address the complexities
introduced by federation; provide a well-defined and straightforward
approach to error handling; support targeted queries to federated data
sources; or define mechanisms by which to distinguish the source of
results in a given response. IHE (in collaboration with ONC, eHealth
Exchange and the EHR [verbar] HIE Interoperability Work Group) has

[[Page 16864]]

worked to update the IHE HPD profile to address federation. In
September of 2013 ONC submitted a change proposal to IHE to incorporate
the MSPD IG into the HPD profile. Through the IHE balloting process
modifications were made to the change proposal to be backwards
compatible with the existing IHE HPD Profile. These changes were
implemented by multiple organizations to prove the feasibility and ease
of implementation of the change proposal. This revised change proposal
was approved by IHE in September 2014.\191\ In August 2013, the HITPC
recommended including a provider directory standard in the EHR
Incentive Programs Stage 3.\192\ The Voluntary Edition proposed rule
included a request for public comment on a potential future ``provider
directory'' certification criterion that would, ``at a minimum,''
require health IT to be able to query provider directories for the
following information and electronically process the response returned
in accordance with the IHE HPD profile requirements
---------------------------------------------------------------------------

\190\ http://wiki.ihe.net/index.php?title=Healthcare_Provider_Directory.
\191\ ftp://ftp.ihe.net/IT_Infrastructure/TF_Maintenance-2015/CPs/3_FinalText/from_Ballot_24/CP-ITI-792-05.doc.
\192\ http://www.healthit.gov/FACAS/sites/faca/files/IE%20WG_Recommendation%20Transmittal_MU3v2.docx.
---------------------------------------------------------------------------

Query for an individual provider;
Query for an organizational provider; and
Query for relationships between individual providers and
organizational providers.
We received twenty-three comments related to the provide directory
question. Twenty of those comments were supportive of the inclusion of
a provider directory standard in the 2015 Edition. In July 2014, the
HITSC released their analysis on the IHE HPD profile, stating that the
IHE HPD+ profile \193\ was a good start, but not yet mature enough for
nationwide implementation.\194\
---------------------------------------------------------------------------

\193\ http://ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_Suppl_HPD_Rev1.4_TI_2013-09-20.pdf.
\194\ http://www.healthit.gov/FACAS/sites/faca/files/HITSC_NwHIN_Provider_Directory_2014-07-16.pdf.
---------------------------------------------------------------------------

Based on the feedback we received from stakeholders on the
Voluntary Edition proposed rule recommending the adoption of IHE HPD
and the results of pilots undertaken by EHR [verbar] HIE
Interoperability Workgroup and others, we believe that making the IHE
HPD profile available for testing and certification would benefit its
further use and implementation in the field. Therefore, we propose a
new certification criterion that would require a Health IT Module to be
capable of querying a directory using the IHE HPD Profile.\195\ In
addition, we propose including an optional capability within this
certification criterion that addresses federated requirements. In this
optional capability, we propose that the Health IT Module would be
required to follow the approved federation option of IHE HPD \196\ to
accomplish querying in federated environments. The federation change
proposal was approved in September, 2014 and was incorporated into the
IHE HPD Profile.\197\ While the IHE HPD profile provides the ability to
perform queries about individual providers, organizational providers,
provider credentials and other details about providers, this proposed
certification criterion seeks to establish a minimum set of queries
that a Health IT Module would be required to support. The capabilities
that would need to be supported by a Health IT Module include: (1)
Querying for an individual provider; (2) Querying for an organizational
provider; (3) Querying for both individual and organizational provider
in a single query; (4) Querying for relationships between individual
and organizational providers; and (5) electronically processing the
response according to the IHE HPD Profile.
---------------------------------------------------------------------------

\195\ http://www.ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_Suppl_HPD.pdf.
\196\ http://www.ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_Suppl_HPD.pdf.
\197\ http://www.ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_Suppl_HPD.pdf.
---------------------------------------------------------------------------

We believe making this basic infrastructure component available for
testing and certification could assist EPs, EHs, and CAHs in achieving
the ToC requirements under the EHR Incentive Programs by enabling them
to find electronic service information such as Direct addresses for
providers who participate in other HISPs/HIEs. It would also drive a
common approach to directories across trust communities, which would
improve interoperability across these communities.
Healthcare Provider Directory--Query Response

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(h)(5) (Healthcare Provider Directory--query response)
------------------------------------------------------------------------

To complement the certification criterion we propose for adoption
at 170.315(h)(4) related to health IT issuing a ``query request,'' we
also propose to adopt a certification criterion at 170.315(h)(5) that
would focus on the ``query response'' and include the corresponding set
of capabilities to respond to a provider directory query. This proposed
separation would provide developers with the flexibility to test and
certify for provider directory ``query'' independent of the provider
directory ``response.'' A health IT system would be able to be
presented for testing and certification to both proposed certification
criteria if applicable or just to one or the other as appropriate based
on the product's capabilities.
Health IT systems serving as ``directory sources'' that would be
seeking testing and certification to (h)(5) would have to support
responding to the same queries initiated by systems seeking testing and
certification to (h)(4) for interoperability purposes. As part of this
proposed certification criterion, we propose that directory sources
must demonstrate the capability to respond to provider directory
queries according to the IHE HPD profile. Additionally, as part of the
certification criteria, we propose that the directory sources must
respond to the following provider directory queries
Query for an individual provider;
Query for an organizational provider; and
Query for relationships between individual providers and
organizational providers.
In addition we propose including an optional capability within this
certification criterion to address federated requirements. In this
optional capability, we propose that the Health IT Module would be
required to follow the approved federation option of for IHE HPD to
accomplish querying in federated environments. The federation change
proposal was approved in September, 2014 was incorporated into the IHE
HPD Profile.
Electronic Submission of Medical Documentation

------------------------------------------------------------------------

-------------------------------------------------------------------------
2015 Edition Health IT Certification Criterion
Sec. 170.315(i)(1) (Electronic submission of medical documentation)
------------------------------------------------------------------------

We propose to adopt a new certification criterion as part of the
proposed 2015 Edition at Sec. 170.315(i)(1) that would focus on the
electronic submission of medical documentation.
According to CMS, the Medicare Fee for Service (FFS) program
currently spends in excess of $360 billion annually to provide services
to over 35 million beneficiaries (excludes Medicare eligible
individuals enrolled in non-FFS Medicare Programs).\198\ The 2013 CMS
Office of Financial Management (OFM) Improper Payment

[[Page 16865]]

Report \199\ noted that 12.7% (or $45.8 B) of the payments from the
Medicare trust fund were for claims for services that were either: 1)
not medically necessary and appropriate based on documentation that was
submitted; or 2) insufficiently documented to determine if the billed
service was necessary.
---------------------------------------------------------------------------

\198\ http://www.hhs.gov/budget/fy2015/fy-2015-budget-in-brief.pdf.
\199\ http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/index.html?redirect=/cert.
---------------------------------------------------------------------------

To respond to Congress' mandate \200\ to more effectively manage
improper payments, while recognizing the importance of reducing
administrative burden for providers, CMS OFM's Provider Compliance
Group (PCG) established the electronic submission of Medical
Documentation (esMD) program to begin to enable the electronic
submission of medical documentation.\201\ As part of this program, CMS
worked with ONC to establish the ``esMD Initiative'' under the S&I
Framework.\202\ This initiative created use cases and identified
appropriate standards to facilitate the electronic exchange of medical
documentation among providers and Medicare FFS review contractors.
Currently, esMD Phase 1 supports the submission of unstructured data in
PDF format. This method of submission is broadly deployed and accounts
for over 25% of all Medicare FFS post-payment medical review
submissions. In addition to post-payment review, new demonstration
programs are focused on prior-authorization for specific services that
have high improper payment rates. Prior-authorization ensures
appropriate documentation is reviewed prior to these services/items
being performed or delivered in order to avoid post-payment denials
that may affect the beneficiary, the provider, or both.
---------------------------------------------------------------------------

\200\ http://www.whitehouse.gov/sites/default/files/omb/financial/_improper/PL_107-300.pdf; http://www.thefederalregister.org/fdsys/pkg/PLAW-112publ248/pdf/PLAW-112publ248.pdf; and www.whitehouse.gov/sites/default/files/omb/financial/_improper/PL_111-204.pdf.
\201\ http://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/ESMD/index.html?redirect=/ESMD.
\202\ http://wiki.siframework.org/esMD+-+Charter+and+Members.
---------------------------------------------------------------------------

In addition to current methods for submitting medical documentation
(e.g., mail, fax, PDF), Medicare FFS seeks to also enable a
standardized and interoperable electronic approach that would reduce
the time, expense, and paper required in current manual processes used
for prior authorization, pre-payment review, post-payment audit, and
quality management. Acceptable methods must ensure that providers are
able to submit any documentation they believe is required in order to
show that a proposed or provided service meets applicable requirements.
The esMD Initiative electronic Determination of Coverage (eDoC)
workgroup provided an open forum for providers and payers to establish
a mutual understanding of the requirements necessary for submission of
structured medical documentation to support prior authorization, pre-
payment review and post-payment audit. Standards analysis by the
workgroup revealed a significant gap in the current standards with
respect to uses that went beyond the exchange of a summary care record
between providers. To address this gap, participants in the eDoC
workgroup created a new Clinical Documents for Payers--Set 1 (CDP1) IG
to further extend and constrain the C-CDA Release 2.0 standard.
Non-repudiation of signatures for electronic submission of medical
documentation was a complementary challenge faced by the esMD
Initiative. While keeping in mind the cost and impact of certain
requirements, the esMD Initiative focused on two approaches to digital
signatures. The ``Author of Record Level 1'' use case addressed the
need for digital signatures on groups of documents and on single
transactions. The ``Author of Record Level 2'' use case focused on
digital signatures that could be embedded in HL7 CDA documents and
included support for multiple signers where each declares their role
and signature purpose. In addition to the ability to support digital
signatures using industry standards, the use cases also addressed a
standards-based method for the delegation, by a holder of a digital
certificate, of the right to sign on their behalf by another holder of
a digital certificate. While digital signatures have been implemented
in the healthcare industry for other purposes, this effort will extend
their use to declare and secure the provenance of single documents,
bundles of documents, and transactions. The use of digital signatures
on C-CDA documents will guarantee the identity of the author and ensure
the integrity of the data once the document has been signed.
In summary, the esMD Initiative and its participants successfully
produced standards and implementation guides to help minimize improper
payments; improve interoperability for electronic submission of medical
documentation, including parameters for non-repudiation, and reduce
administrative burden associated with prior authorization, pre-payment
review, post-payment audit and quality management.
In light of this work, we propose to adopt a certification
criterion at Sec. 170.315(i)(1) to support the electronic submission
of medical documentation that includes four specific capabilities,
which are each discussed in more detail below. As we mentioned in the
Executive Summary of this proposed rule and discuss in more detail
under section IV.B of this preamble (Modifications to the ONC Health IT
Certification Program), we propose to broaden the scope of the ONC
Health IT Certification Program beyond just focusing on supporting the
EHR Incentive Programs. As such, we seek to make clear that this
certification criterion is not within those programs' scope and is
meant to be available to support other CMS program policy objectives as
well as health care providers' ability to communicate encounter
documentation to a payer, in particular to satisfy Medicare FFS
coverage determination rules.
Capability 1--We propose that a Health IT Module be able to support
the creation of a document in accordance with the HL7 Implementation
Guide for CDA Release 2: Additional CDA R2 Templates--Clinical
Documents for Payers--Set 1, Release 1--US Realm \203\ in combination
with the C-CDA Release 2.0 standard (proposed for adoption at Sec.
170.205(a)(4)). We propose to adopt the most recent version of the CDP1
IG at Sec. 170.205(a)(5)(i).\204\ The CDP1 IG is designed to be used
in conjunction with C-CDA Release 2.0 templates and makes it possible
for providers to exchange a more comprehensive set of clinical
information. For example, payers such as Medicare FFS allow providers
to submit any information they believe substantiates that a service is
medically necessary and appropriate under the applicable coverage
determination rules.
---------------------------------------------------------------------------

\203\ http://www.hl7.org/special/Committees/claims/index.cfm. We
also note that access to the current draft of the CDP1 IG is freely
available for review during the public comment period by
establishing an HL7 user account.
\204\ This would be the version of the IG (DSTU) that completes
the ballot cycle before issuance of a subsequent final rule.
---------------------------------------------------------------------------

A Health IT Module's support for the document-level templates
formatted in accordance with the CDP1 IG would ensure that the
technology is able to communicate all information relative to a patient
encounter or assert that information for each ``required'' section is
not available/included. If the provider then applies a digital
signature to the document (as discussed in more detail below), the
result is a non-repudiation

[[Page 16866]]

declaration of the encounter information.
The CDP1 IG was balloted in February of 2014 and should complete
balloting this spring.\205\ The February 2014 balloted version includes
the following new templates:
---------------------------------------------------------------------------

\205\ http://www.hl7.org/special/Committees/claims/index.cfm. We
also note that access to the current draft of the CDP1 IG is freely
available for review during the public comment period by
establishing an HL7 user account.
---------------------------------------------------------------------------

(1) Five (5) new or additionally constrained document level
templates:
Enhanced Encounter Document
Enhanced Hospitalization Document
Enhanced Operative Note Document
Enhanced Procedure Document
Interval Document
(2) Four (4) new section level templates:
Additional Documentation Section
Externally Defined Clinical Data Elements Section
Placed Orders Section
Transportation Section
(3) Three (3) additionally constrained C-CDA Release 2.0 section
level templates:
Functional Status Section
Plan of Treatment Section
Social History Section
(4) New or additionally constrained entry level templates that
provide support for new section level templates.
The most recent changes to the CDP1 IG include:
Expanded descriptions regarding the use of the IG;
References to and a list of additional constraints for
templates that are based on the C-CDA Release 2.0 templates;
Updates required for conformance with the published
version of the C-CDA Release 2.0 ;
Removal of attestation language and addition of a document
succession description (clarification of standard C-CDA document
succession);
Technical corrections; and
Name changes for the IG and the individual document level
templates.
The CDP1 IG enables documentation to be completely and accurately
conveyed in the new document templates. To do this, the document level
templates referenced by the CDP1 IG require the inclusion of the
referenced section level templates, which also include additional
specificity and constraints. While a Health IT Module would need to
support the entry of additional information, providers would not
necessarily be required to collect any additional information to
satisfy the new constraints. In other words, a specific nullFlavor may
be used by the Health IT Module when creating the CDP1 IG document to
indicate that no information is available for the relevant section or
entry level template. Likewise, the Health IT Module may enable the
provider to indicate that while information is present in the medical
record it is not applicable to the purpose for which the document is
intended and would subsequently result in an appropriate nullFlavor in
the created CDP1 document.
To meet this capability included in the proposed certification
criterion, a Health IT Module must be able to create a document that
also conforms to the CDP1 IG's requirements along with appropriate use
of nullFlavors to indicate when information is not available in the
medical record for section or entry level template required in the CDP1
IG. In addition, a conformant Health IT Module must also demonstrate
the ability to generate the document level templates as defined in the
C-CDA Release 2.0, including the unstructured document.
We propose to further refine this certification criterion's scope
relative to the applicable document templates within the C-CDA Release
2.0 and CDP1 IG that would need to be tested and certified for specific
settings for which a Health IT Module is designed. Specifically, we
propose that a Health IT Module:
Would, regardless of the setting for which its designed,
need to be tested and certified to the following document templates:
[cir] Diagnostic Imaging Report;
[cir] Unstructured Document;
[cir] Enhanced Operative Note Document;
[cir] Enhanced Procedure Note Document; and
[cir] Interval Document.
Designed for the ambulatory setting would also need to be
certified to the Enhanced Encounter Document.
Designed for the inpatient setting would also need to be
certified to Enhanced Hospitalization Document.
Capability 2--We propose that a Health IT Module be able to support
the use of digital signatures embedded in C-CDA Release 2.0 and CDP1 IG
documents templates by adopting the HL7 Implementation Guide for CDA
Release 2: Digital Signatures and Delegation of Rights, Release 1 (DSDR
IG) (proposed for adoption at Sec. 170.205(a)(5)(ii)).\206\ This DSDR
IG defines a method to embed digital signatures in a CDA document and
provides an optional method to specify delegation of right assertions
that may be included with the digital signatures. We note, however,
that for the purposes of certification, we propose to require that that
optional method must be demonstrated to meet this certification
criterion. The implementation of this IG will allow payers, such as
Medicare, to accurately authenticate the authorized signers of CDA
document and trust the validity and authenticity of signed medical
documentation. The DSDR IG provides specific guidance on the use of
digital signatures embedded in a CDA document to:
---------------------------------------------------------------------------

\206\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=375.
---------------------------------------------------------------------------

Provide a non-repudiation signature that attests to the
role and signature purpose of each authorized signer to the document.
Provide for a delegation of rights where the signer is a
delegated signer and not the authorized signer responsible individual
or organization (e.g., the signer is acting as an authorized agent).
Define the method of incorporating multiple digital
signatures and delegation of right assertions into the header of a CDA
document.
Define how to create the digest of the CDA document
Define how to sign and incorporate the:
[cir] CDA digest;
[cir] Timestamp;
[cir] Role of the signer;
[cir] Purpose of signature.
Define how to incorporate the:
[cir] The public certificate of the signer;
[cir] Long term validation data, including Online Certificate
Status Protocol (OCSP) response and/or Certificate Revocation List
(CRL).
Digital signatures ensure that the recipient of the signed document
can authenticate the authorized signer's digital certificate, the
signature artifact(s), determine the signer's role and signature
purpose and validate the data integrity of the document. To create a
valid digital signature that meets Federal Information Processing
Standards (FIPS) \207\, Federal Information Security Management Act of
2002 (FISMA) \208\, and Federal Bridge Certification Authority (FBCA)
requirements \209\, the system used to digitally sign C-CDA Release 2.0
or CDP1 IG documents in accordance with

[[Page 16867]]

the DSDR IG must meet the following requirements:
---------------------------------------------------------------------------

\207\ http://www.nist.gov/itl/fips.cfm.
\208\ http://csrc.nist.gov/drivers/documents/FISMA-final.pdf.
\209\ http://www.idmanagement.gov/sites/default/files/documents/FBCA%20Certificate%20Policy%20v2.27.pdf.
---------------------------------------------------------------------------

(1) The cryptographic module \210\ used must:
---------------------------------------------------------------------------

\210\ A cryptographic module is defined in FIPS 140-2 as ``a set
of hardware, software, firmware, or some combination thereof that
implements cryptographic functions or processes, including
cryptographic algorithms and, optionally, key generation, and is
contained within a defined cryptographic boundary.''
---------------------------------------------------------------------------

a. Be validated to meet or exceed FIPS 140-2, Level 1.
b. Implement a digital signature system and hash function must be
compliant with FIPS 186-2 and FIPS 180-2.
c. Store the private key on a FIPS 140-2 Level 1 validated
cryptographic module using a FIPS-approved encryption algorithm.
(2) The system must support multi-factor authentication that meets
or exceeds Level 3 assurance as defined in NIST SP 800-63-2.
(3) The system must set a 10-minute inactivity time period after
which the certificate holder must re-authenticate the password to
access the private key.
(4) For software implementations, when the signing module is
deactivated, the system must clear the plain text private key from the
system memory to prevent the unauthorized access to, or use of, the
private key.
(5) The system must have a time system that is synced with the
official National Institute of Standards and Technology time source (as
described by the standard adopted at 45 CFR 170.210(g)).
For the purposes of testing and certification, we propose that the
first requirement (cryptographic module requirements) be met through
compliance documentation. For all other specific capabilities in the
list above, we expect testing and certification to assess the
capabilities expressed.
We also propose that a Health IT Module must demonstrate the
ability to validate a digital signature embedded in a C-CDA Release 2.0
document that is conformant with the DSDR IG. The requirements to
perform this action are included in the DSDR IG.
Capability 3--We propose that a Health IT Module be able to support
the creation and transmission of ``external digital signatures'' for
documents. These digital signatures may be used to sign any document
for the purpose of both data integrity and non-repudiation. The esMD
Initiative defines the requirements in the Author of Record Level 1:
Implementation Guide.\211\ We propose to adopt this IG at Sec.
170.205(a)(5)(iii). The Author of Record Level I IG uses the IHE DSG
standard to provide a signer with the ability to digitally sign
multiple documents and embed the W3C compliant XADES signature in a
signature document that may accompany the signed documents or as a
``wrapper'' for the documents. This signing capability is intended for
use when the sender of one or more documents needs to ensure that the
transmitted documents include the non-repudiation identity of the
sender and ensure that the recipient can validate that the document s
have not been altered from the time of signing. This is not intended to
replace the ability to embed multiple digital signatures in a C-CDA
Release 2.0 and CDP1 IG document. The Author of Record Level 1 IG
provides specific guidance on the use of a single digital signature,
external to document, to:
---------------------------------------------------------------------------

\211\ http://wiki.siframework.org/file/view/esMD%20AoR%20Level%201%20Implementation%20Guide%20v5%20FINAL.docx/539084894/esMD%20AoR%20Level%201%20Implementation%20Guide%20v5%20FINAL.docx.
---------------------------------------------------------------------------

Provide a non-repudiation signature that attests to the
identity of the signer;
Allows the recipient to validate the data integrity of the
signed document;
Provide for a delegation of rights where the signer is a
delegated signer and not the authorized signer responsible individual
or organization (e.g., the signer is acting as an authorized agent);
and
Defines how to incorporate the public certificate of the
signer.
Digital signatures ensure that the recipient of the signed document
can authenticate the authorized signer's digital certificate, the
signature artifact(s), and validate the data integrity of the document.
The system requirements in place to apply digital signatures on
documents are the same as in capability 2 with the addition of a
requirement that specifies that a Health IT Module must be able to
digitally sign single or bundles of documents in conformance with the
Author of Record Level 1 IG.
Capability 4--We propose that a Health IT Module be able to support
the creation and transmission of digital signatures for electronic
transactions for the purpose of both data integrity and non-repudiation
authenticity. The esMD Initiative defines the requirements in the
Provider Profiles Authentication: Registration Implementation
Guide.\212\ We propose to adopt this IG at Sec. 170.205(a)(5)(iv). The
Provider Profiles Authentication: Registration IG uses the W3C XADES
digital signature standard to ``sign'' the contents of an electronic
transaction and include the signature as accompanying metadata in the
signed transaction. This signing capability is intended for use when
the sender or recipient of a transaction needs to ensure that the
transmitted information include the non-repudiation identity of the
sender and ensure that the recipient can validate that the authenticity
and integrity of the transaction information. This is not intended to
replace the digital signature requirements defined in either Capability
2 or 3 above. The Provider Profiles Authentication: Registration IG
provides specific guidance on the creation and use of a single digital
signature for an electronic transaction, as accompanying metadata, to:
---------------------------------------------------------------------------

\212\ http://wiki.siframework.org/file/view/esMD%20Use%20Case%201%20Implementation%20Guide%20V24%20FINAL.docx/539084920/esMD%20Use%20Case%201%20Implementation%20Guide%20V24%20FINAL.docx.
---------------------------------------------------------------------------

Provide a non-repudiation signature that attests to the
identity of the signer;
Allow the recipient to validate the data integrity of the
signed transaction;
Provide for a delegation of rights where the signer is a
delegated signer and not the authorized signer responsible individual
or organization (e.g., the signer is acting as an authorized agent);
and
Define how to incorporate the public certificate of the
signer.
Digital signatures ensure that the recipient of the signed
transaction can authenticate the authorized signer's digital
certificate, the signature artifact(s), and validate the data integrity
of the transaction. The system requirements in place to apply digital
signatures for transactions are the same as in capability 2 with the
addition of a requirement that specifies that a Health IT Module must
be able to digitally sign a transaction and create the appropriate
metadata in conformance with the Provider Profiles Authentication:
Registration IG.
4. Gap Certification Eligibility Table for 2015 Edition Health IT
Certification Criteria
We define gap certification at 45 CFR 170.502 as the certification
of a previously certified Complete EHR or EHR Module(s) to: (1) all
applicable new and/or revised certification criteria adopted by the
Secretary at subpart C of part 170 based on the test results of a
NVLAP-accredited testing laboratory; and (2) all other applicable
certification criteria adopted by the Secretary at subpart C of part
170 based on the test results used to previously certify the Complete
EHR or EHR Module(s) (for further explanation, see 76 FR 1307-1308).
Our gap certification policy

[[Page 16868]]

focuses on the differences between certification criteria that are
adopted through rulemaking at different points in time. This allows
health IT to be certified to only the differences between certification
criteria editions rather than requiring health IT to be fully retested
and recertified to certification criteria (or capabilities) that remain
unchanged from one edition to the next and for which previously
acquired test results are sufficient. Under our gap certification
policy, ``unchanged'' criteria are eligible for gap certification, and
each ONC-ACB has discretion over whether it will provide the option of
gap certification.
For the purposes of gap certification, Table 4 below provides a
crosswalk of proposed ``unchanged'' 2015 Edition certification criteria
to the corresponding 2014 Edition certification criteria. We note that
with respect to the 2015 Edition certification criteria proposed for
adoption at Sec. 170.315(g)(1) through (g)(3) that gap certification
eligibility for these criteria is fact-specific and will depend on any
modifications made to the specific certification criteria to which
these ``paragraph (g)'' certification criteria apply.

Table 4--Gap Certification Eligibility for 2015 Edition EHR Certification Criteria
----------------------------------------------------------------------------------------------------------------
2015 edition 2014 edition
----------------------------------------------------------------------------------------------------------------
Regulation section Sec. Title of regulation Regulation section Sec. Title of regulation
170.315 paragraph 170.314 paragraph
----------------------------------------------------------------------------------------------------------------
(a)(1)........................ Computerized provider (a)(1)....................... Computerized provider
order entry-- (a)(18)...................... order entry.
medications. Computerized provider
order entry--
medications.
(a)(3)........................ Computerized provider (a)(1)....................... Computerized provider
order entry--diagnostic (a)(20)...................... order entry.
imaging. Computerized provider
order entry--
diagnostic imaging.
(a)(8)........................ Medication list......... (a)(6)....................... Medication list.
(a)(9)........................ Medication allergy list. (a)(7)....................... Medication allergy
list.
(a)(13)....................... Image results........... (a)(12)...................... Image results.
(a)(16)....................... Patient list creation... (a)(14)...................... Patient list creation.
(a)(18)....................... Electronic medication (a)(16)...................... Electronic medication
administration record. administration record.
(d)(1)........................ Authentication, access (d)(1)....................... Authentication, access
control, and control, and
authorization. authorization.
(d)(2)........................ Auditable events and (d)(2)....................... Auditable events and
tamper-resistance. tamper-resistance.
(d)(3)........................ Audit report(s)......... (d)(3)....................... Audit report(s).
(d)(4)........................ Amendments.............. (d)(4)....................... Amendments.
(d)(5)........................ Automatic access time- (d)(5)....................... Automatic log-off.
out.
(d)(6)........................ Emergency access........ (d)(6)....................... Emergency access.
(d)(7)........................ End-user device (d)(7)....................... End-user device
encryption. encryption.
(d)(8)........................ Integrity............... (d)(8)....................... Integrity.
(d)(9)........................ Accounting of (d)(9)....................... Accounting of
disclosures. disclosures.
(e)(2)........................ Secure messaging........ (e)(3)....................... Secure messaging.
(h)(1)........................ Direct Project.......... (b)(1)(i)(A) and Transitions of care--
(b)(2)(ii)(A). receive, display, and
incorporate transition
of care/referral
summaries.
Transitions of care--
create and transmit
transition of care/
referral summaries.
(h)(1)....................... Transmit--Applicability
Statement for Secure
Health Transport.
(h)(2)........................ Direct Project, Edge (b)(1)(i)(B), (b)(2)(ii)(B), Transitions of care--
Protocol, and XDR/XDM. and (b)(8) \213\. receive, display, and
incorporate transition
of care/referral
summaries.
Transitions of care--
create and transmit
transition of care/
referral summaries.
Transitions of care--
send and receive via
edge protocol.
(h)(2) and (b)(8)............ Transmit--Applicability
Statement for Secure
Health Transport and
XDR/XDM for Direct
Messaging.
Transitions of care--
send and receive via
edge protocol.
(h)(3)........................ SOAP Transport and (b)(1)(i)(C) and Transitions of care--
Security Specification (b)(2)(ii)(C). receive, display, and
and XDR/XDM for Direct incorporate transition
Messaging. of care/referral
summaries.
Transitions of care--
create and transmit
transition of care/
referral summaries.
(h)(3)....................... Transmit--SOAP
Transport and Security
Specification and XDR/
XDM for Direct
Messaging.
----------------------------------------------------------------------------------------------------------------

[[Page 16869]]

5. Pharmacogenomics Data--Request for Comment
Pharmacogenomics data identifies genetic variants in individuals
that alter their metabolism or other interactions with medications and
can lead to serious adverse events. This information is being included
in an increasing number of FDA-approved drug labels. Health IT systems
that can capture pharmacogenomics information could be used to increase
patient safety and enhance patient outcomes.
---------------------------------------------------------------------------

\213\ Technology must have been certified to both edge protocol
methods specified by the standard in Sec. 170.202(d) to be gap
certification eligible.
---------------------------------------------------------------------------

To our knowledge, in general, health IT has not yet captured
genomic and genetic patient information--the presence of clinically
significant genomic variants--in a structured manner such as exists for
other categorical clinical findings or laboratory-derived data.\214\
This information may currently be captured in free text and static PDFs
except in a few individual health centers where custom health IT
solutions have been developed. However, work on standards and other
precursors required for wider adoption is underway, including through
the Institute of Medicine, HL7, and LOINC[supreg].\215\ Many of these
efforts are using pharmacogenomic variations as prototypes because the
clinical utility of a subset of such variants has a greater evidence-
base, has wide clinical applicability, and is already in clinical use.
Pharmacogenomic implementation aims to limit preventable adverse
effects and maximize efficacy by using information about genomic
variants to enable optimal drug choices and patient-specific dosing.
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\214\ http://www.genomebc.ca/education/articles/genomics-vs-genetics/; and http://www.who.int/genomics/geneticsVSgenomics/en/.
\215\ Clinical Pharmacogenetics Implementation Consortium,
http://www.pharmgkb.org/page/cpic/; electronic medical records and
genomics Network (eMERGE), http://emerge.mc.vanderbilt.edu/emerge-network and http://emerge.mc.vanderbilt.edu/emerge-publications-0;
Clinical Sequencing Exploratory Research (CSER) https://cser-consortium.org; Implementing Genomics in Practice (IGNITE), http://www.ignite-genomics.org/IGNITE_ABOUT.html; Institute of Medicine
(IOM) Action Collaborative, http://www.iom.edu/Activities/Research/GenomicBasedResearch.aspx; NHGRI GM7, Genomic Medicine Centers
Meeting VII action items relating to pharmacogenomics
implementation, http://www.genome.gov/Multimedia/Slides/GM7/09_Williams-Middleton.pdf; Clinical Genome Resource, http://www.clinicalgenome.org/about/; Clinical Variation Aggregation
Database, https://www.ncbi.nlm.nih.gov/clinvar/; and HL7 Clinical
Genomics Working Group, http://www.hl7.org/Special/committees/clingenomics/index.cfm.
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For the use case of CDS informed by pharmacogenetic information,
considerable ambiguity exists with respect to the incorporation of CDS
systems that facilitate providers taking advantage of pharmacogenomic
information.\216\ Thus, there is an opportunity for further
specification of standards and implementation of pharmacogenomic data
for CDS within health IT systems. We also believe there may be
opportunities for capturing genomic patient data in laboratory results,
for drug-genome interactions, and for genomic metabolizer status
(defined risks to certain medications) in a structured way within
health IT.
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\216\ Overby CL, Kohane I, Kannry J, et al, Opportunities for
Genomic Clinical Decision Support Interventions, Genet Med. 2013
October 2015(10):817-23; Rasmussen-Torvik LJ, Stallings SC, Gordon
AS, et al, Design and Anticipated Outcomes of the eMERGE-PGx
Project: A Multi-Center Pilot for Pre-Emptive Pharmacogenomics in
Electronic Health Record Systems, Clin Pharmacol Ther. 2014 Jun 24.
doi: 10.1038/clpt.2014.137, [Epub ahead of print]; Karnes JH, Van
Driest S, Bowton EA, et al, Using systems approaches to address
challenges for clinical implementation of pharmacogenomics, Wiley
Interdiscip Rev Syst Biol Med. 2014 Mar-Apr;6(2):125-35,
doi:10.1002/wsbm.1255. Epub 2013 Dec 6; and Peterson JF, Bowton E,
Field JR, et al, Electronic health record design and implementation
for pharmacogenomics: a local perspective, Genet Med. 2013
Oct;15(10):833-41. doi: 10.1038/gim.2013.109. Epub 2013 Sep 5.
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Note that we have previously adopted a 2014 Edition ``family health
history'' certification criterion that referenced the HL7 standard for
representing genomic information and are proposing a 2015 Edition
``family health history--pedigree'' certification criterion that
references that same standard as well as a related IG. In addition to
their relevance for the tested patient, genomic test results are unique
in that they have the potential to inform the health care of blood
relatives of the tested individual, similar to a shared family history.
We note that any application of genomic information across family
members must be done in accordance with the HIPAA Privacy Rule and
other privacy and patient rights laws regarding genetic information at
the federal and state levels.
We acknowledge that individually identifiable genetic information
may be subject to federal and state privacy laws and regulations that
are more privacy restrictive than the HIPAA Privacy Rule. As such,
these privacy issues will impact any certification criteria or policy
we might propose to adopt in future rulemaking. We therefore welcome
input on factors to consider for health IT that allows the user to use
or disclose genetic information in a manner compliant with federal and
state privacy laws. Note that we are proposing two new 2015 Edition
certification criteria for ``data segmentation for privacy--send'' and
``data segmentation for privacy--receive'' that would focus on the
capability to separately track (``segment'') individually identifiable
health information that is protected by rules that are more restrictive
than the HIPAA Privacy Rule (please refer to Section III.A.3 for more
information). We believe that the capabilities offered by the proposed
``data segmentation for privacy'' criteria could be leveraged for the
segmentation of individually identifiable genetic information that are
protected by federal and state privacy laws and regulations.
We also acknowledge that the inclusion of genomic information in
health IT-related mechanisms will need to be carefully implemented to
balance the benefit to patients while avoiding discrimination against
persons with or at risk for the development of future health issues,
and their family members.
In collaboration with the National Institutes of Health, we solicit
comment on whether:
The 2015 Edition ``medication allergy list'' certification
criterion should include the capability to integrate genotype-based
drug metabolizer rate information.
The 2015 Edition ``drug-drug, drug-allergy interactions
checks for CPOE'' certification criterion or as a separate
certification criterion should include pharmacogenomic CDS for ``drug-
genome interactions.''
We should offer 2015 Edition certification for CDS that
incorporate a patient's pharmacogenomic genotype data into the CPOE
prescribing process with the goal of avoiding adverse prescribing
outcomes for known drug-genotype interactions.
There are certification approaches that could enhance the
end-user's (provider's) adoption and continued use of health IT
implementations that guide prescribing through CDS using
pharmacogenomic data.
There are existing or developing standards applicable to
the capture, storage, display, and exchange of potentially clinically
relevant genomic data, including the pharmacogenomic subset.
We should offer certification for health IT functionality
that could facilitate HIPAA-compliant sharing of discrete elements of a
patient's genomic information from their record to the family history
section of a relative's record.
The proposed ``data segmentation for privacy'' criteria
would provide needed health IT functions with respect to the storage,
use, transmission, and disclosure of genetic, genomic, and
pharmacogenomics information that is subject to protections under HIPAA
and

[[Page 16870]]

additional state and federal privacy and protection laws such as the
Genetic Information Nondiscrimination Act (GINA).\217\
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\217\ http://ghr.nlm.nih.gov/spotlight=thegeneticinformationnondiscriminationactgina.
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The proposed ``data segmentation for privacy'' criteria
adequately balance complex genetic privacy issues, such as those
related to behavioral health, with the clinical value of context-
appropriate availability of a patient's actionable genetic and genomic
information.
Health IT should be required to apply different rules for
the use and exchange of genetic, genome, and pharmacogenomics data
based on different groupings of diseases or conditions based on the
sensitivity of the information, such as those related to behavioral
health.
There are other factors we should consider for health IT
that allows the user to use or disclose genetic information in a manner
compliant with federal and state privacy laws.

B. Definitions

1. Base EHR Definitions
We propose to adopt a Base EHR definition specific to the 2015
Edition (i.e., a 2015 Edition Base EHR definition) at Sec. 170.102 and
rename the current Base EHR definition at Sec. 170.102 as the 2014
Edition Base EHR definition. To effectively rename the current Base EHR
definition as the ``2014 Edition Base EHR'' definition, the Base EHR
definition must be removed from the CFR and a ``2014 Edition Base EHR''
definition must be added. This is a procedural requirement and we
affirm that the definition itself is not changing. However, for the
proposed 2015 Edition Base EHR definition, it would differ from the
2014 Edition Base EHR definition in the following ways:
It does not include privacy and security capabilities and
certification criteria. We believe privacy and security capabilities
would be more appropriately addressed through our new proposed approach
for the privacy and security certification of Health IT Modules to the
2015 Edition, as discussed under ``Privacy and Security'' in section
IV.C.1 of this preamble. Our new privacy and security approach would
eliminate EPs', eligible hospitals', and CAHs' responsibilities to
ensure that they have technology certified to all the necessary privacy
and security criteria. Rather, as part of certification, health IT
developers would need to meet applicable privacy and security
certification criteria.
It only includes capabilities to record and export CQM
data (Sec. 170.315(c)(1)). To note, the capabilities to import,
calculate and report CQM data are not included in the proposed 2015
Edition Base EHR definition or any other CQM-related requirements.
Please refer to the ``Clinical Quality Measures'' section (III.A.3)
earlier in this preamble for a more detailed discussion of the CQM
certification criteria. Please also see the EHR Incentive Programs
Stage 3 proposed rule published elsewhere in this issue of the Federal
Register for proposals related to CQMs, including the CEHRT definition
proposal.
It includes the 2015 Edition ``smoking status''
certification criterion as patient demographic and clinical health
information data consistent with statutory requirements.\218\ Smoking
and the use of tobacco in general is the number one cause of
preventable death and disease in the United States. By including this
capability and criterion in the definition, it ensures that providers
participating in the EHR Incentive Programs have the basic capability
to capture the smoking status of patients, which permits more providers
to take part in addressing (through intervention and cessation efforts)
this cause of preventable disease and death.
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\218\ A Base EHR is the regulatory term we have given to what
the HITECH Act defines as a ``qualified EHR.'' Our Base EHR
definition(s) include all capabilities found in the ``qualified
EHR.'' Please see the 2014 Edition final rule (77 FR 54262) for
further explanation.
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It includes the 2015 Edition ``implantable device list''
certification as patient demographic and clinical health information
data consistent with statutory requirements.\219\ The ability to record
and access a patient's unique device identifiers can improve patient
safety. Please see the discussion under the ``implantable device list''
certification criterion for further benefits derived from providers
having access unique device identifier(s) for a patient's implantable
device(s).
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\219\ A capability included in the Base EHR definition, which
originates from the ``qualified EHR'' definition found in the HITECH
Act.
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It includes the 2015 Edition ``application access to
Common Clinical Data Set'' certification criterion as a capability to
both capture and query information relevant to health care quality and
exchange electronic health information with, and integrate such
information from other sources.\220\ Due to the proposed inclusion of
the 2015 Base EHR definition in the proposed CEHRT definition (see
``CEHRT definition'' section below and in the EHR Incentive Programs
Stage 3 proposed rule published elsewhere in this issue of the Federal
Register), like all capabilities and criteria included in the 2015
Edition Base EHR definition, this would ensure that all EPs, eligible
hospitals, and CAHs would need to adopt a Health IT Module certified to
this criterion in order to have the necessary health IT to meet the
CEHRT definition. As such, the inclusion of the 2015 Edition
``application access to Common Clinical Data Set'' certification
criterion in the 2015 Edition Base EHR definition could further
facilitate health information exchange by being specifically used to
meet meaningful use objectives and measures as well as through it
simply being readily available for use by these providers and their
patients.
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\220\ These are capabilities included in the Base EHR
definition, which originate from the ``qualified EHR'' definition
found in the HITECH Act.
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It includes the proposed 2015 Edition Health IT
certification criteria that correspond to the remaining 2014 Edition
certification criteria referenced in the ``2014 Edition'' Base EHR
definition (i.e., CPOE, demographics, problem list, medication list,
medication allergy list, CDS, transitions of care, data portability,
and relevant transport certification criteria). On the inclusion of
transport certification criteria, we propose to include the ``Direct
Project'' criterion (Sec. 170.315(h)(1)) as well as the ``Direct
Project, Edge Protocol and XDR/XDM'' criterion (Sec. 170.315(h)(2)) as
equivalent alternative means for meeting the 2015 Edition Base EHR
definition for the reasons discussed earlier in this preamble under the
``Transport Methods and Other Protocols'' section.

[[Page 16871]]

Table 5--Certification Criteria Required to Satisfy the 2015 Edition
Base EHR Definition
------------------------------------------------------------------------
Base EHR capabilities Certification criteria
------------------------------------------------------------------------
Includes patient demographic and Demographics Sec.
clinical health information, such as 170.315(a)(5)
medical history and problem lists. Problem List Sec.
170.315(a)(7)
Medication List Sec.
170.315(a)(8)
Medication Allergy List Sec.
170.315(a)(9)
Smoking Status Sec.
170.315(a)(12)
Implantable Device List Sec.
170.315(a)(20)
Capacity to provide clinical decision Clinical Decision Support Sec.
support. 170.315(a)(10)
Capacity to support physician order Computerized Provider Order
entry. Entry Sec. 170.315(a)(1),
(2) or (3)
Capacity to capture and query Clinical Quality Measures Sec.
information relevant to health care 170.315(c)(1)
quality.
Capacity to exchange electronic health Transitions of Care Sec.
information with, and integrate such 170.315(b)(1)
information from other sources. Data Portability Sec.
170.315(b)(6)
Application Access to Common
Clinical Data Set Sec.
170.315(g)(7)
Direct Project Sec.
170.315(h)(1) or Direct
Project, Edge Protocol, and
XDR/XDM Sec. 170.315(h)(2)
------------------------------------------------------------------------

Marketing
We note that we would continue the same marketing policy that we
adopted for the 2014 Edition as it relates to the 2015 Edition Base EHR
definition (i.e., health IT developers would have the ability to market
their technology as meeting the 2015 Edition Base EHR definition when
their Health IT Module(s) is/are certified to all the 2015 Edition
health IT certification criteria included in the 2015 Edition Base EHR
definition).
2. Certified EHR Technology Definition
We propose to remove the Certified EHR Technology (CEHRT)
definition from Sec. 170.102, effective with a subsequent final rule
for the following reasons. The CEHRT definition has always been defined
in a manner that supports the EHR Incentive Programs. As such, the
CEHRT definition would more appropriately reside solely within the EHR
Incentive Programs regulations. This would also be consistent with our
approach in this proposed rule to make the ONC Health IT Certification
Program more open and accessible to other types of health IT beyond EHR
technology and for health IT that supports care and practice settings
beyond those included in the EHR Incentive Programs. Further, this
approach should add administrative simplicity in that regulatory
provisions, which EHR Incentive Programs participants must meet (e.g.,
the CEHRT definition), would be defined within the context of
rulemakings for those programs.
The EHR Incentive Programs currently include a regulatory
definition of CEHRT in 42 CFR 495.4 that simply adopts the CEHRT
definition in Sec. 170.102. As proposed in the EHR Incentive Programs
Stage 3 proposed rule, published elsewhere in this issue of the Federal
Register, CMS would adopt a CEHRT definition in 42 CFR 495.4 that would
cover all relevant compliance timelines (i.e., specify the CEHRT
definition applicable for each year/EHR reporting period) and EHR
Incentive Programs requirements. The CEHRT definition proposed by CMS
would also continue to point to the relevant Base EHR definitions \221\
adopted or proposed by ONC and to other ONC-adopted and proposed
certification criteria relevant to the EHR Incentive Programs. We refer
readers to EHR Incentive Programs Stage 3 proposed rule for further
details regarding the CEHRT definition proposal.
---------------------------------------------------------------------------

\221\ This is required by the HITECH Act under the term
``Qualified EHR'' and references a foundational set of certified
capabilities all EPs, eligible hospitals, and CAHs need to adopt.
---------------------------------------------------------------------------

3. Common Clinical Data Set Definition
We propose to revise the ``Common MU Data Set'' definition in Sec.
170.102. We propose to change the name to ``Common Clinical Data Set,''
which aligns with our approach throughout this proposed rule to make
the ONC Health IT Certification Program more open and accessible to
other types of health IT beyond EHR technology and for health IT that
supports care and practice settings beyond those included in the EHR
Incentive Programs. To effectively rename the Common MU Data Set as the
``Common Clinical Data Set,'' the Common MU Data Set definition must be
removed from the CFR and the ``Common Clinical Data Set'' definition
must be added. This is a procedural requirement and all substantive
changes to the definition would only affect certification to the 2015
Edition. We also propose to change references to the ``Common MU Data
Set'' in the 2014 Edition (Sec. 170.314) to ``Common Clinical Data
Set.''
We propose to revise the definition to account for the new and
updated standards and code sets we propose to adopt in this proposed
rule that would improve and advance interoperability through the
exchange of the Common Clinical Data Set. We also propose to revise the
definition to support patient safety through clearly referenced data
elements and the inclusion of new patient data. These proposed
revisions would not change the standards, codes sets, and data
requirements specified in the Common Clinical Data Set for 2014 Edition
certification. They would only apply to a Health IT Module certified to
the 2015 Edition Health IT certification criteria that reference the
Common Clinical Data Set.
Vocabulary Standards
We propose to include HL7 Version 3 (``AdministrativeGender'' and a
nullFlavor value) for sex, ``Race & Ethnicity--CDC'' code system in
PHIN VADS and the OMB standard for race and ethnicity, RFC 5646 for
preferred language, the September 2014 Release of the U.S. Edition of
SNOMED CT[supreg] for problems and procedures, the February 2, 2015
monthly version of RxNorm for medications and medication allergies,
LOINC[supreg] version 2.50 for laboratory tests, and the LOINC[supreg]
codes, metadata, and relevant UCUM unit of measures specified for vital
signs as discussed under the ``vital signs, BMI and growth charts''
certification criterion in section III.A.3 of this preamble. We note
that for race and ethnicity a Health IT Module must be able to express
both detailed races and ethnicities according to the ``Race &
Ethnicity--CDC'' code system and the aggregate OMB code for each race
and ethnicity identified by the patient.
We propose to include immunizations in the ``Common Clinical Data
Set'' for 2015 Edition certification. As described

[[Page 16872]]

in more detail in the preamble for the ``transmission to immunization
registries'' certification criterion in section III.A.3, the C-CDA
Release 2.0 can support NDC codes as a translational data element, but
the CVX code is required to accompany it. The NDC code contains more
information than the CVX code, such as packaging information, that can
assist with tracking for clinical trials and adverse events. We believe
that it would not be a heavy burden to map from an NDC code to a CVX
code because a mapping from NDC codes to CVX codes is publicly
available.\222\ Therefore, for the purposes of including immunizations
in the ``Common Clinical Data Set'' for 2015 Edition certification,
immunizations would be required to be coded according to the CVX code
set (HL7 Standard Code Set CVX--Vaccines Administered, updates through
February 2, 2015) and the NDC code set (NDC--Vaccine Codes, updates
through January 15, 2015) as part of the ``Common Clinical Data Set.''
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\222\ http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=ndc. See also: http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp.
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Unique Device Identifier(s)
We also propose to include the Unique Device Identifier(s) of a
patient's Implantable Device(s) for certification to the 2015 Edition.
As discussed under the ``implantable device list'' certification
criterion, this information leads to improved patient safety when
available to providers. By including this information in the Common
Clinical Data Set, a Health IT Module certified to criteria referencing
the Common Clinical Data Set would be capable of exchanging this
information and further facilitating improvements in patient safety.
Assessment and Plan of Treatment, Goals, and Health Concerns
We propose to include the ``assessment and plan of treatment,''
``goals,'' and ``health concerns'' in the ``Common Clinical Data Set''
for certification to the 2015 Edition. The ``assessment and plan of
treatment,'' ``goals,'' and ``health concerns'' are intended to replace
the concept of the ``care plan field(s), including goals and
instructions'' which is part of the ``Common MU Data Set'' in the 2014
Edition. Based on conversations with stakeholders, we are aware that
the ``care plan field(s), including goals and instructions'' may be
interpreted in two different ways. It might be interpreted to mean the
assessment, plan of care (for treatment), goals, and health concerns
documented for a single patient encounter (in ambulatory settings) or
for the duration of an inpatient stay (in inpatient settings). However,
``care plan field(s), including goals and instructions'' could also be
interpreted to mean a comprehensive shared care plan that represents
the synthesis and reconciliation of multiple plans of care (for
treatment) produced by each provider to address specific health
concerns. Stakeholders have indicated that in implementation, they have
interpreted ``care plan field(s), including goals and instructions'' in
the ``Common MU Data Set'' as the assessment, plan of care (for
treatment), goals, and health concerns for a single patient encounter
or inpatient stay. These stakeholders have expressed safety concerns
that the volume of data in a comprehensive care plan can be so
extensive that it may be difficult for a provider to quickly determine
the information of value for the patient for the given situation.
In consideration of this feedback, we clarify that we intend ``care
plan field(s), including goals and instructions'' to be a single
provider's documentation of their assessment, plan of treatment, goals,
and health concerns for the patient (this clarification applies for
2014 Edition certification). We also make this clarification to better
align with the terms used in the C-CDA Release 2.0, which includes the
``Assessment and Plan Section (V2),'' ``Assessment Section (V2),''
``Plan of Treatment Section (V2),'' ``Goals Section,'' and ``Health
Concerns Section.'' In previous iterations of the C-CDA, the ``Plan of
Treatment Section'' was called the ``Plan of Care Section,'' which
resulted in the same level of confusion on whether the information was
intended to represent a single encounter or the synthesis of multiple
encounters. For that reason, the ``Plan of Care Section'' is now called
the ``Plan of Treatment Section'' to indicate that it is intended to
represent a single encounter and not to be confused with the ``Care
Plan document template.''
For certification to the 2015 Edition, we propose to include in the
Common Clinical Data Set ``assessment and plan of treatment,''
``goals,'' and ``health concerns'' data in accordance with the C-CDA
Release 2.0 ``Assessment and Plan Section (V2)'' or both the
``Assessment Section (V2)'' and ``Plan of Treatment Section (V2);'' the
``Goals Section;'' and the ``Health Concerns Section.'' In practice,
health care providers may document the assessment and plan of treatment
together or separately, and the C-CDA Release 2.0 provides for both
modes of practice. We understand that the C-CDA Release 2.0 permits
both free-text and structured documentation of the assessment, plan of
treatment, goals, and health concerns information in the sections named
above. While we do not propose to require that this information is
documented in a structured way, we encourage health IT developers to
allow for structured documentation or tagging that would allow a
provider to choose relevant pieces of assessment, plan of treatment,
goals, and health concerns data that could be synthesized into a
comprehensive care plan. We note that all proposed 2015 Edition
certification criteria that reference the ``Common Clinical Data Set''
(e.g., the ToC criterion) would therefore also require a Health IT
Module to be able to capture ``assessment and plan of treatment,''
``goals,'' and ``health concerns'' data.
We continue to believe in the value of a comprehensive care plan
and discuss our proposal for a 2015 Edition certification criterion for
this functionality in Section III.A.3 of the preamble (see the ``care
plan'' certification criterion). As stated above, a comprehensive care
plan may contain a large volume of data that is burdensome to transmit
for the purposes of sharing information relevant for a single encounter
or inpatient stay, and thus we do not propose to include it in the
``Common Clinical Data Set'' definition.
Alignment With Clinical Practice
We recognize that the data included in the Common Clinical Data Set
may change over time. Therefore, we request comment on ways in which we
can engage the public to keep the Common Clinical Data Set relevant to
clinical practice.
4. Cross Referenced FDA Definitions
As discussed in our proposal for the 2015 Edition ``implantable
device list'' certification criterion, we propose to adopt in Sec.
170.102 new definitions for ``Implantable Device,'' ``Unique Device
Identifier,'' ``Device Identifier,'' and ``Production Identifier.'' We
propose to adopt the same definitions already provided to these phrases
at 21 CFR 801.3. Again, we believe adopting these definitions in our
rule will prevent any interpretation ambiguity and ensure that each
phrase's specific meaning reflects the same meaning given to them in
the Unique Device Identification System final rule at 21 CFR 801.3.
Capitalization was purposefully applied to each word in these defined
phrases in order to signal to readers that they have specific meanings.

[[Page 16873]]

IV. Provisions of the Proposed Rule Affecting the ONC Health IT
Certification Program

A. Subpart E--ONC Health IT Certification Program

We propose to replace the term ``HIT'' with the term ``health IT''
wherever it may occur in subpart E. While ``HIT'' is a term used in the
HITECH Act, we believe the term ``health IT'' offers more clarity than
``HIT'' for stakeholders. Similarly, we propose to replace the ``ONC
HIT Certification Program'' with ``ONC Health IT Certification
Program'' wherever it may occur in subpart E. In referring to the
certification program, the term ``health'' is capitalized. We also
propose to remove Sec. 170.553 ``Certification of health information
technology other than Complete EHRs and EHR Modules'' as we believe
this section is no longer relevant based on our proposals for the ONC
Health IT Certification Program discussed in more detail below.

B. Modifications to the ONC Health IT Certification Program

In the Voluntary Edition proposed rule (79 FR 10929-30) we recited
our authority and the history of the ONC Health IT Certification
Program, including multiple requests for comment and significant
feedback on making the program more accessible to health IT beyond EHR
technology and health care settings and practices not directly tied to
the EHR Incentive Programs. With consideration of stakeholder feedback
and our policy goals, we attempted to make the ONC Health IT
Certification Program more open and accessible through a proposal in
the Voluntary Edition proposed rule (79 FR 10918-20) to create MU and
non-MU EHR Modules. We subsequently determined that our proposal was
not the best approach (79 FR 54472-73). Since that rulemaking, the
HITPC has issued recommendations supporting certification for care/
practice settings beyond the ambulatory and inpatient settings.\223\ We
have also reconsidered how best to structure the program and make it
open and accessible to more types of health IT, health IT that supports
a variety of care and practice settings, and programs that may
reference the ONC Health IT Certification Program, including Medicaid
and Medicare payment programs and various grant programs.
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\223\ http://www.healthit.gov/facas/sites/faca/files/TransmittalLetter_LTPAC_BH_Certification.pdf and http://www.healthit.gov/facas/sites/faca/files/HITPC_LTPAC_BH_Certification_Recommendations_FINAL.pdf.
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1. Health IT Modules
We propose to rename EHR Modules as Health IT Modules. To
effectively rename EHR Modules as Health IT Modules, the EHR Module
definition must be removed from the CFR at Sec. 170.102 and a ``Health
IT Module'' definition must be added. This proposed change would be
effective on the effective date of a subsequent final rule, which would
make this change applicable for certification to the 2014 Edition and
2015 Edition (if adopted). An EHR Module is defined in Sec. 170.102 as
any service, component, or combination thereof that can meet the
requirements of at least one certification criterion adopted by the
Secretary. The definition essentially covers any type of technology
that could be certified to one or more certification criterion under
the ONC Health IT Certification Program. As such, our proposed change
will have no substantive impact on the technologies that might be, or
have been, certified under the ONC Health IT Certification Program. We
believe this proposal best addresses the full range of health IT that
has and might be certified to adopted certification criteria now and in
the future. This approach also gives more appropriate attribution to
certifications issued to technologies that would not generally be
considered ``EHR'' functionality, such as functionality provided by a
HISP, HIE, or LIS. The switch to ``Health IT Module'' could also have
long-term practicality as the ONC Health IT Certification Program
evolves.
For technologies already certified to the 2014 Edition as EHR
Modules, this proposal would not affect the certification of those
technologies or the ability to use those technologies to meet the CEHRT
definition. Further, we see no reason why these technologies could not
be called Health IT Modules if the developer wished to do so. We
suggest, however, that health IT developers check with the ONC-ACB that
issued the certification to ensure this would be permissible based on
the issued certification.
We also emphasize that a Health IT Module is simply the name for a
technology that gets issued a certification under the ONC Health IT
Certification Program. One Health IT Module certification or multiple
Health IT Modules certifications can be of sufficient scope to meet the
Base EHR definition and even the CEHRT definition.
2. ``Removal'' of Meaningful Use Measurement Certification Requirements
We propose to not require ONC-ACBs to certify Health IT Modules to
the 2015 Edition ``meaningful use measurement'' certification criteria
(Sec. 170.315(g)(1) ``automated numerator recording'' and Sec.
170.315(g)(2) ``automated measure calculation''). This is a change from
prior certification policy, such as with the certification of
technology to the 2014 Edition and the requirements of Sec.
170.550(f)(1). We believe this will make the ONC Health IT
Certification more accessible to the certification of health IT for
other purposes beyond the EHR Incentive Programs. Further, we have
received feedback from stakeholders that these requirements can pose a
significant burden on health IT development and come at the cost of
improving clinical functionality and usability (79 FR 54469). We have
also heard from stakeholders that these criteria can impact innovation.
Whether this feedback is entirely accurate is not the primary reason
for our changed approach. Rather, we believe that not all health IT
certified under the ONC Health IT Certification Program needs to have
these capabilities and that it is more appropriate to align our
approach to these criteria with our primary policy of administering a
certification program that includes certification criteria that broadly
support the health care system, while making available for health IT
developers the flexibility to present their health IT for certification
to the criteria that support their specific customers' and providers'
needs.
We emphasize that this proposed approach does not preclude health
IT developers from seeking certification to Sec. 170.315(g)(1) or (2)
in support of their customers' and provider's needs related to the EHR
Incentive Programs. Moreover, the EHR Incentive Programs Stage 3
proposed rule, published elsewhere in this issue of the Federal
Register, includes a proposed CEHRT definition that would require EPs,
eligible hospitals, and CAHs to have health IT certified to these
criteria in order to meet the CEHRT. Accordingly, health IT developers
supporting providers participating the EHR Incentive Programs should
strongly consider seeking certification to these certification
criteria, as applicable.
3. Types of Care and Practice Settings
As noted above, the HITPC issued recommendations generally
supporting certification for a variety of care and practice settings
under the ONC Health IT Certification Program, particularly

[[Page 16874]]

focusing on long-term post-acute care (LTPAC) and behavioral health
settings. Consistent with those recommendations, we have made proposals
to make the ONC Health IT Certification Program more agnostic to care
and practice settings (e.g., the proposals to revise Sec. 170.300 and
``remove'' ``meaningful use measurement'' certification requirements)
and we have proposed new ``data segmentation'' certification criteria
(Sec. Sec. 170.315(b)(7) and (8)) that include capabilities that can
support care and practice settings that service patients with sensitive
health information, including behavioral health.
In the Voluntary Edition final rule (79 FR 54473), we pointed
stakeholders to the guidance we issued in 2013 for health IT developers
serving providers ineligible for the EHR Incentives Programs. The
guidance, ``Certification Guidance for EHR Technology Developers
Serving Health Care Providers Ineligible for Medicare and Medicaid EHR
Incentive Payments,'' \224\ was developed in close coordination with
HHS agencies, including the Substance Abuse and Mental Health Services
Administration (SAMHSA). The guidance is designed for certification to
the 2014 Edition and focuses on two key area, interoperability-focused
certification criteria (highlighting the ``transitions of care'' and
``clinical information reconciliation'' criteria as criteria that
support interoperable summary care record exchange--a fundamental
capability necessary to enable care coordination across different
settings) and privacy and security certification criteria. The HITPC
similarly concluded that LTPAC and behavioral health providers should
focus on adopting health IT certified to these capabilities
(certification criteria).\225\
---------------------------------------------------------------------------

\224\ http://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf.
\225\ http://www.healthit.gov/facas/sites/faca/files/TransmittalLetter_LTPAC_BH_Certification.pdf and http://www.healthit.gov/facas/sites/faca/files/HITPC_LTPAC_BH_Certification_Recommendations_FINAL.pdf.
---------------------------------------------------------------------------

The 2015 Edition includes many certification criteria with the same
capabilities as those certification criteria identified in the 2014
guidance, but with new and/or enhanced functionality. As one pertinent
example, the 2015 Edition ``transitions of care'' certification
criterion (Sec. 170.315(b)(1)) includes capabilities for formatting a
care/referral summary according to the Common Clinical Data Set and the
C-CDA Release 2.0. The C-CDA Release 2.0 includes new document
templates for: Care Plan; Referral Note; Transfer Summary, and new
sections for: Goals; Health Concerns; Health Status Evaluation/
Outcomes; Mental Status; Nutrition; Physical Findings of Skin and new
entries (e.g. Wound Observation) that may be particularly beneficial to
providers that serves medically-complex patients with chronic care
conditions. As to privacy and security, we highlight that our new
proposed approach in this rule focuses on ensuring that all health IT
presented for certification is certified to the appropriate privacy and
security certification criteria. Overall, we have proposed a diverse
edition of health IT certification criteria with capabilities included
that could support a wide range of providers practicing in various
settings.
We anticipate that, similar to the 2014 Edition guidance, we would
issue general interoperability guidance for the 2015 Edition when it
becomes final. However, we have no plans to independently develop and
issue certification ``paths'' or ``tracks'' by care or practice setting
(e.g., a ``LTPAC certification'') as it would be difficult to
independently devise such ``paths'' or ``tracks'' in a manner that was
sure to align with other relevant programs and specific stakeholder
needs. Rather, we believe we are best suited for supporting the
development of standards for specific settings/use cases and providing
technical assistance to both health IT developers and providers about
the certification criteria, the standards and capabilities they
include, and the processes of the ONC Health IT Certification Program.
In this regard, we would welcome working with HHS or other agencies, or
provider associations, in identifying the appropriate functionality and
certification criteria to support their stakeholders, including jointly
developing specialized certification ``paths'' or ``tracks.'' To note,
we believe this approach is also consistent with stakeholder feedback
we received through rulemaking (79 FR 54473-74) and the HITPC
recommendations for us to work with HHS and other agencies.
We seek comment on potential future certification criteria that
could include capabilities that would uniquely support LTPAC,
behavioral health, or pediatrics care\practice settings, as well as
other settings. We are specifically interested in public comment on
whether certification criteria focused on patient assessments (e.g.,
Minimum Data Set (Nursing Homes), OASIS (Home Health), IRF-PAI
(Inpatient Rehabilitation Facility), or Long Term Care Hospital (CARE
data set) would support key functionality needed in these settings and
if there standards mature enough for structured patient assessments.
Similarly, we seek comment on whether certification criteria focused on
patient assessments for behavioral health settings would be of value to
health IT developers and health care providers.
4. Referencing the ONC Health IT Certification Program
Our proposals throughout this proposed rule, including the proposed
adoption of various criteria that support functionality for different
care and practice settings and the proposals to make the ONC Health IT
Certification Program open and accessible to more types of health IT
and health IT that supports a variety of care and practice settings,
would permit further referencing and use of certified health IT.
Currently, in addition to the EHR Incentive Programs, the adopted
certification criteria editions already support and are referenced by
other HHS programs (e.g., the CMS and HHS Office of Inspector General
(OIG) final rules to modify the Physician Self-Referral Law exception
and Anti-kickback Statute safe harbor for certain EHR donations (78 FR
78751) and (78 FR 79202), respectively).\226\ Certified health IT has
also been referenced in CMS payment rules such as the CY 2015 Physician
Fee Schedule final rule (79 FR 67721-28) for chronic care management
services and in a proposed rule (79 FR 61186) encouraging the use of
certified health IT by home health agencies. The Department of Defense
has also referenced certified health IT in a request for proposal for
its Healthcare Management System Modernization Program.\227\ In the
private sector, The Joint Commission requires the use of certified
health IT to participate as an Outcomes Research Yields Excellence
(ORYX) vendor and submit electronic clinical quality measures on behalf
of hospitals.\228\
---------------------------------------------------------------------------

\226\ CMS final rule, ``Medicare Program; Physicians' Referrals
to Health Care Entities With Which They Have Financial
Relationships: Exception for Certain Electronic Health Records
Arrangements'' (78 FR 78751) (December 27, 2013). OIG final rule,
``Medicare and State Health Care Programs: Fraud and Abuse;
Electronic Health Records Safe Harbor Under the Anti-Kickback
Statute'' (78 FR 79202) (December 27, 2013).
\227\ https://www.fbo.gov/index?s=opportunity&mode=form&id=573cfbaa71e7843341a7c145888c48e0&tab=core&_cview=1.
\228\ http://www.jointcommission.org/assets/1/18/2015_eCQM_Vendor_List.pdf. (page 3).
---------------------------------------------------------------------------

The proposed 2015 Edition and proposed open and flexible
certification processes in this proposed rule would continue to
facilitate the efforts

[[Page 16875]]

described above as well as other ongoing and future efforts to
reference and use certified health IT.

C. Health IT Module Certification Requirements

1. Privacy and Security
We propose a new approach for privacy and security (P&S)
certification to the 2015 Edition. In our past rulemakings, we have
discussed and instituted two different policy approaches and sought
comment on others for ensuring that health IT and providers have
privacy and security capabilities while also trying to minimize the
level of regulatory burden imposed on health IT developers. In the 2011
Edition, we included an upfront requirement that required Health IT
Modules to meet all P&S certification criteria as a condition of
certification unless the health IT developer could demonstrate that
certain P&S capabilities were either technically infeasible or
inapplicable. In the 2014 Edition, we eliminated the upfront
requirement for each Health IT Module to be certified against the P&S
criteria in favor of what we thought would better balance the burden
potentially posed by our rulemaking. Thus, the P&S criteria were made
part of the ``2014 Edition Base EHR definition'' that all EPs, EHs, and
CAHs must meet in order to satisfy the CEHRT definition (meaning each
provider needed, post-certification to ultimately have technology
certified to the P&S criteria).
On March 23, 2013, the HITSC recommended that we should change our
certification policy for P&S. They recommended that each Health IT
Module presented for certification should be certified through one or
more of the following three paths:
Demonstrate, through system documentation and
certification testing, that the Health IT Module includes functionality
that meets at least the ``minimal set'' \229\ of privacy and security
certification criterion.
---------------------------------------------------------------------------

\229\ The minimal set includes the following certification
criteria: ``authentication, access control, and authorization,''
``auditable events and tamper resistance,'' ``audit report(s),''
``amendments,'' ``automatic log-off,'' ``emergency access,'' ``end-
user device encryption,'' and ``integrity.'' The full recommendation
can be found at: http://www.healthit.gov/sites/default/files/pswgtransmittalmemo_032613.pdf.
---------------------------------------------------------------------------

Demonstrate, through system documentation sufficiently
detailed to enable integration, that the Health IT Module has
implemented service interfaces that enable it to access external
services necessary to conform to the ``minimal set'' of privacy and
security certification criterion.
Demonstrate through documentation that the privacy and
security certification criterion (and the minimal set that the HITSC
defined) is inapplicable or would be technically infeasible for the
Health IT Module to meet. In support of this path, the HITSC
recommended that ONC develop guidance on the documentation required to
justify inapplicability or infeasibility.
In response to the HITSC recommendations and stakeholder feedback
we sought comment in the Voluntary Edition proposed rule (79 FR 10925-
26) on the following four options we believed could be applied to
Health IT Module certification for privacy and security: (1) Re-adopt
the 2011 Edition approach; (2) maintain the 2014 Edition approach; (3)
adopt the 2013 HITSC recommendation; or (4) adopt a limited
applicability approach--under which ONC would establish a limited set
of P&S functionality that every Health IT Module would be required to
address in order to be certified.
In response to our request for comments, we received comments
generally in support of the 2014 approach (including P&S in the Base
EHR definition). While some commenters supported requiring a subset of
P&S criteria (option 4), many disagreed on the scope and did not see
the value vis-a-vis HIPAA compliance. The HITSC preferred a different
option. They recommended that ONC revise each privacy and security
criterion to specify the conditions under which it is applicable
(similar to how the end-user device encryption criterion currently is
written), and allow each criterion to be met using one of the three
paths the HITSC recommended in 2013.\230\
---------------------------------------------------------------------------

\230\ http://www.healthit.gov/sites/default/files/pswgtransmittalmemo_032613.pdf.
---------------------------------------------------------------------------

During their discussions regarding the Voluntary Edition proposed
rule, the HITSC's Privacy and Security Workgroup (PSWG) completed an
assessment of which P&S functionality should be required for each
proposed certification criterion. The PSWG recognized that the privacy
and security criteria are not equally applicable or useful to every
criterion in each of the other regulatory functional areas (i.e.,
clinical, care coordination, clinical quality, patient engagement,
public health, utilization, and transmission) because each P&S
criterion is designed to address specific risk conditions that may or
may not be present within a specific regulatory functional area.
The PSWG model allows for the appropriate safeguards to be in place
for each criterion, without overburdening health IT developers by
requiring them to include all P&S functionality for each criterion. We
believe this serves as a good model, in combination with the 2013 HITSC
recommendations, to propose a new, simpler, straight-forward approach
to the P&S certification requirements for Health IT Modules that merges
many of the recommendations and feedback we have received to date.
Under the proposed approach, a health IT developer would know exactly
what it needed to do in order to get its Health IT Module certified and
a purchaser of a Health IT Module would know exactly what privacy and
security functionality against which the Health IT Module had to be
tested in order to be certified.
We propose to require that an ONC-ACB must ensure that a Health IT
Module presented for certification to any of the certification criteria
that fall into each regulatory text ``first level paragraph'' category
(e.g., Sec. 170.315(a)) of Sec. 170.315 identified below is certified
to either approach 1 (technically demonstrate) or approach 2 (system
documentation) as follows:

[[Page 16876]]

------------------------------------------------------------------------
It will need to be certified to
approach 1 or approach 2 for each of
If the Health IT Module the P&S certification criteria listed
includes capabilities for in the ``approach 1'' column
certification listed under: ----------------------------------------
Approach 1 Approach 2
------------------------------------------------------------------------
Sec. 170.315(a).............. Sec. For each
170.315(d)(1) applicable P&S
(authentication, certification
access control, criterion not
and certified for
authorization), approach 1, there
(d)(2) (auditable must be system
events and tamper documentation
resistance), sufficiently
(d)(3) (audit detailed to
reports), (d)(4) enable
(amendments), integration such
(d)(5) (automatic that the Health
log-off), IT Module has
(d)(6)(emergency implemented
access), and service
(d)(7) (end-user interfaces for
device encryption). each applicable
privacy and
security
certification
criterion that
enable the Health
IT Module to
access external
services
necessary to meet
the privacy and
security
certification
criterion.
Sec. 170.315(b).............. Sec.
170.315(d)(1)
through (d)(3) and
(d)(5) through
(d)(8) (integrity).
Sec. 170.315(c).............. Sec.
170.315(d)(1)
through (d)(3).
Sec. 170.315(e).............. Sec.
170.315(d)(1)
through (d)(3),
(d)(5), and (d)(7).
Sec. 170.315(f).............. Sec.
170.315(d)(1)
through (d)(3) and
(d)(7).
Sec. 170.315(h).............. Sec.
170.315(d)(1)
through (d)(3).
Sec. 170.315(i).............. Sec.
170.315(d)(1)
through (d)(3) and
(d)(5) through
(d)(8).
------------------------------------------------------------------------

To illustrate approach 1 of privacy and security certification, if
a Health IT Module is presented for certification to Sec.
170.315(a)(5) (``demographics''), then the Health IT Module must also
be certified to Sec. 170.315(d)(1) through (7). We refer readers to
Appendix A of this proposed rule for a listing of the P&S certification
requirements for each 2015 Edition criterion under approach 1.
Because we have explicitly proposed which P&S certification
criteria would be applicable to the associated criteria adopted in each
regulatory text ``first level paragraph'' category and have also
proposed approach 2, we have not proposed to permit the 2011 Edition
policy of allowing for a criterion to be met through documentation that
the criterion is inapplicable or would be technically infeasible for
the Health IT Module to meet.
We seek comment on the overall clarity and feasibility of this
approach.
2. Design and Performance (Sec. 170.315(g))
We propose to revise Sec. 170.550 to add paragraph (g), which
would require ONC-ACBs to certify Health IT Modules to certain proposed
certification criteria under Sec. 170.315(g). We propose to require
ONC-ACBs to certify Health IT Modules to Sec. 170.315(g)(3) (safety-
enhanced design) and Sec. 170.315(g)(6) (Consolidated CDA creation
performance) consistent with the requirements included in these
criteria. Paragraph (g) also includes a requirement for ONC-ACBs to
certify all Health IT Modules presented for certification to the 2015
Edition to Sec. 170.315(g)(4) (quality system management) and (g)(8)
(accessibility-centered design). The proposed certification
requirements for Sec. 170.315(g)(3) and (4) maintain the policy
approach established with certification to the 2014 Edition (see Sec.
170.550(f)(2) and (3)), which ensures Health IT Modules, as applicable,
are certified to these specific safety and quality certification
criteria. The proposed certification requirements for Sec.
170.315(g)(6) is associated with the new ``Consolidated CDA creation
performance'' criterion we have proposed for the 2015 Edition and
discuss in more detail in section III.A.3 of this preamble. Again, the
requirement is similarly designed to ensure that Health IT Modules
(with Consolidated CDA creation capabilities within their scope) are
also certified to the ``Consolidated CDA creation performance''
criterion. The proposed certification requirements for Sec.
170.315(g)(8) is associated with the new ``accessibility-centered
design'' criterion we have proposed for the 2015 Edition and discuss in
more detail in section III.A.3 of this preamble. This criterion and
approach to certification is patterned after the 2014 Edition ``quality
system management'' criterion.

D. Principles of Proper Conduct for ONC-ACBs

1. ``In-the-Field'' Surveillance and Maintenance of Certification
We propose to adopt new requirements for ``in-the-field''
surveillance under the ONC Health IT Certification Program. Our
proposal would build on ONC-ACBs' existing surveillance
responsibilities by requiring ONC-ACBs to initiate in-the-field
surveillance of certified Complete EHRs and certified Health IT Modules
in certain circumstances and in accordance with certain standards and
procedures described below. Our proposal would also clarify ONC-ACBs'
responsibilities for requiring certified Health IT Module and certified
Complete EHR developers to take corrective action in instances where
the technology fails to conform to the requirements of its
certification. We believe these proposed requirements would promote
greater consistency, transparency, and rigor in the surveillance of
certified capabilities in the field. They would also provide ONC-ACBs,
health IT developers, and users of certified health IT subject to
surveillance with greater clarity and predictability regarding this
important aspect of the ONC Health IT Certification Program.
Our proposal focuses on ONC-ACBs' responsibilities for conducting
surveillance ``in the field.'' In-the-field surveillance is already a
requirement of the ONC Health IT Certification Program \231\ and is
among the most

[[Page 16877]]

important responsibilities with which an ONC-ACB is charged. It is
rooted in the need to provide assurance to purchasers, implementers,
and users that certified Complete EHRs and certified Health IT Modules
not only meet the requirements of certification in a controlled testing
environment but will continue to do so when implemented and used in a
production environment. This basic assurance protects the integrity of
the ONC Health IT Certification Program and federal health IT
investments by enabling individuals to rely upon certifications issued
on behalf of ONC to select appropriate technologies and capabilities;
identify potential implementation or performance issues; and implement
certified health IT in a predictable, reliable, and successful
manner.\232\ The need to evaluate certified health IT in the field is
particularly important for capabilities related to interoperability,
patient safety, and privacy and security, which present special
implementation challenges, complexities, or risks.\233\
---------------------------------------------------------------------------

\231\ We explicitly recognized an ``in-the-field surveillance''
requirement in the Proposed Establishment of Certification Programs
for Health Information Technology; Proposed Rule, 75 FR 11328 (Mar
10, 2010), wherein we proposed that an ONC-ACB would be required to
``evaluate and reevaluate previously certified Complete EHRs and/or
EHR Modules to determine whether [they] continued to perform in an
acceptable, if not the same, manner in the field as they had
performed when they were certified.'' 75 FR 11349 (emphasis added).
We finalized this requirement in the Establishment of the Permanent
Certification for Health Information Technology; Final Rule, 76 FR
1262 (Jan. 7, 2011) (hereinafter ``PCP Final Rule''). Subsequently,
we issued initial and annual guidance to ONC-ACBs clarifying our
interpretation of the requirements for in-the-field surveillance
under the ONC HIT Certification Program, the preparation and
submission of ONC-ACBs' annual surveillance plans, and the reporting
of surveillance results to the National Coordinator on an annual
basis. See ONC HIT Certification Program Guidance #13-01 (July
2013), available at http://www.healthit.gov/sites/default/files/onc-acb_2013annualsurveillanceguidance_final_0.pdf; see also ONC HIT
Certification Program Guidance #14-01 (July 2014), available at
http://www.healthit.gov/sites/default/files/onc-acb_cy15annualsurveillanceguidance.pdf.
\232\ See, e.g., FDASIA Health IT Report: Proposed Strategy and
Recommendations for a Risk-Based Framework (April 2014) (draft for
public comment) (hereinafter ``FDASIA Report''), available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM391521.pdf, at
Sec. 5.3.2 (``For the consumer, ONC certification provides
purchasing clarity and assurance that the certified EHR product
meets certain criteria and/or functions in a certain way.'')
\233\ See, e.g., FDASIA Report, supra, at section 5.2.1
(``Errors in communication due to inadequate interoperability, such
as the transmission of test results inaccurately or for the wrong
patient, do occur and can lead to patient harm.''); ONC HIT
Certification Program Guidance #13-01, supra, at 3-4 (prioritizing
surveillance for safety-related capabilities); Health IT Safety
Plan, supra, at 14 (discussing incorporation of health IT safety in
post-market surveillance of certified EHR technology).
---------------------------------------------------------------------------

Recognizing that in-the-field surveillance presents technical,
operational, and other challenges, we have previously avoided
prescribing specific requirements in this area; instead we have
provided guidance to ONC-ACBs and encouraged them to develop and refine
their own approaches to surveillance. We continue to regard such
flexibility as important for minimizing the burden of surveillance on
all stakeholders and ensuring that ONC-ACBs' approaches to surveillance
reflect their unique expertise and judgment. However, we also believe
that establishing certain minimum expectations and procedures for in-
the-field surveillance could provide ONC-ACBs as well as health IT
developers and users with greater clarity and predictability regarding
this important aspect of the ONC Health IT Certification Program.
Accordingly, we propose the following additional requirements for in-
the-field surveillance under the ONC Health IT Certification Program.
``In-The-Field Surveillance'' Defined
Our proposal explicitly defines in-the-field surveillance to mean
an ONC-ACB's assessment of whether a certified Complete EHR or
certified Health IT Module to which it has issued a certification
continues to conform to the certification's requirements once
implemented and in use in the field. This assessment would, by
definition, require the ONC-ACB to assess the certified Complete EHR or
certified Health IT Module's capabilities in a production environment.
The assessment of a capability would be based on the use of the
capability with protected health information (PHI) unless the use of
test data would provide an equivalent assessment of the capability and
were specifically approved by the National Coordinator.\234\
---------------------------------------------------------------------------

\234\ In consultation with the Office for Civil Rights, we have
clarified that under the ``health oversight agency'' exception of
the HIPAA Privacy Rule, a healthcare provider would be permitted to
disclose protected health information (PHI) to an ONC-ACB during the
course of authorized in-the-field surveillance activities, without
patient authorization and without a business associate agreement.
See ONC Regulation FAQ #45 [12-13-045-1], available at http://www.healthit.gov/policy-researchers-implementers/45-question-12-13-045.
---------------------------------------------------------------------------

The following hypothetical scenarios illustrate our proposed
approach.
Scenario 1: An ONC-ACB initiates in-the-field surveillance
for a certified Health IT Module for the medication list certification
criterion (proposed at 45 CFR 170.315(a)(8)). An ONC-ACB would then
assess this capability at several locations at which the certified
Health IT Module has been implemented. The ONC-ACB would assess whether
the implemented capability can electronically record, change, and
access one or more patients' active medication lists and medication
histories as required by the certification criterion.
Scenario 2: An ONC-ACB initiates in-the-field surveillance
for a certified Health IT Module's transitions of care capability and
one or more applicable transport certification criteria (proposed at 45
CFR 170.315(b)(1) and (h), respectively). During this surveillance, the
ONC-ACB would assess these capabilities at several locations at which
the certified Health IT Module is implemented to determine whether
these certified capabilities perform in compliance with the applicable
certification criteria.
Scenario 3: An ONC-ACB initiates in-the-field surveillance
for a certified Health IT Module related to the data portability
criterion adopted at 45 CFR 170.314(b)(7). Again, the ONC-ACB would
need to assess at several locations at which the Health IT Module is
implemented whether the certified Health IT Module's data portability
capability performed in compliance with the certification criterion.
As these scenarios illustrate, an ONC-ACB's evaluation of health IT
in the field must focus on compliance with one or more certification
criteria to which a Complete EHR or Health IT Module is certified. Such
compliance must be assessed in the production environment in which the
Complete EHR or Health IT Module is actually implemented and used.
Because certified Complete EHRs and certified Health IT Modules
will be integrated with other systems, processes, and people, we
acknowledge that the unique circumstances and contexts in which a
certified Complete EHR or certified Health IT Module operates could
impact an ONC-ACB's ability to assess whether it continues to perform
in compliance with adopted certification criteria once it has been
implemented and in use. For example, if during in-the-field
surveillance an ONC-ACB observed that the certified capability did not
perform in a compliant manner, the ONC-ACB would need to determine
whether the failure was the result of a problem with the certified
capability or, alternatively, whether the failure was caused entirely
by other factors beyond the scope of certification, such as a
configuration or implementation issue (for which the user was primarily
responsible) or the failure of a third-party technology or service over
which the health IT developer had limited or no control.
Further, we recognize that the assessment of a certified Complete
EHR or certified Health IT Module in a production environment would
require ONC-ACBs to employ different methodologies than testing and
certification in a controlled environment. Given the additional factors
and complexities described above, there could be situations in which an
in-person site visit is the best or perhaps the only reliable means of
evaluating whether health IT, as implemented in the field, conforms to
the requirements of its certification. However, in general, we expect
that ONC-ACBs should be able to effectively assess certified
capabilities ``in the

[[Page 16878]]

field'' using other remote methods that would not involve in-person
site visits. We believe that such methods may be less intrusive for
health care providers, less costly or burdensome for ONC-ACBs, or offer
other benefits. Therefore, we request comment on these and other
approaches to in-the-field surveillance, on ways to minimize the burden
and costs of in-the-field surveillance for ONC-ACBs and health care
providers, and on appropriate industry standards or best practices that
we should consider adopting to provide ONC-ACBs with consistent,
objective, and reliable methods for conducting these evaluations.
Duty To Initiate In-The-Field Surveillance
In addition to defining in-the-field surveillance, this proposal
would require ONC-ACBs to initiate in-the-field surveillance in at
least two sets of circumstances. These two separate requirements--which
we refer to as ``reactive'' and ``randomized'' in-the-field
surveillance--are discussed in detail below. Together they would
implement sections 7.9.2 and 7.9.3 of ISO/IEC 17065 (the standard to
which ONC-ACBs are accredited under the ONC HIT Certification Program),
which provide that surveillance ``shall include periodic surveillance .
. . to ensure ongoing validity of the demonstration of fulfilment of []
requirements.'' \235\ As such, the requirements would become part of
the ``certification scheme'' for purposes of ISO/IEC 17065 and would
therefore be directly enforceable by the ONC-AA, which is responsible
for accrediting ONC-ACBs and verifying their conformance to ISO/IEC
17065 and other program requirements.
---------------------------------------------------------------------------

\235\ ISO/IEC 17065:2012, available at http://www.iso.org/iso/catalogue_detail.htm?csnumber=46568.
---------------------------------------------------------------------------

Reactive Surveillance
To satisfy the proposed ``reactive'' surveillance requirement, an
ONC-ACB would be required to initiate in-the-field surveillance
whenever it becomes aware of facts or circumstances that call into
question a certified Complete EHR or certified Health IT Module's
continued conformance to the requirements of its certification. This
reactive surveillance requirement aligns with ONC-ACBs' existing annual
surveillance plans, which should specify how an ONC-ACB will
``[s]ystematically obtain and synthesize feedback from users of [health
IT] that the ONC-ACB has certified to determine if certain capabilities
should be evaluated with the [health IT] developer or with the user in
the field, or both.'' \236\ We anticipate that such feedback would
include (although not be limited to) complaints received from existing
and prospective users and implementers of the Complete EHRs and Health
IT Modules the ONC-ACB has certified.
---------------------------------------------------------------------------

\236\ ONC HIT Certification Program Guidance #13-01, supra, at
3.
---------------------------------------------------------------------------

We clarify that the receipt of a single complaint would not
automatically trigger an ONC-ACB's duty to initiate in-the-field
surveillance. In general, an ONC-ACB would be required to consider and
weigh the volume, substance, and credibility of complaints received
against the type and extent of the alleged non-conformance, in light of
the ONC-ACB's expertise and experience with the particular
capabilities, health IT, and certification criteria at issue.
We also propose as part of ``reactive'' surveillance that an ONC-
ACB must consider the impact and effect of the disclosures made by a
Complete EHR or Health IT Module developer on the product's continued
conformance to adopted certification criteria. We have proposed this
additional review because we believe there are additional factors and
circumstances that an ONC-ACB will be unable to assess at the time the
health IT was initially certified based on tests completed by the
developer in a controlled environment. For example, the ONC-ACB may
determine that while a health IT developer's Complete EHR or Health IT
Module demonstrated it could perform a required capability in a
controlled environment, users in the field cannot reasonably access or
use the capability because the health IT developer does not make the
capability available; substantially restricts or limits its use; or has
not disclosed known material information about the implementation or
use of the capability. These and other practices, such as those
discussed in our proposal ``Transparency and Disclosure Requirements''
below, could substantially interfere with the performance of certified
capabilities in the field and creates a substantial risk that existing
or prospective users will encounter problems implementing the
capability in a manner consistent with a Complete EHR or Health IT
Module's certification. As a result, we have proposed that as part of
``reactive'' surveillance ONC-ACBs evaluate the disclosures in
connection with, and in the context of, the certified capability/
capabilities under surveillance to gain a full understanding of the way
in which the product performs in the field.
We clarify our expectation that ONC-ACBs could render a certified
Complete EHR or certified Health IT Module non-conformant to the
certification criteria in instances where the developer does not make
the capability available; substantially restricts or limits its use; or
has not disclosed known material information about the implementation
or use of the capability. We also note that we expect ONC-ACBs to give
considerable weight to complaints or other indications that a developer
has failed meet the disclosure requirements of Sec. 170.523(k)(1).
Consistent with current practice, we expect that the National
Coordinator will continue to prioritize certain certification criteria
for purposes of surveillance. For example, certification criteria may
be prioritized based on the special implementation challenges or risks
associated with certain capabilities, especially those related to
interoperability, patient safety, and privacy and security. ONC-ACBs
would be required to give special scrutiny to complaints about
capabilities or disclosures related to these prioritized certification
criteria. If an ONC-ACB detected a pattern or trend of such complaints,
it would be required to initiate in-the-field surveillance to
investigate the complaints and the extent of any non-conformance with
the requirements of a certified Complete EHR or certified Health IT
Module's certification.
Finally, for the reasons discussed earlier in this proposal and
immediately below in our proposal ``Transparency and Disclosure
Requirements,'' during reactive surveillance of a certified Complete
EHR or Health IT Module in the field, an ONC-ACB would need to verify
that the health IT developer has satisfied the mandatory disclosure
requirements currently and proposed a Sec. 170.523(k)(1), as
applicable, for the certification criteria that are the subject of the
ONC-ACB's surveillance.
Randomized Surveillance
Separate from the reactive surveillance described above, we also
propose to require ONC-ACBs to conduct ``randomized'' surveillance of
the Complete EHRs and Health IT Modules they have certified. We believe
randomized surveillance will serve two important purposes: First, it
will enable ONC-ACBs to identify nonconformities that are difficult to
detect through complaint-based or other reactive forms of surveillance.
Second, it will enable ONC-ACBs to detect patterns of non-conformance
that indicate a more widespread or recurring problem requiring a more
comprehensive

[[Page 16879]]

corrective action plan, as discussed below. For these reasons, we
believe that randomized surveillance will complement reactive
surveillance and strengthen the overall surveillance of certified
health IT under the ONC Health IT Certification Program.
Under our proposal, an ONC-ACB would be required to conduct
randomized surveillance of prioritized certification criteria (as
described in the context of reactive surveillance earlier in this
proposal). Focusing on these prioritized certification criteria would
maximize the impact and minimize any associated costs or burdens of
randomized surveillance. For the same reason, ONC-ACBs would be
required to not select certified Complete EHRs and certified Health IT
Modules that were selected for randomized surveillance at any time
within the preceding twelve months. \237\
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\237\ This screening requirement would apply only for the
purpose of randomized surveillance. The ONC-ACB would still be
expected to initiate reactive and other surveillance, including in-
the-field surveillance, as necessary to ensure that the Complete
EHRs and Health IT Modules it has certified continue to perform in
an acceptable manner and meet all certification program
requirements.
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To satisfy the proposed randomized surveillance requirement, an
ONC-ACB would be required during each calendar year to randomly select
at least 10% of the Complete EHRs and Health IT Modules to which it has
issued a certification. For each certified Complete EHR or certified
Health IT Module selected, the ONC-ACB would initiate in-the-field
surveillance at the lesser of 10 or 5% of locations at which the
Complete EHR or Health IT Module is implemented and in use in the
field.
Example: A Health IT Module is in use at 1,000 locations.
Five percent of 1,000 locations equals 50 locations, which is greater
than 10 locations. Therefore, the ONC-ACB must evaluate the Health IT
Module at a minimum of 10 locations.
Example: A Health IT Module is in use at 100 locations.
Five percent of 100 locations equals 5 locations, which is less than 10
locations. Therefore the ONC-ACB must evaluate the Health IT Module at
a minimum of 5 locations.
The locations would need to be selected at random by the ONC-ACB
from a list of all locations at which the certified Complete EHR or
certified Health IT Module is implemented. Where practicable, the
sample would need to reflect a diversity of practice types, sizes,
settings, and locales.
Similar to reactive surveillance, if in the course of randomized
surveillance an ONC-ACB finds that a certified Complete EHR or
certified Health IT Module is non-conformant at one or more locations
at which surveillance takes place, the ONC-ACB must take appropriate
action with the health IT developer, consistent with the ONC-ACB's
accreditation, to remedy the nonconformity.
In addition to addressing individual, potentially one-off,
nonconformities, an ONC-ACB would also be required to evaluate the
overall results of any certified Complete EHR or certified Health IT
Module that is subjected to randomized surveillance. If the ONC-ACB
finds a pattern of nonconformity--defined as a failure to demonstrate
conformance to any prioritized certification criterion at 20% or more
of the locations surveilled--the ONC-ACB would regard these results as
deficient and would need to require the health IT developer to submit a
corrective action plan to address the apparent widespread or recurring
issue. Upon making such determination, an ONC-ACB would be required to
contact the health IT developer and require that it submit a proposed
corrective action plan to the ONC-ACB. The corrective action plan would
be required to include, at a minimum, for each certification criterion
or required disclosure for which the health IT was deemed deficient:
A description of the identified deficiencies;
an assessment of how widespread or isolated the identified
deficiencies may be;
how the developer will address the identified conformance
deficiencies in general and at the locations under which surveillance
occurred; and
the timeframe under which corrective action will be
completed.
The ONC-ACB would require the health IT developer to submit a
proposed corrective action plan to the ONC-ACB within 30 days of the
date that the developer was notified by the ONC-ACB of the deficiency
or deficiencies above. In general, ONC-ACBs would be responsible for
prescribing the required form and content of corrective action plans,
consistent with the general elements required above, and for developing
specific procedures for the submission and approval of corrective
action plans. ONC may also issue guidance to ensure consistency across
ONC-ACBs corrective action procedures.
Consistent with an ONC-ACB's accreditation and procedures for
suspending a certification, an ONC-ACB would be permitted to initiate
certification suspension procedures for a Complete EHR or Health IT
Module if the heath IT developer thereof:
Does not submit a proposed corrective action plan to the
ONC-ACB within 30 days of being notified of its deficient surveillance
results;
does not comply with the ONC-ACB's directions for
addressing any aspects of the proposed corrective action plan that do
not meet the requirements of the ONC-ACB or the ONC Health IT
Certification Program; or
does not complete an approved corrective action plan
within 6 months of approval of the plan by the ONC-ACB.
Following the suspension of a certified Complete EHR or certified
Health IT Module's certification for the reasons above, an ONC-ACB
would be permitted to initiate certification termination procedures for
the Complete EHR or Health IT Module (consistent with its accreditation
to ISO/IEC 17065 and procedures for terminating a certification) should
the developer not complete the actions necessary to reinstate the
suspended certification.
Reporting of Surveillance Results
Under our proposal, ONC-ACBs would be required to report the
results of in-the-field surveillance to the National Coordinator on at
least a quarterly basis. This requirement would reduce the time between
when surveillance is initiated and when results are submitted to ONC.
Currently under the ONC Health IT Certification Program, ONC-ACBs are
not required to submit surveillance results for as long as 14 months
after initiating in-the-field surveillance--a significant limitation in
our ability to be responsive, including providing relevant information
to stakeholders.
Upon requiring a corrective action plan for a certified Complete
EHR or certified Health IT Module, an ONC-ACB would be required to
report the corrective action plan and related data to the publicly
accessible open data CHPL, as detailed below in our proposal ``Open
Data Certified Health IT Product List (CHPL).'' The purpose of this
reporting requirement, as described in that proposal, would be to
ensure that health IT users, implementers, and purchasers are alerted
to potential conformance issues in a timely and effective manner,
consistent with the patient safety, program integrity, and transparency
objectives described subsequently in this proposed rule.
To implement the new requirements for in-the-field surveillance
outlined in this proposal, we propose to add Sec. 170.556 (In-the-
field surveillance and

[[Page 16880]]

maintenance of certification for health IT). We would also amend Sec.
170.503 (ONC-AA Ongoing Responsibilities) and Sec. 170.523 (ONC-ACB
Principles of Proper Conduct) consistent with the requirements
described in this proposal and the related proposals ``Transparency and
Disclosure Requirements'' and ``Open Data Certified Health IT Product
List (CHPL)'' below. The requirements would provide a floor only, and
would in no way limit an ONC-ACB's ability or responsibility to conduct
additional surveillance, including in-the-field surveillance, according
to the requirements of its accreditation and the ONC Health IT
Certification Program. As we have done in the past, we would continue
to give ONC-ACBs substantial flexibility and discretion to decide how
to implement these requirements as part of their overall approach to
surveillance. ONC-ACBs would continue to describe their surveillance
programs in their annual surveillance plans, which must be submitted to
the National Coordinator prior to the covered calendar year
surveillance period. We would also continue to provide annual
surveillance guidance to ONC-ACBs, and other guidance or programmatic
direction as needed.
At the time of this proposed rule, ONC-ACBs have submitted their
annual surveillance plans for calendar year 2015, which include their
existing approaches and methodologies for randomized surveillance. To
minimize disruption to ONC-ACBs' current surveillance activities, we
propose to phase in the requirements proposed at Sec. 170.556(c) for
randomized surveillance. As such, the randomized surveillance
requirements would become effective beginning January 1, 2016, enabling
ONC-ACBs to implement these new requirements in their next annual
surveillance plans and incorporate additional guidance and
clarification from ONC and the ONC-AA. All other new requirements for
in-the-field surveillance--i.e., the requirements proposed at Sec.
170.556(a), (b), and (d)--would be effective immediately; we would
expect ONC-ACBs to implement these requirements within 3 months of the
effective date of a subsequent final rule. We request comment on
whether this timeline and plan for implementation is appropriate and on
ways to minimize disruption and ensure that the requirements and
purpose of this proposal are timely and effectively achieved.
2. Transparency and Disclosure Requirements
We propose to revise the principles of proper conduct for ONC-ACBs
in order to provide for greater and more effective disclosure by health
IT developers of certain types of limitations and additional types of
costs that could interfere with the ability to implement or use health
IT in a manner consistent with its certification. We believe that these
additional disclosure requirements are necessary to ensure that
existing and potential users and implementers of certified health IT
are fully informed about these implementation considerations that
accompany capabilities certified under the ONC Health IT Certification
Program.
In the 2014 Edition final rule, we adopted new ``price
transparency'' requirements that require ONC-ACBs to ensure that health
IT developers include--on their Web sites and in all marketing
materials, communications, and other assertions related to certified
health IT--any ``additional types of costs'' that an EP, eligible
hospital, or CAH would pay to implement certified health IT
capabilities in order to meet meaningful use objectives and measures
(Sec. 170.523(k)(1)(iii)). \238\ We stated that there is value in
requiring ONC-ACBs to ensure that developers are transparent about the
types of costs associated with certified health IT and that such
transparency could provide greater purchasing clarity to EPs, eligible
hospitals, and CAHs (77 FR 54274). In regard to purchasing clarity, we
further stated that this disclosure requirement could help prevent
purchasers from being surprised by additional costs beyond those
associated with the adoption and implementation of capabilities
certified as part of their certified health IT (77 FR 54275). With this
requirement and other transparency requirements under Sec.
170.523(k)(1), we have sought to mitigate potential confusion in the
marketplace and reduce the risk that consumers will encounter
unexpected difficulties in the implementation and use of certified
health IT.
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\238\ 77 FR 54273-75. For example, under our current disclosure
requirements, if health IT is certified to the ``view, download, and
transmit to 3rd party'' certification criterion, and an EP would be
expected to pay an ``ongoing'' monthly service fee to the technology
developer for it to host/administer this capability in order for the
EP to meet the correlated meaningful use objective and measure, the
existence of this potential ``ongoing'' cost (though not the actual
amount or ``dollar value'' of the cost itself) would need to be
disclosed by the health IT developer. As another example, a Health
IT Module certified to the public health electronic lab reporting
certification criterion (Sec. 170.314(f)(4)) would be able to
create a valid HL7 message for electronic submission. However, for
the purposes of achieving meaningful use a hospital may be expected
to pay their technology developer a separate ``one-time'' and/or
``ongoing'' interface development and configuration fee to establish
connectivity between their certified Health IT Module and a public
health authority. In such a situation, the potential costs of the
interface development and configuration fee would need to be
disclosed (though, again, the developer would not be required to
disclose the actual ``dollar amount'' of the fee). A final example
would be where a health IT developer charges a ``one-time'' fee to
integrate its certified health IT with a hospital's other certified
technology or a health information exchange organization. Again,
just like the other examples, the potential for this fee (but not
the ``dollar amount'' itself) would need to be disclosed by the
technology developer. Building off these examples, we said that a
health IT developer could meet the disclosure requirements by
disclosing: 1) the type(s) of additional cost; and 2) to what the
cost is attributed. In reference to the first example above, we
stated that a developer could meet our price transparency
requirement by disclosing that ``an additional ongoing fee may apply
to implement XYZ online patient service.'' In situations where the
same types of cost apply to different services, we stated that
listing each as part of one sentence would be acceptable, such as
``a one-time fee is required to establish interfaces for reporting
to immunization registries, cancer registries, and public health
agencies.''
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Notwithstanding these modest disclosure requirements, many health
IT consumers still have limited access to certain types of information
necessary to accurately assess the potential costs, benefits,
limitations, and trade-offs of alternative technologies and
solutions.\239\ This is especially true for small health care providers
and other individuals and organizations who may not have the time,
resources, or expertise to conduct extensive market research.\240\
Health care and health IT industry participants and observers describe
a marketplace in certified health IT products and services that is
largely opaque and in which consumers often lack up-front information
about the products and services they purchase or license. For example,
the American Medical Association (AMA) has expressed concern on behalf
of its provider members about ``the lack of transparency in EHR
contracts,'' which ``may be unclear or fail to itemize specific
expenses'' associated with certified health IT capabilities.\241\ The

[[Page 16881]]

AMA further noted that while ONC has taken steps to promote greater
contract transparency, these efforts have fallen short, ``leaving broad
discretion and uncertainty'' in the marketplace for certified health IT
products.\242\
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\239\ See, e.g., Jodi G. Daniel & Karson Mahler, Promoting
Competition to Achieve Our Health IT and Health Care Goals (Oct. 7,
2014), http://www.healthit.gov/buzz-blog/health-information-exchange-2/promoting-competition-achieve-healthit-health-care-goals/.
\240\ See, e.g., Kelly Devers, Arnav Shah, and Fredric Blavin,
How Local Context Affects Providers' Adoption and Use of
Interoperable Health Information Technology: Case Study Evidence
from Four Communities in 2012 (Round One) (2014), at 7 (describing
significant challenges faced by smaller providers dealing with
certified EHR vendors, including ``understanding vendor contracts
that were very complex.'')
\241\ FTC Workshop, Submission #00151 on behalf of the American
Medical Association (April 30, 2014), available at http://www.ftc.gov/system/files/documents/public_comments/2014/04/00151-89996.pdf (accessed Dec. 19, 2014).
\242\ Id.
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Other observers have described practices that may interfere with
the performance of certified health IT capabilities in ways that are
not obvious to consumers at the time they purchase or license
technology or services. For example, some health IT contracts may
restrict a health care provider's ability to use data contained within
an EHR \243\ require health care provider staff to complete costly
developer-imposed training and accreditation programs before they are
allowed to extract patient data; or impose ``access and use
agreements'' that restrict a provider's ability to ``engage a third
party to assist with extracting and using data to benefit patients . .
. .'' \244\ Some developers also purportedly charge ``additional fees
to allow providers to extract patient data from their systems, even
though the marginal cost of providing that data is small. \245\ In
addition, as discussed elsewhere in this proposed rule, Congress has
expressed concern that some health IT developers of certified health IT
may be engaging in business practices that block health information
exchange and thereby frustrate congressional intent, devalue taxpayer
investments in health IT, and make health IT less valuable and more
burdensome for eligible hospitals and eligible providers to use.\246\
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\243\ FTC Workshop, Submission #00187 on behalf of the Advisory
Board Company (April 30, 2014), available at http://www.ftc.gov/system/files/documents/public_comments/2014/04/00187-89979.pdf
(accessed Dec. 19, 2014).
\244\ Id.
\245\ FTC Workshop, Submission #00045 on behalf of the Health IT
Now Coalition (March 10, 2014), available at http://www.ftc.gov/system/files/documents/public_comments/2014/03/00045-88879.pdf
(accessed Dec. 19, 2014).
\246\ 160 Cong. Rec. H9047, H9839 (daily ed. Dec. 11, 2014) (see
explanatory statement submitted by Rep. Rogers, chairman of the
House Committee on Appropriations, regarding the Consolidated and
Further Continuing Appropriations Act, 2015).
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We do not assume that examples cited above are typical or
widespread. Yet it must be acknowledged that even ONC has but limited
visibility into developers' business practices and cannot reliably
assess the extent to which such practices are occurring or the degree
to which they may be interfering with the successful implementation and
use of certified health IT. That acknowledgement alone should be a
sufficient indication of the need to require greater transparency in
the marketplace.\247\
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\247\ We recognize that there is value in encouraging developers
to experiment, innovate, and compete to deliver products and
services that consumers demand and also to price and distribute such
products and services in ways that consumers find attractive and
that meet the needs of individual customers. Our proposal to require
greater transparency in developers' business practices is intended
not to limit but to promote such price and non-price innovation and
competition by providing individuals who purchase or license
certified health IT with access to basic information necessary to
make informed decisions in the marketplace.
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The prevailing lack of transparency raises several specific and
serious concerns. Most importantly, health IT developers not disclosing
known material limitations or additional types of costs associated with
the implementation or use of certified health IT creates a substantial
risk that existing or prospective users will encounter problems
implementing the capabilities of the health IT in a manner consistent
with its certification. This in turn diminishes the reliability of
certifications issued under the ONC Health IT Certification Program.
Moreover, inadequate or incomplete information about health IT products
and services distorts the marketplace for certified health IT, for
without reliable information consumers cannot accurately estimate costs
and assess capabilities in order to effectively compare technologies
and choose appropriate solutions for their individual circumstances or
needs.\248\ Poor health IT purchasing decisions increase the likelihood
of downstream implementation challenges and, ultimately, reduced
opportunities to use health IT to improve health and health care.
Finally, consumers who purchase or license inappropriate or suboptimal
technologies may find it difficult to switch to superior alternatives
due to the often significant financial and other resources they have
already invested in implementation, training, integration with other IT
systems, new clinical and administrative processes, and the many other
costs and organizational changes associated with implementing health
IT. When providers become ``locked in'' to technologies or solutions
that do not meet their needs or the needs of their patients, health IT
developers may have fewer incentives to innovate and compete on those
aspects of health IT that these consumers most value.
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\248\ Compare American Academy of Family Physicians,
Understanding EHR Contracting and Pricing, http://www.aafp.org/practice-management/health-it/product/contracting-pricing.html
(accessed Dec 7, 2014) (noting that there are ``many different ways
of pricing EHR software'' and that to ``compare `apples to apples'''
potential purchasers need to consider many variables when selecting
an EHR) with FTC Workshop, Submission #00151 on behalf of the
American Medical Association (April 30, 2014) (expressing concern
about ``lack of transparency in EHR vendor contracts'' and ``broad
discretion and uncertainty'' despite ONC efforts to promote greater
transparency).
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For all of these reasons, we propose to revise the principles of
proper conduct for ONC-ACBs in order to supplement and strengthen our
existing transparency and disclosure requirements under the ONC Health
IT Certification Program. As currently set forth in Sec. 170.523(k),
ONC-ACBs must require health IT developers to disclose conspicuously on
their Web sites and in all marketing materials, communications
statements, and other assertions related to certified health IT any
additional types of costs \249\ that an EP, eligible hospital, or CAH
would pay to implement certified health IT to meet meaningful use
objectives and measures. We propose to carry forward and expand these
requirements as follows.
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\249\ Costs vary widely across different developers, products,
and services. They may include but are not limited to the cost of
purchasing or licensing necessary equipment and software;
installing, configuring, maintaining, and updating technology;
training staff and integrating technology into clinical workflows;
securing and backing up data; licensing information or services used
in conjunction with technology; and establishing interfaces or
connectivity to other IT systems. Costs may also be incurred on a
``one time'' or on a ``recurring'' or ``ongoing'' basis.
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First, we would no longer limit health IT developers' disclosure
obligations to the scope of the EHR Incentive Programs. In the context
of our proposals in this proposed rule to make the ONC Health IT
Certification Program open and accessible to more types of health IT
and to health IT that support various care and practice settings beyond
the EHR Incentive Programs, we believe that disclosure requirements
should go beyond a link to the EHR Incentive Programs. Consumers are
increasingly seeking to leverage certified health IT for a wide range
of uses beyond the EHR Incentive Programs, such as to support care
coordination with other types of health care providers as part of new
quality improvement initiatives and public and private sector value-
based payment programs. These consumers of certified health IT need
reliable information associated with implementing and using health IT
for all of these uses, not just those that are tied to a meaningful use
objective or measure. Likewise, as the ONC Health IT Certification
Program begins to focus on supporting these new users and uses, it will
be important to ensure that certification is meaningful and that
surveillance is effective for all certified health IT and capabilities,
not just those

[[Page 16882]]

that that are directly tied to the EHR Incentive Programs. For these
reasons, we would require ONC-ACBs to ensure that developers disclose
any ``additional types of costs'' that a user may incur in order to
implement or use capabilities of certified health IT, whether to
demonstrate meaningful use objectives or measures or for any other
purpose within the scope of the health IT's certification.
Second, the important reasons we have described above for requiring
greater transparency and disclosure convince us that we must move
beyond our current focus on identifying additional types of costs and
consider other factors that may similarly interfere with a user's
ability to successfully implement certified health IT. In particular,
the failure to disclose material information about limitations
associated with certified health IT creates a substantial risk that
current or prospective users will encounter problems implementing
certified health IT in a manner consistent with its certification. From
the perspective of both ONC and the consumer, therefore, the disclosure
of this information is no less important than the disclosure of
information about additional types of costs. Accordingly, we propose to
add this additional category of information to those which a health IT
developer must disclose.
Third, to ensure that these disclosure requirements serve their
intended purpose, we propose that developers' disclosures be broader
and provide greater detail than is currently required. In contrast with
our current price transparency requirement, which requires disclosure
only of additional types of costs that a user ``would pay'' to
implement certain capabilities, our proposal would require health IT
developers to be more proactive in identifying the kinds of limitations
and additional types of costs that a user may pay or encounter in order
to achieve any use within the scope of a Complete EHR or Health IT
Module's certification. For example, we expect that health IT
developers would disclose any additional types of costs or limitations
that may be based on potential conditions applicable to the user or
options available to the user. This would be different than the current
``would pay'' requirement that focuses on more definitive
circumstances. We believe that it is reasonable to require health IT
developers to identify this information because they are uniquely
familiar with the costs and limitations of their own products and
services and possess sophisticated technical knowledge related to the
implementation and use of health IT in a variety of settings in which
their products are services are deployed.
Health IT developers would therefore be required to provide, in
plain language, a detailed description of any material information
about limitations that a purchaser may encounter and additional types
of costs that a user may be required to pay in the course of
implementing or using capabilities to achieve any use within the scope
of the its certification. Such information would be ``material'' (and
its disclosure therefore required) if the failure to disclose it could
substantially interfere with the ability of a user or prospective user
to implement certified health IT in a manner consistent with its
certification.
To illustrate our expectations as to the types of information that
health IT developers would be required to disclose, we provide the
following list of types of limitations and additional types of costs
that would always be ``material'' and required to be disclosed. We seek
comment on whether we should revise or add to the types of information
delineated below, including whether we should require the disclosure of
more specific cost structures (e.g., the cost structure of a health IT
developer's for sending transitions of care summaries, including all
relevant factors--e.g., volume transmissions, geography, interfaces,
and exchange partner technology).
Additional types of costs or fees (whether fixed,
recurring, transaction-based, or otherwise) imposed by a developer (or
any third-party from whom the developer purchases, licenses, or obtains
any technology, products, or services in connection with its certified
health IT) to purchase, license, implement, maintain, upgrade, use, or
otherwise enable and support the use of capabilities to which health IT
is certified; or in connection with any data generated in the course of
using any capability to which health IT is certified.
Limitations, whether by contract or otherwise, on the use
of any capability to which technology is certified for any purpose
within the scope of the technology's certification; or in connection
with any data generated in the course of using any capability to which
health IT is certified.
Limitations, including but not limited to technical or
practical limitations of technology or its capabilities, that could
prevent or impair the successful implementation, configuration,
customization, maintenance, support, or use of any capabilities to
which technology is certified; or that could prevent or limit the use,
exchange, or portability of any data generated in the course of using
any capability to which technology is certified.
Because this proposal would significantly expand a health IT
developer's existing disclosure obligations, we further clarify our
expectations regarding what a health IT developer would and would not
be required to disclose. A health IT developer would not be required to
disclose specific prices or price information. The health IT developer
would be required, however, to describe with particularity the nature
and magnitude of any additional types of costs, providing sufficient
detail from which a person could arrive at a reasonably accurate
estimation of what the likely costs might be, given the person's
circumstances and intended use of the capabilities within the certified
health IT. For example, if a health IT developer charged a fee every
time a user wished to send a transition of care summary record to
another user of certified health IT, the health IT developer would be
required to fully disclose not only the existence of the fee but the
circumstances in which it would apply. The health IT developer would
also be required to provide additional information to assist the user
in realistically estimating what the cost would be to use the
transitions of care capability. The health IT developer could satisfy
this requirement by providing data illustrating that there are levels
of costs for different types of users (e.g., users who send a ``low,''
``medium,'' or ``high'' number of summary of care records per month).
Alternatively, the health IT developer could indicate that for most
(e.g., nine out of every ten) of its users, transaction fees represent
less than 1% of a user's total monthly service costs. Other methods of
disclosure would also suffice, provided they were similarly calculated
and likely to inform.
Health IT developers would not be required to disclose trade
secrets or intellectual property. Similar to the disclosure of
information about additional types of costs, health IT developers could
describe other types of limitations in terms that protect their
intellectual property interests and trade secrets. Generalized
assertions of ``proprietary information'' would not immunize a
developer, however, from a finding by an ONC-ACB that the developer
failed to disclose known material information.
Health IT developers would not be required to disclose information
of which they are not and could not

[[Page 16883]]

reasonably be aware. In particular, we recognize that health IT
functions in combination with many third party technologies and
services whose specific costs/limitations may be difficult for a health
IT developer to precisely predict or ascertain. Local implementation
factors and other individual circumstances also vary substantially
among customers and impact the cost and complexity of implementing
certified health IT. In addition, the costs of upgrading health IT to
meet new regulatory requirements or compliance timelines, which are
subject to change, may make some particular types of additional costs
especially difficult to forecast. While we do not expect health IT
developers to account for every conceivable cost or implementation
hurdle that a customer may encounter in order to successfully implement
and use the capabilities of a developer's certified health IT, we
believe it reasonable to assume that health IT developers are experts
in their own products and services and possess sophisticated technical
knowledge related to the implementation and use of health IT in a
variety of settings in which their products are used. Through their
accumulated experience developing and providing health IT solutions to
their customers, health IT developers should over time become familiar
with the types of costs and limitations that most users encounter, and
should be able to describe these in sufficient detail so as to provide
potential customers with the information they need to make informed
purchasing and implementation decisions. We also believe that it is
reasonable to expect that a health IT developer would provide a
detailed description of any additional considerations that a customer
should be aware of in order to reliably estimate the resources needed
to purchase the certified health IT and arrive at a realistic
expectation of the product's capabilities and performance in the field,
to the extent that the health IT developer has knowledge of the
customer's circumstances and based on its range of experience
(including with other customers).
We propose one additional aspect that we believe will complement
the mandatory disclosure requirements set forth in this proposal. In
addition to requiring health IT developers to disclose known material
information about their certified health IT, an ONC-ACB would be
required to obtain a voluntary public attestation from every health IT
developer to which it issues or has at any previous time issued a
certification for any edition of certified health IT. The attestation
would take the form of a written ``pledge'' by the health IT developer
to be transparent with regard to the information it is required to
disclose under the ONC Health IT Certification Program. Specifically,
the health IT developer would be required to attest that, in addition
to disclosing such information via its public Web site, marketing
materials, communications statements, and other assertions related to
certified health IT, it will voluntarily provide this information to:
(1) Customers, prior to providing any certified health IT or related
product or service (including subsequent updates, add-ons, or
additional products or services to be provided during the course of an
on-going contract); (2) prospective customers (i.e., persons who
request or receive a quotation, estimate, or other similar marketing or
promotional material); and (3) other persons who request such
information.
To be clear, this attestation would not broaden or change the types
of information that a health IT developer would be required to disclose
as a condition of certification, nor the persons to whom such
information would have to be disclosed. While all health IT developers
would be required to make the attestation, their adherence to it would
be strictly voluntary, and an ONC-ACB would continue to hold health IT
developers only to the mandatory disclosure requirements already
described above in this proposal and proposed at Sec. 170.523(k)(1).
Although the attestation would not establish any new regulatory
disclosure obligations for health IT developers, it would create a
powerful incentive for health IT developers to go beyond what is
strictly required of them by regulation and to be more transparent
about their health IT products, services, and business practices. The
attestation would accomplish this goal by publicly committing health IT
developers to make a good faith effort to ensure that consumers
actually receive the information that developers are required to
disclose at such times and in such a manner as is likely to be useful
in informing their health IT purchasing or licensing, implementation,
and other decisions.
In particular, health IT developers would be required to attest
publicly that they will provide information about their certified
health IT to any person who requests it. This would empower not only
existing or prospective customers but all consumers and their
representatives (e.g., providers' professional associations) to
approach developers directly and request information that is most
relevant to consumers' health IT purchasing or licensing, and
implementation decisions. We believe that as a result consumers will
come to expect greater transparency from health IT developers in
general, and that developers, having publicly attested that they will
provide this information, will have a stronger interest in doing so in
order to protect their reputations. Moreover, health IT developers who
are the most transparent and provide the most meaningful information
about their products and services will be able to differentiate
themselves from their competitors, creating additional incentives for
other developers to be more transparent.
Attestation will, by encouraging greater interaction between health
IT developers and all consumers, provide important feedback to
developers about the types of information that consumers find
important, and which are therefore likely to be material for purposes
of health IT developers' mandatory disclosure obligations under the ONC
Health IT Certification Program. For example, requests for information
and other feedback from consumers may alert a health IT developer to
the fact that it has failed to disclose (or to disclose with sufficient
specificity) material information about a particular limitation or
additional type of cost associated with its certified health IT. By
encouraging consumers to make such inquiries, the proposed attestation
requirement will assist health IT developers in meeting their
disclosure obligations.
Overall, we believe these proposed requirements will enable more
transparency in the marketplace for certified health IT, provide
consumers with greater and more ready access to information relevant to
their health IT planning, purchasing, and implementation decisions, and
reduce the risk of implementation problems and surprise described in
this proposal.
3. Open Data Certified Health IT Product List (CHPL)
In the initial rulemaking that we used to establish the Temporary
Certification Program, we indicated that the National Coordinator
intended to make a master CHPL of all Complete EHRs and EHR Modules
tested and certified by ONC-ATCBs available on the ONC Web site and
that the CHPL would be a public service and would be a single,
aggregate source of all the certified product information ONC-ATCBs
provide to the National Coordinator (75 FR 36170). Since 2010, we have
maintained the CHPL and as the ONC Health IT Certification Program has
matured,

[[Page 16884]]

ONC-ACBs have continued to report the products and information about
the products they have certified to ONC for listing on the CHPL.
As part of the 2014 Edition final rule (77 FR 54271), we required
additional transparency in the ONC Health IT Certification Program in
the form of a hyperlink that ONC-ACBs needed to maintain that would
enable the public to access the test results that the ONC-ACB used as
the basis for issuing a certification. In the time post-final rule, the
NVLAP Accredited Testing Laboratories (ATLs) and ONC-ACBs worked
together to develop a standard test results summary template for
consistent data presentation and use throughout the ONC Health IT
Certification Program. For all 2014 Edition products certified under
the ONC Health IT Certification Program, the test result summary is
accessible and can be found as part of the product's detailed
information page on the CHPL Web page.
The test result summary includes granular detail from ATLs about
the testing performed, including, among other information: The
certification criteria tested; the test procedure, test data, and test
tool versions used during testing for each certification criterion;
instances where optional portions of certification criteria were
tested; and which standard was used for testing when a certification
criterion allowed for more than one standard to be used to meet the
certification criterion. The test result summary also includes the
user-centered design information and summative tests results applicable
to a product in cases where it was required to meet the ``safety-
enhanced design'' certification criterion (Sec. 170.314(g)(3)) in
order to ultimately be certified.
Multiple stakeholders have commented to us that while the
availability of the test report summary and the addition detail it
contains is beneficial, its location on the CHPL and its overall
accessibility as a PDF makes it difficult to use for any kind of
product analysis. In response to this feedback and our overall vision
to efficiently administer the CHPL in the future, we intend to convert
the CHPL in its current form to an open data file represented in both
XML and JSON and with accompanying API functionality. We estimate that
this conversion along with the future additional data collection we
have proposed for 2015 Edition certifications will occur over the next
12 to 18 months.
To complement this conversion, we propose to require ONC-ACBs to
report an expanded set of information to ONC for inclusion in the open
data file that would make up the CHPL. Specifically, we propose to
revise Sec. 170.523(f) to move the current (f) to (f)(2) and to create
a new paragraph (f)(1) that would require ONC-ACBs upon issuing a 2015
Edition (or any subsequent edition certification) to report on the same
data elements they report to ONC under Sec. 170.523(f), the
information contained in the publicly available test report, and
additional data. The data that would be required is as follows:
The Health IT Module developer name; product name; product
version; developer Web site, physical address, email, phone number, and
contact name;
The ONC-ACB Web site, physical address, email, phone
number, and contact name, contact function/title;
The ATL Web site, physical address, email, phone number,
and contact name, contact function/title;
Location and means by which the testing was conducted
(e.g., remotely with developer at its headquarters location);
The date(s) the Health IT Module was tested;
The date the Health IT Module was certified;
The unique certification number or other specific product
identification;
The certification criterion or criteria to which the
Health IT Module has been certified, including the test procedure and
test data versions used, test tool version used, and whether any test
data was altered (i.e., a yes/no) and for what purpose;
The way in which each required privacy and security
criterion was addressed for the purposes of certification (note: this
is proposed to track the privacy and security certification proposal
for Health IT Modules);
The standard or mapping used to meet the quality
management system certification criterion;
The standard(s) or lack thereof used to meet the
accessibility-centered design certification criterion;
Where applicable, the hyperlink to access an API's
documentation and terms of use;
Where applicable, which certification criteria were gap
certified;
Where applicable, if a certification issued was a result
of an inherited certified status request;
Where applicable, the clinical quality measures to which
the Health IT Module has been certified;
Where applicable, any additional software a Health IT
Module relied upon to demonstrate its compliance with a certification
criterion or criteria adopted by the Secretary;
Where applicable, the standard(s) used to meet a
certification criterion where more than one is permitted;
Where applicable, any optional capabilities within a
certification criterion to which the Health IT Module was tested and
certified;
Where applicable, and for each applicable certification
criterion, all of the information required to be submitted by Health IT
Module developers to meet the safety-enhanced design certification
criterion (note: This would include each user-centered design element
required to be reported at a granular level (e.g., task success/
failure)); and
Where applicable, for each instance in which a Health IT
Module failed to conform to its certification and for which a
corrective action plan was instituted under Sec. 170.556:
[cir] The specific certification criterion or certification program
requirement (e.g., required disclosure) to which the health IT failed
to conform as determined by the ONC-ACB;
[cir] the dates surveillance was initiated and when available,
completed;
[cir] the results of the surveillance (pass rate for each
criterion);
[cir] the number of sites that were used in surveillance;
[cir] the date corrective action began;
[cir] when available, the date corrective action ended;
[cir] a summary of the deficiency or deficiencies identified by the
ONC-ACB as the basis for its determination of non-conformance; and
[cir] when available, the developer's explanation of the deficiency
or deficiencies identified by the ONC-ACB as the basis for its
determination of non-conformance.
Consistent with ONC-ACBs' current reporting practice required by
Sec. 170.523(f), ONC-ACBs would be required to submit the additional
data listed above no less frequently than weekly. Because this expanded
list of data would largely subsume the data included in the test
results summary, we would no longer require for 2015 Edition and
subsequent edition certifications that ONC-ACBs provide a publicly
accessible hyperlink to the test results used to certify a Health IT
Module.
The last category of data above would be reportable for Complete
EHRs and Health IT Modules that have been designated for corrective
action as described in our proposal ```In-the-field' Surveillance and
Maintenance of Certification'' above. Under that proposal, an ONC-ACB
would be required to initiate a corrective action plan for a Complete
EHR or Health IT

[[Page 16885]]

Module when randomized in-the-field surveillance reveals a pattern of
non-conformance to any prioritized certification criterion. Under this
Open Data CHPL proposal, the initiation of corrective action would
trigger the duty to report the surveillance-related information
specified in the last category above for inclusion in the open data
file. This reporting requirement would be separate from and in addition
to the ``rolling'' (i.e., at least quarterly) reporting of all
surveillance results described in our in-the-field surveillance
proposal referenced above. The purpose of this separate reporting
requirement would be to ensure that health IT users, implementers, and
purchasers are alerted to potential conformance issues in a timely and
effective manner, consistent with the patient safety, program
integrity, and transparency objectives described in this proposed rule.
By incorporating data on health IT that has failed surveillance in the
open data file, such information would be updated and available to the
public at least weekly. Combined with the API functionality described
above, such data could also be used more effectively by patient safety,
consumer, and other organizations to analyze and disseminate
information about product safety and performance.
Our rationale with respect to the reporting of data for health IT
that has failed surveillance applies to all, and not only 2015 Edition,
certified health IT. Accordingly, we propose to revise new Sec.
170.523(f)(2) (formerly Sec. 170.523(f)) so as to also require the
reporting of this surveillance-related data for health IT certified to
the 2014 Edition.
In submitting this data related to surveillance of certified health
IT, ONC-ACBs would be required to exclude any information that would
identify any user or location that participated in or was subject to
surveillance (as currently required for ONC-ACBs' annual surveillance
results reported to the ONC).
None of the reporting requirements above would require (or
authorize) an ONC-ACB to submit or disclose health IT developer's
proprietary business information or trade secrets. ONC-ACBs would be
required to implement appropriate safeguards to ensure that any
proprietary business information or trade secrets of the health IT
developer the ONC-ACB might encounter during the course of its
surveillance activities would be kept confidential by the ONC-ACB and
protected from disclosure. With respect to the safety-enhanced-design
data, as stated in our proposal for the 2015 Edition ``safety-enhanced
design'' certification criterion (section III.A.3 of this preamble), we
do not expect health IT developers to include proprietary information
in the submission of summative usability test results to ONC-ACBs.
Accordingly, ONC-ACBs would not be required and should take care not to
submit proprietary information to ONC for inclusion in the open data
file. Similarly, with respect to the reporting of surveillance
information for health IT for which corrective action has been
initiated, an ONC-ACB would be able to meet the requirement to report a
summary of the deficiencies leading to its determination that health IT
no longer conforms to the requirements of its certification without
disclosing information that the ONC-ACB believes could be proprietary
or expose it to liability. Should we adopt this proposal, we would
provide additional guidance to ONC-ACBs regarding the particular format
of the data required to be submitted to the open data file.
While we recognize that this additional data places a new reporting
burden on ONC-ACBs, we believe that the benefit to the public of having
all of this data about product certification in granular detail far
outweighs the administrative burden it will take to report this
information. Further, depending on the certification scope sought some
of this data will not need to be collected by ONC-ACBs or will be in
hand for subsequent issued certifications. We seek public comment on
whether we have omitted any additional data generated during the
testing and certification process or the surveillance process that
would be useful to the public.
Consistent with these proposals, we also propose to make a
conforming modification to 45 CFR 170.523(k)(1)(ii) which currently
cross references Sec. 170.523(f) to cross reference proposed paragraph
(f)(2) for 2014 Edition certifications and an equivalent set of data
(minus the test results summary) in paragraph (f)(1) for 2015 Edition
and subsequent certifications.
4. Records Retention
We propose to change the records retention requirement in Sec.
170.523(g) in two ways. We propose to require that ONC-ACBs retain all
records related to the certification of Complete EHRs and/or Health IT
Module(s) (including EHR Modules) for a minimum of six years instead of
five years as currently required. This proposed revision would make
certification records available longer, which may be necessary for HHS
programs' purposes, such as evaluations our audits. To illustrate,
certification to the 2014 Edition began in early 2013 and CMS proposes
in the EHR Incentive Programs Stage 3 proposed rule, published
elsewhere in this issue of the Federal Register, to permit the use of
health IT certified to the 2014 Edition through 2017. With attestation
taking place in 2018, records may need to be available for a minimum of
six years. In addition, a six-year records retention requirement aligns
with current accreditation standards within the industry. We also
propose that records of certifications performed under the ONC Health
IT Certification Program must be available to HHS upon request during
the six-year period that a record is retained. We believe this would
help clarify the availability of certification records for agencies
(e.g., CMS) and authorities (e.g., the Office of Inspector General)
within HHS.
5. Complaints Reporting
We propose that ONC-ACBs provide ONC (the National Coordinator)
with a list of complaints received on a quarterly basis. We propose
that ONC-ACBs indicate in their submission how many complaints were
received, the nature or substance of the complaint, and the type of
complainant (e.g., type of provider, health IT developer, etc.). We
believe this information will provide further insight into potential
concerns with certified health IT or the ONC Health IT Certification
Program and give ONC a better ability to identify trends or issues that
may require action including notification of the public. We propose to
include this new requirement in Sec. 170.523(n).
6. Adaptations and Updates of Certified Health IT
We propose a new principle of proper conduct (PoPC) that would
serve to benefit ONC-ACBs as well as all stakeholders interested in the
ONC Health IT Certification Program and the health IT certified under
the program. We propose to require that ONC-ACBs obtain monthly reports
from health IT developers regarding their certified health IT.
Specifically, we propose to require that ONC-ACBs obtain a record of
all adaptations and updates, including changes to user-facing aspects,
made to certified health IT (i.e., Complete EHRs and certified Health
IT Modules), on a monthly basis each calendar year. We request comment
on whether we should require even more frequent reporting.
This new PoPC would apply for all certified Complete EHRs and
certified Health IT Modules (which includes ``EHR Modules'') to the
2014 Edition and all certified Health IT Modules to

[[Page 16886]]

the 2015 Edition. The PoPC would become effective with a subsequent
final rule and we would expect ONC-ACBs to begin complying with the
PoPC at the beginning of the first full calendar month that is at least
30 days after the effective date of the final rule. For example, if a
final rule became effective on September 6, 2015, then the first full
calendar month would be November 2015. In this instance and others,
there may be no record to obtain from some health IT developers because
their Complete EHRs and Health IT Modules may have been recently
certified and they may not have yet created any adaptations or made any
updates. We would, however, expect that a health IT developer would
still provide a ``record'' indicating that no adaptations had been
created and that no updates had occurred to its ONC-ACB for its
certified health IT.
We would not expect the information in these records to be reported
to ONC and listed on the CHPL. Rather, in weighing the need for ONC-
ACBs to properly manage the certifications they issue versus the
additional burden a regulatory scheme of ``check-ins'' and potential
re-testing/certification for every adaptation and update, we determined
that the best course of action would be to provide awareness to ONC-
ACBs on adaptations and updates made to technologies they certified. By
doing so, we believe ONC-ACBs would be able to make informed decisions
when conducting surveillance of certified Complete EHRs and certified
Health IT Modules. For example, if an ONC-ACB became aware that a
certified Health IT Module had been updated 10 or more times in a month
(which could be common with cloud-based products), resulted in 6
adaptations over three months, or had its user-facing aspects altered
in an apparent significant way, then an ONC-ACB may want to conduct
surveillance on that certified Health IT Module. Overall, we believe
our proposed approach protects the integrity of certified health IT and
promotes safety and security of certified health IT in a way that seeks
to minimizes burden for health IT developers.

E. ``Decertification'' of Health IT--Request for Comment

In the explanatory statement \250\ accompanying Public Law 113-235
(Consolidated and Further Continuing Appropriations Act, 2015) the
Congress urged ONC to use its certification program to ensure certified
electronic health record technology (CEHRT) provides value to eligible
hospitals, eligible providers and taxpayers. It also stated that ONC
should use its authority to certify only those products that clearly
meet current meaningful use program standards and that do not block
health information exchange. Further, it stated that ONC should take
steps to ``decertify'' products that proactively block the sharing of
information.
---------------------------------------------------------------------------

\250\ 160 Cong. Rec. H9047, H9839 (daily ed. Dec. 11, 2014)
(explanatory statement submitted by Rep. Rogers, chairman of the
House Committee on Appropriations, regarding the Consolidated and
Further Continuing Appropriations Act, 2015); and https://www.congress.gov/congressional-record/2014/12/11/house-section/article/H9307-1.
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This proposed rule takes certain steps to support the certification
of health IT that meets relevant program standards and permits the
unrestricted use of certified capabilities that facilitate health
information exchange (see the ``In-The-Field Surveillance and
Maintenance of Certification'' and ``Transparency and Disclosure
Requirements'' proposals in section IV.D of this preamble). We believe,
however, that additional rulemaking would be necessary to implement any
approach that would include ONC appropriating an ONC-ACB's delegated
authority to issue and terminate a certification, including
establishing new program requirements and processes by which ONC or an
ONC-ACB would have the grounds to terminate an issued certification.
Any such rulemaking would need to, at a minimum, address the
circumstances, due process, and remedies for the termination of an
issued certification. Given that Congress also requested the HITPC to
consider and submit a report to them on the challenges and barriers to
interoperability within the year,\251\ we believe it is premature to
include such proposals in this rulemaking. We do, however, solicit
public comment on the circumstances, due process, remedies, and other
factors that we should consider regarding the termination of a
certification. In preparing comments in response to this solicitation,
we ask commenters to keep in mind all parties involved, including ONC-
ACBs, health IT developers, and consumers (including those providers
that participate in the EHR Incentives Programs). Additionally, to help
inform commenters, the following provides a brief background of the ONC
Health IT Certification Program and examples of the complexities and
potential impacts associated with terminating a certification.
---------------------------------------------------------------------------

\251\ https://www.congress.gov/congressional-record/2014/12/11/house-section/article/H9307-1.
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Section 3001(c)(5) of the Public Health Service Act (PHSA) provides
the National Coordinator with the authority to establish a
certification program or programs for the voluntary certification of
health information technology.\252\ Specifically, this section requires
the National Coordinator, in consultation with the Director of the
National Institute of Standards and Technology (NIST), to keep or
recognize a program or programs for the voluntary certification of
health information technology as being in compliance with applicable
certification criteria \253\ (i.e., certification criteria adopted by
the Secretary under section 3004 of the PHSA). Section 3001(c)(5) also
requires that any such certification program(s) must include, as
appropriate, testing in accordance with section 13201(b) of the HITECH
Act, which requires that with respect to the development of standards
and implementation specifications, the Director of NIST support the
establishment of a conformance testing infrastructure, including the
development of technical test beds.
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\252\ ``health information technology'' is defined in Section
3000(5) to mean ``hardware, software, integrated technologies or
related licenses, intellectual property, upgrades, or packaged
solutions sold as services that are designed for or support the use
by health care entities or patients for the electronic creation,
maintenance, access, or exchange of health information''.
\253\ ``certification criteria'' is defined in Section
3001(c)(5)(B) to mean ``with respect to standards and implementation
specifications for health information technology, criteria to
establish that the technology meets such standards and
implementation specifications.''
---------------------------------------------------------------------------

In developing the ONC Health IT Certification Program, ONC
consulted with NIST and created the program structure based on industry
best practice. This structure includes the use of two separate
accreditation bodies: (1) An accreditor that evaluates the competency
of a health IT testing laboratory to operate a testing program in
accordance with international standards; and (2) an accreditor that
evaluates the competency of a health IT certification body to operate a
certification program in accordance with international standards. After
a certification body is accredited, it may apply to the National
Coordinator to receive authorization to certify health IT on ONC's
behalf. Once authorized, we refer to these certification bodies as ONC-
Authorized Certification Bodies or ONC-ACBs. The ONC Health IT
Certification Program includes a full process by which ONC oversees the
operations of ONC-ACBs. It also includes a process for the issuance of
certain types of violations as well as a process to revoke an ONC-ACBs
authorization to certify health IT on ONC's behalf.\254\
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\254\ See the Permanent Certification Program final rule (76 FR
1262); subpart E, part 170 of title 45; and http://www.healthit.gov/policy-researchers-implementers/about-onc-hit-certification-program.

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[[Page 16887]]

With respect to ONC-ACBs and the international standard (ISO Guide
65/ISO 17065) to which they are accredited, they are uniquely
positioned and accountable for determining whether a certified product
continues to conform to the certification requirements to which the
product was certified. If an ONC-ACB can substantiate a non-conformity,
either as a result of surveillance or otherwise, the international
standard requires that the ONC-ACB consider and decide upon the
appropriate action, which could include: (1) The continuation of the
certification under specified conditions (e.g. increased surveillance);
(2) a reduction in the scope of certification to remove nonconforming
product variants; (3) suspension of the certification pending remedial
action by the developer; or (4) withdrawal/termination of the
certification.\255\
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\255\ ISO 17065 (Sec. 170.599(b)(3)). See also Sec. 170.599(a)
for general availability of this standard.
---------------------------------------------------------------------------

With respect to ONC's role and ability to revoke or terminate an
issued certification, ONC's regulations do not address this point
directly and have largely deferred, with one exception, to the ONC-ACBs
autonomy and delegated authority to effectively administer its
certification business. The one exception involves the scenario where
ONC revokes an ONC-ACB's authorization due to a ``type-1'' program
violation that calls into question the legitimacy of the issued
certification (see 45 CFR 170.570). In such an instance, we established
a process by which the National Coordinator would review and determine
whether an ONC-ACB's misconduct justifies revoking the certification
issued to one or more products (76 FR 1297-99).
In general, we believe that it's important for commenters to
account for the potentially profound asymmetric impacts revoking a
certification could create, especially if based on the business
practices (by a health IT developers or their customers) associated
with the health IT's use and not necessarily the health IT's
performance according to certification requirements. These asymmetric
impacts are present in any paradigm in which a certified product is
required for compliance with a program (e.g., the use of certified
health IT under the Medicare and Medicaid EHR Incentive Programs and
Electronic Prescribing of Controlled Substances). To illustrate, the
impact of revoking a certification based on a health IT developer's
business practice(s) may create a lopsided (and arguably unfair/
inequitable) impact to all those who rely on the certification in order
to comply with the legal requirement(s) of a program they are
participating in. Additionally, if such a health IT developer's
business practice(s) were not universally applied to all customers, the
outright removal of a certification could unfairly penalize the health
IT developer's other customers who were unaffected by the business
practice. Similarly, if the practices of a group of a health IT
developer's customers were found to be impeding information exchange,
outright revoking the product's certification (for how it was requested
to be implemented or configured) could in this case unfairly penalize
the health IT developer as well as other ``good actor'' customers and
information exchange partners of the developer. We also note that there
could be contractual and other legal agreements affected by any action
that terminates a certification.
All of the above potential circumstances are meant to highlight for
commenters the significant analysis, complexity, and need for root
cause determinations that would be necessary to develop and implement a
regulatory scheme supporting an equitable certification termination
process led or directed by ONC under the ONC Health IT Certification
Program. To support justification of such a process based on the
blocking of health information exchange, we further solicit comment on
examples of health IT certified under the ONC Health IT Certification
Program that may have been used in the past, or currently, to
proactively block the sharing of health information.

V. Response to Comments

Because of the large number of public comments normally received in
response to Federal Register documents, we are not able to acknowledge
or respond to them individually. We will consider all comments we
receive by the date and time specified in the DATES section of this
preamble, and, when we proceed with a subsequent document, we will
respond to the comments in the preamble of that document.

VI. Incorporation by Reference

The Office of the Federal Register has established new requirements
for materials (e.g., standards and implementation specifications) that
agencies propose to incorporate by reference in the Federal Register
(79 FR 66267; 1 CFR 51.5(a)). Specifically, Sec. 51.5(a) requires
agencies to discuss, in the preamble of a proposed rule, the ways that
the materials it proposes to incorporate by reference are reasonably
available to interested parties or how it worked to make those
materials reasonably available to interested parties; and summarize, in
the preamble of the proposed rule, the material it proposes to
incorporate by reference.
To make the materials we intend to incorporate by reference
reasonably available, we provide a uniform resource locator (URL) for
the standards and implementation specifications. In many cases, these
standards and implementation specifications are directly accessible
through the URL provided. In instances where they are not directly
available, we note the steps and requirements necessary to gain access
to the standard or implementation specification. In most of these
instances, access to the standard or implementation specification can
be gained through no-cost (monetary) participation, subscription, or
membership with the applicable standards developing organization (SDO)
or custodial organization. In a few instances, where noted, access
requires a fee or paid membership.
The National Technology Transfer and Advancement Act (NTTAA) of
1995 (15 U.S.C. 3701 et seq.) and the Office of Management and Budget
(OMB) Circular A-119 \256\ require the use of, wherever practical,
technical standards that are developed or adopted by voluntary
consensus standards bodies to carry out policy objectives or
activities, with certain exceptions. The NTTAA and OMB Circular A-119
provide exceptions to selecting only standards developed or adopted by
voluntary consensus standards bodies, namely when doing so would be
inconsistent with applicable law or otherwise impractical. As discussed
in section III of this preamble, we have followed the NTTAA and OMB
Circular A-119 in proposing standards and implementation specifications
for adoption, including describing any exceptions in the proposed
adoption of standards and implementation specifications. Over the years
of adopting standards and implementation specifications for
certification, we have worked with SDOs, such as HL7, to make the
standards we propose to adopt, and subsequently adopt and incorporate
by reference in the Federal Register, available to interested
stakeholders. As described above, this includes making the standards
and implementation specifications available

[[Page 16888]]

through no-cost memberships and no-cost subscriptions.
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\256\ http://www.whitehouse.gov/omb/circulars_a119.
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As required by Sec. 51.5(a), we provide summaries of the standards
and implementation specifications we propose to adopt and subsequently
incorporate by reference in the Federal Register. We also provide
relevant information about these standards and implementation
specifications throughout section III of the preamble. In particular,
in relevant instances, we identify differences between currently
adopted versions of standards and implementation specifications and
proposed versions of standards and implementation specifications.
We have organized the following standards and implementation
specifications that we propose to adopt through this rulemaking
according to the sections of the Code of Federal Regulation (CFR) in
which they would be codified and cross-referenced for associated
certification criteria that we propose to adopt in 45 CFR 170.315. We
note, in certain instances, we request comment in this proposed rule on
multiple standards or implementation specifications that we are
considering for adoption and incorporation by reference for a
particular use case. We include all of these standards and
implementation specifications in this section of the preamble.

Transport and Other Protocol Standards--45 CFR 170.202

ONC Implementation Guide for Delivery Notification in
Direct.
URL: http://wiki.directproject.org/file/view/Implementation+Guide+for+Delivery+Notification+in+Direct+v1.0.pdf. This
is a direct link.
Summary: This document provides implementation guidance enabling
Security/Trust Agents (STAs) to provide a high level of assurance that
a message has arrived at its destination. It also outlines the various
exception flows that result in a compromised message delivery and the
mitigation actions that should be taken by STAs to provide success and
failure notifications to the sending system.
Healthcare Provider Directory, Trial Implementation,
October 13, 2014.
URL: http://www.ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_Suppl_HPD.pdf. This is a direct link.
Summary: This document introduces the Healthcare Provider Directory
(HPD) that supports queries against and management of, health care
provider information that may be publicly shared in a directory
structure. HPD directory structure is a listing of two categories of
health care providers, individual and organizational providers.

Functional Standards--45 CFR 170.204

HL7 Version 3 Standard: Context Aware Knowledge Retrieval
Application. (``Infobutton''), Knowledge Request, Release 2.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=208. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: The Context-aware knowledge retrieval specifications
(Infobutton) provide a standard mechanism for clinical information
systems to request context-specific clinical knowledge from online
resources. Based on the clinical context, which includes
characteristics of the patient, provider, care setting, and clinical
task, Infobutton(s) anticipates clinicians' and patients' questions and
provides automated links to resources that may answer those questions.
HL7 Implementation Guide: Service-Oriented Architecture
Implementations of the Context-aware Knowledge Retrieval (Infobutton)
Domain, Release 1.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=283. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: Context-aware knowledge retrieval (Infobutton) into
clinical information systems help deliver clinical knowledge to the
point of care as well as patient-tailored education material. This
specification enables the implementation of context-aware knowledge
retrieval applications through a Service Oriented Architecture based on
the RESTful software architectural style.
HL7 Version 3 Implementation Guide: Context-Aware
Knowledge Retrieval (Infobutton), Release 4.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=22. Access requires a ``user account'' and
a license agreement. There is no monetary cost for a user account and
license agreement.
Summary: Context-aware knowledge retrieval (Infobutton) in clinical
information systems help deliver clinical knowledge to the point of
care as well as patient-tailored education material. This
implementation guide provides a standard mechanism for EHR systems to
submit knowledge requests over the HTTP protocol through a standard
using a URL format.
HL7 Version 3 Standard: Clinical Decision Support
Knowledge Artifact Specification, Release 1.2 Draft Standard for Trial
Use.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=337. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: The Clinical Decision Support Knowledge Artifact
Specification provides guidance on how to specify and implement
shareable CDS knowledge artifacts using XML. The scope of the
Specification includes event-condition-action rules, order sets, and
documentation templates.
HL7 Implementation Guide: Decision Support Service,
Release 1.1, US Realm, Draft Standard for Trial Use.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=334. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: A Decision Support Service takes in patient data as the
input and provides back patient-specific assessments and
recommendations. A Decision Support Service facilitates the
implementation of CDS capabilities in a scalable manner. This
implementation guide defines a Decision Support Service implementation
approach that combines the HL7 Decision Support Service Release 2
standard with the HL7 Virtual Medical Record for CDS information model
standard to enable the provision of standards-based, interoperable
decision support services.

Content Exchange Standards and Implementation Specifications for
Exchanging Electronic Health Information--45 CFR 170.205

HL7 Implementation Guide for CDA[supreg] R2: Quality
Reporting Document Architecture--Category I, DSTU Release 2 (US Realm)
and Errata (September 2014).
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=35. Access requires a ``user account'' and
a license agreement. There is no monetary cost for a user account and
license agreement. The DSTU package must be downloaded in order to
access the errata.
Summary: The Quality Reporting Document Architecture (QRDA) is an
electronic document format that provides a standard structure with
which to report quality measure data to organizations that will analyze
and interpret the data. The Implementation Guide is consistent with
CDA, and Category I is an individual-patient-level quality report. The
September 2014 Errata reflects updates for the implementation of QRDA
Category I consistent with the Quality Data Model-

[[Page 16889]]

based Health Quality Measures Format Release 2.1, an incremental
version of harmonized clinical quality measure and CDS standards.
HL7 Implementation Guide for CDA[supreg] Release 2:
Consolidated CDA Templates for Clinical Notes, Draft Standard for Trial
Use, Release 2.0.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=379. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: The Consolidated CDA (C-CDA) implementation guide contains
a library of CDA templates, incorporating and harmonizing previous
efforts from HL7, IHE, and Health Information Technology Standards
Panel (HITSP). It represents harmonization of the HL7 Health Story
guides, HITSP C32, related components of IHE Patient Care Coordination
(IHE PCC), and Continuity of Care (CCD). The C-CDA Release 2
implementation guide, in conjunction with the HL7 CDA Release 2 (CDA
R2) standard, is to be used for implementing the following CDA
documents and header constraints for clinical notes: Care Plan
including Home Health Plan of Care, Consultation Note, CCD, Diagnostic
Imaging Reports, Discharge Summary, History and Physical, Operative
Note, Procedure Note, Progress Note, Referral Note, Transfer Summary,
Unstructured Document, and Patient Generated Document (US Realm
Header).
HL7 Implementation Guide for CDA[supreg] Release 2:
Additional CDA R2 Templates--Clinical Documents for Payers--Set 1,
Release 1--US Realm, Draft Standard for Trial Use.
URLs: http://www.hl7.org/special/Committees/claims/index.cfm and
http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember.
This is a direct access link to the most recent publicly available
version of the implementation guide. HL7 policy normally requires a
paid membership or a ``non-member participation'' fee to access the
balloting process of a standard or implementation guide. HL7 has,
however, agreed to make current balloted versions of the implementation
guide freely available for review during the public comment period of
this proposed rule. Access requires a ``user account'' and a license
agreement. There is no monetary cost for a user account and license
agreement.
Summary: The purpose of the Clinical Documents for Payers--Set
1(CDP1) implementation guide is to provide guidance on a standardized,
implementable, interoperable electronic solution to reduce the time and
expense related to the exchange of clinical and administrative
information between and among providers and payers. This guide
describes structured documentation templates that meet requirements for
documentation of medical necessity and appropriateness of services to
be delivered or that have been delivered in the course of patient care.
These document templates are designed for use when the provider needs
to exchange more clinical information than is required by the C-CDA R2
document-level templates and/or must indicate why information for
specific section-level or entry-level templates is not included.
HL7 Implementation Guide for CDA Release 2: Digital
Signatures and Delegation of Rights, Release 1.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=375. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: The Digital Signature and Delegation of Rights
Implementation Guides provide a standardized method of applying Digital
Signatures to CDA documents. The standard provides for multiple
signers, signer's declaration of their role, declaration of purpose of
the signature, long-term validation of the Digital Signatures and data
validation of the signed content.
Author of Record Level 1: Implementation Guide.
URL: http://wiki.siframework.org/file/view/esMD%20AoR%20Level%201%20Implementation%20Guide%20v5%20FINAL.docx/539084894/esMD%20AoR%20Level%201%20Implementation%20Guide%20v5%20FINAL.docx. This
is a direct link. This implementation guide was developed under the
Standards and Interoperability (S&I) Framework.\257\
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\257\ http://www.healthit.gov/policy-researchers-implementers/standards-interoperability-si-framework.
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Summary: The Author of Record Level 1 Implementation Guide utilizes
the IHE Document Digital Signature standard and Security Assertion
Markup Language (SAML) assertions to support applying digital
signatures and delegation of rights information to bundles of documents
exchanged over content neutral transports.
Provider Profiles Authentication: Registration
Implementation Guide.
URL: http://wiki.siframework.org/file/view/esMD%20Use%20Case%201%20Implementation%20Guide%20V24%20FINAL.docx/539084920/esMD%20Use%20Case%201%20Implementation%20Guide%20V24%20FINAL.docx. This
is a direct link. This implementation guide was developed under the
Standards and Interoperability (S&I) Framework.\258\
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\258\ http://www.healthit.gov/policy-researchers-implementers/standards-interoperability-si-framework.
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Summary: The Provider Profiles Authentication Implementation Guide
provides methods for applying digital signatures and delegation of
rights information to the most common administrative and clinical
transactions, including: ASC X12, CONNECT, Direct, and HL7 V2.
HL7 Version 2.5.1 Implementation Guide: S&I Framework
Laboratory Orders from EHR, Draft Standard for Trial Use, Release 2--US
Realm.
URL: http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. HL7 policy normally requires a
paid membership or a ``non-member participation'' fee to access the
balloting process of a standard or implementation guide. HL7 has,
however, agreed to make current balloted versions of the implementation
guide freely available for review during the public comment period of
this proposed rule. Access requires a ``user account'' and a license
agreement. There is no monetary cost for a user account and license
agreement.
Summary: The Laboratory Orders Implementation Guide identifies the
requirements, specifications, and standards, and provides the
implementation guidance for the electronic ordering of laboratory tests
in the US Realm. The scope of the Laboratory Orders Interface Use Case
includes requirements to enable a particular implementation of an
Electronic Health Record System (EHR-S) to use standardized structured
data in a defined inter-organizational laboratory transaction. The Use
Case requirements are directed at laboratory test orders between an
Ambulatory Provider's EHR-S and a Laboratory's Laboratory Information
System (LIS). Future versions of this guide may harmonize with existing
guides to extend interoperability of laboratory results across care
settings, e.g., acute care.
HL7 Version 2.5.1 Implementation Guide: S&I Framework
Laboratory Test Compendium Framework, Release 2, Version 1.2 (eDOS).
URL: http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. HL7 policy normally requires a
paid membership or a ``non-member participation'' fee to access the
balloting process of a standard or implementation guide. HL7 has,
however, agreed to

[[Page 16890]]

make current balloted versions of the implementation guide freely
available for review during the public comment period of this proposed
rule. Access requires a ``user account'' and a license agreement. There
is no monetary cost for a user account and license agreement.
Summary: The focus of the Laboratory Test Compendium Framework is
to provide a standardized means of electronically communicating a
Laboratory's Directory of Services (eDOS). The content is owned by the
sending laboratory for the purpose of being used by the compendium
consumer to order laboratory services and to understand the
requirements and components of those services. The consumer (and
consuming systems) should not modify or delete the content unless
instructed to do so by the producer via eDOS updates or some other form
of written communication. Adding to the content to provide additional
information specific to the consumer's needs such as cross reference to
local codes and/or other performing labs, or other information that
does not change or conflict with the content of the original
information provided by the performing laboratory, is permitted.
HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab
Results Interface, Draft Standard for Trial Use, Release 2--US Realm.
URL: http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. HL7 policy normally requires a
paid membership or a ``non-member participation'' fee to access the
balloting process of a standard or implementation guide. HL7 has,
however, agreed to make current balloted versions of the implementation
guide freely available for review during the public comment period of
this proposed rule. Access requires a ``user account'' and a license
agreement. There is no monetary cost for a user account and license
agreement.
Summary: The Laboratory Results Interface (LRI) Implementation
Guide identifies the requirements, defines specifications and
standards, and provides implementation guidance for electronic
reporting of laboratory test results to ambulatory care providers in
the US Realm. The scope of the Laboratory Results Interface Use Case
includes requirements to enable the incorporation of clinical
laboratory test results into an EHR-S as standardized structured data
using the defined inter-organizational laboratory transaction. The Use
Case requirements are directed at laboratory test results reporting
between a LIS and an ambulatory EHR-S in different organizational
entities (e.g., different corporate structure, ownership or
governance). Future versions of this guide may harmonize with existing
guides to extend interoperability of laboratory results across care
settings (e.g., acute care).
HL7 Version 3 Implementation Guide: Family History/
Pedigree Interoperability.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=301. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: The HL7 Clinical Genomics Family Health History (Pedigree)
Model is a data standard for capturing, within a system, and
transmitting family histories between systems. This includes describing
a patient's full pedigree (family and familial relationships) with
diseases and conditions, and the option to link genetic information and
risk analysis. This standard allows EHR/personal health record
interoperability.
NCPDP Formulary and Benefit Standard Implementation Guide
v3.0.
URL: http://ncpdp.org/Standards/Standards-Info and http://ncpdp.org/?ReturnUrl=%2fmembers%2fStandards-Lookup.aspx. Access
requires completion of a membership application and a paid membership.
NCPDP has stated that membership allows NCPDP to provide a forum
wherein a diverse membership can develop business solutions, standards,
and guidance for promoting information exchanges related to
medications, supplies, and services within the health care system
through consensus building processes. We note that CMS has already
adopted the NCPDP Formulary and Benefit Standard Implementation Guide
v3.0 and incorporated it by reference in the Federal Register as a
standard for electronic prescribing under the voluntary Medicare
prescription drug benefit program.\259\
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\259\ 42 CFR 423.160(b)(5)(iii). http://www.ecfr.gov/cgi-bin/text-idx?SID=776f4d6a1759e76160516348d3ca4454&node=se42.3.423_1160&rgn=div8.
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Summary: The NCPDP Formulary and Benefit Standard Implementation
Guide provides a standard means for pharmacy benefit payers to
communicate formulary and benefit information to prescribers via
technology vendor systems. It enables the physician to consider
information during the prescribing process to help make an appropriate
drug choice for the patient. Compared to v2.1, v3.0 removes some unused
information, provides some value clarifications, adds additional RxNorm
references to fields, and adds support for text messaging.
NCPDP Formulary and Benefit Standard Implementation Guide
v4.0.
URL: http://ncpdp.org/Standards/Standards-Info and http://ncpdp.org/?ReturnUrl=%2fmembers%2fStandards-Lookup.aspx. Access
requires completion of a membership application and a paid membership.
NCPDP has stated that membership allows NCPDP to provide a forum
wherein a diverse membership can develop business solutions, standards,
and guidance for promoting information exchanges related to
medications, supplies, and services within the health care system
through consensus building processes.
Summary: The NCPDP Formulary and Benefit Standard Implementation
Guide provides a standard means for pharmacy benefit payers to
communicate formulary and benefit information to prescribers via
technology vendor systems. It enables the physician to consider
information during the prescribing process to help make an appropriate
drug choice for the patient. Compared to v3.0, v4.0 modifies a field
size, removes some values, and makes editorial edits to a figure.
NCPDP Formulary and Benefit Standard Implementation Guide
v4.1.
URL: http://ncpdp.org/Standards/Standards-Info and http://ncpdp.org/?ReturnUrl=%2fmembers%2fStandards-Lookup.aspx. Access
requires completion of a membership application and a paid membership.
NCPDP has stated that membership allows NCPDP to provide a forum
wherein a diverse membership can develop business solutions, standards,
and guidance for promoting information exchanges related to
medications, supplies, and services within the health care system
through consensus building processes.
Summary: The NCPDP Formulary and Benefit Standard Implementation
Guide provides a standard means for pharmacy benefit payers to
communicate formulary and benefit information to prescribers via
technology vendor systems. It enables the physician to consider
information during the prescribing process to help make an appropriate
drug choice for the patient. Compared to v4.0, v4.1 removes files to
support electronic Prior Authorization (ePA) transactions since these
were added to the NCPDP SCRIPT Standard Implementation Guide v2013011
(January 2013) and later versions, makes typographical corrections,
adds a new coverage type for ePA routing, and adds an RxNorm qualifier
to some data elements.

[[Page 16891]]

NCPDP Formulary and Benefit Standard Implementation Guide
v42.
URL: http://ncpdp.org/Standards/Standards-Info and http://ncpdp.org/?ReturnUrl=%2fmembers%2fStandards-Lookup.aspx. Access
requires completion of a membership application and a paid membership.
NCPDP has stated that membership allows NCPDP to provide a forum
wherein a diverse membership can develop business solutions, standards,
and guidance for promoting information exchanges related to
medications, supplies, and services within the health care system
through consensus building processes.
Summary: The NCPDP Formulary and Benefit Standard Implementation
Guide provides a standard means for pharmacy benefit payers to
communicate formulary and benefit information to prescribers via
technology vendor systems. It enables the physician to consider
information during the prescribing process to help make an appropriate
drug choice for the patient. Compared to v4.1, v42 \260\ includes
changes to reduce the formulary file size, modifies some code lists and
values, and revises some fields.
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\260\ Please note a change to the naming convention starting
with Version 42.
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NCPDP Telecommunication Standard Implementation Guide vE6.
URL: http://ncpdp.org/Standards/Standards-Info and http://ncpdp.org/?ReturnUrl=%2fmembers%2fStandards-Lookup.aspx. Access
requires completion of a membership application and a paid membership.
NCPDP has stated that membership allows NCPDP to provide a forum
wherein a diverse membership can develop business solutions, standards,
and guidance for promoting information exchanges related to
medications, supplies, and services within the health care system
through consensus building processes.
Summary: The Telecommunication Standard was developed to provide a
standard format for the electronic submission of third party drug
claims. The development of the standard was to accommodate the
eligibility verification process at the point-of-sale and to provide a
consistent format for electronic claims processing. The
Telecommunication Standard includes transactions for eligibility
verification, claim and service billing, predetermination of benefits,
prior authorization, information reporting, and controlled substance
(general and regulated) transaction exchanges.
ASC X12 270/271 Health Care Eligibility Benefit Inquiry
and Response Implementation Guide.
URL: http://store.x12.org/store/healthcare-5010-consolidated-guides. Access requires either a membership with ASC X12 or the user to
purchase a single user or unlimited user license. ASC X12 develops and
maintains EDI and CICA standards along with XML standards for a number
of sectors, including health care, insurance, transportation, finance,
government, and supply chain. ASC X12 has stated that membership allows
it to support standards development and participation; meetings,
conferences, and educational venues; standards and publications; tools
for members; and networking and visibility.
Summary: The Health Care Eligibility/Benefit Inquiry and
Information Response Implementation Guide describes the use of the
Eligibility, Coverage or Benefit Inquiry (270) Version/Release 005010
transaction set and the Eligibility, Coverage, or Benefit Information
(271) Version/Release 005010 transaction set for the following usages:
Determine if an Information Source organization, such as an insurance
company, has a particular subscriber or dependent on file; and
determine the details of health care eligibility and/or benefit
information.
HL7 Implementation Guide: Data Segmentation for Privacy
(DS4P), Release 1.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=354. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: This guide supports segmenting clinical records so that
protected health information (PHI) can be appropriately shared as may
be permitted by privacy policies or regulations.
HL7 2.5.1 Implementation Guide for Immunization Messaging,
Release 1.5.
URL: http://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdf. This is a direct link.
Summary: This document represents the collaborative effort of the
American Immunization Registry Association and CDC to improve inter-
system communication of immunization records. The guide is intended to
facilitate exchange of immunization records between different systems.
PHIN Messaging Guide for Syndromic Surveillance: Emergency
Department, Urgent, Ambulatory Care, and Inpatient Settings, Release
2.0.
URL: http://www.cdc.gov/phin/library/guides/SyndrSurvMessagGuide2_MessagingGuide_PHN.pdf. This is a direct link.
Summary: This document represents the collaborative effort of the
International Society for Disease Surveillance, CDC, and NIST to
specify a national electronic messaging standard that enables disparate
health care applications to submit or transmit administrative and
clinical data for public health surveillance and response. The scope of
the guide is to provide guidelines for sending HL7 v.2.5.1 compliant
messages from emergency department, urgent and ambulatory care, and
inpatient settings to public health authorities.
HL7 Version 2.5.1 Implementation Guide: Electronic
Laboratory Reporting to Public Health, Release 2 (US Realm), Draft
Standard for Trial Use R1.1.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=329. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: This guide is the result of collaborative efforts between
HL7 and the S&I Laboratory Results Interface Initiative. The guide
describes constraints, comments, and elements necessary for laboratory
reporting to public health.
HL7 Implementation Guide for CDA[sup](copyright) Release
2: Reporting to Public Health Cancer Registries From Ambulatory
Healthcare Providers, Release 1.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=383. Access requires a ``user account''
and a license agreement. There is no monetary cost for a user account
and license agreement.
Summary: As ambulatory health care providers adopt modern EHR
systems, the opportunity to automate cancer registry reporting from
ambulatory health care provider settings is also increasing and
becoming more feasible. This document provides clear and concise
specifications for electronic reporting form ambulatory health care
provider EHR systems to public health central cancer registries using
the HL7 CDA based standards. This document is designed to guide EHR
vendors and public health central cancer registries in the
implementation of standardized electronic reporting.
IHE IT Infrastructure Technical Framework Volume 2b (ITI
TF-2b).
URL: http://www.ihe.net/Technical_Framework/upload/IHE_ITI_TF_Rev7-0_Vol2b_FT_2010-08-10.pdf. This is a direct link.
Summary: This document defines specific implementations of
established

[[Page 16892]]

standards to achieve integration goals that promote appropriate sharing
of medical information to support ongoing patient care. The IHE IT
Infrastructure Technical Framework identifies a subset of functional
components of the health care enterprise, called ``IHE actors,'' and
specified their interactions in terms of a set of coordinated,
standards-based transactions. Volume 2b corresponds to transactions
[ITI-29] through [ITI-57].
IHE Quality, Research, and Public Health Technical
Framework Supplement, Structured Data Capture, Trial Implementation.
URL: http://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_SDC.pdf. This is a direct link.
Summary: The Structured Data Capture Content Profile provides
specifications to enable an EHR system or other application to retrieve
a data capture form and submit data from the completed form. This
supplement is based on the work of ONC's S&I Framework Structured Data
Capture (SDC) Initiative. The SDC Initiative has developed use cases,
identified national standards for the structure of common data elements
and form model definition, developed guidance to assist in
implementation, and conducted pilots for evaluation of SDC.
HL7 FHIR Implementation Guide: Structured Data Capture
(SDC).
URL: http://hl7.org/implement/standards/FHIR-Develop/sdc.html#SDC.
This is a direct link.
Summary: This implementation guide is intended to support clinical
systems in the creation and population of forms with patient-specific
data. It defines a mechanism for linking questions in forms to pre-
defined data elements to enable systems to automatically populate
portions of the form based on existing data, either locally or by
invoking an operation on a third-party system. Note that the SDC FHIR
Implementation Guide is balloted as comment-only.
HL7 Implementation Guide for CDA[supreg] Release 2--Level
3: Healthcare Associated Infection Reports, Release 1, U.S. Realm.
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=20. Access requires a ``user account'' and
a license agreement. There is no monetary cost for a user account and
license agreement.
Summary: This document specifies a standard for electronic
submission of health care associated infection reports (HAI) to the
National Healthcare Safety Network of the CDC. This document defines
the overall approach and method of electronic submission and develops
constraints defining specific HAI report types.
HL7 Implementation Guide for CDA[supreg] Release 2:
National Health Care Surveys (NHCS), Release 1--US Realm, Draft
Standard for Trial Use (December 2014).
URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=385. Consistent with HL7 policy, non-
member access would not be available until April 14, 2015. HL7 has,
however, agreed to waive the normal 90-day waiting period and make the
implementation guide freely available during the public comment period
of this proposed rule. Access requires a ``user account'' and license
agreement. There is no monetary cost for a user account and license
agreement.
Summary: The HL7 Implementation Guide for CDA Release 2: National
Health Care Surveys (NHCS), Release 1--US Realm will provide a
standardized format for implementers to submit data to fulfill
requirements of the Centers for Disease Control and Prevention/National
Center for Health Statistics/National Health Care Surveys. This guide
will support automatic extraction of the data from a provider's EHR
system or data repository. The data are collected through three surveys
of ambulatory care services in the United States: The National
Ambulatory Medical Care Survey with information from physicians and two
national hospital care surveys: The National Hospital Ambulatory
Medical Care Surveys and the National Hospital Care Survey with data
from hospital emergency and outpatient departments.
NCPDP SCRIPT Implementation Recommendations Version 1.29.
URL: http://www.ncpdp.org/NCPDP/media/pdf/SCRIPTImplementationRecommendationsV1-29.pdf. This is a direct link.
The Implementation Recommendations Version 1.29 is available at no
monetary cost, but references the NCPDP Structured and Codified Sig
Implementation Guide Version 1.2. Access to NCPDP standards requires
completion of a membership application and a paid membership. NCPDP has
stated that membership allows NCPDP to provide a forum wherein a
diverse membership can develop business solutions, standards, and
guidance for promoting information exchanges related to medications,
supplies, and services within the health care system through consensus
building processes.
Summary: This Implementation Recommendations document includes
recommendations for implementation of the structured and codified sig
format for a subset of component composites that represent the most
common Sig segments using NCPDP Structured and Codified Sig
Implementation Guide Version 1.2. The recommendations promote
consistent and complete prescription transactions of the NCPDP SCRIPT
Standard.

Vocabulary Standards for Representing Electronic Health Information--45
CFR 170.207

IHTSDO SNOMED CT[supreg], U.S. Edition, September 2014
Release.
URL: http://www.nlm.nih.gov/research/umls/Snomed/us_edition.html.
Access requires a user account and license agreement. There is no
monetary cost for a user account and license agreement.
Summary: Systemized Nomenclature of Medicine--Clinical Terms
(SNOMED CT[supreg]) is a comprehensive clinical terminology, originally
created by the College of American Pathologists and, as of April 2007,
owned, maintained, and distributed by the International Health
Terminology Standards Development Organisation. SNOMED CT[supreg]
improves the recording of information in an EHR system and facilitates
better communication, leading to improvements in the quality of care.
Logical Observation Identifiers Names and Codes
(LOINC[supreg]) Database version 2.50, a universal code system for
identifying laboratory and clinical observations produced by the
Regenstrief Institute, Inc.
URL: http://loinc.org/downloads. Access requires registration, a
user account, and license agreement. There is no monetary cost for
registration, a user account, and license agreement.
Summary: LOINC[supreg] was initiated in 1994 by the Regenstrief
Institute and developed by Regenstrief and the LOINC[supreg] committee
as a response to the demand for electronic movement of clinical data
from laboratories that produce the data to hospitals, provider's
offices, and payers who use the data for clinical care and management
purposes. The scope of the LOINC[supreg] effort includes laboratory and
other clinical observations. The LOINC[supreg] database facilitates the
exchange and pooling of results for clinical care, outcomes management,
and research.
RxNorm, a standardized nomenclature for clinical drugs
produced by the United States National Library of Medicine, February 2,
2015 Release.
URL: http://www.nlm.nih.gov/research/umls/rxnorm/docs/rxnormfiles.html. Access requires a user account and license agreement.
There is no monetary cost for a user account and license agreement.

[[Page 16893]]

Summary: RxNorm provides normalized names for clinical drugs and
links its names to many of the drug vocabularies commonly used in
pharmacy management and drug interaction software. By providing links
between vocabularies commonly used in pharmacy management and drug
interaction software, RxNorm can mediate messages between systems not
using the same software and vocabulary. RxNorm now includes the
National Drug File--Reference Terminology (NDF-RT) from the Veterans
Health Administration, which is used to code clinical drug properties,
including mechanism of action, physiologic effect, and therapeutic
category.
HL7 Standard Code Set CVX--Vaccines Administered, updates
through February 2, 2015.
URL: http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cvx. This is a direct link.
Summary: CDC's National Center of Immunization and Respiratory
Diseases developed and maintains HL7 Table 0292, Vaccine Administered
(CVX). CVX includes both active and inactive vaccines available in the
U.S. CVX codes for inactive vaccines allow transmission of historical
immunization records; when paired with a manufacturer (MVX) code, the
specific trade named vaccine may be indicated.
National Drug Code Directory--Vaccine Codes, updates
through January 15, 2015.
URL: http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp. This is a direct access link.
Summary: The Drug Listing Act of 1972 requires registered drug
establishments to provide the FDA with a current list of all drugs
manufactured, prepared, propagated, compounded, or processed by it by
commercial distribution. Drug products are identified and reported
using a unique, three-segment number, called the National Drug Code
(NDC), which services as the universal product identifier for drugs.
This standard is limited to the NDC vaccine codes identified by CDC at
the URL provided.
HL7 Standard Code Set MVX--Manufacturers of Vaccines Code
Set, updates through October 30, 2014.
URL: http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=mvx. This is a direct link.
Summary: CDC's National Center of Immunization and Respiratory
Diseases developed and maintains HL7 Table 0227, Manufacturers of
Vaccines (MVX). The MVX table includes both active and inactive
vaccines available in the U.S. MVX codes allow transmission of
historical immunization records. When MVX code is paired with a CVX
code, the specific trade named vaccine may be indicated.
``Race & Ethnicity--CDC'' code system in the PHIN
Vocabulary Access and Distribution System (VADS), Release 3.3.9.
URL: https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.113883.6.238. This is a direct
link.
Summary: The Public Health Information Network (PHIN) VADS is a
web-based enterprise vocabulary systems for accessing, searching, and
distributing vocabularies used within the PHIN. PHIN VADS provides
standard vocabularies to CDC and its public health partners in one
place. It promotes the use of standards-based vocabulary to support the
exchange of consistent information among public health partners.
Request for Comments (RFC) 5646.
URL: http://www.rfc-editor.org/info/rfc5646. This is a direct
access link.
Summary: RFC 5646 describes the structure, content, construction,
and semantics of language tags for use in cases where it is desirable
to indicate the language used in an information object. It also
describes how to register values for use in language tags and the
creation of user-defined extensions for private interchange.
The Unified Code of Units of Measure, Revision 1.9.
URL: http://unitsofmeasure.org/trac/. This is a direct access link.
The codes can be viewed in html or xml.
Summary: The Unified Code of Units of Measure is a code system
intended to include all units of measures being contemporarily used in
international science, engineering, and business. The purpose is to
facilitate unambiguous electronic communication of quantities together
with units.

Standards for Health Information Technology To Protect Electronic
Health Information Created, Maintained, and Exchanged--45 CFR 170.210

Any encryption algorithm identified by the National
Institute of Standards and Technology (NIST) as an approved security
function in Annex A of the Federal Information Processing Standards
(FIPS) Publication 140-2, October 8, 2014.
URL: http://csrc.nist.gov/publications/fips/fips140-2/fips1402annexa.pdf. This is a direct link.
Summary: Federal Information Processing Standards Publication (FIPS
PUB) 140-2, Security Requirements for Cryptographic Modules, specifies
the security requirements that are to be satisfied by the cryptographic
module utilized within a security system protecting sensitive
information within computer and telecommunications systems. The
standard provides four increasing qualitative levels of security that
are intended to cover the wide range of potential applications and
environments in which cryptographic modules may be employed.

VII. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995 (PRA), agencies are
required to provide 60-day notice in the Federal Register and solicit
public comment on a proposed collection of information before it is
submitted to the Office of Management and Budget for review and
approval. In order to fairly evaluate whether an information collection
should be approved by the Office of Management and Budget, section
3506(c)(2)(A) of the PRA requires that we solicit comment on the
following issues:
1. Whether the information collection is necessary and useful to
carry out the proper functions of the agency;
2. The accuracy of the agency's estimate of the information
collection burden;
3. The quality, utility, and clarity of the information to be
collected; and
4. Recommendations to minimize the information collection burden on
the affected public, including automated collection techniques.
Under the PRA, the time, effort, and financial resources necessary
to meet the information collection requirements referenced in this
section are to be considered. We explicitly seek, and will consider,
public comment on our assumptions as they relate to the PRA
requirements summarized in this section. To comment on the collection
of information or to obtain copies of the supporting statements and any
related forms for the proposed paperwork collections referenced in this
section, email your comment or request, including your address and
phone number to [email protected], or call the Reports
Clearance Office at (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above email
address within 60 days.

Abstract

Under the ONC Health IT Certification Program, accreditation
organizations that wish to become the ONC-Approved Accreditor (ONC-AA)
must submit certain information, organizations that wish to become an

[[Page 16894]]

ONC-ACB must submit the information specified by the application
requirements, and ONC-ACBs must comply with collection and reporting
requirements, records retention requirements, and submit annual
surveillance plans and annually report surveillance results.
In the Permanent Certification Program final rule (76 FR 1312-14),
we solicited public comment on each of the information collections
associated with the requirements described above (and included in
regulation at 45 CFR 170.503(b), 170.520, and 170.523(f), (g), and (i),
respectively). In the 2014 Edition final rule (77 FR 54275-76), we
sought comment on these collection requirements again and finalized an
additional requirement at Sec. 170.523(f)(8) for ONC-ACBs to report to
ONC a hyperlink with each EHR technology they certify that provides the
public with the ability to access the test results used to certify the
EHR technology. These collections of information were approved under
OMB control number 0955-0013 (previous OMB control number 0990-0378).
As discussed in more detail below, we estimate less than 10 annual
respondents for all of the regulatory ``collection of information''
requirements under Part 170 of Title 45, including those previously
approved by OMB and proposed in this proposed rule. Accordingly, the
regulatory ``collection of information'' requirements under the ONC
Health IT Certification Program described in this section are not
subject to the PRA under 5 CFR 1320.3(c). We welcome comments on this
conclusion and our supporting rationale for this conclusion as recited
below. We also set out below proposed revisions to previously approved
``collections of information'' and potential new ``collections of
information'' as well as our burden estimates for these ``collections
of information.''
We propose to change the records retention requirement in Sec.
170.523(g) from five years to six years. It is our understanding that a
six-year records retention requirement aligns with current
accreditation standards that ONC-ACBs follow. Therefore, we do not
believe there will be any additional burden based on this proposed
change.
We propose in Sec. 170.523(o) that ONC-ACBs provide ONC with a
list of complaints received on a quarterly basis. We only request that
ONC-ACBs indicate in their submission how many complaints were
received, the nature or substance of the complaint, and the type of
complainant (e.g., type of provider, health IT developer, etc.).
Therefore, we believe ONC-ACBs will face little burden in complying
with this new proposed requirement.
For regulatory clarity in relation to new proposed ONC-ACB
collection and reporting requirements, we have proposed to move all of
the current ONC-ACB collection and reporting requirements in Sec.
170.523(f) to Sec. 170.523(f)(2). These collection and reporting
requirements are specific to the certification of health IT to the 2014
Edition. We note that we have also proposed to add a data element to
the list of collection and reporting requirements for 2014 Edition
certifications. The data element is the reporting of any corrective
action instituted under the proposed provisions of Sec. 170.556 (see
section IV.D.3 of this preamble; see also Sec. 170.523(f)(2)(ix)).
We propose to add a new ONC-ACB collection and reporting
requirements for the certification of health IT to the 2015 Edition
(and any subsequent edition certification) in Sec. 170.523(f)(1). As
proposed for Sec. 170.523(f)(1), ONC-ACBs would be required to report
on the same data elements they report to ONC under current Sec.
170.523(f), the information contained in the publicly available test
report, and additional data in an open data file format. These
collection and reporting requirements are described in more detail in
section IV.D.3, titled ``Open Data Certified Health IT Product List
(CHPL).'' We do not anticipate any additional burden on ONC-ACBs for
reporting similar information for 2015 Edition certifications as they
do for 2014 Edition certifications. For the additional data that we
propose they report, we believe that burden would be minimal as
discussed below.
For the purposes of estimating the additional potential burden for
reporting under Sec. 170.523(f)(1) and (2):
We assume there will be three ONC-ACBs as this is the
current number of ONC-ACBs.
We assume ONC-ACBs will continue to report weekly (i.e.,
respondents will respond 52 times per year) as is the current practice.
We assume an equal distribution among ONC-ACBs in
certifying Health IT Modules on a weekly basis. As such, based on the
number of Complete EHRs and EHR Modules listed on the CHPL at the end
of July of 2014 (approximately one and a half years since ONC began
certifying 2014 Edition products), we estimate that, on average, each
ONC-ACB will report information to ONC on 2015 Edition certifications
for 2.5 Health IT Modules per week.
We expect 2014 Edition certifications to slow upon
issuance of a subsequent final rule and estimate that each ONC-ACB will
only issue, on average, one 2014 Edition certification per week after a
subsequent final rule is effective. Therefore, we have reduced the
average burden hours per response to .75 from 1.33 for Sec.
170.523(f)(2). This new average burden hour estimate takes into account
any potential ONC-ACB reporting of data associated with the new
proposed provisions for corrective action instituted under Sec.
170.556 (see Sec. 170.523(f)(2)(ix)).
We believe it will take approximately 1.5 hours per week
on average to collect and report to ONC the information required for
2015 Edition certifications in Sec. 170.523(f)(1), including the
information that goes beyond what is currently collected and reported
for 2014 Edition certifications. Our estimate includes a potential wide
range of certifications issued for Health IT Modules, including, but
not limited to, certifying Health IT Modules to multiple certification
criteria and CQMs. Our estimates also take into account that it may
take ONC-ACBs more time in the beginning of the collection and
reporting processes as they may need to recode their systems to collect
and report the new information in an automated manner. Therefore, we
believe 1.5 hours represents a reasonable average of the amount of time
for an ONC-ACB to collect and report the information proposed under
Sec. 170.523(f)(1). Our burden estimate is incorporated into the table
below.
As stated above, we anticipate that there will be three ONC-ACBs
participating in the ONC Health IT Certification Program as this is the
current number of ONC-ACBs. Further, since the establishment of the ONC
Health IT Certification Program in 2010, ONC has never had more than
six applicants for ONC-ACB or ONC-ATCB status or selected more than six
ONC-ACBs or ONC-ATCBs.\261\ Therefore, we have aligned the estimated
number of respondents for the applicable regulation provisions (i.e.,
Sec. 170.523(f)(1) and (2), (g), (i), and (o); and Sec. 170.540(c))
with the current number of ONC-ACBs. We have also revised the estimated
number of respondents for Sec. 170.503(b) (applicants for ONC-Approved
Accreditor (ONC-AA) status) based on past selection processes for the
ONC-AA, which have

[[Page 16895]]

included no more than two applicants. We have retained the same number
of responses per respondent and average burden hours per response for
the regulation provisions currently included in OMB control number
0995-0013, except for Sec. 170.523(f) as specified above (now Sec.
170.523(f)(2)). Our estimates for the total burden hours are expressed
in the table below.
---------------------------------------------------------------------------

\261\ See also: http://www.healthit.gov/policy-researchers-implementers/authorized-testing-and-certifications-bodies and http://www.healthit.gov/policy-researchers-implementers/certification-bodies-testing-laboratories.

Estimated Annualized Total Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
45 CFR 170.503(b)............................... 2 1 1 2
45 CFR 170.520.................................. 1 1 1 1
45 CFR 170.523(f)(1)............................ 3 52 1.5 234
45 CFR 170.523(f)(2)............................ 3 52 .75 117
45 CFR 170.523(g)............................... 3 n/a n/a n/a
45 CFR 170.523(i)............................... 3 2 1 6
45 CFR 170.523(o)............................... 3 4 1 12
45 CFR 170.540(c)............................... 3 1 1 3
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total burden hours.......................... .............. .............. .............. 375
----------------------------------------------------------------------------------------------------------------

VIII. Regulatory Impact Statement

A. Statement of Need

This proposed rule is being published to adopt the 2015 Edition.
Certification criteria and associated standards and implementation
specifications would be used to test and certify health IT in order to
make it possible for EPs, eligible hospitals, and CAHs to adopt and
implement health IT that can be used to meet the CEHRT definition. EPs,
eligible hospitals, and CAHs who participate in the EHR Incentive
Programs are required by statute to use CEHRT.\262\
---------------------------------------------------------------------------

\262\ Section 1848(o) of the Social Security Act.
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The certification criteria and associated standards and
implementation specifications would also support the certification of
more types of health IT and health IT that supports care and practice
settings beyond the scope of the EHR Incentive Programs.
The adoption and implementation of health IT certified to the 2015
Edition promotes interoperability in support of a nationwide health
information infrastructure and improves health care quality, safety and
efficiency consistent with the goals of the HITECH Act.

B. Overall Impact

We have examined the impact of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (February 2, 2011), the Regulatory Flexibility Act (5 U.S.C. 601
et seq.), section 202 of the Unfunded Mandates Reform Act of 1995 (2
U.S.C. 1532), and Executive Order 13132 on Federalism (August 4, 1999).
1. Executive Orders 12866 and 13563--Regulatory Planning and Review
Analysis
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
OMB has determined that this proposed rule is an economically
significant rule as ONC has estimated the costs to develop and prepare
health IT to be tested and certified may be greater than $100 million
per year. Because of the public interest in this proposed rule, we have
prepared an RIA that to the best of our ability presents the costs and
benefits of the proposed rule.
a. Costs
This proposed rule proposes the adoption of standards,
implementation specifications, and certification criteria that would
establish the capabilities that health IT would need to demonstrate to
be certified to the 2015 Edition. Our analysis focuses on the direct
effects of the provisions of this proposed rule--the costs incurred by
health IT developers to develop and prepare health IT to be tested and
certified in accordance with the certification criteria (and the
standards and implementation specifications they include) adopted by
the Secretary. That is, we focus on the technological development and
preparation costs necessary for health IT already certified to the 2014
Edition to upgrade to the proposed 2015 Edition and for, in limited
cases, developing and preparing a new Health IT Module to meet the 2015
Edition. The costs for the testing and certification of health IT to
the 2015 Edition were captured in the regulatory impact analysis of the
Permanent Certification Program final rule as we discuss in more detail
below (VIII.B.1.a.iii ``Testing and Certification Costs for the 2015
Edition''). Because the costs that EPs, eligible hospitals, and CAHs
would incur in adopting and implementing (including training,
maintenance, and any other ongoing costs) health IT certified to the
2015 Edition is overwhelmingly attributable to CMS's EHR Incentive
Programs Stage 3 proposed rule (proposed elsewhere in this issue of the
Federal Register), and would not be incurred in the absence of such
rulemaking, such costs are not within the scope of the analysis of this
proposed rule; similarly, any benefits that are contingent upon
adoption and implementation would be attributable to CMS's
rulemaking.\263\ We also note that this proposed rule does not impose
the costs cited as compliance costs, but rather as investments which
health IT

[[Page 16896]]

developers voluntarily take on and expect to recover with an
appropriate rate of return.
---------------------------------------------------------------------------

\263\ ONC administers a voluntary certification program that
provides no incentives for certification. Therefore, to the extent
that providers' implementation and adoption costs are attributable
to CMS's rulemaking, health IT developers' preparation and
development costs would also be attributable to that rulemaking
(because all of the costly activities are, directly or indirectly,
incentivized by CMS's proposed payment structure). However, even if
CMS's proposed rule were not finalized, a professional organization
or other such entity could require or promote certification, thus
generating costs and benefits that are attributable to this proposed
rule. To avoid giving the misleading impression that such effects
equal zero, we present in this RIA a subset of the relevant
impacts--a quantification of costs that are incurred by health IT
developers and a qualitative discussion of benefits. (The missing
portion of the subset is providers' implementation and adoption
costs.)
---------------------------------------------------------------------------

i. Development and Preparation Costs for the 2015 Edition
The development and preparation costs we estimate are derived
through a health IT developer per criterion cost. In simple terms, we
estimate: (1) How many health developers will prepare and develop
products against the proposed certification criteria; (2) how many
products they will develop; and (3) what it will likely cost them to
develop and prepare those products to meet the proposed certification
criteria.
We are not aware of an available independent study (e.g., a study
capturing the preparation efforts and costs to develop and Health IT
Modules to meet the requirements of the 2014 Edition) that we could
rely upon as a basis for estimating the efforts and costs required to
develop and prepare health IT to meet the 2015 Edition. We welcome
comments identifying such a study or on any valid and reliable data
upon which we could base our estimates in a subsequent final rule.
Proposed Certification Criteria
We have divided the proposed certification criteria into two
tables. One table is for the certification criteria associated with EHR
Incentive Programs Stage 3 proposed objectives and measures (``Stage 3
Criteria''). This table also includes certification criteria that are
included in conditional certification requirements, such as privacy and
security, safety-enhanced design, and quality management system
certification criteria as certified Health IT Modules certified to
these criteria would likely be used to meet the CEHRT definition under
the EHR Incentive Programs. The second table is for all other proposed
certification criteria (``Independent Criteria''). We have done this
because, based on available data, we can more accurately estimate the
number of health IT developers that may develop and prepare Health IT
Modules for certification to proposed certification criteria associated
with the EHR Incentive Programs.
Health IT Developers
We derive our estimates for the number of health IT developers by
beginning with the number of Health IT developers certified to each of
the 2014 Edition certification criteria as identified in CHPL data from
November 10, 2014. For the Stage 3 Criteria that correspond to 2014
Edition certification criteria, we have reduced the number of Health IT
developers by 30% from the number that certified against the 2014
Edition. We have done this because we have found a 22% drop in the
number of health IT developers that certified technology against the
2014 Edition versus the 2011 Edition. We believe that as both
interoperability requirements increase by edition and certain health IT
developers gain more market share through competition and acquisition
of other health IT developers, there will be an even greater drop in
the number of health IT developers that seek certification to the 2015
Edition. We welcome comments on this assumption.
For the Independent Criteria, we have established a number of
health IT developers for all the criteria at 16. We derived this number
by taking the lowest number of health IT developers certified to a 2014
Edition certification criteria and reducing that number by 50%. Only 32
health IT developers have certified to the 2014 Edition ``transmission
to cancer registries'' certification criterion (Sec. 170.314(f)(6))
even though it is associated with an EHR Incentive Programs Stage 2
menu objective. The Independent Criteria are not currently associated
with the EHR Incentive Programs or other HHS payment programs.
Therefore, we estimate that a small number of health IT developers
would certify to these criteria (i.e., 50% less than the least amount
of health IT developers certified to a certification criterion that
supports the EHR Incentive Programs). We welcome comments on our
approach to estimating the number of health IT developers for
Independent Criteria. We also seek comment on reasons (e.g., use cases)
why health IT developers would currently seek certification to these
criteria in general or for each proposed criteria.
To note, the estimated number of Health IT developers for each
criterion includes any potential new entrants to the market.
Number of Health IT Modules
We estimate 2.5 products per health IT developer for each Stage 3
criterion. We reached this estimate based both on the number of unique
\264\ certified products listed on the CHPL as of November 10, 2014
divided by the number of health IT developers certified and stakeholder
feedback on our Voluntary Edition proposed rule (79 FR 54474). We
estimate 1 product for each of the Independent Criteria (60% less). As
noted above, the Independent Criteria are not currently associated with
the EHR Incentive Programs or other HHS payment programs. Therefore, it
is not only unclear how many health IT developers will seek
certification to these criteria, but also how many products they would
certify to these criteria. We can only assume that the number of
products certified by each health IT developer will likely be less than
for Stage 3 Criteria. Again, we welcome comments on estimates.
---------------------------------------------------------------------------

\264\ We attempted to discern how many Complete EHRs and Health
IT Modules were used that would not constitute a newer version of
the same technology.
---------------------------------------------------------------------------

Average Development and Preparation Hours
Our estimated average development hours are based on feedback we
received in response to the RIA we completed for on our Voluntary
Edition proposed rule and internal estimates for criteria where there
is no external data to validly rely upon. As noted in the Voluntary
Edition final rule, we have generally used estimates from the
Electronic Health Record Association as a basis for our high estimates,
where applicable. For the Stage 3 Criteria, we include the development
and preparation for 2.5 certified products per health IT developer in
the estimated average development and preparation hours. For the
Independent Criteria, we have built in an estimate of 60% less overall
development and preparation hours due to our assumption that a health
IT developer would develop only one product.
As mentioned above, for proposed 2015 Edition certification
criteria that have a corresponding 2014 Edition criterion, we estimate
only the development and preparation hours to meet the new and revised
capabilities included in a proposed criterion.
Health IT Developer Hourly Cost and Cost Range
We have based the effort levels on the hours necessary for a
software developer to develop and prepare the health IT for testing and
certification. The U.S. Department of Labor, Bureau of Labor Statistics
estimates that the median hourly wage for a software developer is
$44.55.\265\ We have also calculated the costs of an employee's
benefits by assuming that an employer expends thirty-six percent (36%)
of an employee's hourly wage on benefits for the employee. We have
concluded that a 36% expenditure on benefits is an appropriate estimate
because it is the routine percentage used by HHS for contract cost
estimates. We have rounded up the average software

[[Page 16897]]

developer's wage with benefits to $61 per hour.
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\265\ http://www.bls.gov/oes/current/oes151132.htm.
---------------------------------------------------------------------------

To calculate our cost estimates for each certification criterion in
the tables below, we have multiplied both the average low and average
high number of development and preparation hours by $61. For tables 8
and 9, dollar amounts are expressed in 2013 dollars.
For unchanged certification criteria,\266\ we have estimated a
range of 0-50 hours to account for new entrants in the Stage 3 Criteria
table (Table 6) and used 60% less of that estimate in the ``Independent
Criteria'' table (Table 7). To illustrate, that would produce a high
development hours of 12,700 for the ``medication list'' criterion (item
# 7). This likely still overestimates the burden hours of all potential
new entrants.
---------------------------------------------------------------------------

\266\ For the purposes of estimating development hours, we are
currently characterizing the 2015 Edition ``automatic access time-
out'' (Sec. 170.315(d)(5)) and ``end-user device encryption''
certification criterion (Sec. 170.315(d)(7)) as unchanged despite
clarifying edits to the criteria and updates.
---------------------------------------------------------------------------

Estimated Health IT Developers and Development Hours Per Criterion

Table 6--Estimated Health IT Developers and Development and Preparation Hours for Proposed Certification
Criteria--Criteria Associated With the EHR Incentive Programs Stage 3
[Stage 3 Criteria]
----------------------------------------------------------------------------------------------------------------
Number of Hourly development effort by
health IT health IT developer
developers who -------------------------------
Item No. CFR text Certification develop
criterion name product(s) for
certification Low Avg High Avg
to criterion
----------------------------------------------------------------------------------------------------------------
1.................... Sec. CPOE--medications.. 83.3 0 50
170.315(a)(1).
2.................... Sec. CPOE--laboratory... 83.3 1,000 2,000
170.315(a)(2).
3.................... Sec. CPOE--diagnostic 83.3 0 50
170.315(a)(3). imaging.
4.................... Sec. DD/DAI Checks for 242.2 400 800
170.315(a)(4). CPOE.
5.................... Sec. Demographics....... 268.8 500 1,000
170.315(a)(5).
6.................... Sec. Problem List....... 256.9 100 200
170.315(a)(7).
7.................... Sec. Medication List.... 254.8 0 50
170.315(a)(8).
8.................... Sec. Medication Allergy 252.7 0 50
170.315(a)(9). List.
9.................... Sec. Clinical Decision 235.2 600 1,200
170.315(a)(10). Support.
10................... Sec. Drug-formulary and 233.1 310 620
170.315(a)(11). Preferred Drug
List Checks.
11................... Sec. Smoking Status..... 266.7 100 200
170.315(a)(12).
12................... Sec. Family Health 216 100 200
170.315(a)(14). History.
13................... Sec. Family Health 24 500 1,200
170.315(a)(15). History--pedigree.
14................... Sec. Patient-specific 249.2 600 1,200
170.315(a)(17). Education
Resources.
15................... Sec. Patient Health 88.9 500 1,000
170.315(a)(19). Information
Capture.
16................... Sec. Implantable Device 90 1,100 1,700
170.315(a)(20). List.
17................... Sec. Transitions of Care 242.9 1,550 3,100
170.315(b)(1).
18................... Sec. Clinical 224 600 1,200
170.315(b)(2). Information
Reconciliation and
Incorporation.
19................... Sec. Electronic 224.7 1,050 2,100
170.315(b)(3). Prescribing.
20................... Sec. Data Portability... 228.9 800 1,600
170.315(b)(6).
21................... Sec. CQMs--record and 246.4 200 500
170.315(c)(1). export.
22................... Sec. Authentication, 333.9 0 50
170.315(d)(1). Access Control,
Authorization.
23................... Sec. Auditable Events 272.3 0 50
170.315(d)(2). and Tamper-
resistance.
24................... Sec. Audit Report(s).... 280 0 50
170.315(d)(3).
25................... Sec. Amendments......... 243.6 0 50
170.315(d)(4).
26................... Sec. Automatic Access 333.9 0 50
170.315(d)(5). Time-out.
27................... Sec. Emergency Access... 308.7 0 50
170.315(d)(6).
28................... Sec. End-User Device 267.4 0 50
170.315(d)(7). Encryption.
29................... Sec. Integrity.......... 312.2 0 50
170.315(d)(8).
30................... Sec. View, Download, and 256.2 1,000 2,000
170.315(e)(1). Transmit to 3rd
party.
31................... Sec. Secure Messaging... 246.4 0 50
170.315(e)(2).
32................... Sec. Transmission to 220.5 680 1,360
170.315(f)(1). Immunization
Registries.
33................... Sec. Transmission to 213.5 480 960
170.315(f)(2). Public Health
Agencies--syndromi
c surveillance.
34................... Sec. Transmission to 49 520 1,040
170.315(f)(3). Public Health
Agencies--reportab
le laboratory
tests and values/
results.
35................... Sec. Transmission to 22.4 500 1,000
170.315(f)(4). Cancer Registries.
36................... Sec. Transmission to 21 500 1,000
170.315(f)(5). Public Health
Agencies--case
reporting.
37................... Sec. Transmission to 21 500 1,000
170.315(f)(6). Public Health
Agencies--antimicr
obial use and
resistance
reporting.
38................... Sec. Transmission to 21 500 1,000
170.315(f)(7). Public Health
Agencies--health
care surveys.
39................... Sec. Automated Numerator 113.4 400 800
170.315(g)(1). Recording.
40................... Sec. Automated Measure 264.6 600 1,200
170.315(g)(2). Calculation.
41................... Sec. Safety-enhanced 266 300 600
170.315(g)(3). Design.

[[Page 16898]]

42................... Sec. Quality Management 401.8 400 800
170.315(g)(4). System.
43................... Sec. Consolidated CDA 242 400 1,000
170.315(g)(6). Creation
Performance.
44................... Sec. Application Access 242 500 1,000
170.315(g)(7). to Common Clinical
Data Set.
45................... Sec. Accessibility- 401.8 50 100
170.315(g)(8). Centered Design.
46................... Sec. Direct Project..... 140 0 50
170.315(h)(1).
47................... Sec. Direct Project, 70 0 50
170.315(h)(2). Edge Protocol, and
XDR/XDM.
----------------------------------------------------------------------------------------------------------------

Table 7--Estimated Health IT Developers and Development and Preparation Hours for Proposed Certification
Criteria--Criteria Not Associated With the EHR Incentive Programs Stage 3
[``Independent Criteria'']
----------------------------------------------------------------------------------------------------------------
Number of health Hourly development
IT developers effort by health IT
Certification who develop developer
Item No. CFR text criterion name product(s) for -------------------------
certification to
criterion Low Avg High Avg
----------------------------------------------------------------------------------------------------------------
1........................... Sec. Vital Signs, BMI, 16 614 922
170.315(a)(6). and Growth Charts.
2........................... Sec. Image Results....... 16 0 20
170.315(a)(13).
3........................... Sec. Patient List 16 0 20
170.315(a)(16). Creation.
4........................... Sec. Electronic 16 0 20
170.315(a)(18). Medication
Administration
Record.
5........................... Sec. Social, 16 235 470
170.315(a)(21). Psychological, and
Behavioral Data.
6........................... Sec. Decision Support-- 16 394 788
170.315(a)(22). knowledge artifact.
7........................... Sec. Decision Support-- 16 229 458
170.315(a)(23). service.
8........................... Sec. Incorporate 16 313 626
170.315(b)(4). Laboratory Tests
and Values/Results.
9........................... Sec. Transmission of 16 360 720
170.315(b)(5). Laboratory Test
Reports.
10.......................... Sec. Data Segmentation 16 450 900
170.315(b)(7). for Privacy--send.
11.......................... Sec. Data Segmentation 16 450 900
170.315(b)(8). for Privacy--
receive.
12.......................... Sec. Care Plan........... 16 300 500
170.315(b)(9).
13.......................... Sec. CQMs--import and 16 0 200
170.315(c)(2). calculate.
14.......................... Sec. CQMs--filter........ 16 316 632
170.315(c)(4).
15.......................... Sec. Accounting of 16 0 20
170.315(d)(9). Disclosures.
16.......................... Sec. Accessibility 16 800 1,400
170.315(g)(5). Technology
Compatibility.
17.......................... Sec. SOAP Transport and 16 0 20
170.315(h)(3). Security
Specification and
XDR/XDR for Direct
Messaging.
18.......................... Sec. Healthcare Provider 16 120 240
170.315(h)(4). Directory--query
request.
19.......................... Sec. Healthcare Provider 16 120 240
170.315(h)(5). Directory--query
response.
20.......................... Sec. Electronic 16 1,000 2,000
170.315(i)(1). Submission of
Medical
Documentation.
----------------------------------------------------------------------------------------------------------------

Estimated Cost Per Criterion for Health IT Developers

Table 8--Total Development and Preparation Costs per Criterion for Health IT Developers--Criteria Associated
With the EHR Incentive Programs Stage 3
[``Stage 3 Criteria'']
----------------------------------------------------------------------------------------------------------------
Average cost estimates ($)
Certification criterion -------------------------------
Item No. CFR text name Average low Average high
($) ($)
----------------------------------------------------------------------------------------------------------------
1................................ Sec. CPOE--medications....... 0 254,065
170.315(a)(1).
2................................ Sec. CPOE--laboratory........ 508,1300 1,0162,600
170.315(a)(2).
3................................ Sec. CPOE--diagnostic imaging 0 254,065
170.315(a)(3).
4................................ Sec. DD/DAI Checks for CPOE.. 5,909,680 11,819,360
170.315(a)(4).
5................................ Sec. Demographics............ 8,198,400 16,396,800
170.315(a)(5).

[[Page 16899]]

6................................ Sec. Problem List............ 1,567,090 3,134,180
170.315(a)(7).
7................................ Sec. Medication List......... 0 777,140
170.315(a)(8).
8................................ Sec. Medication Allergy List. 0 770,735
170.315(a)(9).
9................................ Sec. Clinical Decision 8,608,320 17,216,640
170.315(a)(10). Support.
10............................... Sec. Drug-formulary and 4,407,921 8,815,842
170.315(a)(11). Preferred Drug List
Checks.
11............................... Sec. Smoking Status.......... 1,626,870 3,253,740
170.315(a)(12).
12............................... Sec. Family Health History... 1,317,600 2,635,200
170.315(a)(14).
13............................... Sec. Family Health History-- 732,000 1,756,800
170.315(a)(15). pedigree.
14............................... Sec. Patient-specific 9,120,720 18,241,440
170.315(a)(17). Education Resources.
15............................... Sec. Patient Health 2,711,450 5,422,900
170.315(a)(19). Information Capture.
16............................... Sec. Implantable Device List. 6,039,000 9,333,000
170.315(a)(20).
17............................... Sec. Transitions of Care..... 22,966,195 45,932,390
170.315(b)(1).
18............................... Sec. Clinical Information 8,198,400 16,396,800
170.315(b)(2). Reconciliation and
Incorporation.
19............................... Sec. Electronic Prescribing.. 14,392,035 28,784,070
170.315(b)(3).
20............................... Sec. Data Portability........ 1,117,0320 22,340,640
170.315(b)(6).
21............................... Sec. CQMs--record and export. 3,006,080 7,515,200
170.315(c)(1).
22............................... Sec. Authentication, Access 0 1,018,395
170.315(d)(1). Control, Authorization.
23............................... Sec. Auditable Events and 0 830,515
170.315(d)(2). Tamper-resistance.
24............................... Sec. Audit Report(s)......... 0 854,000
170.315(d)(3).
25............................... Sec. Amendments.............. 0 742,980
170.315(d)(4).
26............................... Sec. Automatic Access Time- 0 1,018,395
170.315(d)(5). out.
27............................... Sec. Emergency Access........ 0 941,535
170.315(d)(6).
28............................... Sec. End-User Device 0 815,570
170.315(d)(7). Encryption.
29............................... Sec. Integrity............... 0 952,210
170.315(d)(8).
30............................... Sec. View, Download, and 15,628,200 31,256,400
170.315(e)(1). Transmit to 3rd party.
31............................... Sec. Secure Messaging........ 0 751,520
170.315(e)(2).
32............................... Sec. Transmission to 9,146,340 18,292,680
170.315(f)(1). Immunization Registries.
33............................... Sec. Transmission to Public 6,251,280 12,502,560
170.315(f)(2). Health Agencies--
syndromic surveillance.
34............................... Sec. Transmission to Public 1,554,280 3,108,560
170.315(f)(3). Health Agencies--
reportable laboratory
tests and values/
results.
35............................... Sec. Transmission to Cancer 683,200 1,366,400
170.315(f)(4). Registries.
36............................... Sec. Transmission to Public 640,500 1,281,000
170.315(f)(5). Health Agencies--case
reporting.
37............................... Sec. Transmission to Public 640,500 1,281,000
170.315(f)(6). Health Agencies--
antimicrobial use and
resistance reporting.
38............................... Sec. Transmission to Public 640,500 1,281,000
170.315(f)(7). Health Agencies--health
care surveys.
39............................... Sec. Automated Numerator 2,766,960 5,533,920
170.315(g)(1). Recording.
40............................... Sec. Automated Measure 9,684,360 19,368,720
170.315(g)(2). Calculation.
41............................... Sec. Safety-enhanced Design.. 4867800 9,735,600
170.315(g)(3).
42............................... Sec. Quality Management 9,803,920 19,607,840
170.315(g)(4). System.
43............................... Sec. Consolidated CDA 5,904,800 14,762,000
170.315(g)(6). Creation Performance.
44............................... Sec. Application Access to 7,381,000 14,762,000
170.315(g)(7). Common Clinical Data
Set.
45............................... Sec. Accessibility-Centered 1,225,490 2,450,980
170.315(g)(8). Design.
46............................... Sec. Direct Project.......... 0 427,000
170.315(h)(1).
47............................... Sec. Direct Project, Edge 0 213,500
170.315(h)(2). Protocol, and XDR/XDM.
----------------------------------------------------------------------------------------------------------------

Table 9--Total Development and Preparation Costs per Criterion for Health IT Developers--Criteria Not Associated
With the EHR Incentive Programs Stage 3
[``Stage 3 Criteria'']
----------------------------------------------------------------------------------------------------------------
Average cost estimates ($)
Certification criterion -------------------------------
Item No. CFR text name Average low Average high
($) ($)
----------------------------------------------------------------------------------------------------------------
1................................ Sec. Vital Signs, BMI, and 599,264 899,872
170.315(a)(6). Growth Charts.
2................................ Sec. Image Results........... 0 19,520
170.315(a)(13).
3................................ Sec. Patient List Creation... 0 19,520
170.315(a)(16).
4................................ Sec. Electronic Medication 0 19,520
170.315(a)(18). Administration Record.
5................................ Sec. Social, Psychological, 229,360 458,720
170.315(a)(21). and Behavioral Data.
6................................ Sec. Decision Support-- 384,544 769,088
170.315(a)(22). knowledge artifact.
7................................ Sec. Decision Support-- 223,504 447,008
170.315(a)(23). service.
8................................ Sec. Incorporate Laboratory 305,488 610,976
170.315(b)(4). Tests and Values/
Results.
9................................ Sec. Transmission of 351,360 702,720
170.315(b)(5). Laboratory Test Reports.

[[Page 16900]]

10............................... Sec. Data Segmentation for 439,200 878,400
170.315(b)(7). Privacy--send.
11............................... Sec. Data Segmentation for 439,200 878,400
170.315(b)(8). Privacy--receive.
12............................... Sec. Care Plan............... 292,800 488000
170.315(b)(9).
13............................... Sec. CQMs--import and 0 195,200
170.315(c)(2). calculate.
14............................... Sec. CQMs--filter............ 308,416 616,832
170.315(c)(4).
15............................... Sec. Accounting of 0 19,520
170.315(d)(9). Disclosures.
16............................... Sec. Accessibility Technology 780,800 1,366,400
170.315(g)(5). Compatibility.
17............................... Sec. SOAP Transport and 0 19,520
170.315(h)(3). Security Specification
and XDR/XDR for Direct
Messaging.
18............................... Sec. Healthcare Provider 117,120 234,240
170.315(h)(4). Directory--query
request.
19............................... Sec. Healthcare Provider 117,120 234,240
170.315(h)(5). Directory--query
response.
20............................... Sec. Electronic Submission of 976,000 1,952,000
170.315(i)(1). Medical Documentation.
----------------------------------------------------------------------------------------------------------------

ii. Overall Development and Preparation Costs Over a Four-Year Period
We estimate the development and preparation costs over a four-year
period because a four-year period aligns with our estimated publication
date for a subsequent final rule (Summer 2015) and the year in which
CMS proposes that participants in the EHR Incentive Programs must use
health IT certified to the 2015 Edition (2018) (see the EHR Incentive
Programs Stage 3 proposed rule published elsewhere in this issue of the
Federal Register).
In total, we estimate the overall costs to develop and prepare
health IT for certification over a four-year period to be $197.43
million to $407.20 million, with a cost mid-point of approximately
$302.32 million. Evenly distributed over calendar years 2015 through
2018, the cost range would be $49.36 million to $101.80 per year with
an annual cost mid-point of approximately $75.58. However, we project
these costs to be unevenly distributed. We estimate the distribution as
follows: 2015 (25%); 2016 (30%); 2017 (30%); and 2018 (15%). We reached
this distribution based on these assumptions and information:
We expect a subsequent 2015 Edition final rule to be
published in the summer of 2015 and for health IT developers to spend
the rest of the year preparing and developing their health IT to meet
the 2015 Edition.
We expect health IT developers to aggressively work in
2016 and 2017 to prepare and develop their health IT to meet the 2015
Edition as the compliance date for the EHR Incentive Programs CEHRT
definition draws near (i.e., 2018) and because health IT certified to
the 2015 Edition could be used in 2017 under the EHR Incentive Programs
Stage 3 proposal for the CEHRT definition.
We expect health IT developers to continue to prepare and
develop health IT to the 2015 Edition in 2018 based on their approach
to the 2014 Edition.
Table 10 below represents the costs attributable to this proposed
rule distributed as discussed above. The dollar amounts expressed in
Table 10 are expressed in 2013 dollars.

Table 10--Distributed Total Development and Preparation Costs for Health IT Developers (4-Year Period)--Totals
Rounded
----------------------------------------------------------------------------------------------------------------
Total high Total average
Year Ratio (%) Total low cost cost estimate cost estimate
estimate ($M) ($M) ($M)
----------------------------------------------------------------------------------------------------------------
2015.............................................. 25 49.36 101.80 75.58
2016.............................................. 30 59.23 122.16 90.70
2017.............................................. 30 59.23 122.16 90.70
2018.............................................. 15 29.61 61.08 45.35
--------------------------------------------------
4-Year Totals................................. ......... 197.43 407.20 302.32
----------------------------------------------------------------------------------------------------------------

iii. Testing and Certification Costs for the 2015 Edition
In the RIA of the Permanent Certification Program final rule, we
estimated the costs for testing and certification of technologies that
would be used for providers to attempt to achieve EHR Incentive
Programs Stages 1-3.\267\ These costs were based on the requirements of
the certification program and a two-year rulemaking cycle for the CEHRT
definition and each EHR Incentive Programs stage. We believe the costs
we attributed to testing and certification of technologies in support
of EHR Incentive Programs Stage 2 in the Permanent Certification
Program final rule would encompass the actual testing and certification
of technologies to both the 2014 and 2015 Editions. This assessment is
based on the number of technologies currently certified to the 2014
Edition and our projections in this proposed rule for the number of
technologies that would likely be tested and certified to the 2015
Edition. Further, we note that the estimated costs in the Permanent
Certification Program final rule included costs for surveillance of
technologies and also estimated the costs for testing and certification
above what we understand are the cost ranges

[[Page 16901]]

charged by ONC-ACBs today. We welcome comments on our determination and
our cost estimates.
---------------------------------------------------------------------------

\267\ 76 FR 1318
---------------------------------------------------------------------------

b. Benefits
We believe that there will be several significant benefits that may
arise from this proposed rule for patients, health care providers, and
health IT developers. The 2015 Edition continues to improve health IT
interoperability through the adoption of new and updated standards and
implementation specifications. For example, many proposed certification
criteria include standards and implementation specifications for
interoperability that directly support the EHR Incentive Programs,
which include objectives and measures for the interoperable exchange of
health information and for providing patients electronic access to
their health information in structured formats. In addition, proposed
certification criteria that support the collection of patient data that
could be used to address health disparities would not only benefit
patients, but the entire health care delivery system through improved
quality of care. The 2015 Edition also supports usability and patient
safety through new and enhanced certification requirements for health
IT.
Our proposals to make the ONC Health IT Certification Program open
and accessible to more types of health IT and for health IT that
supports a variety of care and practice settings should benefit health
IT developers, providers practicing in other care/practice settings,
and consumers through the availability and use of certified health IT
that includes capabilities that promote interoperability and enhanced
functionality.\268\
---------------------------------------------------------------------------

\268\ We note that, in general, these benefits will be realized
only if health care providers actually adopt new technology. As
discussed elsewhere in this RIA, we believe that such adoption--and
thus the benefits noted in this section--would be overwhelmingly
attributable to CMS's proposed rulemaking.
---------------------------------------------------------------------------

We welcome comment on other benefits, including monetary savings,
which could be achieved through the proposals we have put forth in this
proposed rule.
2. Regulatory Flexibility Act (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small businesses if a rule has a significant impact on a substantial
number of small entities.
The Small Business Administration (SBA) establishes the size of
small businesses for federal government programs based on average
annual receipts or the average employment of a firm. While health IT
developers that pursue certification under the ONC Health IT
Certification Program represent a small segment of the overall
information technology industry, we believe that the entities impacted
by this proposed rule most likely fall under the North American
Industry Classification System (NAICS) code 541511 ``Custom Computer
Programming Services'' specified at 13 CFR 121.201 where the SBA
publishes ``Small Business Size Standards by NAICS Industry.'' The SBA
size standard associated with this NAICS code is set at $27.5 million
in annual receipts \269\ which ``indicates the maximum allowed for a
concern and its affiliates to be considered small entities.''
---------------------------------------------------------------------------

\269\ The SBA references that annual receipts means ``total
income'' (or in the case of a sole proprietorship, ``gross income'')
plus ``cost of goods sold'' as these terms are defined and reported
on Internal Revenue Service tax return forms. http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf
---------------------------------------------------------------------------

Based on our analysis, we believe that there is enough data
generally available to establish that between 75% and 90% of entities
that are categorized under the NAICS code 541511 are under the SBA size
standard, but note that the available data does not show how many of
these entities will develop a health IT product that will be certified
to the 2015 Edition under the ONC Health IT Certification Program. We
also note that with the exception of aggregate business information
available through the U.S. Census Bureau and the SBA related to NAICS
code 541511, it appears that many health IT developers that pursue
certification under the ONC Health IT Certification Program are
privately held or owned and do not regularly, if at all, make their
specific annual receipts publicly available. As a result, it is
difficult to locate empirical data related to many of these health IT
developers to correlate to the SBA size standard. However, although not
correlated to the size standard for NAICS code 541511, we do have
information indicating that over 60% of health IT developers that have
had Complete EHRs and/or EHR Modules certified to the 2011 Edition have
less than 51 employees.
We estimate that this proposed rule would have effects on health IT
developers that are likely to pursue certification under the ONC Health
IT Certification Program, some of which may be small entities. However,
we believe that we have proposed the minimum amount of requirements
necessary to accomplish our policy goals, including a reduction in
regulatory burden and additional flexibility for the regulated
community, and that no additional appropriate regulatory alternatives
could be developed to lessen the compliance burden associated with this
proposed rule. We note that this proposed rule does not impose the
costs cited in the RIA as compliance costs, but rather as investments
which these health IT developers voluntarily take on and expect to
recover with an appropriate rate of return. Accordingly, we do not
believe that the proposed rule will create a significant impact on a
substantial number of small entities, but request comment on whether
there are small entities that we have not identified that may be
affected in a significant way by this proposed rule. Additionally, the
Secretary certifies that this proposed rule will not have a significant
impact on a substantial number of small entities.
3. Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has federalism
implications. Nothing in this proposed rule imposes substantial direct
compliance costs on state and local governments, preempts state law or
otherwise has federalism implications. We are not aware of any State
laws or regulations that are contradicted or impeded by any of the
standards, implementation specifications, or certification criteria
that we propose for adoption.
4. Unfunded Mandates Reform Act of 1995
Section 202 of the Unfunded Mandates Reform Act of 1995 requires
that agencies assess anticipated costs and benefits before issuing any
rule whose mandates require spending in any one year of $100 million in
1995 dollars, updated annually for inflation. The current inflation-
adjusted statutory threshold is approximately $141 million. This
proposed rule will not impose an unfunded mandate on State, local, and
tribal governments or on the private sector that will reach the
threshold level.
OMB reviewed this proposed rule.

List of Subjects in 45 CFR Part 170

Computer technology, Electronic health record, Electronic
information system, Electronic transactions, Health, Health care,
Health information technology, Health insurance, Health records,
Hospitals, Incorporation by

[[Page 16902]]

reference, Laboratories, Medicaid, Medicare, Privacy, Reporting and
recordkeeping requirements, Public health, Security.

For the reasons set forth in the preamble, 45 CFR subtitle A,
subchapter D, part 170, is proposed to be amended as follows:

PART 170--HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION
SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION
PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY

0
1. The authority citation for part 170 continues to read as follows:

Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 5 U.S.C.
552.

0
2. Amend Sec. 170.102 by:
0
a. Removing the ``Base EHR'', ``Certified EHR Technology'', ``Common MU
Data Set'', and ``EHR Module'' definitions; and
0
b. Adding in alphanumeric order the definitions for ``2014 Edition Base
EHR'', ``2015 Edition Base EHR'', ``2015 Edition health IT
certification criteria'', ``Common Clinical Data Set'', ``Device
identifier'', ``Global Unique Device Identification Database (GUDID)'',
``Health IT Module'', ``Implantable device'', ``Production
identifier'', and ``Unique device identifier''.
The revisions read as follows:

Sec. 170.102 Definitions.

2014 Edition Base EHR means an electronic record of health-related
information on an individual that:
(1) Includes patient demographic and clinical health information,
such as medical history and problem lists;
(2) Has the capacity:
(i) To provide clinical decision support;
(ii) To support physician order entry;
(iii) To capture and query information relevant to health care
quality;
(iv) To exchange electronic health information with, and integrate
such information from other sources;
(v) To protect the confidentiality, integrity, and availability of
health information stored and exchanged; and
(3) Has been certified to the certification criteria adopted by the
Secretary:
(i) For at least one of the four criteria adopted at Sec.
170.314(a)(1), (18), (19), or (20);
(ii) At Sec. 170.314(a)(3);
(iii) At Sec. 170.314(a)(5) through (8);
(iv) Both Sec. 170.314(b)(1) and (2); or, both Sec. 170.314(b)(8)
and (h)(1); or Sec. 170.314(b)(1) and (2) combined with either Sec.
170.314(b)(8) or (h)(1), or both Sec. 170.314(b)(8) and (h)(1);
(v) At Sec. 170.314(b)(7);
(vi) At Sec. 170.314(c)(1) through (3);
(vii) At Sec. 170.314(d)(1) through (8);
(4) Has been certified to the certification criteria at Sec.
170.314(c)(1) and (2):
(i) For no fewer than 9 clinical quality measures covering at least
3 domains from the set selected by CMS for eligible professionals,
including at least 6 clinical quality measures from the recommended
core set identified by CMS; or
(ii) For no fewer than 16 clinical quality measures covering at
least 3 domains from the set selected by CMS for eligible hospitals and
critical access hospitals.
* * * * *
2015 Edition Base EHR means an electronic record of health-related
information on an individual that:
(1) Includes patient demographic and clinical health information,
such as medical history and problem lists;
(2) Has the capacity:
(i) To provide clinical decision support;
(ii) To support physician order entry;
(iii) To capture and query information relevant to health care
quality;
(iv) To exchange electronic health information with, and integrate
such information from other sources; and
(3) Has been certified to the certification criteria adopted by the
Secretary at Sec. 170.315(a)(1), (2), or (3); (a)(5); (a)(7) through
(10); (a)(12); (a)(20); (b)(1) and (6); (c)(1); (g)(7) and (h)(1) or
(2);
(4) [Reserved]
2015 Edition health IT certification criteria means the
certification criteria at Sec. 170.315.
* * * * *
Common Clinical Data Set means the following data expressed, where
indicated, according to the specified standard(s):
(1) Patient name. For certification to both the 2014 Edition EHR
certification criteria and the 2015 Edition health IT certification
criteria.
(2) Sex. (i) No required standard for certification to the 2014
Edition EHR certification criteria.
(ii) The standard specified in Sec. 170.207(n)(1) for
certification to the 2015 Edition health IT certification criteria.
(3) Date of birth. For certification to both the 2014 Edition EHR
certification criteria and the 2015 Edition health IT certification
criteria.
(4) Race. (i) The standard specified in Sec. 170.207(f)(1) for
certification to the 2014 Edition EHR certification criteria.
(ii) For certification to the 2015 Edition health IT certification
criteria:
(A) The standard specified in Sec. 170.207(f)(2);
(B) The standard specified in Sec. 170.207(f)(1) for each race
identified in accordance Sec. 170.207(f)(2).
(5) Ethnicity. (i) The standard specified in Sec. 170.207(f)(1)
for certification to the 2014 Edition EHR certification criteria.
(ii) For certification to the 2015 Edition health IT certification
criteria:
(A) The standard specified in Sec. 170.207(f)(2);
(B) The standard specified in Sec. 170.207(f)(1) for each
ethnicity identified in accordance Sec. 170.207(f)(2).
(6) Preferred language. (i) The standard specified in Sec.
170.207(g)(1) for certification to the 2014 Edition EHR certification
criteria.
(ii) The standard specified in Sec. 170.207(g)(2) for
certification to the 2015 Edition Health IT certification criteria.
(7) Smoking status. For certification to both the 2014 Edition EHR
certification criteria and the 2015 Edition health IT certification
criteria: The standard specified in Sec. 170.207(h).
(8) Problems. (i) At a minimum, the standard specified in Sec.
170.207(a)(3) for certification to the 2014 Edition EHR certification
criteria.
(ii) At a minimum, the standard specified in Sec. 170.207(a)(4)
for certification to the 2015 Edition Health IT certification criteria.
(9) Medications. (i) At a minimum, the standard specified in Sec.
170.207(d)(2) for certification to the 2014 Edition EHR certification
criteria.
(ii) At a minimum, the standard specified in Sec. 170.207(d)(3)
for certification to the 2015 Edition Health IT certification criteria.
(10) Medication allergies. (i) At a minimum, the standard specified
in Sec. 170.207(d)(2) for certification to the 2014 Edition EHR
certification criteria.
(ii) At a minimum, the standard specified in Sec. 170.207(d)(3)
for certification to the 2015 Edition Health IT certification criteria.
(11) Laboratory test(s). (i) At a minimum, the standard specified
in Sec. 170.207(c)(2) for certification to the 2014 Edition EHR
certification criteria.
(ii) At a minimum, the standard specified in Sec. 170.207(c)(3)
for certification to the 2015 Edition Health IT certification criteria.
(12) Laboratory value(s)/result(s). For certification to both the
2014 Edition EHR certification criteria and the 2015 Edition health IT
certification criteria.
(13) Vital signs. (i) Height/length, weight, blood pressure, and
BMI for

[[Page 16903]]

certification to the 2014 Edition EHR certification criteria.
(ii) For certification to the 2015 Edition Health IT certification
criteria:
(A) The patient's body height, body weight measured, diastolic
blood pressure, systolic blood pressure, heart rate, respiratory rate,
body temperature, oxygen saturation in arterial blood by pulse
oximetry, body mass index (ratio), and mean blood pressure must be
recorded in numerical values only;
(B) In accordance with the standard specified in Sec.
170.207(k)(1) and with the associated applicable unit of measure for
the vital sign in the standard specified in Sec. 170.207(m)(1); and
including
(1) Date and time of vital sign measurement or end time of vital
sign measurement;
(2) The measuring- or authoring-type source of the vital sign
measurement; and
(3) Optional. Date and time of vital sign measurement or end time
of vital sign measurement in accordance with the standard in Sec.
170.210(g).
(14) Care plan field(s), including goals and instructions. For
certification to the 2014 Edition EHR certification criteria.
(15) Procedures--
(i)(A) At a minimum, the version of the standard specified in Sec.
170.207(a)(3) for certification to the 2014 Edition EHR certification
criteria and Sec. 170.207(a)(4) for certification to the 2015 Edition
health IT certification criteria, or Sec. 170.207(b)(2); or
(B) For technology primarily developed to record dental procedures,
the standard specified in Sec. 170.207(b)(3) for certification to both
the 2014 Edition EHR certification criteria and the 2015 Edition health
IT certification criteria.
(ii) Optional. The standard specified at Sec. 170.207(b)(4) for
certification to both the 2014 Edition EHR certification criteria and
the 2015 Edition health IT certification criteria.
(16) Care team member(s). For certification to both the 2014
Edition EHR certification criteria and the 2015 Edition health IT
certification criteria.
(17) Immunizations. In accordance with, at a minimum, the standards
specified in Sec. 170.207(e)(3) and (4) for certification to the 2015
Edition health IT certification criteria.
(18) Unique device identifier(s) for a patient's implantable
device(s). For certification to the 2015 Edition health IT
certification criteria.
(19) Assessment and plan of treatment. For certification to the
2015 Edition health IT certification criteria:
(i) In accordance with the ``Assessment and Plan Section (V2)'' of
the standard specified in Sec. 170.205(a)(4); or
(ii) In accordance with the ``Assessment Section (V2)'' and ``Plan
of Treatment Section (V2)'' of the standard specified in Sec.
170.205(a)(4).
(20) Goals. In accordance with the ``Goals Section'' of the
standard specified in Sec. 170.205(a)(4) for certification to the 2015
Edition health IT certification criteria.
(21) Health concerns. In accordance with the ``Health Concerns
Section'' of the standard specified in Sec. 170.205(a)(4) for
certification to the 2015 Edition health IT certification criteria.
* * * * *
Device identifier is defined as it is in 21 CFR 801.3.
* * * * *
Global Unique Device Identification Database (GUDID) is defined as
it is in 21 CFR 801.3.
Health IT Module means any service, component, or combination
thereof that can meet the requirements of at least one certification
criterion adopted by the Secretary.
* * * * *
Implantable device is defined as it is in 21 CFR 801.3.
* * * * *
Production identifier is defined as it is in 21 CFR 801.3.
* * * * *
Unique device identifier is defined as it is in 21 CFR 801.3.

Sec. 170.200 [Amended]

0
3. In Sec. 170.200, remove the term ``EHR Modules'' and add in its
place ``Health IT Modules.''
0
4. In Sec. 170.202, revise the section heading and add paragraphs (e)
and (f) to read as follows:

Sec. 170.202 Transport standards and other protocols.

* * * * *
(e) Delivery notification--(1) Standard. ONC Implementation Guide
for Delivery Notification in Direct.
(2) [Reserved]
(f) Provider directories--(1) Standard. Healthcare Provider
Directory, Trial Implementation, October 13, 2014.
(2) [Reserved]
0
5. Amend Sec. 170.204 by--
0
a. Revising paragraphs (a) and (b)(2); and
0
b. Adding paragraphs (b)(3) and (4), (d), and (e).
The additions and revisions read as follows:

Sec. 170.204 Functional standards.

* * * * *
(a) Accessibility--(1) Standard. Web Content Accessibility
Guidelines (WCAG) 2.0, Level A Conformance (incorporated by reference
in Sec. 170.299).
(2) [Reserved]
(b) * * *
(2) Implementation specifications. HL7 Implementation Guide:
Service-Oriented Architecture Implementations of the Context-aware
Knowledge Retrieval (Infobutton) Domain, Draft Standard for Trial Use,
Release 1.
(3) Standard. HL7 Version 3 Standard: Context Aware Knowledge
Retrieval Application. (``Infobutton''), Knowledge Request, Release 2.
Implementation specifications. HL7 Implementation Guide: Service-
Oriented Architecture Implementations of the Context-aware Knowledge
Retrieval (Infobutton) Domain, Release 1.
(4) Standard. HL7 Version 3 Standard: Context Aware Knowledge
Retrieval Application (``Infobutton''), Knowledge Request, Release 2.
Implementation specifications. HL7 Version 3 Implementation Guide:
Context-Aware Knowledge Retrieval (Infobutton), Release 4.
* * * * *
(d) Clinical decision support knowledge artifacts--(1) Standard.
HL7 Version 3 Standard: Clinical Decision Support Knowledge Artifact
Specification, Release 1.2, Draft Standard for Trial Use.
(2) [Reserved]
(e) Clinical decision support service. (1) HL7 Implementation
Guide: Decision Support Service, Release 1.1, US Realm, Draft Standard
for Trial Use.
(2) [Reserved]
0
6. Amend Sec. 170.205 by--
0
a. Adding paragraphs (a)(4) and (5), (d)(4), and (e)(4);
0
b. Revising paragraphs (g), (i), and (j); and
0
c. Adding paragraphs (l), (m), (n), (o), (p), (q), (r), and (s).
The additions and revisions read as follows:

Sec. 170.205 Content exchange standards and implementation
specifications for exchanging electronic health information.

* * * * *
(a) * * *
(4) Standard. HL7 Implementation Guide for CDA[supreg] Release 2:
Consolidated CDA Templates for Clinical Notes, Draft Standard for Trial
Use, Release 2.0.
(5) Implementation specifications. (i) HL7 Implementation Guide for
CDA[supreg] Release 2: Additional CDA R2 Templates--Clinical Documents
for Payers--Set 1, Release 1--US Realm.
(ii) HL7 Implementation Guide for CDA Release 2: Digital Signatures
and Delegation of Rights, Release 1.
(iii) Author of Record Level 1: Implementation Guide.
(iv) Provider Profiles Authentication: Registration Implementation
Guide.
* * * * *

[[Page 16904]]

(d) * * *
(4) Standard. HL7 2.5.1 (incorporated by reference in Sec.
170.299). Implementation specifications. PHIN Messaging Guide for
Syndromic Surveillance: Emergency Department, Urgent, Ambulatory Care,
and Inpatient Settings, Release 2.0.
(e) * * *
(4) Standard. HL7 2.5.1 (incorporated by reference in Sec.
170.299). Implementation specifications. HL7 2.5.1 Implementation Guide
for Immunization Messaging, Release 1.5.
* * * * *
(g) Electronic transmission of lab results to public health
agencies--(1) Standard. HL7 2.5.1 (incorporated by reference in Sec.
170.299). Implementation specifications. HL7 Version 2.5.1
Implementation Guide: Electronic Laboratory Reporting to Public Health,
Release 1 (incorporated by reference in Sec. 170.299) with Errata and
Clarifications, (incorporated by reference in Sec. 170.299) and ELR
2.5.1 Clarification Document for EHR Technology Certification
(incorporated by reference in Sec. 170.299).
(2) Standard. HL7 2.5.1 (incorporated by reference in Sec.
170.299). Implementation specifications. HL7 Version 2.5.1
Implementation Guide: Electronic Laboratory Reporting to Public Health,
Release 2 (US Realm), Draft Standard for Trial Use, Release 1.1.
* * * * *
(i) Cancer information--(1) Standard. HL7 Clinical Document
Architecture (CDA), Release 2.0, Normative Edition (incorporated by
reference in Sec. 170.299). Implementation specifications.
Implementation Guide for Ambulatory Healthcare Provider Reporting to
Central Cancer Registries, HL7 Clinical Document Architecture (CDA),
Release 1.0 (incorporated by reference in Sec. 170.299).
(2) Standard. HL7 Clinical Document Architecture (CDA), Release
2.0, Normative Edition (incorporated by reference in Sec. 170.299).
Implementation specifications. HL7 Implementation Guide for CDA
(copyright) Release 2: Reporting to Public Health Cancer Registries
from Ambulatory Healthcare Providers, Release 1.
(j) Electronic incorporation and transmission of lab results--(1)
Standard. HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab
Results Interface (incorporated by reference in Sec. 170.299).
(2) Standard. HL7 Version 2.5.1 Implementation Guide: S&I Framework
Lab Results Interface, Draft Standard for Trial Use, Release 2--US
Realm (S&I Framework LRI).
* * * * *
(l) Laboratory orders--(1) Standard. HL7 Version 2.5.1
Implementation Guide: S&I Framework Laboratory Orders from EHR, Draft
Standard for Trial Use, Release 2--US Realm.
(2) Standard. HL7 Version 2.5.1 Implementation Guide: S&I Framework
Laboratory Test Compendium Framework, Release 2, Version 1.2.
(m) Family health history. (1) HL7 Version 3 Standard: Clinical
Genomics; Pedigree (incorporated by reference in Sec. 170.299).
Implementation specifications. HL7 Version 3 Implementation Guide:
Family History/Pedigree Interoperability.
(2) [Reserved]
(n) Drug formulary checking--(1) Standard. The standard specified
at 42 CFR 423.160(b)(5)(iii).
(2) [Reserved]
(o) Data segmentation for privacy--(1) Standard. HL7 Implementation
Guide: Data Segmentation for Privacy (DS4P), Release 1.
(2) [Reserved]
(p) XDM package processing--(1) Standard. IHE IT Infrastructure
Technical Framework Volume 2b (ITI TF-2b).
(2) [Reserved]
(q) Public health--case reporting information--(1) Standard. IHE
Quality, Research, and Public Health Technical Framework Supplement,
Structured Data Capture, Trial Implementation.
(2) [Reserved]
(r) Public health--antimicrobial use and resistance information--
(1) Standard. The following sections of HL7 Implementation Guide for
CDA[supreg] Release 2--Level 3: Healthcare Associated Infection
Reports, Release 1, U.S. Realm. Technology is only required to conform
to the following sections of the implementation guide:
(i) HAI Antimicrobial Use and Resistance (AUR) Antimicrobial
Resistance Option (ARO) Report (Numerator) specific document template
in Section 2.1.2.1 (pages 69-72);
(ii) Antimicrobial Resistance Option (ARO) Summary Report
(Denominator) specific document template in Section 2.1.1.1 (pages 54-
56); and
(iii) Antimicrobial Use (AUP) Summary Report (Numerator and
Denominator) specific document template in Section 2.1.1.2 (pages 56-
58).
(2) [Reserved]
(s) Public health--health care survey information--(1) Standard.
HL7 Implementation Guide for CDA Release 2: National Health Care
Surveys (NHCS), Release 1--US Realm, Draft Standard for Trial Use.
(2) [Reserved]
0
7. Amend Sec. 170.207 by--
0
a. Adding paragraphs (a)(4), (c)(3), (d)(3), (e)(3) and (4);
0
b. Revising paragraphs (f) and (g); and
0
c. Adding paragraph (k), reserved paragraph (l), and paragraphs (m),
(n), and (o).
The additions and revisions read as follows:

Sec. 170.207 Vocabulary standards for representing electronic health
information.

* * * * *
(a) * * *
(4) Standard. IHTSDO SNOMED CT[supreg], U.S. Edition, September
2014 Release.
* * * * *
(c) * * *
(3) Standard. Logical Observation Identifiers Names and Codes
(LOINC[supreg]) Database version 2.50, a universal code system for
identifying laboratory and clinical observations produced by the
Regenstrief Institute, Inc.
(d) * * *
(3) Standard. RxNorm, a standardized nomenclature for clinical
drugs produced by the United States National Library of Medicine,
February 2, 2014 Release.
(e) * * *
(3) Standard. HL7 Standard Code Set CVX--Vaccines Administered,
updates through February 2, 2015.
(4) Standard. National Drug Code Directory--Vaccine Codes, updates
through January 15, 2015.
(f) Race and Ethnicity--(1) Standard. The Office of Management and
Budget Standards for Maintaining, Collecting, and Presenting Federal
Data on Race and Ethnicity, Statistical Policy Directive No. 15, as
revised, October 30, 1997.
(2) Standard. ``Race & Ethnicity--CDC'' code system in the PHIN
Vocabulary Access and Distribution System (VADS), Release 3.3.9.
(g) Preferred language--(1) Standard. As specified by the Library
of Congress, ISO 639-2 alpha-3 codes limited to those that also have a
corresponding alpha-2 code in ISO 639-1 (incorporated by reference in
Sec. 170.299).
(2) Standard. Request for Comments (RFC) 5646.
* * * * *
(k) Vital signs--(1) Standard. Vital signs must be identified, at a
minimum, with the version of LOINC[supreg] codes adopted at paragraph
(c)(3) of this section attributed as follows:
(i) Systolic blood pressure. 8480-6
(ii) Diastolic blood pressure. 8462-4
(iii) Body height. 8302-2
(iv) Body weight measured. 3141-9

[[Page 16905]]

(v) Heart rate. 8867-4
(vi) Respiratory rate. 9279-1
(vii) Body temperature. 8310-5
(viii) Oxygen saturation in arterial blood by pulse oximetry.
59408-5
(ix) Body mass index (BMI) [ratio]. 39156-5
(x) Mean blood pressure. 8478-0
(2) [Reserved]
(l) [Reserved]
(m) Numerical references--(1) Standard. The Unified Code of Units
of Measure, Revision 1.9.
(2) [Reserved]
(n) Sex--(1) Standard. Birth sex must be coded in accordance with
HL7 Version 3 attributed as follows:
(i) Male. M
(ii) Female. F
(iii) Unknown. UNK
(2) [Reserved]
(o) Social, psychological, and behavioral data--(1) Standard.
Sexual orientation must be coded in accordance with, at a minimum, the
version of SNOMED CT[supreg] codes adopted at paragraph (a)(4) of this
section for paragraphs (o)(1)(i) through (iii) of this section and HL7
Version 3 for paragraphs (o)(1)(iv) through (vi) of this section,
attributed as follows:
(i) Homosexual. 38628009
(ii) Heterosexual. 20430005
(iii) Bisexual. 42035005
(iv) Other. nullFlavor OTH
(v) Asked but unknown. nullFlavor ASKU
(vi) Unknown. nullFlavor UNK
(2) Standard. Gender identity must be coded in accordance with, at
a minimum, the version of SNOMED CT[supreg] codes adopted at paragraph
(a)(4) of this section for paragraphs (o)(2)(i) through (v) of this
section and HL7 Version 3 for paragraphs (o)(2)(vi) and (vii) of this
section, attributed as follows:
(i) Identifies as male gender. 446151000124109
(ii) Identifies as female gender. 446141000124107
(iii) Female-to-male transsexual. 407377005
(iv) Male[hyphen]to[hyphen]female transsexual. 407376001
(v) Identifies as non-conforming gender. 446131000124102
(vi) Other. nullFlavor OTH
(vii) Asked but unknown. nullFlavor ASKU
(3) Financial resource strain. Financial resource strain must be
coded in accordance with, at a minimum, the version of LOINC[supreg]
codes adopted at paragraph (c)(3) of this section and attributed with
the LOINC[supreg] code and LOINC[supreg] answer list ID.
(4) Education. Education must be coded in accordance with, at a
minimum, the version of LOINC[supreg] codes adopted at paragraph (c)(3)
of this section and attributed with LOINC[supreg] code 63504-5 and
LOINC[supreg] answer list ID LL1069-5.
(5) Stress. Stress must be coded in accordance with, at a minimum,
the version of LOINC[supreg] codes adopted at paragraph (c)(3) of this
section and attributed with the LOINC[supreg] code and LOINC[supreg]
answer list ID.
(6) Depression. Depression must be coded in accordance with, at a
minimum, the version of LOINC[supreg] codes adopted at paragraph (c)(3)
of this section and attributed with LOINC[supreg] codes 55757-9, 44250-
9 (with LOINC[supreg] answer list ID LL358-3), 44255-8 (with
LOINC[supreg] answer list ID LL358-3), and 55758-7 (with the answer
coded with the associated applicable unit of measure in the standard
specified in Sec. 170.207(m)(1)).
(7) Physical activity. Physical activity must be coded in
accordance with, at a minimum, the version of LOINC[supreg] codes
adopted at paragraph (c)(3) of this section and attributed with
LOINC[supreg] codes 68515-6 and 68516-4. The answers must be coded with
the associated applicable unit of measure in the standard specified in
Sec. 170.207(m)(1).
(8) Alcohol use. Alcohol use must be coded in accordance with, at a
minimum, the version of LOINC[supreg] codes adopted at paragraph (c)(3)
of this section and attributed with LOINC[supreg] codes 72109-2, 68518-
0 (with LOINC[supreg] answer list ID LL2179-1), 68519-8 (with
LOINC[supreg] answer list ID LL2180-9), 68520-6 (LOINC[supreg] answer
list ID LL2181-7), and 75626-2.
(9) Social connection and isolation. Social connection and
isolation must be coded in accordance with, at a minimum, the version
of LOINC[supreg] codes adopted at paragraph (c)(3) of this section and
attributed with the LOINC[supreg] code and LOINC[supreg] answer list
ID.
(10) Exposure to violence (intimate partner violence). Exposure to
violence: intimate partner violence must be coded in accordance with,
at a minimum, the version of LOINC[supreg] codes adopted at paragraph
(c)(3) of this section and attributed with the LOINC[supreg] code and
LOINC[supreg] answer list ID.
0
8. In Sec. 170.210:
0
a. Amend paragraphs (e)(1)(i) and (e)(3) by removing the term ``EHR
technology'' and adding in its place ``health IT''; and
0
b. Add paragraph (a)(3).
The addition reads as follows:

Sec. 170.210 Standards for health information technology to protect
electronic health information created, maintained, and exchanged.

* * * * *
(a) * * *
(3) General. Any encryption algorithm identified by the National
Institute of Standards and Technology (NIST) as an approved security
function in Annex A of the Federal Information Processing Standards
(FIPS) Publication 140-2, October 8, 2014.
* * * * *
0
9. In Sec. 170.300, revise paragraph (d) to read as follows:

Sec. 170.300 Applicability.

* * * * *
(d) In Sec. Sec. 170.314 and 170.315, all certification criteria
and all capabilities specified within a certification criterion have
general applicability (i.e., apply to any health care setting) unless
designated as ``inpatient setting only'' or ``ambulatory setting
only.''
(1) Inpatient setting only means that the criterion or capability
within the criterion is only required for certification of technology
designed for use in an inpatient setting.
(2) Ambulatory setting only means that the criterion or capability
within the criterion is only required for certification of technology
designed for use in an ambulatory setting.

Sec. 170.314 [Amended]

0
10. In Sec. 170.314:
0
a. In paragraph (a)(3)(i)(A), remove ``Sec. 170.207(f)'' and add in
its place ``Sec. 170.207(f)(1)'';
0
b. In paragraph (a)(3)(i)(B), remove ``Sec. 170.207(g)'' and add in
its place ``Sec. 170.207(g)(1)'';
0
c. In paragraph (a)(8)(iii)(B)(2), remove ``paragraph (b)(1)(iii)'' and
add in its place ``paragraph (b)(1)(iii)(B) or (b)(9)(ii)(D)'';
0
d. In paragraphs (b)(2)(i) introductory test, (b)(7) introductory text,
(b)(8)(iii) introductory text, (e)(1)(i)(A)(1), and (e)(2)(iii)(A),
remove the term ``Common MU Data Set'' and add in its place ``Common
Clinical Data Set'';
0
e. In paragraph (b)(5)(i)(A)(1), remove ``Sec. 170.205(j)'' and add in
its place ``Sec. 170.205(j)(1)'';
0
f. In paragraph (b)(6), remove ``Sec. 170.205(j)'' and add in its
place ``Sec. 170.205(j)(1)'';
0
g. In paragraph (e)(1)(i)(A) introductory text, remove ``Sec.
170.204(a)'' and add in its place ``Sec. 170.204(a)(1)'';
0
h. In paragraph (f)(4)(i), remove ``Sec. 170.205(g)'' and add in its
place ``Sec. 170.205(g)(1)''; and
0
i. In paragraph (f)(6)(i), remove ``Sec. 170.205(i)'' and add in its
place '' Sec. 170.205(i)(1)''.
0
11. Add Sec. 170.315 to read as follows:

[[Page 16906]]

Sec. 170.315 2015 Edition health IT certification criteria.

The Secretary adopts the following certification criteria for
health IT. Health IT must be able to electronically perform the
following capabilities in accordance with all applicable standards and
implementation specifications adopted in this part:
(a) Clinical--(1) Computerized provider order entry--medications.
Technology must enable a user to record, change, and access medication
orders.
(2) Computerized provider order entry--laboratory. (i) Technology
must enable a user to record, change, and access laboratory orders.
(ii) Technology must be able to receive and incorporate a new or
updated laboratory order compendium in accordance with the standard
specified in Sec. 170.205(l)(2) and, at a minimum, the version of the
standard in Sec. 170.207(c)(3).
(iii) Ambulatory setting only. Technology must enable a user to
create laboratory orders for electronic transmission in accordance with
the standard specified in Sec. 170.205(l)(1) and, at a minimum, the
version of the standard in Sec. 170.207(c)(3).
(3) Computerized provider order entry--diagnostic imaging.
Technology must enable a user to record, change, and access diagnostic
imaging orders.
(4) Drug-drug, drug-allergy interaction checks for CPOE--(i)
Interventions. Before a medication order is completed and acted upon
during computerized provider order entry (CPOE), interventions must
automatically indicate to a user drug-drug and drug-allergy
contraindications based on a patient's medication list and medication
allergy list.
(ii) Adjustments. (A) Enable the severity level of interventions
provided for drug-drug interaction checks to be adjusted.
(B) Limit the ability to adjust severity levels to an identified
set of users or available as a system administrative function.
(iii) Interaction check response documentation. (A) Technology must
be able to record at least one action taken and by whom in response to
drug-drug or drug-allergy interaction checks.
(B) Technology must be able to generate either a human readable
display or human readable report of actions taken and by whom in
response to drug-drug or drug-allergy interaction checks.
(5) Demographics. (i) Enable a user to record, change, and access
patient demographic data including preferred language, sex, race,
ethnicity, and date of birth.
(A) Race and ethnicity. (1) Enable each one of a patient's races to
be recorded in accordance with, at a minimum, the standard specified in
Sec. 170.207(f)(2) and whether a patient declines to specify race.
(2) Enable each one of a patient's ethnicities to be recorded in
accordance with, at a minimum, the standard specified in Sec.
170.207(f)(2) and whether a patient declines to specify ethnicity.
(3) Aggregate each one of the patient's races and ethnicities
recorded in accordance with paragraphs (a)(5)(i)(A)(1) and (2) of this
section to the categories in the standard specified in Sec.
170.207(f)(1).
(B) Enable preferred language to be recorded in accordance with the
standard specified in Sec. 170.207(g)(2) and whether a patient
declines to specify a preferred language.
(C) Enable sex to be recorded in accordance with the standard
specified in Sec. 170.207(n)(1).
(ii) Inpatient setting only. Enable a user to record, change, and
access the preliminary cause of death and date of death in the event of
mortality.
(6) Vital signs, body mass index, and growth charts--(i) Vital
signs. Enable a user to record, change, and access, at a minimum, a
patient's height, weight, diastolic blood pressure, systolic blood
pressure, heart rate, respiratory rate, temperature, oxygen saturation
in arterial blood by pulse oximetry, body mass index [ratio], and mean
blood pressure in accordance with the following (The patient's height/
length, weight, diastolic blood pressure, systolic blood pressure,
heart rate, respiratory rate, temperature, oxygen saturation in
arterial blood by pulse oximetry, body mass index [ratio], and mean
blood pressure must be recorded in numerical values only.):
(A) The standard specified in Sec. 170.207(k)(1) and with the
associated applicable unit of measure for the vital sign in the
standard specified in Sec. 170.207(m)(1);
(B) Metadata. For each vital sign in paragraph (a)(6)(i) of this
section, the technology must also record the following:
(1) Date and time of vital sign measurement or end time of vital
sign measurement;
(2) The measuring- or authoring-type source of the vital sign
measurement; and
(3) Optional. Date and time of vital sign measurement or end time
of vital sign measurement in accordance with the standard in Sec.
170.210(g); and
(C) Metadata for oxygen saturation in arterial blood by pulse
oximetry. For the oxygen saturation in arterial blood by pulse
oximetry, the technology must enable a user to record, change, and
access the patient's inhaled oxygen concentration identified, at a
minimum, with the version of the standard adopt in Sec. 170.207(c)(3)
and attributed with LOINC[supreg] code 8478-0.
(ii) Optional--Body mass index percentile per age and sex. Enable a
user to record, change, and access a patient's body mass index
[percentile] per age and sex for patients two to twenty years of age in
accordance with the following (The patient's body mass index
[percentile] per age and sex must be recorded in numerical values
only.):
(A) Identified, at a minimum, with the version of the standard
adopt in Sec. 170.207(c)(3) and attributed with LOINC[supreg] code
59576-9 and with the associated applicable unit of measure in the
standard specified in Sec. 170.207(m)(1); and
(B) Metadata. The technology must also record the following:
(1) Date and time of vital sign measurement or end time of vital
sign measurement;
(2) The measuring- or authoring-type source of the vital sign
measurement;
(3) The patient's date of birth;
(4) The patient's sex in accordance with the standard specified in
Sec. 170.207(n)(1); and
(5) Optional. Date and time of vital sign measurement or end time
of vital sign measurement in accordance with the standard in Sec.
170.210(g).
(iii) Optional--Weight for length per age and sex. Enable a user to
record, change, and access a patient's weight for length per age and
sex for patients less than three years of age in accordance with the
following (The patient's weight for length per age and sex must be
recorded in numerical values only.):
(A) Identified, at a minimum, with the version of the standard
adopt in Sec. 170.207(c)(3) and attributed with the LOINC[supreg] code
and with the associated applicable unit of measure in the standard
specified in Sec. 170.207(m)(1); and
(B) Metadata. The technology must record the following:
(1) Date and time of vital sign measurement or end time of vital
sign measurement;
(2) The measuring- or authoring-type source of the vital sign
measurement;
(3) The patient's date of birth;
(4) The patient's sex in accordance with the standard specified in
Sec. 170.207(n)(1); and
(5) Optional. Date and time of vital sign measurement or end time
of vital

[[Page 16907]]

sign measurement in accordance with the standard in Sec. 170.210(g).
(iv) Optional--Head occipital-frontal circumference. Enable a user
to record, change, and access a patient's head occipital-frontal
circumference for patients less than three years of age in accordance
with the following (The patient's head occipital-frontal circumference
must be recorded in numerical values only.):
(A) Identified, at a minimum, with the version of the standard
adopt in Sec. 170.207(c)(3) and attributed with LOINC[supreg] code
8287-5 and with the associated applicable unit of measure in the
standard specified in Sec. 170.207(m)(1); and
(B) Metadata. The technology must also record the following:
(1) Date and time of vital sign measurement or end time of vital
sign measurement;
(2) The measuring- or authoring-type source of the vital sign
measurement;
(3) The patient's date of birth;
(4) The patient's age in accordance with the standard specified in
Sec. 170.207(n)(1); and
(5) Optional. Date and time of vital sign measurement or end time
of vital sign measurement in accordance with the standard in Sec.
170.210(g).
(v) Optional--Calculate body mass index. Automatically calculate
and display body mass index based on a patient's height and weight.
(vi) Optional--Plot and display growth charts. Plot and display,
upon request, growth charts for patients.
(7) Problem list. Enable a user to record, change, and access a
patient's active problem list:
(i) Ambulatory setting. Over multiple encounters in accordance
with, at a minimum, the version of the standard specified in Sec.
170.207(a)(4); or
(ii) Inpatient setting. For the duration of an entire
hospitalization in accordance with, at a minimum, the version of the
standard specified in Sec. 170.207(a)(4).
(8) Medication list. Enable a user to record, change, and access a
patient's active medication list as well as medication history:
(i) Ambulatory setting. Over multiple encounters; or
(ii) Inpatient setting. For the duration of an entire
hospitalization.
(9) Medication allergy list. Enable a user to record, change, and
access a patient's active medication allergy list as well as medication
allergy history:
(i) Ambulatory setting. Over multiple encounters; or
(ii) Inpatient setting. For the duration of an entire
hospitalization.
(10) Clinical decision support--(i) Evidence-based decision support
interventions. Enable a limited set of identified users to select
(i.e., activate) one or more electronic clinical decision support
interventions (in addition to drug-drug and drug-allergy
contraindication checking) based on each one and at least one
combination of the following data:
(A) Problem list;
(B) Medication list;
(C) Medication allergy list;
(D) At least one demographic specified in paragraph (a)(5)(i) of
this section;
(E) Laboratory tests; and
(F) Vital signs.
(ii) Linked referential clinical decision support. (A) Technology
must be able to identify for a user diagnostic and therapeutic
reference information in accordance with the standard and
implementation specifications at Sec. 170.204(b)(3) or (4).
(B) For paragraph (a)(10)(ii)(A) of this section, technology must
be able to identify for a user diagnostic or therapeutic reference
information based on each one and at least one combination of the data
referenced in paragraphs (a)(10)(i)(A), (B), and (D) of this section.
(iii) Clinical decision support configuration. (A) Enable
interventions and reference resources specified in paragraphs
(a)(10)(i) and (ii) of this section to be configured by a limited set
of identified users (e.g., system administrator) based on a user's
role.
(B) Technology must enable interventions to be:
(1) Based on the data referenced in paragraphs (a)(10)(i)(A)
through (F) of this section.
(2) When a patient's medications, medication allergies, problems,
and laboratory tests and values/results are incorporated from a
transition of care/referral summary received and pursuant to paragraph
(b)(2)(iii)(D) of this section.
(3) Ambulatory setting only. When a patient's laboratory tests and
values/results are incorporated pursuant to paragraph (b)(4) of this
section.
(iv) CDS intervention interaction. Interventions provided to a user
in paragraphs (a)(10)(i) through (iii) of this section must occur when
a user is interacting with technology.
(v) Source attributes. Enable a user to review the attributes as
indicated for all clinical decision support resources:
(A) For evidence-based decision support interventions under
paragraph (a)(10)(i) of this section:
(1) Bibliographic citation of the intervention (clinical research/
guideline);
(2) Developer of the intervention (translation from clinical
research/guideline);
(3) Funding source of the intervention development technical
implementation; and
(4) Release and, if applicable, revision date(s) of the
intervention or reference source.
(B) For linked referential clinical decision support in paragraph
(a)(10)(ii) of this section and drug-drug, drug-allergy interaction
checks in paragraph (a)(4) of this section, the developer of the
intervention, and where clinically indicated, the bibliographic
citation of the intervention (clinical research/guideline).
(vi) Intervention response documentation. (A) Technology must be
able to record at least one action taken and by whom in response to
clinical decision support interventions.
(B) Technology must be able to generate either a human readable
display or human readable report of actions taken and by whom in
response to clinical decision support interventions.
(11) Drug-formulary and preferred drug list checks. Technology must
either meet paragraph (a)(11)(i) or (ii) of this section.
(i) Drug formulary checks. (A) Automatically check whether a drug
formulary exists for a given patient and medication.
(B) Indicate for a user the last update of the drug formulary; and
(C) Receive and incorporate a formulary and benefit file in
accordance with the standard specified in Sec. 170.205(n)(1).
(ii) Preferred drug list checks. (A) Automatically check whether a
preferred drug list exists for a given patient and medication.
(B) Indicate for a user the last update of the preferred drug list.
(12) Smoking status. Enable a user to record, change, and access
the smoking status of a patient in accordance with, at a minimum, the
version of the standard specified in Sec. 170.207(a)(4).
(13) Image results. Indicate to a user the availability of a
patient's images and narrative interpretations (relating to the
radiographic or other diagnostic test(s)) and enable electronic access
to such images and narrative interpretations.
(14) Family health history. Enable a user to record, change, and
access a patient's family health history in accordance with the
familial concepts or expressions included in, at a minimum, the version
of the standard in Sec. 170.207(a)(4).
(15) Family health history--pedigree. Technology must be able to
create and incorporate a patient's family health history in accordance
with the standard

[[Page 16908]]

and implementation specification specified in Sec. 170.205(m)(1).
(16) Patient list creation. Enable a user to dynamically select,
sort, access, and create patient lists by: date and time; and based on
each one and at least one combination of the following data:
(i) Problems;
(ii) Medications;
(iii) Medication allergies;
(iv) At least one demographic specified in paragraph (a)(5)(i) of
this section;
(v) Laboratory tests and values/results; and
(vi) Ambulatory setting only. Patient communication preferences.
(17) Patient-specific education resources. Technology must be able
to:
(i) Identify patient-specific education resources based on data
included in the patient's problem list and medication list in
accordance with the standard (and implementation specifications)
specified in Sec. 170.204(b)(3) or (4); and
(ii) Request that patient-specific education resources be
identified in accordance with the standard in Sec. 170.207(g)(2).
(18) Electronic medication administration record. (i) In
combination with an assistive technology that provides automated
information on the ``rights'' specified in paragraphs (a)(18)(i)(A)
through (E) of this section, enable a user to verify the following
before administering medication(s):
(A) Right patient. The patient to whom the medication is to be
administered matches the medication to be administered.
(B) Right medication. The medication to be administered matches the
medication ordered for the patient.
(C) Right dose. The dose of the medication to be administered
matches the dose of the medication ordered for the patient.
(D) Right route. The route of medication delivery matches the route
specified in the medication order.
(E) Right time. The time that the medication was ordered to be
administered compared to the current time.
(ii) Right documentation. Record the time and date in accordance
with the standard specified in Sec. 170.210(g), and user
identification when a medication is administered.
(19) Patient health information capture. Technology must be able to
enable a user to:
(i) Identify, record, and access patient health information
documents;
(ii) Reference and link to patient health information documents;
and
(iii) Record and access information directly shared by a patient.
(20) Implantable device list. (i) Enable a user to record, change,
and access, a list of Unique Device Identifiers associated with a
patient's Implantable Device(s).
(ii) Parse the following data elements from a Unique Device
Identifier:
(A) Device Identifier;
(B) Batch/lot number;
(C) Expiration date;
(D) Production date; and
(E) Serial number.
(iii) Retrieve the ``Device Description'' attribute associated with
a Unique Device Identifier in the Global Unique Device Identification
Database.
(iv) For each Unique Device Identifier in a patient's list of
implantable devices, enable a user to access the following:
(A) The parsed data elements specified under paragraph (a)(20)(ii)
of this section that are associated with the UDI; and
(B) The retrieved data element specified under paragraph
(a)(20)(iii) of this section.
(21) Social, psychological, and behavioral data. Enable a user to
record, change, and access, at a minimum, one of the following patient
social, psychological, and behavioral data.
(i) Sexual orientation. Enable sexual orientation to be recorded in
accordance with the standard specified in Sec. 170.207(o)(1) and
whether a patient declines to specify sexual orientation.
(ii) Gender identity. Enable gender identity to be recorded in
accordance with the standard specified in Sec. 170.207(o)(2) and
whether a patient declines to specify gender identity.
(iii) Financial resource strain. Enable financial resource strain
to be recorded in accordance with the standard specified in Sec.
170.207(o)(3) and whether a patient declines to specify financial
resource strain.
(iv) Education. Enable education to be recorded in accordance with
the standard specified in Sec. 170.207(o)(4) and whether a patient
declines to specify education.
(v) Stress. Enable stress to be recorded in accordance with the
standard specified in Sec. 170.207(o)(5) and whether a patient
declines to specify stress.
(vi) Depression. Enable depression to be recorded in accordance
with the standard specified in Sec. 170.207(o)(6) and whether a
patient declines to specify stress.
(vii) Physical activity. Enable physical activity to be recorded in
accordance with the standard specified in Sec. 170.207(o)(7) and
whether a patient declines to specify physical activity.
(viii) Alcohol use. Enable alcohol use to be recorded in accordance
with the standard specified in Sec. 170.207(o)(8) and whether a
patient declines to specify alcohol use.
(ix) Social connection and isolation. Enable social connection and
isolation to be recorded in accordance the standard specified in Sec.
170.207(o)(9) and whether a patient declines to specify social
connection and isolation.
(x) Exposure to violence (intimate partner violence). Enable
exposure to violence (intimate partner violence) to be recorded in
accordance with the standard specified in Sec. 170.207(o)(10) and
whether a patient declines to specify exposure to violence (intimate
partner violence).
(22) Decision support--knowledge artifact. Enable a user to send
and receive clinical decision support knowledge artifacts in accordance
with the standard specified in Sec. 170.204(d)(1).
(23) Decision support--service. Enable a user to send and receive
electronic clinical guidance in accordance with the standard specified
in Sec. 170.204(e)(1).
(b) Care coordination--(1) Transitions of care--(i) Send and
receive via edge protocol. Technology must be able to:
(A) Send transitions of care/referral summaries through a method
that conforms to the standard specified in Sec. 170.202(d); and
(B) Receive transitions of care/referral summaries through a method
that conforms to the standard specified in Sec. 170.202(d) from a
service that has implemented the standard specified in Sec.
170.202(a).
(C) XDM processing. Receive and make available the contents of a
XDM package formatted in accordance with the standard adopted in Sec.
170.205(p)(1) if the technology is also being certified using an SMTP-
based edge protocol.
(ii) Validate and display--(A) Validate C-CDA conformance--system
performance. Technology must demonstrate its ability to detect valid
and invalid transition of care/referral summaries received and
formatted in accordance with both of the standards specified in Sec.
170.205(a)(3) and
(4). This includes the ability to:
(1) Parse each of the document types formatted according to the
following document templates: CCD; Consultation Note; History and
Physical; Progress Note; Care Plan; Transfer Summary; Referral Note,
and Discharge Summary.
(2) Detect errors in corresponding ``document-templates,''
``section-templates,'' and ``entry-templates,'' including invalid
vocabulary standards and codes not specified in either of the standards
adopted in Sec. 170.205(a)(3) and (4);
(3) Identify valid document-templates and process the data elements
required

[[Page 16909]]

in the corresponding section-templates and entry-templates from either
of the standards adopted in Sec. 170.205(a)(3) and (4);
(4) Correctly interpret empty sections and null combinations; and
(5) Record errors encountered and allow for a user to be notified
of or review the errors produced.
(B) Technology must be able to display in human readable format the
data included in transition of care/referral summaries received and
formatted according to the standards specified in Sec. 170.205(a)(3)
and (4).
(C) Section views. Allow for individual display each additional
section or sections (and the accompanying document header information)
that were included in a transition of care/referral summary received
and formatted in accordance with either of the standards adopted in
Sec. 170.205(a)(3) and (4).
(iii) Create. (A) Enable a user to create a transition of care/
referral summary:
(1) Formatted according to the standards adopted in Sec.
170.205(a)(3);
(2) Formatted according to the standards adopted in Sec.
170.205(a)(4); and
(3) Includes, at a minimum, the Common Clinical Data Set and the
following data expressed, where applicable, according to the specified
standard(s):
(i) Encounter diagnoses. The standard specified in Sec. 170.207(i)
or, at a minimum, the version of the standard specified in Sec.
170.207(a)(4);
(ii) Cognitive status;
(iii) Functional status;
(iv) Ambulatory setting only. The reason for referral; and
referring or transitioning provider's name and office contact
information; and
(v) Inpatient setting only. Discharge instructions.
(B) Patient matching data quality. Technology must be capable of
creating a transition of care/referral summary that includes the
following data and, where applicable, represent such data according to
the additional constraints specified below:
(1) Data. first name, last name, maiden name, middle name
(including middle initial), suffix, date of birth, place of birth,
current address, historical address, phone number, and sex.
(2) Constraint. Represent last/family name according to the CAQH
Phase II Core 258: Eligibility and Benefits 270/271 Normalizing Patient
Last Name Rule version 2.1.0.
(3) Constraint. Represent suffix according to the CAQH Phase II
Core 258: Eligibility and Benefits 270/271 Normalizing Patient Last
Name Rule version 2.1.0 (JR, SR, I, II, III, IV, V, RN, MD, Ph.D.,
ESQ). If no suffix exists, the field should be entered as null.
(4) Constraint. Represent the year, month and date of birth are
required fields while hour, minute and second should be optional
fields. If hour, minute and second are provided then either time zone
offset should be included unless place of birth (city, region, country)
is provided; in latter local time is assumed. If date of birth is
unknown, the field should be marked as null.
(5) Constraint. Represent phone number (home, business, cell) in
the ITU format specified in ITU-T E.123 and ITU-T E.164. If multiple
phone numbers are present, all should be included.
(6) Constraint. Represent sex in accordance with the standard
adopted at Sec. 170.207(n)(1).
(2) Clinical information reconciliation and incorporation--(i)
General requirements. Paragraphs (b)(2)(ii) and (iii) of this section
must be completed based on the receipt of a transition of care/referral
summary formatted in accordance with the standard adopted in Sec.
170.205(a)(3) as well as separately to the standard adopted in Sec.
170.205(a)(4) using the Continuity of Care Document, Discharge Summary
Document and Referral Summary document templates.
(ii) Correct patient. Upon receipt of a transition of care/referral
summary formatted according to either of the standards adopted at Sec.
170.205(a)(3) or (4), technology must be able to demonstrate that the
transition of care/referral summary received is or can be properly
matched to the correct patient.
(iii) Reconciliation. Enable a user to reconcile the data that
represent a patient's active medication list, medication allergy list,
and problem list as follows. For each list type:
(A) Simultaneously display (i.e., in a single view) the data from
at least two sources in a manner that allows a user to view the data
and their attributes, which must include, at a minimum, the source and
last modification date;
(B) Enable a user to create a single reconciled list of
medications, medication allergies, or problems;
(C) Enable a user to review and validate the accuracy of a final
set of data; and
(D) Upon a user's confirmation, automatically update the list, and
incorporate the following data expressed according to the specified
standard(s):
(1) Medications. At a minimum, the version of the standard
specified in Sec. 170.207(d)(3);
(2) Medication allergies. At a minimum, the version of the standard
specified in Sec. 170.207(d)(3); and
(3) Problems. At a minimum, the version of the standard specified
in Sec. 170.207(a)(4).
(iv) System verification. Based on the data reconciled and
incorporated, the technology must be able to create a file formatted
according to the standard adopted at Sec. 170.205(a)(4) using the
Continuity of Care Document document template.
(3) Electronic prescribing. (i) Enable a user to prescribe, send,
and respond to prescription-related transactions for electronic
transmission in accordance with the standard specified at Sec.
170.205(b)(2), and, at a minimum, the version of the standard specified
in Sec. 170.207(d)(3), as follows:
(A) Create new prescriptions (NEWRX);
(B) Change prescriptions (RXCHG, CHGRES);
(C) Cancel prescriptions (CANRX, CANRES);
(D) Refill prescriptions (REFREQ, REFRES);
(E) Receive fill status notifications (RXFILL); and
(F) Request and receive medication history information (RXHREQ,
RXHRES).
(ii) Enable a user to enter, receive, and transmit structured and
codified prescribing instructions for the transactions listed in
paragraph (b)(3)(i) of this section for electronic transmission in
accordance with the standard specified at Sec. 170.205(b)(2) and, at a
minimum, for at least the following component composites:
(A) Repeating Sig;
(B) Code System;
(C) Sig Free Text String;
(D) Dose;
(E) Dose Calculation;
(F) Vehicle;
(G) Route of Administration;
(H) Site of Administration;
(I) Sig Timing;
(J) Duration;
(K) Maximum Dose Restriction;
(L) Indication; and
(M) Stop.
(iii) Technology must limit a user's ability to prescribe all
medications in only the metric standard.
(iv) Technology must always insert leading zeroes before the
decimal point for amounts less than one and must not allow trailing
zeroes after a decimal point when a user prescribes medications.
(4) Incorporate laboratory tests and values/results--(i) Receive
results--(A) Ambulatory setting only. (1) Receive and incorporate
clinical laboratory tests and

[[Page 16910]]

values/results in accordance with the standard specified in Sec.
170.205(j)(2); and, at a minimum, the version of the standard specified
in Sec. 170.207(c)(3).
(2) Display the tests and values/results received in human readable
format.
(B) Inpatient setting only. Receive clinical laboratory tests and
values/results in a structured format and display such tests and
values/results in human readable format.
(ii) Display the test report information:
(A) Specified in 42 CFR 493.1291(a)(1) through (3) and (c)(1)
through (7);
(B) Related to reference intervals or normal values as specified in
42 CFR 493.1291(d);
(C) For alerts and delays as specified in 42 CFR 493.1291(g) and
(h); and
(D) For corrected reports as specified in 42 CFR 493.1291(k)(2).
(iii) Attribute, associate, or link a laboratory test and value/
result with a laboratory order or patient record.
(5) Transmission of laboratory test reports. Technology must be
able to electronically create laboratory test reports for electronic
transmission in accordance with the standard specified in Sec.
170.205(j)(2) and, at a minimum, the version of the standard specified
in Sec. 170.207(c)(3).
(6) Data portability--(i) General requirements for export summary
configuration. A user must be able to set the following configuration
options when using technology to create an export summary or set of
export summaries for patients whose information is stored in the
technology. A user must be able to execute these capabilities at any
time the user chooses and without subsequent developer assistance to
operate.
(ii) Document creation configuration--(A) Document-template types.
A user must be able to configure the technology to create an export
summary or export summaries formatted according to the standard adopted
at Sec. 170.205(a)(4) for any of the following document-template
types.
(1) Generally applicable. CCD; Consultation Note; History and
Physical; Progress Note; Care Plan; Transfer Summary; and Referral
Note.
(2) Inpatient setting only. Discharge Summary.
(B) For any document-template selected the technology must be able
to include, at a minimum, the Common Clinical Data Set and the
following data expressed, where applicable, according to the specified
standard(s):
(1) Encounter diagnoses. The standard specified in Sec. 170.207(i)
or, at a minimum, the version of the standard at Sec. 170.207(a)(4);
(2) Cognitive status;
(3) Functional status;
(4) Ambulatory setting only. The reason for referral; and referring
or transitioning provider's name and office contact information; and
(5) Inpatient setting only. Discharge instructions.
(C) Use of the ``unstructured document'' document-level template is
prohibited for compliance with the standard adopted at Sec.
170.205(a)(4)).
(iii) Timeframe configuration. A user must be able to configure the
technology to set the time period within which data would be used to
create the export summary or summaries. This must include the ability
to enter in a start and end date range as well as the ability to set a
date at least three years into the past from the current date.
(iv) Event configuration. A user must be able to configure the
technology to create an export summary or summaries based on the
following user selected events:
(A) A relative date or time (e.g., the first of every month);
(B) A specific date or time (e.g., on 10/24/2015); and
(C) When a user signs a note or an order.
(v) Location configuration. A user must be able to configure and
set the storage location to which the export summary or export
summaries are intended to be saved.
(7) Data segmentation for privacy--send. Technology must enable a
user to create a summary record formatted in accordance with each of
the standards adopted in Sec. 170.205(a)(3) and (4) that is tagged as
restricted and subject to restrictions on re-disclosure according to
the standard adopted in Sec. 170.205(o)(1).
(8) Data segmentation for privacy--receive. Technology must enable
a user to:
(i) Receive a summary record that is tagged as restricted and
subject to restrictions on re-disclosure according to the standard
adopted in Sec. 170.205(o)(1);
(ii) Apply document-level tagging and sequester the document from
other documents received; and
(iii) View the restricted document (or data), without incorporating
the document (or data).
(9) Care plan. Technology must enable a user to record, change,
access, create, and receive care plan information in accordance with
the Care Plan document template in the standard adopted in Sec.
170.205(a)(4).
(c) Clinical quality measures--(1) Clinical quality measures--
record and export--(i) Record. For each and every CQM for which the
technology is presented for certification, the technology must be able
to record all of the data that would be necessary to calculate each
CQM. Data required for CQM exclusions or exceptions must be codified
entries, which may include specific terms as defined by each CQM, or
may include codified expressions of ``patient reason,'' ``system
reason,'' or ``medical reason.''
(ii) Export. A user must be able to export a data file formatted in
accordance with the standard specified at Sec. 170.205(h) for one or
multiple patients that includes all of the data captured for each and
every CQM to which technology was certified under paragraph (c)(1)(i)
of this section. A user must be able to execute this capability at any
time the user chooses and without subsequent developer assistance to
operate.
(2) Clinical quality measures--import and calculate--(i) Import.
Enable a user to import a data file in accordance with the standard
specified at Sec. 170.205(h) for one or multiple patients and use such
data to perform the capability specified in paragraph (c)(2)(ii) of
this section. A user must be able to execute this capability at any
time the user chooses and without subsequent developer assistance to
operate.
(ii) Technology must be able to calculate each and every clinical
quality measure for which it is presented for certification.
(3) [Reserved]
(4) Clinical quality measures--filter. (i) Technology must be able
to record the data listed in paragraph (c)(4)(iii) of this section in
accordance with the identified standards, where specified.
(ii) Technology must be able to filter CQM results at the patient
and aggregate levels by each one and any combination of the data listed
in paragraph (c)(4)(iii) of this section.
(iii) Data. (A) TIN;
(B) NPI;
(C) Provider type;
(D) Patient insurance;
(E) Patient age;
(F) Patient sex in accordance with, at a minimum, the version of
the standard specified in Sec. 170.207(n)(1);
(G) Patient race and ethnicity in accordance with, at a minimum,
the version of the standard specified in Sec. 170.207(f)(2);
(H) Patient problem list data in accordance with, at a minimum, the
version of the standard specified in Sec. 170.207(a)(4); and
(I) Practice site address.
(d) Privacy and security--(1) Authentication, access control, and

[[Page 16911]]

authorization. (i) Verify against a unique identifier(s) (e.g.,
username or number) that a person seeking access to electronic health
information is the one claimed; and
(ii) Establish the type of access to electronic health information
a user is permitted based on the unique identifier(s) provided in
paragraph (d)(1)(i) of this section, and the actions the user is
permitted to perform with the technology.
(2) Auditable events and tamper-resistance--(i) Record actions.
Technology must be able to:
(A) Record actions related to electronic health information in
accordance with the standard specified in Sec. 170.210(e)(1);
(B) Record the audit log status (enabled or disabled) in accordance
with the standard specified in Sec. 170.210(e)(2) unless it cannot be
disabled by any user; and
(C) Record the encryption status (enabled or disabled) of
electronic health information locally stored on end-user devices by
technology in accordance with the standard specified in Sec.
170.210(e)(3) unless the technology prevents electronic health
information from being locally stored on end-user devices (see
paragraph (d)(7) of this section).
(ii) Default setting. Technology must be set by default to perform
the capabilities specified in paragraph (d)(2)(i)(A) of this section
and, where applicable, paragraph (d)(2)(i)(B) or (C) of this section,
or both paragraphs (d)(2)(i)(B) and (C).
(iii) When disabling the audit log is permitted. For each
capability specified in paragraphs (d)(2)(i)(A) through (C) of this
section that technology permits to be disabled, the ability to do so
must be restricted to a limited set of users.
(iv) Audit log protection. Actions and statuses recorded in
accordance with paragraph (d)(2)(i) of this section must not be capable
of being changed, overwritten, or deleted by the technology.
(v) Detection. Technology must be able to detect whether the audit
log has been altered.
(3) Audit report(s). Enable a user to create an audit report for a
specific time period and to sort entries in the audit log according to
each of the data specified in the standards in Sec. 170.210(e).
(4) Amendments. Enable a user to select the record affected by a
patient's request for amendment and perform the capabilities specified
in paragraph (d)(4)(i) or (ii) of this section.
(i) Accepted amendment. For an accepted amendment, append the
amendment to the affected record or include a link that indicates the
amendment's location.
(ii) Denied amendment. For a denied amendment, at a minimum, append
the request and denial of the request to the affected record or include
a link that indicates this information's location.
(5) Automatic access time-out. (i) Automatically stop user access
to health information after a predetermined period of inactivity.
(ii) Require user authentication in order to resume or regain the
access that was stopped.
(6) Emergency access. Permit an identified set of users to access
electronic health information during an emergency.
(7) End-user device encryption. Paragraph (d)(7)(i) or (ii) of this
section must be met to satisfy this certification criterion.
(i) Technology that is designed to locally store electronic health
information on end-user devices must encrypt the electronic health
information stored on such devices after use of the technology on those
devices stops.
(A) Electronic health information that is stored must be encrypted
in accordance with the standard specified in Sec. 170.210(a)(3).
(B) Default setting. Technology must be set by default to perform
this capability and, unless this configuration cannot be disabled by
any user, the ability to change the configuration must be restricted to
a limited set of identified users.
(ii) Technology is designed to prevent electronic health
information from being locally stored on end-user devices after use of
the technology on those devices stops.
(8) Integrity. (i) Create a message digest in accordance with the
standard specified in Sec. 170.210(c).
(ii) Verify in accordance with the standard specified in Sec.
170.210(c) upon receipt of electronically exchanged health information
that such information has not been altered.
(9) Accounting of disclosures. Record disclosures made for
treatment, payment, and health care operations in accordance with the
standard specified in Sec. 170.210(d).
(e) Patient engagement--(1) View, download, and transmit to 3rd
party. (i) Patients (and their authorized representatives) must be able
to use technology to view, download, and transmit their health
information to a 3rd party in the manner specified below. Access to
these capabilities must be online and through a secure channel that
ensures all content is encrypted and integrity-protected in accordance
with the standard for encryption and hashing algorithms specified at
Sec. 170.210(f).
(A) View. Patients (and their authorized representatives) must be
able to use health IT to view in accordance with the standard adopted
at Sec. 170.204(a)(1), at a minimum, the following data:
(1) The Common Clinical Data Set (which should be in their English
(i.e., non-coded) representation if they associate with a vocabulary/
code set).
(2) Ambulatory setting only. Provider's name and office contact
information.
(3) Inpatient setting only. Admission and discharge dates and
locations; discharge instructions; and reason(s) for hospitalization.
(4) Laboratory test report(s). Laboratory test report(s),
including:
(i) The information for a test report as specified all the data
specified in 42 CFR 493.1291(c)(1) through (7);
(ii) The information related to reference intervals or normal
values as specified in 42 CFR 493.1291(d); and
(iii) The information for corrected reports as specified in 42 CFR
493.1291(k)(2).
(5) Diagnostic image report(s).
(B) Download. (1) Patients (and their authorized representatives)
must be able to use technology to download an ambulatory summary or
inpatient summary (as applicable to the health IT setting for which
certification is requested) in only human readable format, in only the
format specified in accordance to the standard adopted at Sec.
170.205(a)(4), or in both formats. The use of the ``unstructured
document'' document-level template is prohibited for compliance with
the standard adopted at Sec. 170.205(a)(4).
(2) When downloaded according to the standard adopted at Sec.
170.205(a)(4), the ambulatory summary or inpatient summary must
include, at a minimum, the following data (which, for the human
readable version, should be in their English representation if they
associate with a vocabulary/code set):
(i) Ambulatory setting only. All of the data specified in paragraph
(e)(1)(i)(A)(1), (2), (4), and (5) of this section.
(ii) Inpatient setting only. All of the data specified in
paragraphs (e)(1)(i)(A)(1), and (3) through (5) of this section.
(3) Inpatient setting only. Patients (and their authorized
representatives) must be able to download transition of care/referral
summaries that were created as a result of a transition of care
(pursuant to the capability expressed in

[[Page 16912]]

the certification criterion adopted at paragraph (b)(1) of this
section).
(C) Transmit to third party. Patients (and their authorized
representatives) must be able to:
(1) Transmit the ambulatory summary or inpatient summary (as
applicable to the health IT setting for which certification is
requested) created in paragraph (e)(1)(i)(B)(2) of this section in
accordance with at least one of the following:
(i) The standard specified in Sec. 170.202(a).
(ii) Through a method that conforms to the standard specified at
Sec. 170.202(d) and leads to such summary being processed by a service
that has implemented the standard specified in Sec. 170.202(a).
(2) Inpatient setting only. Transmit transition of care/referral
summaries (as a result of a transition of care/referral) selected by
the patient (or their authorized representative) in accordance with at
least one of the following:
(i) The standard specified in Sec. 170.202(a).
(ii) Through a method that conforms to the standard specified at
Sec. 170.202(d) and leads to such summary being processed by a service
that has implemented the standard specified in Sec. 170.202(a).
(ii) Activity history log. (A) When electronic health information
is viewed, downloaded, or transmitted to a third-party using the
capabilities included in paragraphs (e)(1)(i)(A) through (C) of this
section or when an application requests electronic health information
using the capability specified at paragraph (e)(1)(iii) of this
section, the following information must be recorded and made accessible
to the patient:
(1) The action(s) (i.e., view, download, transmission, API
response) that occurred;
(2) The date and time each action occurred in accordance with the
standard specified at Sec. 170.210(g);
(3) The user who took the action; and
(4) Where applicable, the addressee to whom an ambulatory summary
or inpatient summary was transmitted.
(B) Technology presented for certification may demonstrate
compliance with paragraph (e)(1)(ii)(A) of this section if it is also
certified to the certification criterion adopted at Sec. 170.315(d)(2)
and the information required to be recorded in paragraph (e)(1)(ii)(A)
is accessible by the patient.
(iii) Application access. Patients (and their authorized
representatives) must be able to use an application that can interact
with the following capabilities. Additionally, the following technical
outcomes and conditions must be met through the demonstration of an
application programming interface (API) that can respond to requests
from other applications for data specified within the Common Clinical
Data Set.
(A) Security. The API must include a means to establish a trusted
connection with the application requesting patient data, including a
means for the requesting application to register with the data source,
be authorized to request data, and log all interactions between the
application and the data source.
(B) Patient selection. The API must include a means for the
application to query for an ID or other token of a patient's record in
order to subsequently execute data requests for that record in
accordance with (e)(1)(iii)(C) of this section.
(C) Data requests, response scope, and return format. The API must
enable and support both of the following data request interactions:
(1) Data-category request. The API must support syntax that allows
it to respond to requests for each of the individual data categories
specified in the Common Clinical Data Set and return the full set of
data for that data category (according to the specified standards,
where applicable) in either XML or JSON.
(2) All-request. The API must support syntax that allows it to
respond to a request for all of the data categories specified in the
Common Clinical Data Set at one time and return such data (according to
the specified standards, where applicable) in a summary record
formatted according to the standard adopted at Sec. 170.205(a)(4).
(D) Documentation. The API must include accompanying documentation
that contains, at a minimum:
(1) API syntax, function names, required and optional parameters
and their data types, return variables and their types/structures,
exceptions and exception handling methods and their returns.
(2) The software components and configurations that would be
necessary for an application to implement in order to be able to
successfully interact with the API and process its response(s).
(E) Terms of use. The terms of use for the API must be provided,
including, at a minimum, any associated developer policies and required
developer agreements.
(2) Secure messaging. Enable a user to send messages to, and
receive messages from, a patient in a manner that ensures:
(i) Both the patient (or authorized representative) and technology
user are authenticated; and
(ii) The message content is encrypted and integrity-protected in
accordance with the standard for encryption and hashing algorithms
specified at Sec. 170.210(f).
(f) Public health--(1) Transmission to immunization registries. (i)
Technology must be able to create immunization information for
electronic transmission in accordance with:
(A) The standard and applicable implementation specifications
specified in Sec. 170.205(e)(4);
(B) At a minimum, the version of the standard specified in Sec.
170.207(e)(3) for historical vaccines; and
(C) At a minimum, the version of the standard specified in Sec.
170.207(e)(4) for administered vaccines.
(ii) Technology must enable a user to request, access, and display
a patient's evaluated immunization history and the immunization
forecast from an immunization registry in accordance with the standard
at Sec. 170.205(e)(4).
(2) Transmission to public health agencies--syndromic
surveillance--(i) Ambulatory setting only. (A) Technology must be able
to create syndrome-based public health surveillance information for
electronic transmission.
(B) Optional. Technology must be able to create syndrome-based
public health surveillance information for electronic transmission that
contains the following data:
(1) Patient demographics;
(2) Provider specialty;
(3) Provider address;
(4) Problem list;
(5) Vital signs;
(6) Laboratory test values/results;
(7) Procedures;
(8) Medication list; and
(9) Insurance.
(ii) Inpatient setting only. Technology must be able to create
syndrome-based public health surveillance information for electronic
transmission in accordance with the standard (and applicable
implementation specifications) specified in Sec. 170.205(d)(4).
(3) Transmission to public health agencies--reportable laboratory
tests and values/results. Technology must be able to create reportable
laboratory tests and values/results for electronic transmission in
accordance with:
(i) The standard (and applicable implementation specifications)
specified in Sec. 170.205(g)(2); and
(ii) At a minimum, the versions of the standards specified in Sec.
170.207(a)(4) and (c)(3).
(4) Transmission to cancer registries. Technology must be able to
create cancer case information for electronic transmission in
accordance with:

[[Page 16913]]

(i) The standard (and applicable implementation specifications)
specified in Sec. 170.205(i)(2); and
(ii) At a minimum, the versions of the standards specified in Sec.
170.207(a)(4) and (c)(3).
(5) Transmission to public health agencies--case reporting.
Technology must be able to create case reporting information for
electronic transmission in accordance with the standard specified in
Sec. 170.205(q)(1).
(6) Transmission to public health agencies--antimicrobial use and
resistance reporting. Technology must be able to create antimicrobial
use and resistance reporting information for electronic transmission in
accordance with the standard specified in Sec. 170.205(r)(1).
(7) Transmission to public health agencies--health care surveys.
Technology must be able to create health care survey information for
electronic transmission in accordance with the standard specified in
Sec. 170.205(s)(1).
(g) Design and performance--(1) Automated numerator recording. For
each meaningful use objective with a percentage-based measure,
technology must be able to create a report or file that enables a user
to review the patients or actions that would make the patient or action
eligible to be included in the measure's numerator. The information in
the report or file created must be of sufficient detail such that it
enables a user to match those patients or actions to meet the measure's
denominator limitations when necessary to generate an accurate
percentage.
(2) Automated measure calculation. For each meaningful use
objective with a percentage-based measure that is supported by a
capability included in a technology, record the numerator and
denominator and create a report including the numerator, denominator,
and resulting percentage associated with each applicable meaningful use
measure.
(3) Safety-enhanced design. (i) User-centered design processes must
be applied to each capability technology includes that is specified in
the following certification criteria: paragraphs (a)(1) through (10)
and (18), (20), (22), (23), and (b)(2) through (4) of this section.
(ii) The following information must be submitted on the user-
centered design processed used:
(A) Name, description and citation (ULR and/or publication
citation) for an industry or federal government standard; or
(B) Name the process(es), provide an outline of the process(es), a
short description of the process(es), and an explanation of the
reason(s) why use of any of the existing user-centered design standards
was impractical.
(iii) The following information/sections from NISTIR 7742 must be
submitted for each capability to which user-centered design processes
were applied:
(A) Name and version of the product; date and location of the test;
test environment; description of the intended users; and total number
of participants;
(B) Description of participants, including: sex; age; education;
occupation/role; professional experience; computer experience; and
product experience;
(C) Description of the user tasks that were tested and association
of each task to corresponding certification criteria;
(D) List of the specific metrics captured during the testing,
including; task success (%); task failures (%); task standard
deviations (%); task performance time; and user satisfaction rating
(based on a scale with 1 as very difficult and 5 as very easy);
(E) Test results for each task using metrics listed above in
paragraphs (g)(3)(ii)(A) through (D) of this section;
(F) Results and data analysis narrative, including: major test
finding; effectiveness; efficiency; satisfaction; and areas for
improvement.
(iv) Submit test scenarios used in summative usability testing.
(4) Quality management system. (i) For each capability that a
technology includes and for which that capability's certification is
sought, the use of a Quality Management System (QMS) in the
development, testing, implementation, and maintenance of that
capability must be identified that is:
(A) Compliant with a QMS established by the Federal government or a
standards developing organization; or
(B) Mapped to one or more QMS established by the Federal government
or standards developing organization(s).
(ii) If a single QMS was used for applicable capabilities, it would
only need to be identified once.
(iii) If different QMS were applied to specific capabilities, each
QMS applied would need to be identified.
(5) Accessibility technology compatibility. For each capability
technology includes that is specified in the certification criteria at
paragraphs (a), (b), and (e) of this section, the capability must be
compatible with at least one accessibility technology that includes
text-to-speech functionality.
(6) Consolidated CDA creation performance. The following technical
and performance outcomes must be demonstrated related to Consolidated
CDA creation. The capabilities required under paragraphs (g)(6)(i)
through (iii) of this section can be demonstrated in tandem and do not
need to be individually addressed in isolation or sequentially.
(i) Reference C-CDA match. Upon the entry of clinical data
consistent with the Common Clinical Data Set, the technology must be
able to create a data file formatted in accordance with each of the
standards adopted in Sec. 170.205(a)(3) and (4) that matches a gold-
standard, reference data file.
(ii) Document-template conformance. Upon the entry of clinical data
consistent with the Common Clinical Data Set, the technology must be
able to create a data file formatted in accordance with each of the
standards adopted in Sec. 170.205(a)(3) and (4) that demonstrates a
valid implementation of each of the following document templates (as
applicable to the adopted standard):
(A) Generally applicable. CCD; Consultation Note; History and
Physical; Progress Note; Care Plan; Transfer Summary; and Referral
Note.
(B) Inpatient setting only. Discharge Summary.
(iii) Vocabulary conformance. Upon the entry of clinical data
consistent with the Common Clinical Data Set, the technology must be
able to create a data file formatted in accordance with each of the
standards adopted in Sec. 170.205(a)(3) and (4) that demonstrates the
required vocabulary standards (and value sets) are properly
implemented.
(7) Application access to Common Clinical Data Set. The following
technical outcomes and conditions must be met through the demonstration
of an application programming interface (API) that can respond to
requests from other applications for data specified within the Common
Clinical Data Set.
(i) Security. The API must include a means to establish a trusted
connection with the application requesting patient data, including a
means for the requesting application to register with the data source,
be authorized to request data, and log all interactions between the
application and the data source.
(ii) Patient selection. The API must include a means for the
application to query for an ID or other token of a patient's record in
order to subsequently execute data requests for that record in
accordance with paragraph (g)(7)(iii) of this section.
(iii) Data requests, response scope, and return format. The API
must enable

[[Page 16914]]

and support both of the following data request interactions:
(A) Data-category request. The API must support syntax that allows
it to respond to requests for each of the individual data categories
specified in the Common Clinical Data Set and return the full set of
data for that data category (according to the specified standards,
where applicable) in either XML or JSON.
(B) All-request. The API must support syntax that allows it to
respond to a request for all of the data categories specified in the
Common Clinical Data Set at one time and return such data (according to
the specified standards, where applicable) in a summary record
formatted according to the standard adopted at Sec. 170.205(a)(4).
(iv) Documentation. The API must include accompanying documentation
that contains, at a minimum:
(A) API syntax, function names, required and optional parameters
and their data types, return variables and their types/structures,
exceptions and exception handling methods and their returns.
(B) The software components and configurations that would be
necessary for an application to implement in order to be able to
successfully interact with the API and process its response(s).
(v) Terms of use. The terms of use for the API must be provided,
including, at a minimum, any associated developer policies and required
developer agreements.
(8) Accessibility-centered design. For each capability that a
Health IT Module includes and for which that capability's certification
is sought, the use of a health IT accessibility-centered design
standard or law in the development, testing, implementation and
maintenance of that capability must be identified.
(i) If a single accessibility-centered design standard or law was
used for applicable capabilities, it would only need to be identified
once.
(ii) If different accessibility-centered design standards and laws
were applied to specific capabilities, each accessibility-centered
design standard or law applied would need to be identified. This would
include the application of an accessibility-centered design standard or
law to some capabilities and none to others.
(iii) If no accessibility-centered design standard or law was
applied to all applicable capabilities such a response is acceptable to
satisfy this certification criterion.
(h) Transport methods and other protocols--(1) Direct Project--(i)
Applicability Statement for Secure Health Transport. Technology must be
able to send and receive health information in accordance with the
standards specified in Sec. 170.202(a).
(ii) Optional--Applicability Statement for Secure Health Transport
and Delivery Notification in Direct. Technology must be able to send
and receive health information in accordance with the standard
specified in Sec. 170.202(e)(1).
(2) Direct Project, Edge Protocol, and XDR/XDM. Technology must be
able to send and receive health information in accordance with:
(i) The standards specified in Sec. 170.202(a);
(ii) The standard specified in Sec. 170.202(b); and
(iii) Both edge protocol methods specified by the standard in Sec.
170.202(d).
(3) SOAP Transport and Security Specification and XDR/XDM for
Direct Messaging. Technology must be able to send and receive health
information in accordance with the standards specified in Sec.
170.202(b) and (c).
(4) Healthcare provider directory--query request. In accordance
with the standard specified in Sec. 170.202(f)(1), technology must be
able to make, at a minimum, the following queries to a directory and
subsequently process the response returned:
(i) Query for an individual provider;
(ii) Query for an organizational provider;
(iii) Query for both individual and organizational providers in a
single query; and
(iv) Query for relationships between individual and organizational
providers.
(v) Optional--federation. In accordance with the standard specified
in Sec. 170.202(f)(1), technology must be able to process federated
responses.
(5) Healthcare provider directory--query response. In accordance
with the standard specified in Sec. 170.202(f)(1), technology must be
able to, at a minimum, respond to the following queries to a directory:
(i) Query for an individual provider;
(ii) Query for an organizational provider;
(iii) Query for both individual and organizational providers in a
single query; and
(iv) Query for relationships between individual and organizational
providers.
(v) Optional--federation. In accordance with the standard specified
in Sec. 170.202(f)(1), technology must be able to federate queries to
other directories.
(i) Administrative--(1) Electronic submission of medical
documentation--(i) Document templates. Health IT must be able to create
electronic documents for transmission formatted according to the
following standard and applicable implementation specifications adopted
at Sec. 170.205(a)(4) and (a)(5)(i). With respect to Sec.
170.205(a)(5)(i):
(A) Health IT must be able to create the following document types
regardless of the setting for which it is designed: Diagnostic Imaging
Report; Unstructured Document; Enhanced Operative Note Document;
Enhanced Procedure Note Document; and Interval Document.
(B) Ambulatory setting only. Health IT must be able to create an
Enhanced Encounter Document.
(C) Inpatient setting only. Health IT must be able to create an
Enhanced Hospitalization Document.
(ii) Digital signature. (A) Applying a digital signature.
Technology must be able to apply a digital signature in accordance with
the implementation specification adopted at Sec. 170.205(a)(5)(ii) to
a document formatted according to the following standard and applicable
implementation specifications adopted at Sec. 170.205(a)(4) and
(a)(5)(i). It must also be able to demonstrate that it can support the
method for delegation of right assertions.
(1) The cryptographic module used as part of the technology must:
Be validated to meet or exceed FIPS 140-2 Level 1; include a digital
signature system and hashing that are compliant with FIPS 186-2 and
FIPS 180-2; and store the private key in a FIPS-140-2 Level 1 validated
cryptographic module using a FIPS-approved encryption algorithm. This
requirement may be satisfied through documentation only.
(2) Technology must support multi-factor authentication that meets
or exceeds Level 3 assurance as defined in NIST Special Publication
800-63-2.
(3) After ten minutes of inactivity, technology must require the
certificate holder to re-authenticate to access the private key.
(4) If implemented as a software function, the system must clear
the plain text private key from the system memory to prevent the
unauthorized access to, or use of, the private key when the signing
module is deactivated.
(5) Technology must record time and date consistent with the
standard adopted at Sec. 170.210(g).
(B) Validating a digital signature. Technology must be able
validate a digital signature that has been applied to a document
according to the implementation specification adopted at Sec.
170.205(a)(5)(ii).
(iii) Author of record level 1. Using the same system capabilities
expressed

[[Page 16915]]

in paragraph (i)(1)(ii), technology must be able to apply a digital
signature according to the implementation specification adopted at
Sec. 170.205(a)(5)(iii) to sign single or bundles of documents a
document formatted according to the following standard and applicable
implementation specifications adopted at Sec. 170.205(a)(4) and
(a)(5)(i).
(iv) Transactions. Using the same system capabilities expressed in
paragraph (i)(1)(ii) of this section, technology must be able to apply
a digital signature according to the implementation specification
adopted at Sec. 170.205(a)(5)(iv) to a transaction and include the
signature as accompanying metadata in the signed transaction.
(2) [Reserved]

Sec. Sec. 170.500, 170.501, 170.502, 170.503, 170.504, 170.505,
170.510, 170.520, 170.523, 170.525, 170.530, 170.535, 170.540, 170.545,
170.550, 170.553, 170.555, 170.557, 170.560, 170.565, 170.570, 170.575,
and 170.599 [Amended]

0
12. In subpart E, consisting of Sec. Sec. 170.500 through 170.599:
0
a. Remove the term ``ONC HIT Certification Program'' and add in its
place ``ONC Health IT Certification Program'' wherever it may appear;
0
b. Remove the acronym ``HIT'' and add in its place ``health IT''
wherever it may appear;
0
c. Remove the term ``EHR Module'' and add in its place ``Health IT
Module'' wherever it may appear;
0
d. Remove the term ``EHR Modules'' and add in its place ``Health IT
Modules'' wherever it may appear; and
0
e. Remove the term ``EHR Module(s)'' and add in its place ``Health IT
Module(s)'' wherever it may appear.
0
13. In Sec. 170.503, revise paragraph (e)(4) to read as follows:

Sec. 170.503 Requests for ONC-AA status and ONC-AA ongoing
responsibilities.

* * * * *
(e) * * *
(4) Verify that ONC-ACBs are performing surveillance as required by
and in accordance with Sec. 170.556, Sec. 170.523(k), and their
respective annual plans; and
* * * * *
0
14. Amend Sec. 170.523 by--
0
a. Revising paragraphs (f), (g), (i), and (k); and
0
b. Adding paragraphs (m) and (n).
The additions and revisions read as follows:

Sec. 170.523 Principles of proper conduct for ONC-ACBs.

* * * * *
(f) Provide ONC, no less frequently than weekly, a current list of
Health IT Modules, Complete EHRs, and/or EHR Modules that have been
certified that includes, at a minimum:
(1) For the 2015 Edition health IT certification criteria and
subsequent editions of health IT certification criteria:
(i) The Health IT Module developer name; product name; product
version; developer Web site, physical address, email, phone number, and
contact name;
(ii) The ONC-ACB Web site, physical address, email, phone number,
and contact name, contact function/title;
(iii) The ATL Web site, physical address, email, phone number, and
contact name, contact function/title;
(iv) Location and means by which the testing was conducted (e.g.,
remotely with health IT developer at its headquarters location);
(v) The date(s) the Health IT Module was tested;
(vi) The date the Health IT Module was certified;
(vii) The unique certification number or other specific product
identification;
(viii) The certification criterion or criteria to which the Health
IT Module has been certified, including the test procedure and test
data versions used, test tool version used, and whether any test data
was altered (i.e., a yes/no) and for what purpose;
(ix) The way in which each privacy and security criterion was
addressed for the purposes of certification;
(x) The standard or mapping used to meet the quality management
system certification criterion;
(xi) The standard(s) or lack thereof used to meet the
accessibility-centered design certification criterion;
(xii) Where applicable, the hyperlink to access an application
programming interface (API)'s documentation and terms of use;
(xiii) Where applicable, which certification criteria were gap
certified;
(xiv) Where applicable, if a certification issued was a result of
an inherited certified status request;
(xv) Where applicable, the clinical quality measures to which the
Health IT Module has been certified;
(xvi) Where applicable, any additional software a Health IT Module
relied upon to demonstrate its compliance with a certification
criterion or criteria adopted by the Secretary;
(xvii) Where applicable, the standard(s) used to meet a
certification criterion where more than one is permitted;
(xviii) Where applicable, any optional capabilities within a
certification criterion to which the Health IT Module was tested and
certified;
(xix) Where applicable, and for each applicable certification
criterion, all of the information required to be submitted by Health IT
Module developers to meet the safety-enhanced design certification
criterion. Each user-centered design element required to be reported
must be at a granular level (e.g., task success/failure)); and
(xx) Where applicable, for each instance in which a Health IT
Module failed to conform to its certification and for which corrective
action was instituted under Sec. 170.556 (provided no provider or
practice site is identified):
(A) The specific certification criterion to which the technology
failed to conform as determined by the ONC-ACB;
(B) The dates surveillance was initiated and when available,
completed;
(C) The results of the surveillance (pass rate for each criterion);
(D) The number of sites that were used in surveillance;
(E) The date corrective action began;
(F) When available, the date correction action ended;
(G) A summary of the deficiency or deficiencies identified by the
ONC-ACB as the basis for its determination of non-conformance; and
(H) When available, the health IT developer's explanation of the
deficiency or deficiencies identified by the ONC-ACB as the basis for
its determination of non-conformance.
(2) For the 2014 Edition EHR certification criteria:
(i) The Complete EHR or EHR Module developer name (if applicable);
(ii) The date certified;
(iii) The product version;
(iv) The unique certification number or other specific product
identification;
(v) The clinical quality measures to which a Complete EHR or EHR
Module has been certified;
(vi) Where applicable, any additional software a Complete EHR or
EHR Module relied upon to demonstrate its compliance with a
certification criterion or criteria adopted by the Secretary;
(vii) Where applicable, the certification criterion or criteria to
which each EHR Module has been certified; and
(viii) A hyperlink to the test results used to certify the Complete
EHRs and/or EHR Modules that can be accessed by the public.
(ix) Where applicable, for each instance in which a Complete EHR or
EHR Module failed to conform to its certification and for which
corrective action was instituted under Sec. 170.556 (provided no
provider or practice site is identified):

[[Page 16916]]

(A) The specific certification criterion to which the technology
failed to conform as determined by the ONC-ACB;
(B) The dates surveillance was initiated and when available,
completed;
(C) The results of the surveillance (pass rate for each criterion);
(D) The number of sites that were used in surveillance;
(E) The date corrective action began;
(F) When available, the date corrective action ended;
(G) A summary of the deficiency or deficiencies identified by the
ONC-ACB as the basis for its determination of non-conformance; and
(H) When available, the developer's explanation of the deficiency
or deficiencies identified by the ONC-ACB as the basis for its
determination of non-conformance.
(g) Retain all records related to the certification of Complete
EHRs and Health IT Modules for a minimum of 6 years and make them
available to HHS upon request;
* * * * *
(i) Submit an annual surveillance plan to the National Coordinator
and, in accordance with its surveillance plan, its accreditation, and
Sec. 170.556:
(1) Conduct surveillance of certified Complete EHRs and Health IT
Modules; and
(2) Report, at a minimum, on a quarterly basis to the National
Coordinator the results of its surveillance.
* * * * *
(k) Ensure adherence to the following requirements when issuing any
certification and during surveillance of Complete EHRs and Health IT
Modules the ONC-ACB has certified:
(1) A Health IT developer must conspicuously include the following
on its Web site and in all marketing materials, communications
statements, and other assertions related to the Complete EHR or Health
IT Module's certification:
(i) The disclaimer ``This [Complete EHR or Health IT Module] is
[specify Edition of EHR certification criteria] compliant and has been
certified by an ONC-ACB in accordance with the applicable certification
criteria adopted by the Secretary of Health and Human Services. This
certification does not represent an endorsement by the U.S. Department
of Health and Human Services. Complaints related to this [Complete EHR
or Health IT Module]'s certified capabilities or health IT developer's
disclosures should be submitted to [email protected].''
(ii) The information an ONC-ACB is required to report to the
National Coordinator under paragraphs (f)(1) and (2) of this section as
applicable for the specific Complete EHR or Health IT Module.
(iii) In plain language, a detailed description of all known
material information concerning:
(A) Additional types of costs that a user may be required to pay to
implement or use the Complete EHR or Health IT Module's capabilities,
whether to meet meaningful use objectives and measures or to achieve
any other use within the scope of the health IT's certification.
(B) Limitations that a user may encounter in the course of
implementing and using the Complete EHR or Health IT Module's
capabilities, whether to meet meaningful use objectives and measures or
to achieve any other use within the scope of the health IT's
certification.
(iv) The types of information required to be disclosed under
paragraph (k)(iii) of this section include but are not limited to:
(A) Additional types of costs or fees (whether fixed, recurring,
transaction-based, or otherwise) imposed by a health IT developer (or
any third-party from whom the developer purchases, licenses, or obtains
any technology, products, or services in connection with its certified
health IT) to purchase, license, implement, maintain, upgrade, use, or
otherwise enable and support the use of capabilities to which health IT
is certified; or in connection with any data generated in the course of
using any capability to which health IT is certified.
(B) Limitations, whether by contract or otherwise, on the use of
any capability to which technology is certified for any purpose within
the scope of the technology's certification; or in connection with any
data generated in the course of using any capability to which health IT
is certified.
(C) Limitations, including but not limited to technical or
practical limitations of technology or its capabilities, that could
prevent or impair the successful implementation, configuration,
customization, maintenance, support, or use of any capabilities to
which technology is certified; or that could prevent or limit the use,
exchange, or portability of any data generated in the course of using
any capability to which technology is certified.
(vi) Health IT self-developers are excluded from the requirements
of paragraph (k)(1)(iii) of this section.
(2) A health IT developer must attest as a condition of
certification to any certification criterion that it will timely
provide in plain writing, conspicuously, and in sufficient detail:
(i) To all customers, prior to providing or entering into any
agreement to provide any certified health IT or related product or
service (including subsequent updates, add-ons, or additional products
or services during the course of an on-going agreement), the
information required to be disclosed under paragraph (k)(1) of this
section;
(ii) To any person who requests or receives a quotation, estimate,
description of services, or other assertion or information from the
developer in connection with any certified health IT or any
capabilities thereof, the information required to be disclosed under
paragraph (k)(1) of this section; and
(iii) To any person, upon request, all or any part of the
information required to be disclosed under paragraph (k)(1) of this
section.
(3) A certification issued to a pre-coordinated, integrated bundle
of Health IT Modules shall be treated the same as a certification
issued to a Complete EHR for the purposes of paragraph (k)(1) of this
section, except that the certification must also indicate each Health
IT Module that is included in the bundle; and
(4) A certification issued to a Complete EHR or Health IT Module
based solely on the applicable certification criteria adopted by the
Secretary at subpart C of this part must be separate and distinct from
any other certification(s) based on other criteria or requirements.
* * * * *
(m) Obtain a record of all adaptations and updates, including
changes to user-facing aspects, made to certified Complete EHRs and
certified Health IT Modules, on a monthly basis each calendar year.
(n) Submit a list of complaints received to the National
Coordinator on a quarterly basis that includes the number of complaints
received, the nature/substance of each complaint, and the type of
complainant.
0
15. Amend Sec. 170.550 by--
0
a. Redesignating paragraph (g) as paragraph (k);
0
b. Adding paragraphs (g) and (h); and
0
c. Adding reserved paragraph (i) and paragraph (j).
The additions read as follows:

Sec. 170.550 Health IT Module certification.

* * * * *
(g) When certifying a Health IT Module to the 2015 Edition health
IT

[[Page 16917]]

certification criteria, an ONC-ACB must certify the Health IT Module in
accordance with the certification criteria at:
(1) Section 170.315(g)(3) if the Health IT Module is presented for
certification to one or more listed certification criteria in Sec.
170.315(g)(3);
(2) Section 170.315(g)(4);
(3) Section 170.315(g)(5) if the Health IT Module is presented for
certification to one or more of the certification criteria referenced
in Sec. 170.315(g)(5);
(4) Section 170.315(g)(6) if the Health IT Module is presented for
certification with C-CDA creation capabilities within its scope. If the
scope of certification sought includes multiple certification criteria
that require C-CDA creation, Sec. 170.315(g)(6) need only be tested in
association with one of those certification criteria and would not be
expected or required to be tested for each; and
(5) Section 170.315(g)(8).
(h) Privacy and security certification--(1) General rule. When
certifying a Health IT Module to the 2015 Edition health IT
certification criteria, an ONC-ACB can only issue a certification to a
Health IT Module if the following adopted privacy and security
certification criteria have also been met as applicable to the specific
capabilities included for certification:
(i) Section 170.315(a) is also certified to the certification
criteria adopted at Sec. 170.315(d)(1) through (7);
(ii) Section 170.315(b) is also certified to the certification
criteria adopted at Sec. 170.315(d)(1) through (3) and (d)(5) through
(8);
(iii) Section 170.315(c) is also certified to the certification
criteria adopted at Sec. 170.315(d)(1) through (3);
(iv) Section 170.315(e) is also certified to the certification
criteria adopted at Sec. 170.315(d)(1) through (3), (5), and (7);
(v) Section 170.315(f) is also certified to the certification
criteria adopted at Sec. 170.315(d)(1) through (3) and (7);
(vi) Section 170.315(h) is also certified to the certification
criteria adopted at Sec. 170.315(d)(1) through (3); and
(vii) Section 170.315(i) is also certified to the certification
criteria adopted at Sec. 170.315(d)(1) through (3) and (d)(5) through
(8).
(2) Methods to demonstrate compliance with each privacy and
security criterion. One of the following methods must be used to meet
each applicable privacy and security criterion listed in paragraph
(h)(1) of this section:
(i) Directly, by demonstrating a technical capability to satisfy
the applicable certification criterion or certification criteria; or
(ii) Demonstrate, through system documentation sufficiently
detailed to enable integration, that the Health IT Module has
implemented service interfaces for each applicable privacy and security
certification criterion that enable the Health IT Module to access
external services necessary to meet the privacy and security
certification criterion.
(i) [Reserved]
(j) Direct Project transport method. An ONC-ACB can only issue a
certification to a Health IT Module for Sec. 170.315(h)(1) if the
Health IT Module's certification also includes Sec. 170.315(b)(1).
* * * * *

Sec. 170.553 [Removed and Reserved]

0
16. Remove and reserve Sec. 170.553.
0
17. Add Sec. 170.556 to read as follows:

Sec. 170.556 In-the-field surveillance and maintenance of
certification for Health IT.

(a) In-the-field surveillance. Consistent with its accreditation to
ISO/IEC 17065 and the requirements of this subpart, an ONC-ACB must
initiate surveillance ``in the field'' as necessary to assess whether a
certified Complete EHR or certified Health IT Module continues to
conform to the requirements of its certification once the certified
Complete EHR or certified Health IT Module has been implemented and is
in use in a production environment.
(1) Production environment. An ONC-ACB's assessment of a certified
capability in the field must be based on the use of the capability in a
production environment, which means a live environment in which the
capabilities have been implemented and are in use.
(2) Production data. An ONC-ACB's assessment of a certified
capability in the field must be based on the use of the capability with
production data unless the use of test data is specifically approved by
the National Coordinator.
(b) Reactive surveillance. An ONC-ACB must initiate in-the-field
surveillance whenever it becomes aware of facts or circumstances that
would cause a reasonable person to question a certified Complete EHR or
certified Health IT Module's continued conformance to the requirements
of its certification.
(1) Prioritized certification criteria. An ONC-ACB must initiate
in-the-field surveillance if it identifies a trend of non-conformance
complaints associated with any certification criteria prioritized by
the National Coordinator.
(2) Review of required disclosures. When an ONC-ACB performs
reactive surveillance under this paragraph (b), it must verify that the
requirements of Sec. 170.523(k)(1) have been followed as applicable to
the issued certification.
(c) Randomized surveillance. An ONC-ACB must initiate in-the-field
surveillance for at least 10% of the Complete EHRs and Health IT
Modules to which it has issued a certification. Such surveillance must
occur on a rolling basis throughout each calendar year.
(1) Scope. When an ONC-ACB selects a certified Complete EHR or
certified Health IT Module for randomized surveillance under this
paragraph, its evaluation of the certified Complete EHR or certified
Health IT Module must include all certification criteria prioritized by
the National Coordinator under paragraph (b)(1) of this section that
are part of the scope of the certification issued to the Complete EHR
or Health IT Module.
(2) Rolling surveillance. Randomized surveillance required by this
paragraph must be completed on an ongoing basis throughout the calendar
year.
(3) Random selection. An ONC-ACB must randomly select certified
Complete EHRs and certified Health IT Modules for surveillance under
this paragraph.
(4) Number and types of locations for in-the-field surveillance.
For each certified Compete EHR or certified Health IT Module selected
for randomized surveillance under this paragraph (c), an ONC-ACB must
evaluate the certified Complete EHR or certified Health IT Module's
capabilities at the lesser of 10 or 5% of locations where the certified
Complete EHR or certified Health IT Module is implemented and in use in
the field.
(5) Results of randomized surveillance--(i) Successful surveillance
results. A certified Complete EHR or certified Health IT Module will be
deemed successful under this paragraph if and only if an ONC-ACB
determines that, for each and every certification criterion evaluated,
the certified Complete EHR or certified Health IT Module demonstrated
continued conformance at 80% or more locations.
(ii) Deficient surveillance results. A certified Complete EHR or
certified Health IT Module will be deemed deficient under this
paragraph if an ONC-ACB determines that, for any certification
criterion evaluated, the Complete EHR or Health IT Module demonstrated
continued conformance at less than 80% of locations.
(6) Corrective action plan--(i) Whenever a Complete EHR or Health
IT Module is deemed deficient pursuant to paragraph (c)(5)(ii) of this
section, the ONC-ACB must notify the developer of the deficiency and
require the developer

[[Page 16918]]

to submit a proposed corrective action plan for the applicable
certification criterion or certification criteria within 30 days of the
date of said notice.
(ii) The ONC-ACB shall provide direction to the developer as to the
required elements of the corrective action plan.
(iii) The ONC-ACB shall determine the required elements of the
corrective action plan, consistent with its accreditation and any
elements specified by the National Coordinator. At a minimum, any
corrective action plan submitted by a developer to an ONC-ACB must
include:
(A) A description of the identified deficiencies;
(B) An assessment of how widespread or isolated the identified
deficiencies may be across the developer's install base for certified
Complete EHR or certified Health IT Module;
(C) How the developer will address the identified conformance
deficiencies in general and at the locations under which surveillance
occurred; and
(D) The timeframe under which corrective action will be completed.
(7) Certificate suspension procedures in the context of randomized
surveillance and corrective action plans. Under this section and
consistent with an ONC-ACB's accreditation to ISO/IEC 17065 and
procedures for suspending a certification, an ONC-ACB is permitted to
initiate certificate suspension procedures for the Complete EHR or
Health IT Module if the developer thereof:
(i) Does not submit a proposed corrective action plan to the ONC-
ACB within 30 days of being notified of its deficient surveillance
results;
(ii) Does not comply with the ONC-ACB's directions for addressing
any aspects of the proposed corrective action plan that do not meet the
requirements of the ONC-ACB or the ONC Health IT Certification Program;
or
(iii) Does not complete an approved corrective action plan within 6
months of approval of the plan by the ONC-ACB.
(8) Certificate termination procedures in the context of randomized
surveillance. If a certified Complete EHR or certified Health IT
Module's certification has been suspended in the context of randomized
surveillance under this paragraph, an ONC-ACB is permitted to initiate
certification termination procedures for the Complete EHR or Health IT
Module (consistent with its accreditation to ISO/IEC 17065 and
procedures for terminating a certification) when the developer has not
completed the actions necessary to reinstate the suspended
certification.
(9) Prohibition on consecutive selection for randomized
surveillance. An ONC-ACB is prohibited from selecting a certified
Complete EHR or certified Health IT Module for randomized surveillance
under this paragraph more than once during any consecutive 12 month
period. This limitation does not apply to reactive and other forms of
surveillance required under this subpart and the ONC-ACB's
accreditation.
(d) Reporting of surveillance results requirements--(1) Rolling
submission of in-the-field surveillance results. The results of in-the-
field surveillance under this section must be submitted to the National
Coordinator on an ongoing basis throughout the calendar year.
(2) Confidentiality of locations evaluated. The contents of an ONC-
ACB's surveillance results submitted to the National Coordinator must
not include any information that would identify any user or location
that participated in or was subject to surveillance.
(3) Reporting of corrective action plans. When a corrective action
plan is initiated for a Complete EHR or Health IT Module, an ONC-ACB
must report the Complete EHR or Health IT Module (and its product
identification information) to the National Coordinator in accordance
with Sec. 170.523(f)(1)(xix) or (f)(2)(ix), as applicable.
(e) Relationship to other surveillance requirements. Nothing in
this section shall be construed to limit or constrain an ONC-ACB's
general ability to perform surveillance, including in-the-field
surveillance, on any certified Complete EHR or certified Health IT
Module at any time, as determined appropriate by the ONC-ACB.

Dated: March 18, 2015.
Sylvia M. Burwell,
Secretary.

Note: The following appendix will not appear in the Code of
Federal Regulations.

[[Page 16919]]

Appendix A--2015 Edition Health IT Certification Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
Relationship to
Estimated Proposed privacy the proposed
average and security Conditional CEHRT \272\
Proposed CFR Certification developmental certification certification Gap certification Proposed inclusion in definition and
citation criterion hours \270\ requirements requirements (Sec. eligibility 2015 edition base EHR proposed EHR
av. low/av. \271\ (Approach 170.550) definition Incentive
high 1) Programs Stage 3
objectives
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Computerized 0/50 Sec. Sec. Sec. Included \273\....... Objective 4.
170.315(a)(1). Provider Order 170.315(d)(1) 170.315(g)(3) 170.314(a)(1)
Entry (CPOE)-- through (d)(7). Sec. Sec.
medications. 170.315(g)(4) 170.314(a)(18).
Sec.
170.315(g)(8)
Sec. CPOE--laboratory. 1,000/2,000 Sec. Sec. Not eligible..... Included \274\....... Objective 4.
170.315(a)(2). 170.315(d)(1) 170.315(g)(3)
through (d)(7). Sec.
170.315(g)(4)
Sec.
170.315(g)(8)
Sec. CPOE--diagnostic 0/50 Sec. Sec. Sec. Included \275\....... Objective 4.
170.315(a)(3). imaging. 170.315(d)(1) 170.315(g)(3) 170.314(a)(1)
through (d)(7). Sec. Sec.
170.315(g)(4) 170.314(a)(20).
Sec.
170.315(g)(8)
Sec. Drug-drug, Drug- 400/800 Sec. Sec. Not eligible..... Not included......... Objective 3.
170.315(a)(4). allergy 170.315(d)(1) 170.315(g)(3)
Interaction through (d)(7). Sec.
Checks for CPOE. 170.315(g)(4)
Sec.
170.315(g)(8)
Sec. Demographics..... 500/1,000 Sec. Sec. Not eligible..... Included............. No additional
170.315(a)(5). 170.315(d)(1) 170.315(g)(3) relationship
through (d)(7). Sec. beyond the Base
170.315(g)(4) EHR Definition.
Sec.
170.315(g)(8)
Sec. Vital Signs, BMI, 614/922 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(a)(6). and Growth 170.315(d)(1) 170.315(g)(3)
Charts. through (d)(7). Sec.
170.315(g)(4)
Sec.
170.315(g)(8)
Sec. Problem List..... 100/200 Sec. Sec. Not eligible..... Included............. No additional
170.315(a)(7). 170.315(d)(1) 170.315(g)(3) relationship
through (d)(7). Sec. beyond the Base
170.315(g)(4) EHR Definition.
Sec.
170.315(g)(8)
Sec. Medication List.. 0/50 Sec. Sec. Sec. Included............. No additional
170.315(a)(8). 170.315(d)(1) 170.315(g)(3) 170.314(a)(6). relationship
through (d)(7). Sec. beyond the Base
170.315(g)(4) EHR Definition.
Sec.
170.315(g)(8)
Sec. Medication 0/50 Sec. Sec. Sec. Included............. No additional
170.315(a)(9). Allergy List. 170.315(d)(1) 170.315(g)(3) 170.314(a)(7). relationship
through (d)(7). Sec. beyond the Base
170.315(g)(4) EHR Definition.
Sec.
170.315(g)(8)
Sec. Clinical Decision 600/1,200 Sec. Sec. Not eligible..... Included............. Objective 3.
170.315(a)(10). Support. 170.315(d)(1) 170.315(g)(3)
through (d)(7). Sec.
170.315(g)(4)
Sec.
170.315(g)(8)
Sec. Drug-formulary 310/620 Sec. Sec. Not eligible..... Not included......... Objective 2.
170.315(a)(11). and Preferred 170.315(d)(1) 170.315(g)(4)
Drug List Checks. through (d)(7). Sec.
170.315(g)(8)
Sec. Smoking Status... 100/200 Sec. Sec. Not eligible..... Included............. No additional
170.315(a)(12). 170.315(d)(1) 170.315(g)(4) relationship
through (d)(7). Sec. beyond the Base
170.315(g)(8) EHR Definition.
Sec. Image Results.... 0/20 Sec. Sec. Sec. Not included......... No relationship.
170.315(a)(13). 170.315(d)(1) 170.315(g)(4) 170.314(a)(12).
through (d)(7). Sec.
170.315(g)(8)
Sec. Family Health 100/200 Sec. Sec. Not eligible..... Not included......... CEHRT.\276\
170.315(a)(14). History. 170.315(d)(1) 170.315(g)(4)
through (d)(7). Sec.
170.315(g)(8)
Sec. Family Health 500/1,200 Sec. Sec. Not eligible..... Not included......... CEHRT.\277\
170.315(a)(15). History--pedigre 170.315(d)(1) 170.315(g)(4)
e. through (d)(7). Sec.
170.315(g)(8)
Sec. Patient List 0/20 Sec. Sec. Sec. Not included......... No relationship.
170.315(a)(16). Creation. 170.315(d)(1) 170.315(g)(4) 170.314(a)(14).
through (d)(7). Sec.
170.315(g)(8)
Sec. Patient-specific 600/1,200 Sec. Sec. Not eligible..... Not included......... Objective 5.
170.315(a)(17). Education 170.315(d)(1) 170.315(g)(4)
Resources. through (d)(7). Sec.
170.315(g)(8)
Sec. Electronic 0/20 Sec. Sec. Sec. Not included......... No relationship.
170.315(a)(18). Medication 170.315(d)(1) 170.315(g)(3) 170.314(a)(16).
Administration through (d)(7). Sec.
Record. 170.315(g)(4)
Sec.
170.315(g)(8)
Sec. Patient Health 500/1,000 Sec. Sec. Not eligible..... Not included......... CEHRT
170.315(a)(19). Information 170.315(d)(1) 170.315(g)(4) Objective 6.
Capture. through (d)(7). Sec.
170.315(g)(8)
Sec. Implantable 1,100/1,700 Sec. Sec. Not eligible..... Included............. No additional
170.315(a)(20). Device List. 170.315(d)(1) 170.315(g)(3) relationship
through (d)(7). Sec. beyond the Base
170.315(g)(4) EHR Definition.
Sec.
170.315(g)(8)
Sec. Social, 235/470 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(a)(21). Psychological, 170.315(d)(1) 170.315(g)(4)
and Behavioral through (d)(7). Sec.
Data. 170.315(g)(8)
Sec. Decision Support-- 394/788 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(a)(22). knowledge 170.315(d)(1) 170.315(g)(3)
artifact. through (d)(7). Sec.
170.315(g)(4)
Sec.
170.315(g)(8)
Sec. Decision Support-- 229/458 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(a)(23). service. 170.315(d)(1) 170.315(g)(3)
through (d)(7). Sec.
170.315(g)(4)
Sec.
170.315(g)(8)
Sec. Transitions of 1,550/3,100 Sec. Sec. Not eligible..... Included............. Objective 7.
170.315(b)(1). Care. 170.315(d)(1) 170.315(g)(4)
through (d)(3) Sec.
and (d)(5) 170.315(g)(6)
through (d)(8). Sec.
170.315(g)(8)
Sec. Clinical 600/1,200 Sec. Sec. Not eligible..... Not included......... Objective 7.
170.315(b)(2). Information 170.315(d)(1) 170.315(g)(3)
Reconciliation through (d)(3) Sec.
and and (d)(5) 170.315(g)(4)
Incorporation. through (d)(8). Sec.
170.315(g)(6)
Sec.
170.315(g)(8)
Sec. Electronic 1,050/2,100 Sec. Sec. Not eligible..... Not included......... Objective 2.
170.315(b)(3). Prescribing. 170.315(d)(1) 170.315(g)(3)
through (d)(3) Sec.
and (d)(5) 170.315(g)(4)
through (d)(8). Sec.
170.315(g)(8)
Sec. Incorporate 313/626 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(b)(4). Laboratory Tests 170.315(d)(1) 170.315(g)(3)
and Values/ through (d)(3) Sec.
Results. and (d)(5) 170.315(g)(4)
through (d)(8). Sec.
170.315(g)(8)
Sec. Transmission of 360/720 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(b)(5). Laboratory Test 170.315(d)(1) 170.315(g)(4)
Reports. through (d)(3) Sec.
and (d)(5) 170.315(g)(8)
through (d)(8).
Sec. Data Portability. 800/1,200 Sec. Sec. Not eligible..... Included............. No additional
170.315(b)(6). 170.315(d)(1) 170.315(g)(4) relationship
through (d)(3) Sec. beyond the Base
and (d)(5) 170.315(g)(6) EHR Definition.
through (d)(8). Sec.
170.315(g)(8)
Sec. Data Segmentation 450/900 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(b)(7). for Privacy-- 170.315(d)(1) 170.315(g)(4)
send. through (d)(3) Sec.
and (d)(5) 170.315(g)(6)
through (d)(8). Sec.
170.315(g)(8)

[[Page 16920]]

Sec. Data Segmentation 450/900 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(b)(8). for Privacy-- 170.315(d)(1) 170.315(g)(4)
receive. through (d)(3) Sec.
and (d)(5) 170.315(g)(8)
through (d)(8).
Sec. Care Plan........ 300/500 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(b)(9). 170.315(d)(1) 170.315(g)(4)
through (d)(3) Sec.
and (d)(5) 170.315(g)(6)
through (d)(8). Sec.
170.315(g)(8)
Sec. Clinical Quality 200/500 Sec. Sec. Not eligible..... Included............. CEHRT.
170.315(c)(1). Measures--record 170.315(d)(1) 170.315(g)(4)
and export. through (d)(3). Sec.
170.315(g)(8)
Sec. Clinical Quality 0/200 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(c)(2). Measures--import 170.315(d)(1) 170.315(g)(4)
and calculate. through (d)(3). Sec.
170.315(g)(8)
Sec. Reserved for Reserved Sec. Sec. Reserved......... Reserved............. Reserved.\278\
170.315(c)(3). Clinical Quality 170.315(d)(1) 170.315(g)(4)
Measures--record. through (d)(3). Sec.
170.315(g)(8)
Sec. Clinical Quality 316/632 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(c)(4). Measures--filter. 170.315(d)(1) 170.315(g)(4)
through (d)(3). Sec.
170.315(g)(8)
Sec. Authentication, 0/50 Not applicable (N/ Sec. Sec. Not included......... No relationship.
170.315(d)(1). Access Control, A). 170.315(g)(4) 170.314(d)(1).
Authorization. Sec.
170.315(g)(8)
Sec. Auditable Events 0/50 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(2). and Tamper- 170.315(g)(4) 170.314(d)(2).
resistance. Sec.
170.315(g)(8)
Sec. Audit Report(s).. 0/50 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(3). 170.315(g)(4) 170.314(d)(3).
Sec.
170.315(g)(8)
Sec. Amendments....... 0/50 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(4). 170.315(g)(4) 170.314(d)(4).
Sec.
170.315(g)(8)
Sec. Automatic Access 0/50 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(5). Time-out. 170.315(g)(4) 170.314(d)(5).
Sec.
170.315(g)(8)
Sec. Emergency Access. 0/50 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(6). 170.315(g)(4) 170.314(d)(6).
Sec.
170.315(g)(8)
Sec. End-User Device 0/50 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(7). Encryption. 170.315(g)(4) 170.314(d)(7).
Sec.
170.315(g)(8)
Sec. Integrity........ 0/50 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(8). 170.315(g)(4) 170.314(d)(8).
Sec.
170.315(g)(8)
Sec. Accounting of 0/20 N/A.............. Sec. Sec. Not included......... No relationship.
170.315(d)(9). Disclosures. 170.315(g)(4) 170.314(d)(9).
Sec.
170.315(g)(8)
Sec. View, Download, 1,000/2,000 Sec. Sec. Not eligible..... Not included......... Objective 5
170.315(e)(1). and Transmit to 170.315(d)(1) 170.315(g)(4) Objective 6.
3rd Party. through (d)(3), Sec.
(d)(5), and 170.315(g)(6)
(d)(7). Sec.
170.315(g)(8)
Sec. Secure Messaging. 0/50 Sec. Sec. Sec. Not included......... Objective 6.
170.315(e)(2). 170.315(d)(1) 170.315(g)(4) 170.314(e)(3).
through (d)(3), Sec.
(d)(5), and 170.315(g)(8)
(d)(7).
Sec. Transmission to 680/1,360 Sec. Sec. Not eligible..... Not included......... Objective
170.315(f)(1). Immunization 170.315(d)(1) 170.315(g)(4) 8.\279\
Registries. through (d)(3) Sec.
and (d)(7). 170.315(g)(8)
Sec. Transmission to 480/960 Sec. Sec. Not eligible..... Not included......... Objective 8.
170.315(f)(2). Public Health 170.315(d)(1) 170.315(g)(4)
Agencies--syndro through (d)(3) Sec.
mic surveillance. and (d)(7). 170.315(g)(8)
Sec. Transmission to 520/1,040 Sec. Sec. Not eligible..... Not included......... Objective 8.
170.315(f)(3). Public Health 170.315(d)(1) 170.315(g)(4)
Agencies--report through (d)(3) Sec.
able laboratory and (d)(7). 170.315(g)(8)
tests and values/
results.
Sec. Transmission to 500/1,000 Sec. Sec. Not eligible..... Not included......... Objective 8.
170.315(f)(4). Cancer 170.315(d)(1) 170.315(g)(4)
Registries. through (d)(3) Sec.
and (d)(7). 170.315(g)(8)
Sec. Transmission to 500/1,000 Sec. Sec. Not eligible..... Not included......... Objective 8.
170.315(f)(5). Public Health 170.315(d)(1) 170.315(g)(4)
Agencies--case through (d)(3) Sec.
reporting. and (d)(7). 170.315(g)(8)
Sec. Transmission to 500/1,000 Sec. Sec. Not eligible..... Not included......... Objective 8.
170.315(f)(6). Public Health 170.315(d)(1) 170.315(g)(4)
Agencies--antimi through (d)(3) Sec.
crobial use and and (d)(7). 170.315(g)(8)
resistance
reporting.
Sec. Transmission to 500/1,000 Sec. Sec. Not eligible..... Not included......... Objective 8.
170.315(f)(7). Public Health 170.315(d)(1) 170.315(g)(4)
Agencies--health through (d)(3) Sec.
care surveys. and (d)(7). 170.315(g)(8)
Sec. Automated 400/800 N/A.............. Sec. Fact-specific.... Not included......... CEHRT.
170.315(g)(1). Numerator 170.315(g)(4)
Recording.
Sec. Automated Measure 600/1,200 N/A.............. Sec. Fact-specific.... Not included......... CEHRT.
170.315(g)(2). Calculation. 170.315(g)(4)
Sec. Safety-Enhanced 300/600 N/A.............. N/A Fact-specific.... Not included......... No relationship.
170.315(g)(3). Design.
Sec. Quality 400/800 N/A.............. N/A Not eligible..... Not included......... No relationship.
170.315(g)(4). Management
System.
Sec. Accessibility 800/1400 N/A.............. N/A Not eligible..... Not included......... No relationship.
170.315(g)(5). Technology
Compatibility.
Sec. Consolidated CDA 400/1,000 N/A.............. N/A Not eligible..... Not included......... No relationship.
170.315(g)(6). Creation
Performance.
Sec. Application 500/1,000 N/A.............. Sec. Not eligible..... Included............. Objective 5
170.315(g)(7). Access to Common 170.315(g)(4) Objective 6.
Clinical Data Sec.
Set. 170.315(g)(6)
Sec.
170.315(g)(8)
Sec. Accessibility- 50/100 N/A.............. N/A Not eligible..... Not included......... No relationship.
170.315(g)(8). Centered Design.
Sec. Direct Project... 0/50 Sec. Sec. Sec. Included \280\....... No relationship
170.315(h)(1). 170.315(d)(1) 170.315(b)(1) 170.314(b)(1)(i) beyond the Base
through (d)(3). Sec. (A) and Sec. EHR Definition.
170.315(g)(4) 170.314(b)(2)(ii
Sec. )(A)
170.315(g)(8) Sec.
170.314(h)(1).

[[Page 16921]]

Sec. Direct Project, 0/50 Sec. Sec. Sec. Included \282\....... No relationship
170.315(h)(2). Edge Protocol, 170.315(d)(1) 170.315(g)(4) 170.314(b)(1)(i) beyond the Base
and XDR/XDM. through (d)(3). Sec. (B), Sec. EHR Definition.
170.315(g)(8) 170.314(b)(2)(ii
)(B), and Sec.
170.314(b)(8)
\281\
170.314(b)(8)
\283\ and
170.314(h)(2).
Sec. SOAP Transport 0/20 Sec. Sec. Sec. Not included......... No relationship.
170.315(h)(3). and Security 170.315(d)(1) 170.315(g)(4) 170.314(b)(1)(i)
Specification through (d)(3). Sec. (C) and Sec.
and XDR/XDR for 170.315(g)(8) 170.314(b)(2)(ii
Direct Messaging. )(C)
Sec.
170.314(h)(3).
Sec. Healthcare 120/240 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(h)(4). Provider 170.315(d)(1) 170.315(g)(4)
Directory--query through (d)(3). Sec.
request. 170.315(g)(8)
Sec. Healthcare 120/240 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(h)(5). Provider 170.315(d)(1) 170.315(g)(4)
Directory--query through (d)(3). Sec.
response. 170.315(g)(8)
Sec. Electronic 1000/200 Sec. Sec. Not eligible..... Not included......... No relationship.
170.315(j)(1). Submission of 170.315(d)(1) 170.315(g)(4)
Medical through (d)(3) Sec.
Documentation. and (d)(5) 170.315(g)(6)
through (d)(8). Sec.
170.315(g)(8)
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\270\ Please see section VIII (``Regulatory Impact Statement'')
of the preamble for information on how estimated development hours
were calculated. To note, certification to the 2014 Edition serves
as a foundation for estimating costs. For unchanged certification
criteria, in establishing our cost estimates for this proposed rule,
we used burden hours multiplied by all health IT developers
previously certified to the 2014 Edition version of the
certification criteria to account for new entrants. These burden
hour estimates are not estimates for development of a new product to
meet one or more of these certification criteria. For certification
criteria not associated with the EHR Incentive Programs Stage 3,
there is a 60% reduction in burden hours. This reduction is due to
our estimate that health IT developers would develop 1 product
instead of 2.5 products to each of the certification criteria.
\271\ We propose to require that an ONC-ACB must ensure that a
Health IT Module presented for certification to any of the
certification criteria that fall into the regulatory functional
categories of Sec. 170.315 for which privacy and security
certification requirements apply either pursues approach 1 (detailed
in the table) or approach 2: Demonstrate, through system
documentation sufficiently detailed to enable integration, that the
Health IT Module has implemented service interfaces for each
applicable privacy and security certification criterion that enable
the Health IT Module to access external services necessary to meet
the privacy and security certification criterion.
\272\ CMS' CEHRT definition would include the criteria adopted
in the Base EHR definition. For more details on the CEHRT
definition, please see the CMS EHR Incentive Programs proposed rule
published elsewhere in this issue of the Federal Register.
\273\ Technology needs to be certified to Sec. 170.315(a)(1),
(a)(2), or (a)(3).
\274\ Technology needs to be certified to Sec. 170.315(a)(1),
(a)(2), or (a)(3).
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\275\ Technology needs to be certified to Sec. 170.315(a)(1),
(a)(2), or (a)(3).
\276\ Technology needs to be certified to Sec. 170.315(a)(14)
or (a)(15).
\277\ Technology needs to be certified to Sec. 170.315(a)(14)
or (a)(15).
\278\ As discussed in the preamble for the ``clinical quality
measures--report'' criterion, additional CQM certification policy
may be proposed in or with CMS payment rules in CY15. As such,
additional CQM certification criteria may be proposed for the Base
EHR and/or CEHRT definitions.
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\279\ For the public health certification criteria in Sec.
170.315(f), technology would only need to be certified to those
criteria that are required to meet the options the provider intends
to report in order to meet the proposed Objective 8: Public Health
and Clinical Data Registry Reporting.
\280\ Technology needs to be certified to Sec. 170.315(h)(1) or
(h)(2).
\281\ Technology must have been certified to both edge protocol
methods specified by the standard in Sec. 170.202(d) to be gap
certification eligible.
\282\ Technology needs to be certified to Sec. 170.315(h)(1) or
(h)(2).
\283\ Technology must have been certified to both edge protocol
methods specified by the standard in Sec. 170.202(d) to be gap
certification eligible.
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[FR Doc. 2015-06612 Filed 3-20-15; 3:00 pm]
BILLING CODE 4150-45-P

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of proposed rulemaking with comment period.
Dates		To be assured consideration, written or electronic comments must
Contact		Michael Lipinski, Office of Policy, Office of the National Coordinator for Health Information Technology, 202-690-7151.
FR Citation		80 FR 16804
RIN Number		0991-AB93
CFR Associated		Computer Technology; Electronic Health Record; Electronic Information System; Electronic Transactions; Health; Health Care; Health Information Technology; Health Insurance; Health Records; Hospitals; Incorporation by Reference; Laboratories; Medicaid; Medicare; Privacy; Reporting and Recordkeeping Requirements; Public Health and Security

80 FR 16804 - 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 80, Issue 60 (March 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary