80 FR 32477 - Acceptance and Approval of Non-Governmental Developed Test Procedures, Test Tools, and Test Data for Use Under the ONC Health IT Certification Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 110 (June 9, 2015)

Page Range		32477-32477
FR Document		2015-13510

This document further informs the public of ONC's policy that permits any person or entity to submit test procedures, test tools, and test data for approval and use under the ONC Health IT Certification Program.

Federal Register, Volume 80 Issue 110 (Tuesday, June 9, 2015)

[Federal Register Volume 80, Number 110 (Tuesday, June 9, 2015)]
[Rules and Regulations]
[Page 32477]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 170


Acceptance and Approval of Non-Governmental Developed Test 
Procedures, Test Tools, and Test Data for Use Under the ONC Health IT 
Certification Program

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

ACTION: Reissuance.

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SUMMARY: This document further informs the public of ONC's policy that 
permits any person or entity to submit test procedures, test tools, and 
test data for approval and use under the ONC Health IT Certification 
Program.

DATES: Reissued June 9, 2015.

FOR FURTHER INFORMATION CONTACT: Alicia Morton, Director, ONC Health IT 
Certification Program, Office of the National Coordinator for Health 
Information Technology, 202-549-7851.

SUPPLEMENTARY INFORMATION: On January 7, 2011, the Department of Health 
and Human Services issued a final rule establishing a permanent 
certification program for the purposes of testing and certifying health 
information technology (``Establishment of the Permanent Certification 
Program for Health Information Technology,'' 76 FR 1262) (``Permanent 
Certification Program final rule''). The permanent certification 
program was renamed the ``ONC HIT Certification Program'' in a final 
rule published on September 4, 2012 (77 FR 54163) (``2014 Edition EHR 
Certification Criteria final rule''). In the proposed rule entitled 
``2015 Edition Health Information Technology (Health IT) Certification 
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, 
and ONC Health IT Certification Program Modifications'' (80 FR 16804, 
16806), we propose to further rename the program as the ``ONC Health IT 
Certification Program.''
    In the preamble of the Permanent Certification Program final rule, 
we stated that a person or entity may submit a test procedure or test 
tool (to note, which includes any associated test data) to the National 
Coordinator for Health Information Technology (the National 
Coordinator) to be considered for approval and use by NVLAP accredited 
testing laboratories. ``The submission should identify the developer of 
the test tool and/or test procedure; specify the certification 
criterion or criteria that is/are addressed by the test tool and/or 
test procedure; and explain how the test tool and/or test procedure 
would evaluate a Complete EHR's, EHR Module's, or if the applicable, 
and other type of HIT's compliance with the applicable certification 
criterion or criteria. The submission should also provide information 
describing the process used to develop the test tool and/or test 
procedure, including any opportunity for the public to comment on the 
test tool and/or test procedure and the degree to which public comments 
were considered.'' (76 FR 1280) We also stated that ``[i]n determining 
whether to approve a test tool and/or test procedure for purposes of 
the permanent certification program, the National Coordinator will 
consider whether it is clearly traceable to a certification criterion 
or criteria adopted by the Secretary; whether it is sufficiently 
comprehensive (i.e., assesses all required capabilities) for NVLAP-
accredited testing laboratories to use in testing a Complete EHR's, EHR 
Module's, or other type of HIT's compliance with the certification 
criterion or criteria adopted by the Secretary; whether an appropriate 
public comment process was used during the development of the test tool 
and/or test procedure; and any other relevant factors.'' (76 FR 1280)
    During the time in which the ONC Health IT Certification Program 
has operated, health IT developers have suggested that testing 
efficiencies could be achieved if the ONC Health IT Certification 
Program were to leverage operational testing and certification, such as 
the ePrescribing (eRX) network testing (and certification). As 
indicated by the previously recited ONC policy, the National 
Coordinator is open to approving test procedures, test tools, and test 
data that meet the outlined approval requirements above for an 
applicable adopted certification criterion or criteria. By way of this 
document, we strongly encourage persons or entities to submit such test 
procedures, test tools, and test data to ONC if they believe such 
procedures, tools, and data could be used to meet ONC's certification 
criteria and testing approval requirements. We also note that there is 
no programmatic prohibition on the approval of multiple test 
procedures, test tools, and test data for a certification criterion or 
criteria.

    Dated: May 21, 2015.
Alicia Morton,
Director, ONC Health IT Certification Program, Office of the National 
Coordinator for Health Information Technology.
[FR Doc. 2015-13510 Filed 6-8-15; 8:45 am]
 BILLING CODE 4150-45-P

Federal Register / Vol. 80, No. 110 / Tuesday, June 9, 2015 / Rules and Regulations 32477

extend the time within which a petition DEPARTMENT OF HEALTH AND and explain how the test tool and/or test
for judicial review may be filed, and HUMAN SERVICES procedure would evaluate a Complete
shall not postpone the effectiveness of EHR’s, EHR Module’s, or if the
such rule or action. Parties with 45 CFR Part 170 applicable, and other type of HIT’s
objections to this direct final rule are compliance with the applicable
Acceptance and Approval of Non- certification criterion or criteria. The
encouraged to file a comment in Governmental Developed Test
response to the parallel notice of submission should also provide
Procedures, Test Tools, and Test Data information describing the process used
proposed rulemaking for this action for Use Under the ONC Health IT
published in the proposed rules section to develop the test tool and/or test
Certification Program procedure, including any opportunity
of today’s Federal Register, rather than
AGENCY: Office of the National for the public to comment on the test
file an immediate petition for judicial
Coordinator for Health Information tool and/or test procedure and the
review of this direct final rule, so that degree to which public comments were
EPA can withdraw this direct final rule Technology (ONC), Department of
Health and Human Services. considered.’’ (76 FR 1280) We also
and address the comment in the stated that ‘‘[i]n determining whether to
proposed rulemaking action. This action ACTION: Reissuance.
approve a test tool and/or test procedure
to approve Pennsylvania’s base year SUMMARY: This document further for purposes of the permanent
emissions inventory for the Lyons Area informs the public of ONC’s policy that certification program, the National
may not be challenged later in permits any person or entity to submit Coordinator will consider whether it is
proceedings to enforce its requirements. test procedures, test tools, and test data clearly traceable to a certification
(See section 307(b)(2).) for approval and use under the ONC criterion or criteria adopted by the
Health IT Certification Program. Secretary; whether it is sufficiently
List of Subjects in 40 CFR Part 52
DATES: Reissued June 9, 2015. comprehensive (i.e., assesses all
Environmental protection, Air FOR FURTHER INFORMATION CONTACT: required capabilities) for NVLAP-
pollution control, Incorporation by Alicia Morton, Director, ONC Health IT accredited testing laboratories to use in
reference, Intergovernmental relations, Certification Program, Office of the testing a Complete EHR’s, EHR
and Lead. National Coordinator for Health Module’s, or other type of HIT’s
Information Technology, 202–549–7851. compliance with the certification
Dated: May 20, 2015. criterion or criteria adopted by the
SUPPLEMENTARY INFORMATION: On
William C. Early, Secretary; whether an appropriate
January 7, 2011, the Department of
Acting, Regional Administrator, Region III. Health and Human Services issued a public comment process was used
final rule establishing a permanent during the development of the test tool
40 CFR part 52 is amended as follows: and/or test procedure; and any other
certification program for the purposes of
testing and certifying health information relevant factors.’’ (76 FR 1280)
PART 52—APPROVAL AND During the time in which the ONC
PROMULGATION OF technology (‘‘Establishment of the
Health IT Certification Program has
IMPLEMENTATION PLANS Permanent Certification Program for
operated, health IT developers have
Health Information Technology,’’ 76 FR
suggested that testing efficiencies could
1262) (‘‘Permanent Certification
■ 1. The authority citation for part 52 be achieved if the ONC Health IT
Program final rule’’). The permanent
continues to read as follows: Certification Program were to leverage
certification program was renamed the
operational testing and certification,
Authority: 42 U.S.C. 7401 et seq. ‘‘ONC HIT Certification Program’’ in a
such as the ePrescribing (eRX) network
final rule published on September 4,
Subpart NN—Pennsylvania testing (and certification). As indicated
2012 (77 FR 54163) (‘‘2014 Edition EHR
by the previously recited ONC policy,
Certification Criteria final rule’’). In the
the National Coordinator is open to
■ 2. Section 52.2036 is amended by proposed rule entitled ‘‘2015 Edition
approving test procedures, test tools,
adding paragraph (v) to read as follows: Health Information Technology (Health
and test data that meet the outlined
IT) Certification Criteria, 2015 Edition
§ 52.2036 Base year emissions inventory. approval requirements above for an
Base Electronic Health Record (EHR)
applicable adopted certification
* * * * * Definition, and ONC Health IT
criterion or criteria. By way of this
(v) EPA approves as a revision to the Certification Program Modifications’’
document, we strongly encourage
Pennsylvania State Implementation Plan (80 FR 16804, 16806), we propose to
persons or entities to submit such test
the 2011 base year lead emission further rename the program as the ‘‘ONC
procedures, test tools, and test data to
inventory for the Lyons, Pennsylvania Health IT Certification Program.’’
In the preamble of the Permanent ONC if they believe such procedures,
nonattainment area for the 2008 lead tools, and data could be used to meet
Certification Program final rule, we
NAAQS. This SIP revision was stated that a person or entity may ONC’s certification criteria and testing
submitted by the Acting Secretary of the submit a test procedure or test tool (to approval requirements. We also note
Pennsylvania Department of note, which includes any associated test that there is no programmatic
Environmental Protection, on February data) to the National Coordinator for prohibition on the approval of multiple
9, 2015. This submittal consists of the Health Information Technology (the test procedures, test tools, and test data
2011 base year inventories for all National Coordinator) to be considered for a certification criterion or criteria.
relevant sources in the Lyons, for approval and use by NVLAP Dated: May 21, 2015.
tkelley on DSK3SPTVN1PROD with RULES

Pennsylvania nonattainment area for the accredited testing laboratories. ‘‘The Alicia Morton,
pollutant lead (Pb). submission should identify the Director, ONC Health IT Certification
[FR Doc. 2015–13945 Filed 6–8–15; 8:45 am] developer of the test tool and/or test Program, Office of the National Coordinator
procedure; specify the certification for Health Information Technology.
BILLING CODE 6560–50–P
criterion or criteria that is/are addressed [FR Doc. 2015–13510 Filed 6–8–15; 8:45 am]
by the test tool and/or test procedure; BILLING CODE 4150–45–P

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Document Created: 2015-12-15 15:25:20
Document Modified: 2015-12-15 15:25:20

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		Rules and Regulations
Action		Reissuance.
Dates		Reissued June 9, 2015.
Contact		Alicia Morton, Director, ONC Health IT Certification Program, Office of the National Coordinator for Health Information Technology, 202-549-7851.
FR Citation		80 FR 32477