81_FR_29369 81 FR 29278 - Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Move Health Data Forward Challenge”

81 FR 29278 - Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Move Health Data Forward Challenge”

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 91 (May 11, 2016)

Page Range29278-29282
FR Document2016-11102

The Move Health Data Forward Challenge aims to incentivize participants to create an application programming interface (API) solution that utilizes the implementation specifications developed by the HEART Workgroup (Heart WG) to enable individuals to securely authorize the movement of their health data to destinations they choose. The statutory authority for this Challenge is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

Federal Register, Volume 81 Issue 91 (Wednesday, May 11, 2016)
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29278-29282]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11102]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of the National Coordinator for Health Information 
Technology; Announcement of Requirements and Registration for ``Move 
Health Data Forward Challenge''

AGENCY: Office of the National Coordinator for Health Information 
Technology, HHS.

ACTION: Notice.

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

SUMMARY: The Move Health Data Forward Challenge aims to incentivize 
participants to create an application programming interface (API) 
solution that utilizes the implementation specifications developed by 
the HEART Workgroup (Heart WG) to enable individuals to securely 
authorize the movement of their health data to destinations they 
choose. The statutory authority for this Challenge is Section 105 of 
the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

DATES: 

Phase 1:
     Challenge launch: May 10, 2016
     Submissions due: September 8, 2016
     Evaluation period: September 9--October 14, 2016
     Phase 1 winners announced: October 31, 2016
Phase 2:
     Prototyping period begins: October 31, 2016
     Submissions due: January 12, 2017
     Evaluation period: January 12--February 10, 2017
     Phase 2 winners announced: February 23, 2017
Phase 3:
     Scaling period begins: February 23, 2017
     Submission period ends: May 1, 2017
     Phase 3 winners announced: May 31, 2017

FOR FURTHER INFORMATION CONTACT: Caroline Coy, [email protected] 
(preferred), 202-720-2932.

SUPPLEMENTARY INFORMATION:

Award Approving Official

    Karen DeSalvo, National Coordinator for Health Information 
Technology.

Subject of Challenge

    ONC participated with a number of security, privacy and health 
Information technology (health IT) stakeholders to launch the HEART WG. 
The HEART WG was developed to expedite the process of gathering 
representatives from many different health-related

[[Page 29279]]

technical communities worldwide (private-sector, government and non-
governmental organizations) working in areas such as patient 
authentication, authorization, and consent--to collaborate on 
developing open-source specifications. The impetus for creating the 
HEART WG was an effort by the Health IT Standards Committee (HITSC), 
which is charged with making recommendations to the National 
Coordinator for Health IT on standards, implementation specifications, 
and certification criteria for the electronic exchange and use of 
health information. In 2013, the HITSC was tasked with reviewing 
whether ONC should consider enhancing the portfolio of transport 
standards to support the use of RESTful services in health information 
exchanges in 2013 and recommended that ONC support the developing and 
piloting of standards including OpenID Connect and OAuth2.0. In 2015, 
the HITSC recommended tracking development and piloting of new and 
emerging technology specifications including the User Managed Access 
(UMA) profile of OAuth2.0 for obtaining consumer consent. The HEART WG 
has developed a set of privacy and security specifications (HEART 
implementation specifications) using the following open standards: 
OAUTH 2.0, OpenID Connect and User Managed Access (UMA). These 
specifications enable an individual to control the authorization of 
access to health-related data sharing APIs. The goal of this Challenge 
is to incentivize participants to create a Solution that utilizes the 
HEART implementation specifications to enable individuals to securely 
authorize the movement of their health data to destinations they 
choose.
    Engaging individuals is a requirement of the Challenge. 
Participants are expected to engage individuals to test implementation 
of the Solution and enable processes that require individuals to 
authorize the release of their health data to a destination they 
choose. Participants are required to recruit individuals and obtain 
their authorizations to test implementation of the Solution on those 
individuals' health data. The data for the API and Solution should be 
provided by Phase 2 finalists.
    The Challenge will have three phases. Phase 1 will award $5000 for 
up 10 finalists each based on the proposals they submit to the 
Challenge. Phase 1 winners will be eligible to proceed to Phase 2 which 
will award $20,000 for up to 5 finalists each based on the prototype of 
their Solution. Phase 2 winners will be eligible to proceed to Phase 3 
which will award $50,000 for up to two winners each based on the 
participant's ability to implement their Solution. This multi-phased 
approach allows participants to assemble, implement and test their 
Solutions given the novel Solutions expected. The final phase of the 
Challenge will require finalists to demonstrate a consumer-facing 
Solution that incorporates the HEART implementation specifications and 
uses an API to enable consumers to authorize the movement of their 
health data to destinations they choose. This Challenge encourages 
participants who may apply independently or team with others including 
health IT developers, health care providers and other entities with the 
appropriate expertise related to this Solution. Lessons learned and the 
Challenge's results will be shared in order to support other 
organizations implementing solutions enabling consumer-mediated 
exchange.

Challenge Summary

    The Challenge has three phases ending in two finalists each winning 
$75,000.
[GRAPHIC] [TIFF OMITTED] TN11MY16.025

Phase 1--Proposals

    The Proposal Phase is designed to allow participants to articulate 
Solutions to increase consumers' access to and sharing of their 
information within electronic health record systems. In this phase, 
participants are expected to describe the technical, operational, 
financial and business aspects of their proposed Solution. This 
includes but is not limited to the value proposition, target consumer 
population and/or target health care providers, key partners, 
implementation plan, timeline, cost structure and budget overview, key

[[Page 29280]]

activities and resources, and metrics for success (described below). 
The main goal of Phase 1 is for participants to articulate feasible and 
executable plans for innovative Solutions and demonstrate potential for 
impact.
    A panel of independent reviewers will evaluate proposals and select 
finalists. Upon evaluating proposals and interview responses, judges 
will select up to 10 finalists to each receive a $5,000 award and 
advance to Phase 2 of the Challenge.

Phase 1 Submission Requirements

 Submissions in English and in pdf format.
 Submit by the deadline of September 8, 2016 using the online 
platform: https://www.challenge.gov/?post_type=challenge&p=137291
 General information about the participants and any team 
members
 Compliance with Health Insurance Portability and 
Accountability Act (HIPAA) if applicable
 Business Case (5 page maximum)
    [cir] Includes an executive summary stating the value proposition
    [ssquf] Describes how the proposed Solution will improve the 
exchange and accessibility of consumer health data
    [ssquf] Describes the target consumer population and/or target 
health care providers
    [ssquf] Describes the specific problem being solved
    [cir] Description of the methods and technologies used to develop 
the Solution
    [ssquf] Specify the HEART implementation specifications for data 
exchange that will be used by the proposed Solution
    [cir] Financial overview that includes cost structure, projected 
revenue and expense budget, current funders and description of how 
funds will be used/allocated
    [cir] Development plan and timeline
    [ssquf] Describes key activities and resources required to employ 
the Solution
    [ssquf] Plan to make the Solution readily available to consumers, 
for example to be used on existing mobile platforms or deployed on a 
public facing Web site
    [cir] Metrics for success defined by applicant (i.e. Number of 
users of the Solution, money saved by using the Solution, time saved, 
increases in number of data exchanges between consumers and providers)
    [cir] Potential risks and mitigation strategies, including security 
constraints
    [cir] Description of the participant roles, responsibilities and 
capabilities
 Briefing deck presentation in pdf format of the Solution and 
use case(s) to provide a visual picture of the Project (10 slides 
maximum)
    [cir] Content:
    [ssquf] Brief description of proposed Solution and how the 
participants will use the HEART implementation specifications for 
consumer-mediated exchange of health information
    [ssquf] Competitive advantage of the approach
    [ssquf] Example use case
    [ssquf] Proposed workflow & deliverables

Phase 2--Prototype & Pilot

    The finalists of Phase 1 of the Challenge will then advance to a 
second phase focused on prototyping the Solution and demonstrating the 
effectiveness of the Solution and impact on consumer or provider health 
records accessibility and data exchange. The goal of Phase 2 is to 
demonstrate a viable Solution with high technological merit and 
potential to impact the quality of healthcare. Mentors will be 
available to help participants. Participants will have access to a 
community of experts to bring about high quality Solutions. 
Participants will test the HEART implementation specifications. Up to 5 
finalists will receive $20,000 each and advance to Phase 3 of the 
Challenge.

Phase 2 Submission Requirements

 Submit by the deadline of January 16, 2017
 Submissions should be in pdf format
 Develop prototype using test data supplied by participant
 Provide an Implementation plan (up to 10 pages)
    [cir] Describes key activities and resources required
    [cir] Description of the pilot Project and budget
    [cir] Provide timeline to go into production
 Video demonstration of the Solution and test results with live 
webinar
 Demonstration of the Solution's data security, accessibility, 
ease of data movement and HIPAA compliance if applicable

Phase 3--Scale & Implement

    The final phase of the Challenge will involve testing the Solution 
in ``real-life'' situations. Engaging individuals is a requirement of 
this phase of the Challenge. Participants are expected to engage 
individuals to test implementation of the Solution and enable processes 
that require individuals to authorize the release of their health data 
to a destination they choose. Participants are required to recruit 
individuals to test implementation of the Solution. The data for this 
Solution should be provided by Phase 2 finalists. Participants are 
expected to engage and obtain authorization from a minimum of five (5) 
individuals to demonstrate and test implementation. This goal of Phase 
3 is to accelerate the best Solutions in the health IT marketplace. 
This phase will also test the scalability of the Solution, the 
feasibility of implementation, and the impact of the intended outcomes. 
Phase 3 concludes with a presentation to ONC and judges during a live 
Demonstration (Demo) Day to showcase their Solutions and demonstrate 
impact. Two winners will each receive $50,000.

Phase 3 Submission Requirements

 Provide a description of the plan for engaging individuals in 
testing implementation of the Solution and processes for requiring 
individuals to authorize the release of their health data to a 
destination they choose
 Submissions must be in pdf format and should be no more than 
10 pages
 Provide a narrative for the value proposition for the Solution 
and use case
 Report on progress in developing the Solution
 Demonstrate achievement of objectives set forth in the 
Business Case from Phase 1
 Description of lessons learned
 Provide concrete next steps for commercialization and/or 
broadened use, including how to attract consumers and/or providers to 
adopt and use the Solution
 Live demonstration of the Solution and results via webinar. 
This will not require travel by participants.
    [cir] Demonstrate the capability to go live, scalability, HIPAA 
compliance (if applicable), and an interface optimized for consumers 
and/or providers

How to Enter

    Participants can register by visiting: https://www.challenge.gov/?post_type=challenge&p=137291 and click ``Submit Solution'' anytime 
during the proposal submission period stated above. Instructions and 
challenge information will be provided on the Challenge Web site. If 
potential participants are interested in finding team members for the 
Challenge, they may visit https://www.challenge.gov/?post_type=challenge&p=137291 to browse ONC events and register online

[[Page 29281]]

anytime during the proposal submission period stated above.

Eligibility Rules for Participating in the Challenge

    To be eligible to win a prize under this Challenge, an individual 
or entity:
    1. Shall have registered to participate in the Challenge under the 
rules promulgated by the Office of the National Coordinator for Health 
Information Technology.
    2. Shall have complied with all the stated requirements of the Move 
Health Data Forward Challenge
    3. In the case of a private entity, shall be incorporated in and 
maintain a primary place of business in the United States, and in the 
case of an individual, whether participating singly or in a group, 
shall be a citizen or permanent resident of the United States.
    4. May not be a Federal entity or Federal employee acting within 
the scope of their employment.
    5. Shall not be an HHS employee working on their applications or 
Submissions during assigned duty hours.
    6. Shall not be an employee of the Office of the National 
Coordinator for Health Information Technology.
    7. Federal grantees may not use Federal funds to develop COMPETES 
Act challenge applications unless consistent with the purpose of their 
grant award.
    8. Federal contractors may not use Federal funds from a contract to 
develop COMPETES Act challenge applications or to fund efforts in 
support of a COMPETES Act challenge Submission.
    9. No HHS or ONC logo--The product must not use HHS' or ONC's logos 
or official seals and must not claim endorsement.
    10. A product may be disqualified if it fails to function as 
expressed in the description provided by the Participant, or if it 
provides inaccurate or incomplete information.
    11. If applicable, the proposed Solution must be HIPAA compliant to 
be eligible for entry into the Challenge.
    12. All individual members of a team must meet the eligibility 
requirements.
    An individual or entity shall not be deemed ineligible because the 
individual or entity used Federal facilities or consulted with Federal 
employees during a Challenge if the facilities and employees are made 
available to all individuals and entities participating in the 
Challenge on an equitable basis.
    Participants must agree to assume any and all risks and waive 
claims against the Federal Government and its related entities, except 
in the case of willful misconduct, for any injury, death, damage, or 
loss of property, revenue, or profits, whether direct, indirect, or 
consequential, arising from my participation in this prize contest, 
whether the injury, death, damage, or loss arises through negligence or 
otherwise. Participants are required to obtain liability insurance or 
demonstrate financial responsibility in the amount of $500,000, for 
claims by a third party for death, bodily injury, or property damage, 
or loss resulting from an activity carried out in connection with 
participation in a Challenge.
    Participants must also agree to indemnify the Federal Government 
against third party claims for damages arising from or related to 
Challenge activities.

General Submission Requirements

    In order for a Submission to be eligible to win this Challenge, it 
must meet the following requirements:
    1. No HHS or ONC logo--The Solution must not use HHS' or ONC's 
logos or official seals and must not claim endorsement.
    2. Functionality/Accuracy--A Solution may be disqualified if it 
fails to function as expressed in the description provided by the 
participant, or if it provides inaccurate or incomplete information.
    3. Security--Submissions must be free of malware. Participant 
agrees that ONC may conduct testing on the API(s) to determine whether 
malware or other security threats may be present. ONC may disqualify 
the API(s) if, in ONC's judgment, the app may damage government or 
others' equipment or operating environment.

Registration Process for Participants

    To register for this Challenge, participants can access http://www.challenge.gov and search for ``Move Health Data Forward 
Challenge.''

Prize

 Phase 1: up to 10 winners each receive $5000
 Phase 2: up to 5 winners each receive $20,000
 Phase 3: up to 2 winners each receive $50,000
 Total: up to $250,000 in prizes

Payment of the Prize

    Prize will be paid by contractor.

Basis Upon Which Winner Will Be Selected

    Eligible Challenge entries will be judged by a review panel 
composed of federal employees and experts in compliance with the 
requirements of the America COMPETES Act and the Department of Health 
and Human Services judging guidelines: http://www.hhs.gov/idealab/wp-content/uploads/2014/04/HHS-COMPETITION-JUDGING-GUIDELINES.pdf. The 
review panel will make selections based upon the criteria outlined 
below.

Phase 1

Participant Capabilities

     Is there appropriate expertise and capability to bring the 
idea to the testing stage?
     Does the participant have the resources available to carry 
out proposed work?

Impact Potential

     Does the proposed Solution have potential to improve the 
quality of health care?
     Is the proposed Solution using the HEART implementation 
specifications?
     Does the Submission describe how the Solution can be 
optimized for the greater population of consumers and/or providers?
     Is there a clear plan to make the Solution readily 
available to consumers on existing mobile platforms or a public-facing 
Web site?
     Is the Solution relevant to ONC priorities of improving 
the quality of health care?

Executability

     If applicable, does the Solution demonstrate its HIPAA 
compliance? Does the Solution utilize the HEART implementation 
specifications?
     Does the Submission demonstrate a reasonable and credible 
approach to accomplish the proposed objectives, tasks, outcomes and 
deliverable?
     Does the Submission address a pathway or timeline to broad 
use?
     Does the Submission clearly define potential risks?
     Does the Submission include a thorough description for the 
use of funds?

Phase 2

Technical Merit

     Does the Solution utilize privacy and security 
specifications/regulations?
    [cir] If applicable, is the Solution HIPAA compliant?
    [cir] Does the Solution enable an individual to control the 
authorization of access to data sharing APIs, using the HEART (HEART) 
implementation specifications?
     Does the Solution support consumer-mediated exchange?
     Is the consumer's health information easy to find, 
retrieve and access (data-accessibility)?

[[Page 29282]]

     Is the Solution easy to manage (ease of use, ease of data 
movement, user friendly)?

Viability

     Does the Solution present a deep understanding of the 
market for the Solution?
     Is there a clear advantage that differentiates this 
Solution from others?
     Is the Solution a model for real world implementation 
practical?
     Is the Solution economically viable and scalable/
replicable?
     Are consumers and/or providers already participating (e.g. 
have signed up to test the Solution)?

Impact

     Does the participant present a theory or explanation of 
how the proposed Solution would improve the future of consumer-mediated 
health information sharing?
     Is there clear evidence of a health care need based on 
research for a specific consumer population, and is there evidence that 
Solution impacts this population?
     Could the Solution improve the experience of information 
sharing between consumers and their health care providers?
     Is the Solution's design human-centered so that it enables 
the consumer to understand and manage their health?

Phase 3

Impact

     Do the results indicate how the Solution will enable 
consumers to share data in a ``real-life'' setting?
     Does the Solution improve the experience of information 
sharing between consumers and their health care providers?

Deployability

     Is the Solution readily available to consumers to be used 
on existing mobile platforms or a public facing Web site?
     Is the Solution designed for ease of learning and ease of 
use by the target user population?

Scalability

     How scalable is the Solution in a real-world setting? How 
likely are cost efficiencies for delivery at greater scale?
     Is the user experience optimized for the greater 
population of consumers and/or providers?
     Is there a plan for getting consumers and/or providers to 
adopt and use the Solution?

Additional Information

    General Conditions: ONC reserves the right to cancel, suspend, and/
or modify the Challenge, or any part of it, for any reason, at ONC's 
sole discretion.
    Intellectual Property: Each participant retains title and full 
ownership in and to their Submission. Participants expressly reserve 
all intellectual property rights not expressly granted under the 
challenge agreement. By participating in the Challenge, each entrant 
hereby irrevocably grants to the Government a limited, non-exclusive, 
royalty-free, perpetual, worldwide license and right to reproduce, 
publically perform, publically display, and use the Submission to the 
extent necessary to administer the challenge, and to publically perform 
and publically display the Submission, including, without limitation, 
for advertising and promotional purposes relating to the Challenge. 
This may also include displaying the results of the Challenge on a 
public Web site or during a public presentation.

Representation, Warranties and Indemnification

    By entering the Challenge, each applicant represents, warrants and 
covenants as follows:
    (a) Participant is the sole author, creator, and owner of the 
Submission;
    (b) The Submission is not the subject of any actual or threatened 
litigation or claim;
    (c) The Submission does not and will not violate or infringe upon 
the intellectual property rights, privacy rights, publicity rights, or 
other legal rights of any third party;
    (d) The Submission does not and will not contain any harmful 
computer code (sometimes referred to as ``malware,'' ``viruses'' or 
``worms''); and
    (e) The Submission, and participants' use of the Submission, does 
not and will not violate any applicable laws or regulations, including, 
without limitation, HIPAA, applicable export control laws and 
regulations of the U.S. and other jurisdictions.
    If the Submission includes any third party works (such as third 
party content or open source code), participant must be able to 
provide, upon request, documentation of all appropriate licenses and 
releases for such third party works. If participant cannot provide 
documentation of all required licenses and releases, the Federal Agency 
sponsor reserves the right, at their sole discretion, to disqualify the 
applicable Submission. Conversely, they may seek to secure the licenses 
and releases and allow the applicable Submission to remain in the 
Challenge, while reserving all rights with respect to such licenses and 
releases.
    Participants must indemnify, defend, and hold harmless the Federal 
Government from and against all third party claims, actions, or 
proceedings of any kind and from any and all damages, liabilities, 
costs, and expenses relating to or arising from participant's 
Submission or any breach or alleged breach of any of the 
representations, warranties, and covenants of participant hereunder. 
The Federal Agency sponsors reserve the right to disqualify any 
Submission that, in their discretion, deems to violate these Official 
Rules, Terms & Conditions.

     Authority: 15 U.S.C. 3719.

Karen DeSalvo,
National Coordinator for Health Information Technology.
[FR Doc. 2016-11102 Filed 5-9-16; 8:45 am]
 BILLING CODE 4150-45-P



                                                  29278                        Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices

                                                  DEPARTMENT OF HEALTH AND                                  Dr. Walker has entered into a                       DEPARTMENT OF HEALTH AND
                                                  HUMAN SERVICES                                          Voluntary Settlement Agreement                        HUMAN SERVICES
                                                                                                          (Agreement) and has voluntarily agreed:
                                                  Office of the Secretary                                                                                       Office of the National Coordinator for
                                                                                                            (1) To have his research supervised
                                                                                                                                                                Health Information Technology;
                                                  Findings of Research Misconduct                         for a period of three (3) years, beginning
                                                                                                                                                                Announcement of Requirements and
                                                                                                          on April 14, 2016; Respondent agrees                  Registration for ‘‘Move Health Data
                                                  AGENCY:   Office of the Secretary, HHS.                 that prior to submission of an                        Forward Challenge’’
                                                  ACTION:   Notice.                                       application for U.S. Public Health
                                                                                                          Service (PHS) support for a research                  AGENCY: Office of the National
                                                  SUMMARY:     Notice is hereby given that                project on which the Respondent’s                     Coordinator for Health Information
                                                  the Office of Research Integrity (ORI)                  participation is proposed and prior to                Technology, HHS.
                                                  has taken final action in the following                 Respondent’s participation in any                     ACTION: Notice.
                                                  case:                                                   capacity on PHS-supported research,
                                                     Kenneth Walker, Ph.D., University of                                                                       SUMMARY:   The Move Health Data
                                                                                                          Respondent shall ensure that a plan for
                                                  Pittsburgh: Based on the admission of                                                                         Forward Challenge aims to incentivize
                                                                                                          supervision of Respondent’s duties is
                                                  the Respondent, ORI found that Dr.                                                                            participants to create an application
                                                                                                          submitted to ORI for approval; the                    programming interface (API) solution
                                                  Kenneth Walker, former postdoctoral
                                                                                                          supervision plan must be designed to                  that utilizes the implementation
                                                  fellow, Department of Pediatrics,
                                                  University of Pittsburgh (UP), engaged                  ensure the scientific integrity of                    specifications developed by the HEART
                                                  in research misconduct in research                      Respondent’s research contribution;                   Workgroup (Heart WG) to enable
                                                  supported by National Institute of                      Respondent agrees that he shall not                   individuals to securely authorize the
                                                  Diabetes and Digestive and Kidney                       participate in any PHS-supported                      movement of their health data to
                                                  Diseases (NIDDK), National Institutes of                research until such a supervision plan is             destinations they choose. The statutory
                                                  Health (NIH), grant R01 DK081128.                       submitted to and approved by ORI;                     authority for this Challenge is Section
                                                     ORI found that Respondent engaged                    Respondent agrees to maintain                         105 of the America COMPETES
                                                  in research misconduct by falsifying                    responsibility for compliance with the                Reauthorization Act of 2010 (Pub. L.
                                                  and/or fabricating data that were                       agreed upon supervision plan;                         111–358).
                                                  included in the following two (2)                         (2) that any institution employing him              DATES:
                                                  publications, one (1) submitted                         shall submit, in conjunction with each                Phase 1:
                                                  manuscript, and two (2) grant                           application for PHS funds, or report,                   • Challenge launch: May 10, 2016
                                                  applications submitted to NIDDK, NIH:                   manuscript, or abstract involving PHS-                  • Submissions due: September 8,
                                                  • ‘‘Deletion of fibroblast growth factor                supported research in which                                2016
                                                     receptor 2 from the peri-wolffian duct               Respondent is involved, a certification                 • Evaluation period: September 9—
                                                     stroma leads to ureteric induction                   to ORI that the data provided by                           October 14, 2016
                                                     abnormalities and vesicoureteral                     Respondent are based on actual                          • Phase 1 winners announced:
                                                     reflux.’’ PLoS One 8(2):e56062, 2013                                                                            October 31, 2016
                                                                                                          experiments or are otherwise
                                                     (hereafter referred to as ‘‘PLoS 2013’’)                                                                   Phase 2:
                                                                                                          legitimately derived and that the data,                 • Prototyping period begins: October
                                                  • ‘‘Fgfr2 is integral for bladder                       procedures, and methodology are
                                                     mesenchyme patterning and                                                                                       31, 2016
                                                                                                          accurately reported in the application,                 • Submissions due: January 12, 2017
                                                     function.’’ Am J Physiol Renal
                                                     Physiol. 308(8):F888–98, 2015 Apr 15
                                                                                                          report, manuscript, or abstract;                        • Evaluation period: January 12—
                                                     (hereafter referred to as ‘‘AJPRP                      (3) to exclude himself from serving in                   February 10, 2017
                                                     2015’’)                                              any advisory capacity to PHS including,                 • Phase 2 winners announced:
                                                                                                          but not limited to, service on any PHS                     February 23, 2017
                                                  • Unpublished manuscript submitted to
                                                                                                          advisory committee, board, and/or peer                Phase 3:
                                                     PLoS One (hereafter referred to as the                                                                       • Scaling period begins: February 23,
                                                     ‘‘Manuscript’’)                                      review committee, or as a consultant for
                                                                                                                                                                     2017
                                                  • R01 DK104374–01A1                                     period of three (3) years, beginning on
                                                                                                                                                                  • Submission period ends: May 1,
                                                  • R01 DK109682–01                                       April 14, 2016; and
                                                                                                                                                                     2017
                                                     Specifically, ORI found that                           (4) to the retraction and/or correction               • Phase 3 winners announced: May
                                                  Respondent falsified and/or fabricated                  of the PLoS 2013 and AJPRP 2015                            31, 2017
                                                  quantitative real-time polymerase chain                 publications, as determined by the                    FOR FURTHER INFORMATION CONTACT:
                                                  reaction (qPCR) data to demonstrate a                   corresponding author.                                 Caroline Coy, caroline.coy@hhs.gov
                                                  statistically significant or ‘‘trend’’ of                                                                     (preferred), 202–720–2932.
                                                  statistical difference in the expression of             FOR FURTHER INFORMATION CONTACT:
                                                                                                          Director, Office of Research Integrity,               SUPPLEMENTARY INFORMATION:
                                                  renal or bladder urothelium and muscle
                                                  developmental markers between control                   1101 Wootton Parkway, Suite 750,                      Award Approving Official
                                                  and experimental (mutant) mice, when                    Rockville, MD 20852, (240) 453–8200.
                                                                                                                                                                  Karen DeSalvo, National Coordinator
                                                  there was none. The false qPCR data
                                                                                                          Kathryn Partin,                                       for Health Information Technology.
                                                  were reported in:
                                                                                                          Director, Office of Research Integrity.               Subject of Challenge
                                                  • PLoS 2013: Figure 2E
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                          [FR Doc. 2016–11062 Filed 5–10–16; 8:45 am]
                                                  • AJPRP 2015: Figures 1E, 4C, 7G, 7J,                                                                            ONC participated with a number of
                                                                                                          BILLING CODE 4150–31–P
                                                     8F, 12A                                                                                                    security, privacy and health Information
                                                  • Manuscript: Figures 1C, 4C                                                                                  technology (health IT) stakeholders to
                                                  • R01 DK104374–01A1: Figure 14E and                                                                           launch the HEART WG. The HEART
                                                     text on pages 41, 42, 45                                                                                   WG was developed to expedite the
                                                  • R01 DK109682–01: Figures 10G and                                                                            process of gathering representatives
                                                     11 and text on pages 43 and 45                                                                             from many different health-related


                                             VerDate Sep<11>2014   17:20 May 10, 2016   Jkt 238001   PO 00000   Frm 00030   Fmt 4703   Sfmt 4703   E:\FR\FM\11MYN1.SGM   11MYN1


                                                                               Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices                                            29279

                                                  technical communities worldwide                         specifications) using the following open              up to 5 finalists each based on the
                                                  (private-sector, government and non-                    standards: OAUTH 2.0, OpenID Connect                  prototype of their Solution. Phase 2
                                                  governmental organizations) working in                  and User Managed Access (UMA).                        winners will be eligible to proceed to
                                                  areas such as patient authentication,                   These specifications enable an                        Phase 3 which will award $50,000 for
                                                  authorization, and consent—to                           individual to control the authorization               up to two winners each based on the
                                                  collaborate on developing open-source                   of access to health-related data sharing              participant’s ability to implement their
                                                  specifications. The impetus for creating                APIs. The goal of this Challenge is to                Solution. This multi-phased approach
                                                  the HEART WG was an effort by the                       incentivize participants to create a                  allows participants to assemble,
                                                  Health IT Standards Committee                           Solution that utilizes the HEART                      implement and test their Solutions
                                                  (HITSC), which is charged with making                   implementation specifications to enable               given the novel Solutions expected. The
                                                  recommendations to the National                         individuals to securely authorize the                 final phase of the Challenge will require
                                                  Coordinator for Health IT on standards,                 movement of their health data to                      finalists to demonstrate a consumer-
                                                  implementation specifications, and                      destinations they choose.                             facing Solution that incorporates the
                                                                                                             Engaging individuals is a requirement              HEART implementation specifications
                                                  certification criteria for the electronic
                                                                                                          of the Challenge. Participants are                    and uses an API to enable consumers to
                                                  exchange and use of health information.
                                                                                                          expected to engage individuals to test                authorize the movement of their health
                                                  In 2013, the HITSC was tasked with
                                                                                                          implementation of the Solution and                    data to destinations they choose. This
                                                  reviewing whether ONC should                            enable processes that require
                                                  consider enhancing the portfolio of                                                                           Challenge encourages participants who
                                                                                                          individuals to authorize the release of
                                                  transport standards to support the use of                                                                     may apply independently or team with
                                                                                                          their health data to a destination they
                                                  RESTful services in health information                                                                        others including health IT developers,
                                                                                                          choose. Participants are required to
                                                  exchanges in 2013 and recommended                                                                             health care providers and other entities
                                                                                                          recruit individuals and obtain their
                                                  that ONC support the developing and                                                                           with the appropriate expertise related to
                                                                                                          authorizations to test implementation of
                                                  piloting of standards including OpenID                  the Solution on those individuals’                    this Solution. Lessons learned and the
                                                  Connect and OAuth2.0. In 2015, the                      health data. The data for the API and                 Challenge’s results will be shared in
                                                  HITSC recommended tracking                              Solution should be provided by Phase 2                order to support other organizations
                                                  development and piloting of new and                     finalists.                                            implementing solutions enabling
                                                  emerging technology specifications                         The Challenge will have three phases.              consumer-mediated exchange.
                                                  including the User Managed Access                       Phase 1 will award $5000 for up 10                    Challenge Summary
                                                  (UMA) profile of OAuth2.0 for obtaining                 finalists each based on the proposals
                                                  consumer consent. The HEART WG has                      they submit to the Challenge. Phase 1                   The Challenge has three phases
                                                  developed a set of privacy and security                 winners will be eligible to proceed to                ending in two finalists each winning
                                                  specifications (HEART implementation                    Phase 2 which will award $20,000 for                  $75,000.
mstockstill on DSK3G9T082PROD with NOTICES




                                                  Phase 1—Proposals                                       within electronic health record systems.              not limited to the value proposition,
                                                                                                          In this phase, participants are expected              target consumer population and/or
                                                     The Proposal Phase is designed to                    to describe the technical, operational,               target health care providers, key
                                                  allow participants to articulate                        financial and business aspects of their               partners, implementation plan, timeline,
                                                  Solutions to increase consumers’ access                 proposed Solution. This includes but is               cost structure and budget overview, key
                                                                                                                                                                                                            EN11MY16.025</GPH>




                                                  to and sharing of their information


                                             VerDate Sep<11>2014   17:20 May 10, 2016   Jkt 238001   PO 00000   Frm 00031   Fmt 4703   Sfmt 4703   E:\FR\FM\11MYN1.SGM   11MYN1


                                                  29280                        Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices

                                                  activities and resources, and metrics for                   responsibilities and capabilities                 choose. Participants are required to
                                                  success (described below). The main                     • Briefing deck presentation in pdf                   recruit individuals to test
                                                  goal of Phase 1 is for participants to                      format of the Solution and use                    implementation of the Solution. The
                                                  articulate feasible and executable plans                    case(s) to provide a visual picture of            data for this Solution should be
                                                  for innovative Solutions and                                the Project (10 slides maximum)                   provided by Phase 2 finalists.
                                                  demonstrate potential for impact.                         Æ Content:                                          Participants are expected to engage and
                                                     A panel of independent reviewers                       D Brief description of proposed                     obtain authorization from a minimum of
                                                  will evaluate proposals and select                          Solution and how the participants                 five (5) individuals to demonstrate and
                                                  finalists. Upon evaluating proposals and                    will use the HEART                                test implementation. This goal of Phase
                                                  interview responses, judges will select                     implementation specifications for                 3 is to accelerate the best Solutions in
                                                  up to 10 finalists to each receive a                        consumer-mediated exchange of                     the health IT marketplace. This phase
                                                  $5,000 award and advance to Phase 2 of                      health information                                will also test the scalability of the
                                                  the Challenge.                                            D Competitive advantage of the                      Solution, the feasibility of
                                                                                                              approach                                          implementation, and the impact of the
                                                  Phase 1 Submission Requirements                           D Example use case                                  intended outcomes. Phase 3 concludes
                                                  • Submissions in English and in pdf                       D Proposed workflow & deliverables                  with a presentation to ONC and judges
                                                      format.                                                                                                   during a live Demonstration (Demo) Day
                                                                                                          Phase 2—Prototype & Pilot
                                                  • Submit by the deadline of September                                                                         to showcase their Solutions and
                                                      8, 2016 using the online platform:                     The finalists of Phase 1 of the                    demonstrate impact. Two winners will
                                                      https://www.challenge.gov/?post_                    Challenge will then advance to a second               each receive $50,000.
                                                      type=challenge&p=137291                             phase focused on prototyping the
                                                  • General information about the                         Solution and demonstrating the                        Phase 3 Submission Requirements
                                                      participants and any team members                   effectiveness of the Solution and impact              • Provide a description of the plan for
                                                  • Compliance with Health Insurance                      on consumer or provider health records                    engaging individuals in testing
                                                      Portability and Accountability Act                  accessibility and data exchange. The                      implementation of the Solution and
                                                      (HIPAA) if applicable                               goal of Phase 2 is to demonstrate a                       processes for requiring individuals
                                                  • Business Case (5 page maximum)                        viable Solution with high technological                   to authorize the release of their
                                                    Æ Includes an executive summary                       merit and potential to impact the quality                 health data to a destination they
                                                      stating the value proposition                       of healthcare. Mentors will be available                  choose
                                                    D Describes how the proposed                          to help participants. Participants will               • Submissions must be in pdf format
                                                      Solution will improve the exchange                  have access to a community of experts                     and should be no more than 10
                                                      and accessibility of consumer                       to bring about high quality Solutions.                    pages
                                                      health data                                         Participants will test the HEART                      • Provide a narrative for the value
                                                    D Describes the target consumer                       implementation specifications. Up to 5                    proposition for the Solution and use
                                                      population and/or target health care                finalists will receive $20,000 each and                   case
                                                      providers                                           advance to Phase 3 of the Challenge.                  • Report on progress in developing the
                                                    D Describes the specific problem                                                                                Solution
                                                      being solved                                        Phase 2 Submission Requirements                       • Demonstrate achievement of
                                                    Æ Description of the methods and                      • Submit by the deadline of January 16,                   objectives set forth in the Business
                                                      technologies used to develop the                        2017                                                  Case from Phase 1
                                                      Solution                                            • Submissions should be in pdf format                 • Description of lessons learned
                                                    D Specify the HEART implementation                    • Develop prototype using test data                   • Provide concrete next steps for
                                                      specifications for data exchange                        supplied by participant                               commercialization and/or
                                                      that will be used by the proposed                   • Provide an Implementation plan (up                      broadened use, including how to
                                                      Solution                                                to 10 pages)                                          attract consumers and/or providers
                                                    Æ Financial overview that includes                      Æ Describes key activities and                          to adopt and use the Solution
                                                      cost structure, projected revenue                       resources required                                • Live demonstration of the Solution
                                                      and expense budget, current                           Æ Description of the pilot Project and                  and results via webinar. This will
                                                      funders and description of how                          budget                                                not require travel by participants.
                                                      funds will be used/allocated                          Æ Provide timeline to go into                         Æ Demonstrate the capability to go
                                                    Æ Development plan and timeline                           production                                            live, scalability, HIPAA compliance
                                                    D Describes key activities and                        • Video demonstration of the Solution                     (if applicable), and an interface
                                                      resources required to employ the                        and test results with live webinar                    optimized for consumers and/or
                                                      Solution                                            • Demonstration of the Solution’s data                    providers
                                                    D Plan to make the Solution readily                       security, accessibility, ease of data
                                                      available to consumers, for example                                                                       How to Enter
                                                                                                              movement and HIPAA compliance
                                                      to be used on existing mobile                           if applicable                                        Participants can register by visiting:
                                                      platforms or deployed on a public                                                                         https://www.challenge.gov/?post_
                                                                                                          Phase 3—Scale & Implement                             type=challenge&p=137291 and click
                                                      facing Web site
                                                    Æ Metrics for success defined by                         The final phase of the Challenge will              ‘‘Submit Solution’’ anytime during the
                                                      applicant (i.e. Number of users of                  involve testing the Solution in ‘‘real-               proposal submission period stated
                                                      the Solution, money saved by using                  life’’ situations. Engaging individuals is            above. Instructions and challenge
mstockstill on DSK3G9T082PROD with NOTICES




                                                      the Solution, time saved, increases                 a requirement of this phase of the                    information will be provided on the
                                                      in number of data exchanges                         Challenge. Participants are expected to               Challenge Web site. If potential
                                                      between consumers and providers)                    engage individuals to test                            participants are interested in finding
                                                    Æ Potential risks and mitigation                      implementation of the Solution and                    team members for the Challenge, they
                                                      strategies, including security                      enable processes that require                         may visit https://www.challenge.gov/
                                                      constraints                                         individuals to authorize the release of               ?post_type=challenge&p=137291 to
                                                    Æ Description of the participant roles,               their health data to a destination they               browse ONC events and register online


                                             VerDate Sep<11>2014   17:20 May 10, 2016   Jkt 238001   PO 00000   Frm 00032   Fmt 4703   Sfmt 4703   E:\FR\FM\11MYN1.SGM   11MYN1


                                                                               Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices                                              29281

                                                  anytime during the proposal submission                  misconduct, for any injury, death,                    America COMPETES Act and the
                                                  period stated above.                                    damage, or loss of property, revenue, or              Department of Health and Human
                                                                                                          profits, whether direct, indirect, or                 Services judging guidelines: http://
                                                  Eligibility Rules for Participating in the
                                                                                                          consequential, arising from my                        www.hhs.gov/idealab/wp-content/
                                                  Challenge
                                                                                                          participation in this prize contest,                  uploads/2014/04/HHS-COMPETITION-
                                                     To be eligible to win a prize under                  whether the injury, death, damage, or                 JUDGING-GUIDELINES.pdf. The review
                                                  this Challenge, an individual or entity:                loss arises through negligence or                     panel will make selections based upon
                                                     1. Shall have registered to participate              otherwise. Participants are required to               the criteria outlined below.
                                                  in the Challenge under the rules                        obtain liability insurance or
                                                  promulgated by the Office of the                                                                              Phase 1
                                                                                                          demonstrate financial responsibility in
                                                  National Coordinator for Health                         the amount of $500,000, for claims by a               Participant Capabilities
                                                  Information Technology.                                 third party for death, bodily injury, or                • Is there appropriate expertise and
                                                     2. Shall have complied with all the                  property damage, or loss resulting from               capability to bring the idea to the testing
                                                  stated requirements of the Move Health                  an activity carried out in connection                 stage?
                                                  Data Forward Challenge                                  with participation in a Challenge.                      • Does the participant have the
                                                     3. In the case of a private entity, shall              Participants must also agree to                     resources available to carry out
                                                  be incorporated in and maintain a                       indemnify the Federal Government                      proposed work?
                                                  primary place of business in the United                 against third party claims for damages
                                                  States, and in the case of an individual,               arising from or related to Challenge                  Impact Potential
                                                  whether participating singly or in a                    activities.                                             • Does the proposed Solution have
                                                  group, shall be a citizen or permanent                                                                        potential to improve the quality of
                                                  resident of the United States.                          General Submission Requirements
                                                                                                                                                                health care?
                                                     4. May not be a Federal entity or                       In order for a Submission to be                      • Is the proposed Solution using the
                                                  Federal employee acting within the                      eligible to win this Challenge, it must               HEART implementation specifications?
                                                  scope of their employment.                              meet the following requirements:                        • Does the Submission describe how
                                                     5. Shall not be an HHS employee                         1. No HHS or ONC logo—The                          the Solution can be optimized for the
                                                  working on their applications or                        Solution must not use HHS’ or ONC’s                   greater population of consumers and/or
                                                  Submissions during assigned duty                        logos or official seals and must not                  providers?
                                                  hours.                                                  claim endorsement.                                      • Is there a clear plan to make the
                                                     6. Shall not be an employee of the                      2. Functionality/Accuracy—A                        Solution readily available to consumers
                                                  Office of the National Coordinator for                  Solution may be disqualified if it fails              on existing mobile platforms or a
                                                  Health Information Technology.                          to function as expressed in the                       public-facing Web site?
                                                     7. Federal grantees may not use                      description provided by the participant,                • Is the Solution relevant to ONC
                                                  Federal funds to develop COMPETES                       or if it provides inaccurate or                       priorities of improving the quality of
                                                  Act challenge applications unless                       incomplete information.                               health care?
                                                  consistent with the purpose of their                       3. Security—Submissions must be free
                                                  grant award.                                                                                                  Executability
                                                                                                          of malware. Participant agrees that ONC
                                                     8. Federal contractors may not use                   may conduct testing on the API(s) to                    • If applicable, does the Solution
                                                  Federal funds from a contract to develop                determine whether malware or other                    demonstrate its HIPAA compliance?
                                                  COMPETES Act challenge applications                     security threats may be present. ONC                  Does the Solution utilize the HEART
                                                  or to fund efforts in support of a                      may disqualify the API(s) if, in ONC’s                implementation specifications?
                                                  COMPETES Act challenge Submission.                      judgment, the app may damage                            • Does the Submission demonstrate a
                                                     9. No HHS or ONC logo—The product                    government or others’ equipment or                    reasonable and credible approach to
                                                  must not use HHS’ or ONC’s logos or                     operating environment.                                accomplish the proposed objectives,
                                                  official seals and must not claim                                                                             tasks, outcomes and deliverable?
                                                  endorsement.                                            Registration Process for Participants                   • Does the Submission address a
                                                     10. A product may be disqualified if                   To register for this Challenge,                     pathway or timeline to broad use?
                                                  it fails to function as expressed in the                participants can access http://                         • Does the Submission clearly define
                                                  description provided by the Participant,                www.challenge.gov and search for                      potential risks?
                                                  or if it provides inaccurate or                         ‘‘Move Health Data Forward Challenge.’’                 • Does the Submission include a
                                                  incomplete information.                                                                                       thorough description for the use of
                                                     11. If applicable, the proposed                      Prize                                                 funds?
                                                  Solution must be HIPAA compliant to                     • Phase 1: up to 10 winners each                      Phase 2
                                                  be eligible for entry into the Challenge.                 receive $5000
                                                     12. All individual members of a team                 • Phase 2: up to 5 winners each receive               Technical Merit
                                                  must meet the eligibility requirements.                   $20,000                                               • Does the Solution utilize privacy
                                                     An individual or entity shall not be                 • Phase 3: up to 2 winners each receive               and security specifications/regulations?
                                                  deemed ineligible because the                             $50,000                                               Æ If applicable, is the Solution HIPAA
                                                  individual or entity used Federal                       • Total: up to $250,000 in prizes                     compliant?
                                                  facilities or consulted with Federal                                                                            Æ Does the Solution enable an
                                                  employees during a Challenge if the                     Payment of the Prize                                  individual to control the authorization
                                                  facilities and employees are made
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                            Prize will be paid by contractor.                   of access to data sharing APIs, using the
                                                  available to all individuals and entities                                                                     HEART (HEART) implementation
                                                  participating in the Challenge on an                    Basis Upon Which Winner Will Be
                                                                                                                                                                specifications?
                                                                                                          Selected
                                                  equitable basis.                                                                                                • Does the Solution support
                                                     Participants must agree to assume any                  Eligible Challenge entries will be                  consumer-mediated exchange?
                                                  and all risks and waive claims against                  judged by a review panel composed of                    • Is the consumer’s health
                                                  the Federal Government and its related                  federal employees and experts in                      information easy to find, retrieve and
                                                  entities, except in the case of willful                 compliance with the requirements of the               access (data-accessibility)?


                                             VerDate Sep<11>2014   17:20 May 10, 2016   Jkt 238001   PO 00000   Frm 00033   Fmt 4703   Sfmt 4703   E:\FR\FM\11MYN1.SGM   11MYN1


                                                  29282                        Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices

                                                     • Is the Solution easy to manage (ease               the Challenge, or any part of it, for any                Participants must indemnify, defend,
                                                  of use, ease of data movement, user                     reason, at ONC’s sole discretion.                     and hold harmless the Federal
                                                  friendly)?                                                 Intellectual Property: Each participant            Government from and against all third
                                                                                                          retains title and full ownership in and               party claims, actions, or proceedings of
                                                  Viability
                                                                                                          to their Submission. Participants                     any kind and from any and all damages,
                                                    • Does the Solution present a deep                    expressly reserve all intellectual                    liabilities, costs, and expenses relating
                                                  understanding of the market for the                     property rights not expressly granted                 to or arising from participant’s
                                                  Solution?                                               under the challenge agreement. By                     Submission or any breach or alleged
                                                    • Is there a clear advantage that                     participating in the Challenge, each                  breach of any of the representations,
                                                  differentiates this Solution from others?               entrant hereby irrevocably grants to the              warranties, and covenants of participant
                                                    • Is the Solution a model for real                    Government a limited, non-exclusive,                  hereunder. The Federal Agency
                                                  world implementation practical?                         royalty-free, perpetual, worldwide                    sponsors reserve the right to disqualify
                                                    • Is the Solution economically viable                 license and right to reproduce,                       any Submission that, in their discretion,
                                                  and scalable/replicable?                                publically perform, publically display,               deems to violate these Official Rules,
                                                    • Are consumers and/or providers                      and use the Submission to the extent                  Terms & Conditions.
                                                  already participating (e.g. have signed                 necessary to administer the challenge,                  Authority: 15 U.S.C. 3719.
                                                  up to test the Solution)?                               and to publically perform and
                                                                                                          publically display the Submission,                    Karen DeSalvo,
                                                  Impact
                                                                                                          including, without limitation, for                    National Coordinator for Health Information
                                                    • Does the participant present a                                                                            Technology.
                                                                                                          advertising and promotional purposes
                                                  theory or explanation of how the                                                                              [FR Doc. 2016–11102 Filed 5–9–16; 8:45 am]
                                                                                                          relating to the Challenge. This may also
                                                  proposed Solution would improve the
                                                                                                          include displaying the results of the                 BILLING CODE 4150–45–P
                                                  future of consumer-mediated health
                                                                                                          Challenge on a public Web site or
                                                  information sharing?
                                                                                                          during a public presentation.
                                                    • Is there clear evidence of a health                                                                       DEPARTMENT OF HEALTH AND
                                                  care need based on research for a                       Representation, Warranties and                        HUMAN SERVICES
                                                  specific consumer population, and is                    Indemnification
                                                  there evidence that Solution impacts                                                                          Office of the Secretary
                                                                                                             By entering the Challenge, each
                                                  this population?                                                                                              [Document Identifier: HHS–OS–0990–new–
                                                                                                          applicant represents, warrants and
                                                    • Could the Solution improve the                                                                            60D]
                                                                                                          covenants as follows:
                                                  experience of information sharing
                                                  between consumers and their health                         (a) Participant is the sole author,
                                                                                                                                                                Agency Information Collection
                                                  care providers?                                         creator, and owner of the Submission;
                                                                                                                                                                Activities; Proposed Collection; Public
                                                    • Is the Solution’s design human-                        (b) The Submission is not the subject
                                                                                                                                                                Comment Request
                                                  centered so that it enables the consumer                of any actual or threatened litigation or
                                                  to understand and manage their health?                  claim;                                                AGENCY:  Office of the Assistant
                                                                                                             (c) The Submission does not and will               Secretary for Health, Office of
                                                  Phase 3                                                 not violate or infringe upon the                      Adolescent Health, HHS.
                                                  Impact                                                  intellectual property rights, privacy                 ACTION: Notice.
                                                                                                          rights, publicity rights, or other legal
                                                    • Do the results indicate how the                     rights of any third party;                            SUMMARY:   In compliance with section
                                                  Solution will enable consumers to share                    (d) The Submission does not and will               3506(c)(2)(A) of the Paperwork
                                                  data in a ‘‘real-life’’ setting?                        not contain any harmful computer code                 Reduction Act of 1995, the Office of the
                                                    • Does the Solution improve the                       (sometimes referred to as ‘‘malware,’’                Secretary (OS), Department of Health
                                                  experience of information sharing                       ‘‘viruses’’ or ‘‘worms’’); and                        and Human Services, announces plans
                                                  between consumers and their health                         (e) The Submission, and participants’              to submit a Information Collection
                                                  care providers?                                         use of the Submission, does not and will              Request (ICR), described below, to the
                                                  Deployability                                           not violate any applicable laws or                    Office of Management and Budget
                                                                                                          regulations, including, without                       (OMB). Prior to submitting that ICR to
                                                    • Is the Solution readily available to                                                                      OMB, OS seeks comments from the
                                                  consumers to be used on existing mobile                 limitation, HIPAA, applicable export
                                                                                                          control laws and regulations of the U.S.              public regarding the burden estimate,
                                                  platforms or a public facing Web site?                                                                        below, or any other aspect of the ICR.
                                                    • Is the Solution designed for ease of                and other jurisdictions.
                                                                                                             If the Submission includes any third               DATES: Comments on the ICR must be
                                                  learning and ease of use by the target                                                                        received on or before July 11, 2016.
                                                  user population?                                        party works (such as third party content
                                                                                                          or open source code), participant must                ADDRESSES: Submit your comments to
                                                  Scalability                                             be able to provide, upon request,                     Information.CollectionClearance@
                                                     • How scalable is the Solution in a                  documentation of all appropriate                      hhs.gov or by calling (202) 690–6162.
                                                  real-world setting? How likely are cost                 licenses and releases for such third                  FOR FURTHER INFORMATION CONTACT:
                                                  efficiencies for delivery at greater scale?             party works. If participant cannot                    Information Collection Clearance staff,
                                                     • Is the user experience optimized for               provide documentation of all required                 Information.CollectionClearance@
                                                  the greater population of consumers                     licenses and releases, the Federal                    hhs.gov or (202) 690–6162.
                                                                                                          Agency sponsor reserves the right, at                 SUPPLEMENTARY INFORMATION: When
mstockstill on DSK3G9T082PROD with NOTICES




                                                  and/or providers?
                                                     • Is there a plan for getting consumers              their sole discretion, to disqualify the              submitting comments or requesting
                                                  and/or providers to adopt and use the                   applicable Submission. Conversely, they               information, please include the
                                                  Solution?                                               may seek to secure the licenses and                   document identifier HHS–OS–0990–
                                                                                                          releases and allow the applicable                     new–60D for reference.
                                                  Additional Information                                  Submission to remain in the Challenge,                  Information Collection Request Title:
                                                     General Conditions: ONC reserves the                 while reserving all rights with respect to            Federal Evaluation of Making Proud
                                                  right to cancel, suspend, and/or modify                 such licenses and releases.                           Choices! (MPC!)


                                             VerDate Sep<11>2014   17:20 May 10, 2016   Jkt 238001   PO 00000   Frm 00034   Fmt 4703   Sfmt 4703   E:\FR\FM\11MYN1.SGM   11MYN1



Document Created: 2016-05-11 01:12:04
Document Modified: 2016-05-11 01:12:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesPhase 1:
ContactCaroline Coy, [email protected] (preferred), 202-720-2932.
FR Citation81 FR 29278 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR