Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Move Health Data Forward Challenge”, 29278-29282 [2016-11102]

Download as PDF 29278 Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Kenneth Walker, Ph.D., University of Pittsburgh: Based on the admission of the Respondent, ORI found that Dr. Kenneth Walker, former postdoctoral fellow, Department of Pediatrics, University of Pittsburgh (UP), engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant R01 DK081128. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in the following two (2) publications, one (1) submitted manuscript, and two (2) grant applications submitted to NIDDK, NIH: • ‘‘Deletion of fibroblast growth factor receptor 2 from the peri-wolffian duct stroma leads to ureteric induction abnormalities and vesicoureteral reflux.’’ PLoS One 8(2):e56062, 2013 (hereafter referred to as ‘‘PLoS 2013’’) • ‘‘Fgfr2 is integral for bladder mesenchyme patterning and function.’’ Am J Physiol Renal Physiol. 308(8):F888–98, 2015 Apr 15 (hereafter referred to as ‘‘AJPRP 2015’’) • Unpublished manuscript submitted to PLoS One (hereafter referred to as the ‘‘Manuscript’’) • R01 DK104374–01A1 • R01 DK109682–01 Specifically, ORI found that Respondent falsified and/or fabricated quantitative real-time polymerase chain reaction (qPCR) data to demonstrate a statistically significant or ‘‘trend’’ of statistical difference in the expression of renal or bladder urothelium and muscle developmental markers between control and experimental (mutant) mice, when there was none. The false qPCR data were reported in: • PLoS 2013: Figure 2E • AJPRP 2015: Figures 1E, 4C, 7G, 7J, 8F, 12A • Manuscript: Figures 1C, 4C • R01 DK104374–01A1: Figure 14E and text on pages 41, 42, 45 • R01 DK109682–01: Figures 10G and 11 and text on pages 43 and 45 mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:20 May 10, 2016 Jkt 238001 Dr. Walker has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed: (1) To have his research supervised for a period of three (3) years, beginning on April 14, 2016; Respondent agrees that prior to submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent’s duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (3) to exclude himself from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for period of three (3) years, beginning on April 14, 2016; and (4) to the retraction and/or correction of the PLoS 2013 and AJPRP 2015 publications, as determined by the corresponding author. FOR FURTHER INFORMATION CONTACT: Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8200. Kathryn Partin, Director, Office of Research Integrity. [FR Doc. 2016–11062 Filed 5–10–16; 8:45 am] BILLING CODE 4150–31–P PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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’’ Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice. AGENCY: 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, caroline.coy@hhs.gov (preferred), 202–720–2932. SUPPLEMENTARY INFORMATION: SUMMARY: 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 E:\FR\FM\11MYN1.SGM 11MYN1 Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices 29279 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 consumerfacing 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. Phase 1—Proposals 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 The Proposal Phase is designed to allow participants to articulate Solutions to increase consumers’ access 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 Challenge Summary The Challenge has three phases ending in two finalists each winning $75,000. E:\FR\FM\11MYN1.SGM 11MYN1 EN11MY16.025</GPH> mstockstill on DSK3G9T082PROD with NOTICES technical communities worldwide (private-sector, government and nongovernmental 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 29280 Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices 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. mstockstill on DSK3G9T082PROD with NOTICES 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) Æ Includes an executive summary stating the value proposition D Describes how the proposed Solution will improve the exchange and accessibility of consumer health data D Describes the target consumer population and/or target health care providers D Describes the specific problem being solved Æ Description of the methods and technologies used to develop the Solution D Specify the HEART implementation specifications for data exchange that will be used by the proposed Solution Æ Financial overview that includes cost structure, projected revenue and expense budget, current funders and description of how funds will be used/allocated Æ Development plan and timeline D Describes key activities and resources required to employ the Solution D 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 Æ 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) Æ Potential risks and mitigation strategies, including security constraints Æ Description of the participant roles, VerDate Sep<11>2014 17:20 May 10, 2016 Jkt 238001 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) Æ Content: D Brief description of proposed Solution and how the participants will use the HEART implementation specifications for consumer-mediated exchange of health information D Competitive advantage of the approach D Example use case D 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) Æ Describes key activities and resources required Æ Description of the pilot Project and budget Æ 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 ‘‘reallife’’ 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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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. Æ 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 E:\FR\FM\11MYN1.SGM 11MYN1 Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES 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 VerDate Sep<11>2014 17:20 May 10, 2016 Jkt 238001 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 https:// 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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 29281 America COMPETES Act and the Department of Health and Human Services judging guidelines: https:// www.hhs.gov/idealab/wp-content/ uploads/2014/04/HHS-COMPETITIONJUDGING-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? Æ If applicable, is the Solution HIPAA compliant? Æ 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)? 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 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 humancentered 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? mstockstill on DSK3G9T082PROD with NOTICES 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 VerDate Sep<11>2014 17:20 May 10, 2016 Jkt 238001 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS–OS–0990–new– 60D] Agency Information Collection Activities; Proposed Collection; Public Comment Request Office of the Assistant Secretary for Health, Office of Adolescent Health, HHS. ACTION: Notice. AGENCY: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on the ICR must be received on or before July 11, 2016. ADDRESSES: Submit your comments to Information.CollectionClearance@ hhs.gov or by calling (202) 690–6162. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@ hhs.gov or (202) 690–6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the document identifier HHS–OS–0990– new–60D for reference. Information Collection Request Title: Federal Evaluation of Making Proud Choices! (MPC!) SUMMARY: E:\FR\FM\11MYN1.SGM 11MYN1

Agencies

[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29278-29282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11102]


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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, caroline.coy@hhs.gov 
(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 https://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: https://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
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