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United States

Support Medicine Research Throught Opening up Relevant Data of the Field (US0060)

Overview

At-a-Glance

Action Plan: United States Action Plan 2015-2017

Action Plan Cycle: 2015

Status: Inactive

Institutions

Lead Institution: The White House, the Department of Health and Human Services, the Department of Veterans Affairs, and the Department of Defense.

Support Institution(s): NA

Policy Areas

Health, Open Data

IRM Review

IRM Report: United States End-of-Term IRM Report 2015-2017, United States Mid-Term Report 2015-2017

Starred: No

Early Results: Did Not Change

Design i

Verifiable: Yes

Relevant to OGP Values: Access to Information Civic Participation , Technology

Potential Impact:

Implementation i

Completion:

Description

The President’s Precision Medicine Initiative (PMI) seeks to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care, and ultimately help improve public health outcomes. PMI is a cross- governmental effort driven by the White House, the Department of Health and Human Services, the Department of Veterans Affairs, and the Department of Defense. Under PMI, the United States commits to building a volunteer research cohort of more than one million participants who are centrally involved in the design and implementation of the cohort, and to link genomic data, biological samples, data from mobile devices, and lifestyle data with clinical data from electronic health records. The Administration will also promote “direct- from-participant” functionality allowing patients to directly access and donate their health data for research. A priority under PMI is to ensure inclusion of low-income and underserved populations that have traditionally been underrepresented in scientific research — both improving the quality of research and ensuring that existing health disparities are not exacerbated.

IRM Midterm Status Summary

IRM End of Term Status Summary

Commitment 8. Data-Driven Precision Medicine

Commitment Text:

Empower Americans and Improve Health with Data-Driven Precision Medicine

The President’s Precision Medicine Initiative (PMI) seeks to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care, and ultimately help improve public health outcomes. PMI is a cross- governmental effort driven by the White House, the Department of Health and Human Services, the Department of Veterans Affairs, and the Department of Defense. Under PMI, the United States commits to building a volunteer research cohort of more than one million participants who are centrally involved in the design and implementation of the cohort, and to link genomic data, biological samples, data from mobile devices, and lifestyle data with clinical data from electronic health records. The Administration will also promote “direct- from-participant” functionality allowing patients to directly access and donate their health data for research. A priority under PMI is to ensure inclusion of low-income and underserved populations that have traditionally been underrepresented in scientific research — both improving the quality of research and ensuring that existing health disparities are not exacerbated.

Responsible Institutions: Department of Defense, Department of Energy (DOE), Department of Health and Human Services (HHS), Department of Veterans Affairs (VA), and the National Institute of Standards and Technology (NIST) at Commerce

Supporting institutions: Researchers, technologists, health and privacy advocates, medical professionals and care providers, veterans, and the public

Start Date: Not Specified End Date: Not Specified

Commitment Aim

This commitment builds on President Obama’s Precision Medicine Initiative.[1] It aimed to usher in a new era of medicine characterized by individually tailored (i.e., “precision”) medical care using individual-level genomic, biological, lifestyle, and clinical data. The main activity envisioned under this commitment was constructing a volunteer research cohort of one million people to participate in a large-scale genomic study. The commitment sought substantial representation of low-income individuals and those from underserved communities. In addition, all participants were expected to have the ability to freely access and donate their own health data.

Status

Midterm: Limited

The government had made limited progress on this commitment by the midterm. The National Institutes of Health (NIH) had received $130 million in funding[2] to begin building the volunteer research cohort program. In February 2016, the NIH began awarding grants to organizations that would help support the initiative.[3] That same month, the NIH revised its goal of recruiting 79,000 volunteers by the end of 2016[4] and the full cohort by the end of 2019.[5] By June 2016, no participants had been recruited. The program was officially designated the All of Us Research Program in October 2016.[6]

As for enabling members of the public to donate their own health data, the NIH and the Office of the National Coordinator for Health Information Technology, in February 2016, launched Sync for Science (S4S). S4S is a pilot tool that allows individuals to access and share their health information.[7] The government expected the tool become a key aspect of the All of us Research Program.

End of Term: Limited

At the end of term, the government had made limited progress on the core activity described under this commitment: the recruitment of a volunteer research cohort. On 5 June 2017, Eric Dishman, the director of the All of Us Research Program, announced that the program’s recruitment efforts had entered beta testing.[8] This effort will be in conjunction with the program’s community health partners. Recruitment will initially be limited to a single site and later expanded to 100 sites throughout the United States. The program then aimed to recruit a beta test cohort of 10,000 volunteers, with recruitment scheduled to begin in early fall 2017.[9] This time frame falls beyond the assessment period for the commitment (which ends in June 2017). The time frame also indicates that the program did not meet its earlier recruitment goal of 79,000 volunteers by the end of 2016.

Did It Open Government?

Access to Information: Did Not Change

Civic Participation: Did Not Change

The All of Us Research Program was expected to launch its beta recruitment phase in fall 2017, which lies beyond the assessment period for this report. The commitment, therefore, did not open government with respect to access to information during the time frame of the action plan.

Regarding civic participation, the commitment’s relevance to this OGP value stems from a statement made by the director of National Institutes of Health (NIH) in relation to the Precision Medicine Initiative: “Participants will be true partners, not subjects, not patients.”[10] At the close of the end-of-term reporting period, the All of Us Research Program’s advisory panel comprises individuals from the NIH’s Council of Councils. (The advisory panel is presumed to refer to the aforementioned “advisory board”; the Council of Councils serves as an advisory body to the NIH director.[11]) The panel members have professional backgrounds in science and medicine. The advisory panel’s webpage[12] makes no mention of incorporating patients as panel members. Less information is available on the program’s steering committee, which does not appear to have a webpage. However, the NIH has separately noted that the “Program[’s] Steering Committee consists of the Program Directors/Principal Investigators (PDs/PIs) from each of the major awards,” referencing those partner organizations who are program grantees. However, the NIH makes no clear reference to participation by patients or the public more broadly. Based on this information, the commitment cannot be said to have opened government with respect to civic participation.

While this commitment did not result in any changes in government openness during the span of the action plan, other precision medicine initiatives did. These took place outside of the OGP framework. For example, in June 2016, the National Cancer Institute launched the Genomic Data Commons, a repository for open genomic data for cancer research.[13] Researchers can search, download, and upload genomic data. As of early 2018, the database included more than 30,000 cases and 300,000 files.[14] The cost of analyzing a single cancer genomics dataset in 2016 exceeded $1 million.[15] However, the dean of the Biological Sciences Division at the University of Chicago acknowledged that with this new information, “the pace of discovery shifts from slow and sequential to fast and parallel. Discovery processes that today would require many years, millions of dollars, and the coordination of multiple research teams could literally be performed in days, or even hours.”[16]

Carried Forward?

At the time of writing, the government had not yet published its fourth national action plan. The government should nevertheless continue making efforts to support the All of Us Research Program. The program stands unprecedented in size and scope, and may therefore have a potentially transformative impact on healthcare in the United States. To achieve impact in the future, it is important that the government follow through on its promise to build a representative cohort of participants. It should also disclose the results of the study and engage participants in the design and implementation of the program.

There is also widespread public support for the program. This suggests a demand for precision medicine initiatives among the population at large. A blog post from 17 August 2016 on the program’s website confirms this. It noted results from a nationwide representative survey of 2,601 randomly selected individuals conducted by National Institutes of Health researchers. The survey found that 79 percent expressed support for the program after reading a brief description of it. Also, 54 percent of respondents indicated they would definitely or probably participate if invited.[17] Importantly, intended participation rates among respondents who indicated they would “definitely” participate were constant across demographic groups. This includes those from historically underserved communities, highlighting the program’s potential value to individuals from these communities.


[1] “The Precision Medicine Initiative,” The White House, 12 March 2016, https://obamawhitehouse.archives.gov/precision-medicine, consulted 3 October 2017.

[2] “About the All of Us Research Program,” All of Us Research Program, https://allofus.nih.gov/about/about-all-us-research-program, consulted 10 September 2017.

[3] “Awardees,” National Institutes of Health, All of Us Research Program, https://allofus.nih.gov/funding/awardees, consulted 2 October 2017.

[4] Francis S. Collins, “NIH Director’s Statement: Preparing to Launch the Precision Medicine Initiative Cohort Program,” All of Us Research Program, 25 February 2016, https://allofus.nih.gov/news-events-and-media/announcements/nih-directors-statement-preparing-launch-precision-medicine, consulted 10 September 2017.

[5] Ibid.

[6] “PMI Cohort Program Announces New Name: The All of Us Research Program,” All of Us Research Program, 13 October 2016, https://allofus.nih.gov/news-events-and-media/announcements/pmi-cohort-program-announces-new-name-all-us-research-program, consulted 10 September 2017; All of Us Research Program, https://allofus.nih.gov/, consulted 10 September 2017.

[7] Jon White, “NIH and ONC Launch the Sync for Science (S4S) Pilot: Enabling Individual Health Data Access and Donation,” HealthIT Buzz, 21 March 2016, https://www.healthit.gov/buzz-blog/health-innovation/nih-and-onc-launch-the-sync-for-science-pilot/.

[8] Eric Dishman, “Beta Testing Begins for NIH’s All of Us Research Program,” All of Us Research Program, 5 June 2017, https://allofus.nih.gov/news-events-and-media/announcements/beta-testing-begins-nihs-all-us-research-program, consulted 10 September 2017.

[9] Ibid.

[10] Toni Clarke, “White House to Advance Obama's Precision Medicine Initiative,” The Hospitalist, 7 July 2016, http://www.the-hospitalist.org/hospitalist/article/121572/white-house-advance-obamas-precision-medicine-initiative, consulted 28 September 2017.

[11] “Council of Councils,” National Institutes of Health Division of Program Coordination, Planning, and Strategic Initiatives, http://dpcpsi.nih.gov/council, last updated 8 May 2017, consulted 28 September 2017.

[12] “All of Us Research Program Advisory Panel,” All of Us Research Program, https://allofus.nih.gov/about/who-we-are/all-us-research-program-advisory-panel, consulted 28 September 2017.

[13] National Cancer Institute, Genomic Data Commons, https://gdc.cancer.gov/.

[14] National Cancer Institute, GDC Data Portal, https://portal.gdc.cancer.gov/.

[15] Robert L. Grossman et al., “Toward a Shared Vision for Cancer Genomic Data,” The New England Journal of Medicine (22 September 2016), http://www.nejm.org/doi/full/10.1056/NEJMp1607591#t=article.

[16] Amber Harmon, “Genomic Data Commons: Expanded Access to Large-Scale Cancer Genomic Data,” Science Node, 10 December 2014, http://bit.ly/2pVe1Rg.

[17] “Survey Shows Broad Support for National Precision Medicine Study,” All of Us Research Program, 17 August 2016, https://allofus.nih.gov/news-events-and-media/announcements/survey-shows-broad-support-national-precision-medicine-study, consulted 10 September 2017.


United States's Commitments

  1. Federal Data Strategy

    US0105, 2019, E-Government

  2. Grants Accountability

    US0106, 2019, E-Government

  3. Public Access to Federally Funded Research

    US0107, 2019, E-Government

  4. Workforce Data Standards

    US0108, 2019, E-Government

  5. Chief Data Officers

    US0109, 2019, Capacity Building

  6. Open Data for Public Health

    US0110, 2019, E-Government

  7. Enterprise Objective

    US0111, 2019, Capacity Building

  8. Developing Future Action Plans

    US0112, 2019, OGP

  9. Reconstitution of the USA.gov

    US0053, 2015, E-Government

  10. Accessibility of Government Information Online

    US0054, 2015, Marginalized Communities

  11. Access to Educational Resources

    US0055, 2015, Open Data

  12. Public Listing of Every Address in the US

    US0056, 2015, Open Data

  13. Informed Decisions About Higher Education.

    US0057, 2015, Open Data

  14. New Authentication Tools to Protect Individual Privacy and Ensure That Personal Records Go Only to the Intended Recipients.

    US0058, 2015, Public Service Delivery

  15. Transparency of Open311

    US0059, 2015, E-Government

  16. Support Medicine Research Throught Opening up Relevant Data of the Field

    US0060, 2015, Health

  17. Access to Workforce Data

    US0061, 2015, Open Data

  18. Using Evidence and Concrete Data to Improve Public Service Delivery

    US0062, 2015, Capacity Building

  19. Expand Use of the Federal Infrastructure Permitting Dashboard

    US0063, 2015,

  20. Consolidation of Import and Export Systems

    US0064, 2015, E-Government

  21. Improving Government Records

    US0065, 2015, Open Data

  22. Starred commitment Ammendments to FOIA

    US0066, 2015, Open Data

  23. Streamline the Declassification Process

    US0067, 2015, Capacity Building

  24. Implement the Controlled Unclassified Information Program

    US0068, 2015, Open Data

  25. Transparency of Privacy Programs and Practices

    US0069, 2015, Capacity Building

  26. Transparency of Federal Use of Investigative Technologies

    US0070, 2015, E-Government

  27. Increase Transparency of the Intelligence Community

    US0071, 2015, Capacity Building

  28. Open Science Through Open Data

    US0072, 2015, Open Data

  29. Open Data Portal

    US0073, 2015, E-Government

  30. Increase Transparency of Trade Policy and Negotiations

    US0074, 2015, E-Government

  31. Develop a Machine Readable Government Organizational Chart

    US0075, 2015, E-Government

  32. Improving Public Participation

    US0076, 2015, Public Participation

  33. Expand Public Participation in the Development of Regulations

    US0077, 2015, Public Participation

  34. Civic Engagement in Decision-Making Processes

    US0078, 2015, Public Participation

  35. Open Mapping

    US0079, 2015, E-Government

  36. Tracking OGP Implementation

    US0080, 2015, OGP

  37. Strengthening Whistleblower Protection

    US0081, 2015, Capacity Building

  38. Transparency of Legal Entities

    US0082, 2015, Beneficial Ownership

  39. Extractive Industries Transparency

    US0083, 2015, Extractive Industries

  40. Spending Transparency

    US0084, 2015, E-Government

  41. Enhance the Use of U.S. Foreign Assistance Information

    US0085, 2015, Aid

  42. Participatory Budgets and Responsive Spending

    US0086, 2015, Participation in Budget Processes

  43. Expand Access to Justice to Promote Federal Programs

    US0087, 2015, E-Government

  44. Build Safer Communities with Police Open Data

    US0088, 2015, E-Government

  45. Open Federal Data to Benefit Local Communities

    US0089, 2015, E-Government

  46. Support the Municipal Data Network

    US0090, 2015, E-Government

  47. Foster Data Ecosystems

    US0091, 2015, Capacity Building

  48. Extend Digital, Data-Driven Government to Federal Government’S Support for Communities

    US0092, 2015, Capacity Building

  49. Promote Implementation of SDGs

    US0093, 2015, Open Data

  50. Starred commitment Promote Open Climate Data

    US0094, 2015, E-Government

  51. Air Quality Data Available

    US0095, 2015, E-Government

  52. Promote Food Security and Data Sharing for Agriculture and Nutrition

    US0096, 2015, Capacity Building

  53. Promote Data Sharing About Global Preparedness for Epidemic Threats

    US0097, 2015, Capacity Building

  54. Promote Global Interconnectivity

    US0098, 2015, Aid

  55. Open Contracting

    US0099, 2015, Capacity Building

  56. Harness the Data Revolution for Sustainable Development

    US0100, 2015, OGP

  57. Open Government to Support Global Sustainable Development

    US0101, 2015, Anti-Corruption Institutions

  58. Open Collaboration Onf the Arctic

    US0102, 2015, Environment and Climate

  59. Support Capacity Building for Extractives Transparency

    US0103, 2015, Capacity Building

  60. Support Responsible Investment and Business Practices for Companies

    US0104, 2015, Private Sector

  61. Improve Public Participation in Government

    US0027, 2013, Capacity Building

  62. Modernize Management of Government Records

    US0028, 2013, Records Management

  63. Modernize the Freedom of Information Act

    US0029, 2013, Capacity Building

  64. Transform the Security Classification System

    US0030, 2013, Records Management

  65. Implement the Controlled Unclassified Information Program

    US0031, 2013, Security

  66. Increase Transparency of Foreign Intelligence Surveillance Activities

    US0032, 2013, E-Government

  67. Make Privacy Compliance Information More Accessible

    US0033, 2013, E-Government

  68. Support and Improve Agency Implementation of Open Government Plans

    US0034, 2013, OGP

  69. Strengthen and Expand Whistleblower Protections for Government Personnel

    US0035, 2013, Capacity Building

  70. Increase Transparency of Legal Entities Formed in the United States

    US0036, 2013, Legislation & Regulation

  71. Starred commitment Implement the Extractive Industries Transparency Initiative

    US0037, 2013, Environment and Climate

  72. Make Fossil Fuel Subsidies More Transparent

    US0038, 2013, Extractive Industries

  73. Starred commitment Increase Transparency in Spending

    US0039, 2013, Fiscal Transparency

  74. Increase Transparency of Foreign Assistance

    US0040, 2013, Aid

  75. Continue to Improve Performance.Gov

    US0041, 2013, E-Government

  76. Consolidate Import and Export Systems to Curb Corruption

    US0042, 2013, Private Sector

  77. Promote Public Participation in Community Spending Decisions

    US0043, 2013, Infrastructure & Transport

  78. Expand Visa Sanctions to Combat Corruption

    US0044, 2013, Anti-Corruption Institutions

  79. Further Expand Public Participation in the Development of Regulations

    US0045, 2013, Capacity Building

  80. Open Data to the Public

    US0046, 2013, E-Government

  81. Continue to Pilot Expert Networking Platforms

    US0047, 2013, Public Participation

  82. Reform Government Websites

    US0048, 2013, E-Government

  83. Promote Innovation Through Collaboration and Harness the Ingenuity of the American Public

    US0049, 2013, Capacity Building

  84. Promote Open Education to Increase Awareness and Engagement

    US0050, 2013, E-Government

  85. Deliver Government Services More Effectively Through Information Technology

    US0051, 2013, E-Government

  86. Increase Transparency in Spending

    US0052, 2013, E-Government

  87. Reform Records Management

    US0001, 2011, Records Management

  88. Lead a Multi-Agency Effort

    US0002, 2011, Capacity Building

  89. Monitor Agency Implementation of Plans

    US0003, 2011, OGP

  90. Provide Enforcement and Compliance Data Online

    US0004, 2011, Environment and Climate

  91. Advocate for Legislation Requiring Meaningful Disclosure

    US0005, 2011, Legislation & Regulation

  92. Apply Lessons from Recovery Act to Increate Spending Transparency

    US0006, 2011, Fiscal Transparency

  93. Government-Wide Reporting Requirements for Foreign Aid

    US0007, 2011, Aid

  94. Use Performanc.Gov to Improve Government Performance and Accountability

    US0008, 2011, Public Service Delivery

  95. Overhaul the Public Participation Interface on Regulations.Gov

    US0009, 2011, Legislation & Regulation

  96. Launch Expertnet

    US0010, 2011, E-Government

  97. Launch International Space Apps Competition

    US0011, 2011, E-Government

  98. Launch “We the People”

    US0012, 2011,

  99. Open Source “We the People”

    US0013, 2011,

  100. Develop Best Practices and Metrics for Public Participation

    US0014, 2011, Capacity Building

  101. Professionalize the FOIA Administration

    US0015, 2011, Right to Information

  102. Harness the Power of Technology

    US0016, 2011, Right to Information

  103. Advocate for Legislation on Whistleblower Protection

    US0017, 2011, E-Government

  104. Explore Executive Authority to Protect Whistleblowers

    US0018, 2011, Legislation & Regulation

  105. Implement the EITI

    US0019, 2011, Extractive Industries

  106. Partnership to Build on Recent Progress

    US0020, 2011, Extractive Industries

  107. Promote Data.Gov to Spur Innovation Through Open Sourcing

    US0021, 2011, Open Data

  108. Data.Gov: Foster Communities on Data.Gov

    US0022, 2011, Education

  109. Begin Online National Dialogue with the American Public

    US0023, 2011, Public Participation

  110. Update Government-Wide Policies for Websites

    US0024, 2011,

  111. Promote Smart Disclosure to Ensure Timely Release of Information

    US0025, 2011, Capacity Building

  112. Publish Guidelines on Scientific Data

    US0026, 2011, Capacity Building