Life Science Compliance Update

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October 13, 2016

HHS Issues Open Government Plan


On October 6, 2016, the U.S. Department of Health and Human Services announced its fourth Open Government Plan, which details initiatives that build on its goals of increasing transparency and boosting collaboration with stakeholders, particularly through data sharing.

Through its issuance of the newest plan, HHS is seeking new approaches to connect with underserved communities to share ways HHS can help them have the necessary building blocks to lead healthy and productive lives – many of which come in the form of making data and information products available to the public.

The plan outlines efforts toward new legislation that would increase transparency around financial data for information technology programs, as well as HHS’ efforts to better respond to the public through Freedom of Information Act (FOIA) requests. The plan also discusses “substantial progress” that has been achieved by HHS on the initiatives of the first three versions of the HHS Open Government Plan and stresses the role of the public in achieving progress via collaboration.

Over the past eight years, HHS has made available to the public nearly 3,000 datasets that enable the public and private development of technology applications and services that improve HHS’ ability to deliver on its mission. The resources provided are becoming important factors in improving the quality of America’s health care delivery system, enhancing the safety of America’s food supply, increasing program effectiveness in support of early child development and families in need, and developing new approaches to preventing disease.

Flagship Plan Initiatives

The Fourth plan highlights several flagship initiatives that attempt to underscore the key strategies HHS will focus on, including:

  • Promoting the Open Payments initiative, which publishes data on the financial relationships between the health care industry and health care providers;
  • Enhancing the Blue Button service to provide a developer-friendly, standards-based data Application Programming Interface (API) that enables beneficiaries to connect their Medicare claims data to the applications, services, and research programs they trust.
  • Undertaking strategic new projects to improve block grant programs that support children and families under the Title V Block Grant Program; and
  • Creating a public comment database for the Physical Activity Guidelines update process. The database, which will be open for comment over the next two years, will play a role in the development of the Physical Activity Guidelines for Americans.

Another flagship initiative focuses on the PMI Cohort Program, which operates under the Precision Medicine Institute. HHS hopes to recruit at least one million participants to improve HHS’ ability to prevent and treat disease based on individual differences in lifestyle, environment, and genetics.

Precision medicine is expected to revolutionize healthcare, which an eventual market worth over $87 billion. The PMI Cohort Program aims to be revolutionary not just in terms of its data collection, but also in its effort to empower study participants along with healthcare professionals and researchers to create a “new model of research in which people become true partners in the process, not research subjects.” Participants in the program will be able to choose what data to share, have input into study design and implementation, and have access to a “wide range” of their individual data and aggregate study results.

For more information or details on this new Open Government Plan, you can access the plan here. HHS encourages stakeholders to participate and share their opinions at

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