Members of Congress Address NIH Precision Medicine Working Group Workshop on Digital Health Data and Research Cohort Design

Senator Lamar Alexander (R-TN) and Representative Marsha Blackburn (R-TN) addressed a special session of the National Institutes of Health (NIH) Advisory Council to the Director (ACD) Precision Medicine Initiative Working Group at the Public Workshop, Digital Health Data and Research Cohort Design, on the campus of Vanderbilt University on May 28-29.

The workshop is part of series by the ACD Working Group and builds on the April 28-29 workshop held on the NIH campus that focused on the development and implementation of a large national cohort, as well as identification of the unique scientific questions and opportunities of using such a large cohort. Two additional workshops are planned for July. The ACD Working Group is scheduled to submit its recommendations to the ACD at its September meeting, including a plan standing by to fund at the beginning of the fiscal year which begins October 1, should the Congress provide the necessary resources.

NIH director Francis Collins had this to say during the May workshop:

“The idea that we might have a million participants, all consented for research, all excited by the opportunity to participate in research and with access to electronic health records, potentially complete genome sequences and a variety of other information sources in terms of environmental exposures and lifestyle experiences, …we could have the power to really begin to get answers about what works in terms of maintaining health, managing chronic illness.”

According to Collins, the goal is to have the Working Group put forward a plan that is achievable but also “a bit of a stretch because that is often what inspires people to actually go to the next level of challenge.”

As chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, Alexander emphasized that he is working with Ranking Democrat Patty Murray (D-WA) to examine how to “get safe, cutting-edge drugs, medical devices, and treatments from the discovery process through the regulatory process into medicine cabinets and into doctor’s offices more quickly. Precision medicine is an important part of this committee initiative.” He reported that the committee is currently holding hearings and have staff working groups examining several areas of the discovery and approval process that will meet once a week with the NIH director and others to identify the “five or six things that we might do in the next few months.” There is also a subgroup working on electronic health records (EHR). He announced a goal of producing legislation by the end of the year.

Alexander requested input from the working group on legislation to speed the development of “safe, cutting-edge treatments and drugs,” adding, “We need to know from you the specific things that the Congress needs to do in order to have that happen.” He pointed out, however, that if the recommendations can be done administratively, Secretary of Health and Human Services Sylvia Burwell and Collins can do those themselves.

Alexander predicted that the House will pass its version of the 21st Century Cures Act (H.R. 6) in June. The Senate bill, however, is not likely to be finished until the end of the year or early next year. He stressed that the Working Groups’ ideas need to come to the Congress by September or October. He invited the Working Group to involve itself in the process, emphasizing that the President and the Congress are working in a bipartisan way and expect to complete it in 2016.

Representative Blackburn, Vice Chair of the Energy and Commerce Committee, thanked the NIH for working with the Committee on the 21st Century Cures Act. She too predicted that H.R. 6 will pass the House in June, likely with overwhelming, bipartisan support. Blackburn also anticipates that once the measure moves to the Senate it will proceed quickly.

Blackburn highlighted the Innovation Fund within the 21st Century Cures Act, which would provide $10 billion in new funding over five years (See Update, May 19, 2015). Blackburn emphasized the bipartisan cooperation around the legislation, citing the leadership of Ranking Member Diana DeGette (D-CO) over the last 18 months to get the legislation to its current state.

She also reported that she and Representative Peter Welsch (D-VT) led the data privacy and data working group for the past two years, announcing that she expected their data security bill, Data Security and Breach Notification Act of 2015, to go to the House floor soon. The Act would require “certain entities that collect and maintain consumers’ personal information to secure such information and to provide notice to affected individuals in the case of a breach of security involving personal information.” (A fact sheet regarding the bill is available here.) She explained that the Act will “carve out health information and not exercise pre-emption over that but leave health information with the states for the time being.” Everything else would fall under federal pre-emption, she explained, noting that there are currently 47 different state data security laws. They intend to examine healthcare information once they get to the point of opening up the HIPAA Privacy Rule.

Workshop participants discussed the risks and benefits of using existing resources in order to tap health care delivery systems and existing research cohorts and incorporating them into the precision medicine cohort and the challenges and opportunities for data sharing across institutions, which will be important to the success of the cohort, both for data sharing among researchers and with individual participants. There were also conversations regarding the inclusion of underrepresented minorities and underserved populations and the particular opportunities and challenges in how to accomplish this task. This topic, Participant Engagement and Health Equity Workshop, will be the subject of the upcoming July 1-2 workshop on the NIH campus.

All of the workshops are opened to the public and the videocasts of the proceedings are available for viewing:

Additional information regarding the Precision Medicine Initiative is available here.

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