Advancing Precision Medicine Act of 2016
The source supplies the latest action, but no lifecycle stage.
Latest action (18 Apr 2016): Placed on Senate Legislative Calendar under General Orders. Calendar No. 428.
What this bill does
This bill proposes to establish a Precision Medicine Initiative within the Department of Health and Human Services (HHS). This initiative would aim to improve how diseases are prevented, diagnosed, and treated by collecting health information from a diverse group of individuals. It would involve collaboration between HHS, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology, and would include secure data sharing.
The bill would also revise rules regarding the disclosure of identifiable, sensitive information collected from research subjects in federally funded biomedical research. Generally, researchers would be prohibited from disclosing this information to parties not involved in the research, with specific exceptions. Additionally, HHS could exempt certain identifiable biomedical research information from public disclosure under the Freedom of Information Act.
Finally, the NIH would gain the ability to require grant recipients to share scientific data and to fund high-risk, high-reward research through mechanisms other than standard contracts or grants. This bill was introduced in the Senate and has been ordered to be reported by the Committee on Health, Education, Labor, and Pensions, with an amendment.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
Advancing Precision Medicine Act of 2016
(Sec. 2) This bill encourages the Department of Health and Human Services (HHS) to carry out a Precision Medicine Initiative to address disease prevention, diagnosis, and treatment. The initiative may include collection of health information from a diverse cohort of individuals. HHS may carry out specified activities relating to the initiative, including coordinating with the Department of Energy to address supercomputing needs.
In implementing the initiative, HHS must: (1) collaborate with the National Institutes of Health (NIH), the Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology; (2) implement secure data sharing; and (3) ensure inclusion of a broad range of participants, considering factors that contribute to health disparities.
(Sec. 3) This bill amends the Public Health Service Act to revise provisions regarding disclosure by researchers of the identifiable, sensitive information of research subjects. HHS must prohibit researchers from disclosing such information from federally funded research to persons not connected to the research. Researchers may apply to have other research covered by this prohibition.
Disclosures of such information are permitted if required by law, necessary for the medical treatment of the research subject, made with the consent of the subject, or made for the purposes of other research that is in compliance with regulations regarding protection of subjects.
(Sec. 4) HHS may exempt identifiable information collected for biomedical research from disclosure under the Freedom of Information Act.
(Sec. 5) The NIH may require recipients of grants or cooperative agreements to share scientific data.
(Sec. 6) The NIH may approve requests by national research institutes to fund high-impact, cutting-edge research through transactions other than contracts, grants, or cooperative agreements. National research institutes must conduct and support high-risk, high-reward research.
Timeline
18 Apr 2016
Placed on Senate Legislative Calendar under General Orders. Calendar No. 428.
Common questions
- What does S. 2713 do?
- This bill proposes to establish a Precision Medicine Initiative within the Department of Health and Human Services (HHS). This initiative would aim to improve how diseases are prevented, diagnosed, and treated by collecting health information from a diverse group of individuals. It would involve collaboration between HHS, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology, and would include secure data sharing. The bill would also revise rules regarding the disclosure of identifiable, sensitive information collected from research subjects in federally funded biomedical research. Generally, researchers would be prohibited from disclosing this information to parties not involved in the research, with specific exceptions. Additionally, HHS could exempt certain identifiable biomedical research information from public disclosure under the Freedom of Information Act. Finally, the NIH would gain the ability to require grant recipients to share scientific data and to fund high-risk, high-reward research through mechanisms other than standard contracts or grants. This bill was introduced in the Senate and has been ordered to be reported by the Committee on Health, Education, Labor, and Pensions, with an amendment.
- Has S. 2713 become law?
- The source does not supply a confirmed lifecycle stage for S. 2713. Check the latest action and official source below.
- Who sponsored S. 2713?
- S. 2713 was sponsored by Sen. Alexander, Lamar [R-TN] (R-TN), with 1 cosponsor.
- What's the latest action on S. 2713?
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 428. (18 Apr 2016).
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