Advancing Precision Medicine Act of 2016

To provide for the implementation of a Precision Medicine Initiative. 1. Short title This Act may be cited as the Advancing Precision Medicine Act of 2016 2. Precision medicine initiative (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary Precision Medicine Initiative (b) Components The Initiative described under subsection (a) may include— (1) developing a network of scientists to assist in carrying out the purposes of the Initiative; (2) developing new approaches for addressing scientific, medical, public health, and regulatory science issues; (3) applying genomic technologies to provide data on the molecular basis of disease; (4) collecting information voluntarily provided by a diverse cohort of individuals that can be used to better understand health and disease; and (5) other activities determined appropriate by the Secretary to advance the goals of the Initiative. (c) Authority of the Secretary In carrying out this section, the Secretary may— (1) coordinate with the Secretary of Energy, private industry, and others determined appropriate by the Secretary to identify and address the advanced supercomputing needs for the Initiative described under subsection (a); (2) develop and utilize public-private partnerships; and (3) leverage existing data sources. (d) Requirements In the implementation of the Initiative under subsection (a), the Secretary shall— (1) ensure the collaboration of the National Institutes of Health, the Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology; (2) comply with existing laws and regulations for the protection of human subjects involved in research, including the protection of participant privacy; (3) implement policies and mechanisms for appropriate secure data sharing across systems that include protections for privacy and security of data; and (4) consider the diversity of the cohort to ensure inclusion of a broad range of participants, including consideration of biological, social, and other determinants of health that contribute to health disparities.

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.