Precision medicine initiative

42 U.S.C. § 289g–5
in effect
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(a) In generalThe Secretary is encouraged to establish and carry out an initiative, to be known as the “Precision Medicine Initiative” (in this section referred to as the “Initiative”), to augment efforts to address disease prevention, diagnosis, and treatment. (b) ComponentsThe 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, such as whole genomic sequencing, 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 to advance the goals of the Initiative, as the Secretary determines appropriate. (c) Authority of the SecretaryIn carrying out this section, the Secretary may—(1) coordinate with the Secretary of Energy, private industry, and others, as the Secretary determines appropriate, to identify and address the advanced supercomputing and other advanced technology needs for the Initiative; (2) develop and utilize public-private partnerships; and (3) leverage existing data sources. (d) RequirementsIn 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, the Office of the National Coordinator for Health Information Technology, and the Office for Civil Rights of the Department of Health and Human Services; (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; (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; (5) ensure that only authorized individuals may access controlled or sensitive, identifiable biological material and associated information collected or stored in connection with the Initiative; and (6) on the appropriate Internet website of the Department of Health and Human Services, identify any entities with access to such information and provide information with respect to the purpose of such access, a summary of the research project for which such access is granted, as applicable, and a description of the biological material and associated information to which the entity has access. (e) ReportNot later than 1 year after December 13, 2016, the Secretary shall submit a report on the relevant data access policies and procedures to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such report shall include steps the Secretary has taken to consult with experts or other heads of departments or agencies of the Federal Government in the development of such policies.

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