View all text of Part H [§ 289 - § 290a]
§ 289g–5. Precision medicine initiative
(a) In general
(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, 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 Secretary
In 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) 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, 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) Report
(July 1, 1944, ch. 373, title IV, § 498E, as added Pub. L. 114–255, div. A, title II, § 2011, Dec. 13, 2016, 130 Stat. 1047.)