42 U.S.C. § 289g–5: Precision medicine…

Summary

The Secretary is encouraged to set up and run the Precision Medicine Initiative to help prevent, diagnose, and treat disease. The Initiative can build a network of scientists, try new scientific and regulatory approaches, use genomic tools like whole genome sequencing, collect voluntary health and genetic data from a diverse group of people, and do other activities the Secretary thinks will help. In carrying this out, the Secretary may work with the Secretary of Energy, private industry, and others for computing and technology needs, form public‑private partnerships, and use existing data. The Secretary must make NIH, FDA, the Office of the National Coordinator for Health IT, and the Office for Civil Rights work together; follow laws that protect people in research and their privacy; set up secure data‑sharing rules; include diverse participants and consider factors that affect health; limit access to sensitive, identifiable samples and data to authorized people; and post on HHS’s website who has access, why, a research summary, and what samples or data they can use. Not later than 1 year after December 13, 2016, the Secretary must send a report on data access policies and procedures to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce, including steps taken to consult experts or other agency heads.

Title 42, §289g–5

The Public Health and Welfare, Source: USLM XML via OLRC

(a)In general

The 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)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

Not 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.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Funding for SARS–COV–2 Genomic Sequencing and Surveillance Pub. L. 117–2, title II, § 2402, Mar. 11, 2021, 135 Stat. 41, provided that: “(a) In General.—In addition to amounts otherwise available, there is appropriated to the Secretary [of Health and Human Services] for fiscal year 2021 out of any money in the Treasury not otherwise appropriated, $1,750,000,000, to remain available until expended, to strengthen and expand activities and workforce related to genomic sequencing, analytics, and disease surveillance. “(b) Use of Funds.—From amounts appropriated by subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—“(1) conduct, expand, and improve activities to sequence genomes, identify mutations, and survey the circulation and transmission of viruses and other organisms, including strains of SARS–CoV–2; “(2) award grants or cooperative agreements to State, local, Tribal, or territorial public health departments or public health laboratories—“(A) to increase their capacity to sequence genomes of circulating strains of viruses and other organisms, including SARS–CoV–2; “(B) to identify mutations in viruses and other organisms, including SARS–CoV–2; “(C) to use genomic sequencing to identify outbreaks and clusters of diseases or infections, including COVID–19; and “(D) to develop effective disease response strategies based on genomic sequencing and surveillance data; “(3) enhance and expand the informatics capabilities of the public health workforce; and “(4) award grants for the

Construction

, alteration, or renovation of facilities to improve genomic sequencing and surveillance capabilities at the State and local level.”

§289g–5 Precision Medicine Initiative

Summary

Title 42, §289g–5

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Citations & Metadata