---
kind: "section"
citation: "42 U.S.C. § 289g–5"
title: "42"
title_heading: "The Public Health and Welfare"
number: "289g–5"
heading: "Precision medicine initiative"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/289g-5"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter III — National Research Institutes"
  - "Part H — General Provisions"
---

# §289g–5. Precision medicine initiative

- (a) **In general—** The [Secretary](/usc/42/201.md?p=c) 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](/usc/42/11851.md?p=11).
- (b) **Components—** The Initiative described under [subsection (a)](#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](/usc/42/201.md?p=c) determines appropriate.
- (c) **Authority of the Secretary—** In carrying out this section, the [Secretary](/usc/42/201.md?p=c) may—
  - (1) coordinate with the [Secretary](/usc/42/201.md?p=c) of Energy, private industry, and others, as the [Secretary](/usc/42/201.md?p=c) 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)](#a), the [Secretary](/usc/42/201.md?p=c) shall—
  - (1) ensure the collaboration of the National Institutes of Health, the Food and [Drug](/usc/42/11851.md?p=4) 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](/usc/42/201.md?p=a);
  - (2) comply with existing laws and [regulations](/usc/42/201.md?p=d) for the protection of human subjects involved in research, including the protection of [participant](/usc/42/300gg–91.md?p=d-11) 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](/usc/42/300gg–91.md?p=d-11), 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](/usc/42/201.md?p=a), 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](/usc/42/13641.md?p=2) 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](/usc/42/201.md?p=c) 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](/usc/42/201.md?p=c) has taken to consult with experts or other heads of departments or [agencies](/usc/42/8262.md?p=1) of the Federal Government in the development of such policies.

## Source credit

(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.)

## Notes

### 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: 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. Use of Funds.—From amounts appropriated by subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall— 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; award grants or cooperative agreements to State, local, Tribal, or territorial public health departments or public health laboratories— to increase their capacity to sequence genomes of circulating strains of viruses and other organisms, including SARS–CoV–2; to identify mutations in viruses and other organisms, including SARS–CoV–2; to use genomic sequencing to identify outbreaks and clusters of diseases or infections, including COVID–19; and to develop effective disease response strategies based on genomic sequencing and surveillance data; enhance and expand the informatics capabilities of the public health workforce; and award grants for the construction, alteration, or renovation of facilities to improve genomic sequencing and surveillance capabilities at the State and local level.”