S.4862, A bill to ensure that new advances in artificial intelligence are ethically adopted to improve the health of all individuals, and for other purposes.

Summary

Amends the Public Health Service Act to mandate the NIH Director develop AI resources and datasets for health research, provide AI expertise, and maintain data access resources.

Authorizes $400 million for NIH AI initiatives in fiscal year 2025.

Directs the National Coordinator for Health IT to utilize electronic health records for research, establish data standards, and align with national interoperability frameworks.

Appropriates $10 million for data collection and $50 million for data standards.

Requires hospitals to request patient consent to use health records for research, contingent upon patient approval.

Expresses the Senate's view that NIH representation is crucial in steering committees for national AI research resources.

Mandates the National Library of Medicine to establish data-sharing facilities and create a core data science program.

Appropriates $100 million each for these library initiatives in fiscal year 2025.

Directs the National Institutes of Health to expand artificial intelligence in health and biomedical research, develop computational resources for AI applications, create and maintain federated data systems linking research and clinical care, provide education and support, and strengthen clinical research; authorizes $400 million in funding for fiscal year 2025; amends the role of the Office of the National Coordinator for Health Information Technology.

SECTION 1. GOVERNING ETHICAL AI USE AND INNOVATION FOR HEALTH CARE DEVELOPMENT. (a) National Institutes Of Health.—Part A of title IV of the Public Health Service Act is amended by inserting after section 403D (42 U.S.C. 283a–3) the following: “SEC. 403E. ARTIFICIAL INTELLIGENCE. “(a) In General.—The Director of NIH shall— “(1) develop computational resources and datasets necessary to use artificial intelligence approaches for health and health care research; “(2) provide expertise in biomedical research and the use of artificial intelligence; “(3) develop and maintain federated resources that provide unified access to data from fundamental biomedical research and the clinical care environment; “(4) provide education and ongoing support to a nationwide user community to foster scientifically sound, ethical, and inclusive research using artificial intelligence that addresses the health needs of all individuals; and “(5) extend the clinical research capabilities of the National Institutes of Health to address significant gaps in evidence to guide clinical care and to serve the needs of every community. “(b) Authorization Of Appropriations.—There is authorized to be appropriated to the Director of NIH to carry out this section $400,000,000 for fiscal year 2025.”. (b) Office Of The National Coordinator For Health Information Technology.—Subtitle C of title XXX of the Public Health Service Act (42 U.S.C. 300jj–51 et seq.) is amended by adding at the end the following:

Directs the National Coordinator to engage in health research by using electronic health records as data inputs for artificial intelligence; enables individuals to direct the use of their health data for AI-driven research; establishes data and interoperability standards to support a National Artificial Intelligence Research Resource; aligns data systems with national interoperability frameworks to facilitate AI use; requires hospitals to obtain patient consent and share electronic health record data for research supporting AI applications; promotes inclusion of National Institutes of Health expertise in governance of national AI research infrastructure; expands data-sharing infrastructure and data science capabilities to support AI-enabled biomedical research; authorizes funding to support AI-related data use and infrastructure development.

“SEC. 3023. ARTIFICIAL INTELLIGENCE. “(a) In General.—The National Coordinator shall— “(1) carry out activities to engage in health research by— “(A) utilizing the electronic health record as a data collection tool; and “(B) requiring that individuals are offered an opportunity to direct the use of their health data for health care research; and “(2) establish data and interoperability standards for access, exchange, and use of clinical and administrative data from the clinical care environment through a National Artificial Intelligence Research Resource, in alignment with— “(A) the United States Core Data for Interoperability; “(B) the Fast Health Interoperability Resources; and “(C) the Trusted Exchange Framework and Common Agreement. “(b) Authorization Of Appropriations.—There are authorized to be appropriated to the National Coordinator for fiscal year 2025— “(1) $10,000,000 to carry out subsection (a)(1); and “(2) $50,000,000 to carry out subsection (a)(2).”. (c) Medicare Requirement For Hospitals Relating To Use Of Electronic Health Records Data For Biomedical Research Purposes.—Section 1866(a)(1) of the Social Security Act (42 U.S.C. 1395cc(a)(1)) is amended— (1) by moving the indentation of subparagraph (W) 2 ems to the left; (2) in subparagraph (X)— (A) by moving the indentation 2 ems to the left; and (B) by striking “and” at the end; (3) in subparagraph (Y), by striking the period at the end and inserting “; and”; and (4) by inserting after subparagraph (Y) the following new subparagraph: “(Z) in the case of a hospital, with respect to each individual who is admitted to the hospital on or after the date that is 1 year after the date of enactment of this subparagraph, to— “(i) request permission of the individual to share the health data of the individual for health-related research purposes in accordance with section 3023(a)(1) of the Public Health Service Act; and “(ii) in the case where the individual grants permission to the sharing of such data, share the electronic health record of the individual for such purposes in accordance with such section.”. (d) Sense Of The Senate.—It is the sense of the Senate that any steering subcommittee (or similar entity) for a National Artificial Intelligence Research Resource established in the Interagency Committee established under section 5103 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (15 U.S.C. 9413) shall include an officer or employee of the National Institutes of Health. (e) National Library Of Medicine.— (1) IN GENERAL.—Section 465(b) of the Public Health Service Act (42 U.S.C. 286(b)) is amended— (A) in paragraph (7), by striking “and” after the semicolon; (B) by redesignating paragraph (8) as paragraph (10); and (C) by inserting after paragraph (7) the following: “(8) establish facilities so that the Library serves as the central exchange center of federated data sharing; “(9) establish a core data science program to guide and enable a diverse and comprehensive community of health-related research data users; and”. (2) AUTHORIZATION OF APPROPRIATIONS.—Subpart 1 of part D of title IV of the Public Health Service Act (42 U.S.C. 286 et seq.) is amended by adding at the end the following:

Authorize appropriations of $200,000,000 for sections 465(b)(8) and 465(b)(9) in fiscal year 2025.

“SEC. 468. AUTHORIZATION OF APPROPRIATIONS. “There are authorized to be appropriated to the Secretary for fiscal year 2025— “(1) $100,000,000 to carry out section 465(b)(8); and “(2) $100,000,000 to carry out section 465(b)(9).”.