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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4862 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 4862

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 30, 2024

  Mr. Rounds (for himself and Mr. Heinrich) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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:

``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:

``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).''.
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