II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. GOVERNING ETHICAL AI USE AND INNOVATION 

4 FOR HEALTH CARE DEVELOPMENT. 

5 (a) NATIONAL INSTITUTES OF HEALTH.—Part A of 

6 title IV of the Public Health Service Act is amended by 

7 inserting after section 403D (42 U.S.C. 283a–3) the fol8 lowing: 


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1 ‘‘SEC. 403E. ARTIFICIAL INTELLIGENCE. 

2 ‘‘(a) IN GENERAL.—The Director of NIH shall— 

3 ‘‘(1) develop computational resources and 

4 datasets necessary to use artificial intelligence ap5 proaches for health and health care research; 

6 ‘‘(2) provide expertise in biomedical research 

7 and the use of artificial intelligence; 

8 ‘‘(3) develop and maintain federated resources 

9 that provide unified access to data from funda10 mental biomedical research and the clinical care en11 vironment; 

12 ‘‘(4) provide education and ongoing support to 

13 a nationwide user community to foster scientifically 

14 sound, ethical, and inclusive research using artificial 

15 intelligence that addresses the health needs of all in16 dividuals; and 

17 ‘‘(5) extend the clinical research capabilities of 

18 the National Institutes of Health to address signifi19 cant gaps in evidence to guide clinical care and to 

20 serve the needs of every community. 

21 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

22 is authorized to be appropriated to the Director of NIH 

23 to carry out this section $400,000,000 for fiscal year 

24 2025.’’. 

25 (b) OFFICE OF THE NATIONAL COORDINATOR FOR

26 HEALTH INFORMATION TECHNOLOGY.—Subtitle C of title 


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1 XXX of the Public Health Service Act (42 U.S.C. 300jj– 

2 51 et seq.) is amended by adding at the end the following: 

3 ‘‘SEC. 3023. ARTIFICIAL INTELLIGENCE. 

4 ‘‘(a) IN GENERAL.—The National Coordinator 

5 shall— 

6 ‘‘(1) carry out activities to engage in health re7 search by— 

8 ‘‘(A) utilizing the electronic health record 

9 as a data collection tool; and 

10 ‘‘(B) requiring that individuals are offered 

11 an opportunity to direct the use of their health 

12 data for health care research; and 

13 ‘‘(2) establish data and interoperability stand14 ards for access, exchange, and use of clinical and ad15 ministrative data from the clinical care environment 

16 through a National Artificial Intelligence Research 

17 Resource, in alignment with— 

18 ‘‘(A) the United States Core Data for 

19 Interoperability; 

20 ‘‘(B) the Fast Health Interoperability Re21 sources; and 

22 ‘‘(C) the Trusted Exchange Framework 

23 and Common Agreement. 


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1 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to the National Coordi3 nator for fiscal year 2025— 

4 ‘‘(1) $10,000,000 to carry out subsection 

5 (a)(1); and 

6 ‘‘(2) $50,000,000 to carry out subsection 

7 (a)(2).’’. 

8 (c) MEDICARE REQUIREMENT FOR HOSPITALS RE9 LATING TO USE OF ELECTRONIC HEALTH RECORDS

10 DATA FOR BIOMEDICAL RESEARCH PURPOSES.—Section 

11 1866(a)(1) of the Social Security Act (42 U.S.C. 

12 1395cc(a)(1)) is amended— 

13 (1) by moving the indentation of subparagraph 

14 (W) 2 ems to the left; 

15 (2) in subparagraph (X)— 

16 (A) by moving the indentation 2 ems to 

17 the left; and 

18 (B) by striking ‘‘and’’ at the end; 

19 (3) in subparagraph (Y), by striking the period 

20 at the end and inserting ‘‘; and’’; and 

21 (4) by inserting after subparagraph (Y) the fol22 lowing new subparagraph: 

23 ‘‘(Z) in the case of a hospital, with respect 

24 to each individual who is admitted to the hos25 pital on or after the date that is 1 year after 


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1 the date of enactment of this subparagraph, 

2 to— 

3 ‘‘(i) request permission of the indi4 vidual to share the health data of the indi5 vidual for health-related research purposes 

6 in accordance with section 3023(a)(1) of 

7 the Public Health Service Act; and 

8 ‘‘(ii) in the case where the individual 

9 grants permission to the sharing of such 

10 data, share the electronic health record of 

11 the individual for such purposes in accord12 ance with such section.’’. 

13 (d) SENSE OF THE SENATE.—It is the sense of the 

14 Senate that any steering subcommittee (or similar entity) 

15 for a National Artificial Intelligence Research Resource 

16 established in the Interagency Committee established 

17 under section 5103 of the William M. (Mac) Thornberry 

18 National Defense Authorization Act for Fiscal Year 2021 

19 (15 U.S.C. 9413) shall include an officer or employee of 

20 the National Institutes of Health. 

21 (e) NATIONAL LIBRARY OF MEDICINE.— 

22 (1) IN GENERAL.—Section 465(b) of the Public 

23 Health Service Act (42 U.S.C. 286(b)) is amended— 

24 (A) in paragraph (7), by striking ‘‘and’’ 

25 after the semicolon; 


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1 (B) by redesignating paragraph (8) as 

2 paragraph (10); and 

3 (C) by inserting after paragraph (7) the 

4 following: 

5 ‘‘(8) establish facilities so that the Library 

6 serves as the central exchange center of federated 

7 data sharing; 

8 ‘‘(9) establish a core data science program to 

9 guide and enable a diverse and comprehensive com10 munity of health-related research data users; and’’. 

11 (2) AUTHORIZATION OF APPROPRIATIONS.— 

12 Subpart 1 of part D of title IV of the Public Health 

13 Service Act (42 U.S.C. 286 et seq.) is amended by 

14 adding at the end the following: 

15 ‘‘SEC. 468. AUTHORIZATION OF APPROPRIATIONS. 

16 ‘‘There are authorized to be appropriated to the Sec17 retary for fiscal year 2025— 

18 ‘‘(1) $100,000,000 to carry out section 

19 465(b)(8); and 

20 ‘‘(2) $100,000,000 to carry out section 

21 465(b)(9).’’. 

Æ 


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