<?xml version="1.0"?>
<?xml-stylesheet type="text/xsl" href="billres.xsl"?>
<!DOCTYPE bill PUBLIC "-//US Congress//DTDs/bill.dtd//EN" "bill.dtd">
<bill bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public" slc-id="S1-KEN24433-FMR-62-9C1"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>118 S4862 IS: To ensure that new advances in artificial intelligence are ethically adopted to improve the health of all individuals, and for other purposes.</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2024-07-30</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
</dublinCore>
</metadata>
<form>
<distribution-code display="yes">II</distribution-code><congress>118th CONGRESS</congress><session>2d Session</session><legis-num>S. 4862</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20240730">July 30, 2024</action-date><action-desc><sponsor name-id="S381">Mr. Rounds</sponsor> (for himself and <cosponsor name-id="S359">Mr. Heinrich</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To ensure that new advances in artificial intelligence are ethically adopted to improve the health of all individuals, and for other purposes.</official-title></form><legis-body><section id="id80ba24f54f72432a8405b572dadb7a1f" section-type="section-one"><enum>1.</enum><header>Governing ethical AI use and innovation for health care development</header><subsection id="id41a961edc51b495396c9c802f1b6d37b"><enum>(a)</enum><header>National Institutes of Health</header><text display-inline="yes-display-inline">Part A of title IV of the Public Health Service Act is amended by inserting after section 403D (<external-xref legal-doc="usc" parsable-cite="usc/42/283a-3">42 U.S.C. 283a–3</external-xref>) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idB91514B453044ADE8E5C975965581E52"><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id92c20fc12391408d9128057341d0b698"><enum>403E.</enum><header>Artificial intelligence</header><subsection commented="no" display-inline="no-display-inline" id="iddd03c6ecdd3f4f5baebe67a934dfde49"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Director of NIH shall—</text><paragraph id="id9fbdf7e7f2ad4884a35192669c443f6e"><enum>(1)</enum><text>develop computational resources and datasets necessary to use artificial intelligence approaches for health and health care research;</text></paragraph><paragraph id="id0e4bb2a7e75648cdbfd9c0b853f1a0c4"><enum>(2)</enum><text>provide expertise in biomedical research and the use of artificial intelligence;</text></paragraph><paragraph id="idd56a4c9e1cdf4078b01d0703a1909503"><enum>(3)</enum><text>develop and maintain federated resources that provide unified access to data from fundamental biomedical research and the clinical care environment; </text></paragraph><paragraph id="ide3597bb71e624f6a9333395d9a834910"><enum>(4)</enum><text>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</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4ab53da36edc4fc1934e72519091ef56"><enum>(5)</enum><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id8f8c43d81d484ac0bdf461cef640f808"><enum>(b)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">There is authorized to be appropriated to the Director of NIH to carry out this section $400,000,000 for fiscal year 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="id97d41cfef18c406aa1ab375ab64a56db"><enum>(b)</enum><header>Office of the National Coordinator for Health Information Technology</header><text display-inline="yes-display-inline">Subtitle C of title XXX of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300jj-51">42 U.S.C. 300jj–51 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idF772AAF37CFF449995CAFB03627B13B3"><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id02dfd608d28941d69334b9ace4f48743"><enum>3023.</enum><header>Artificial intelligence</header><subsection commented="no" display-inline="no-display-inline" id="id55c984a493124c919902296e9b8316aa"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The National Coordinator shall—</text><paragraph id="id03dcfc96b2a4426fab33cde14042cbec"><enum>(1)</enum><text>carry out activities to engage in health research by—</text><subparagraph commented="no" display-inline="no-display-inline" id="id790c63bb018d49aea8d77a8f02109374"><enum>(A)</enum><text display-inline="yes-display-inline">utilizing the electronic health record as a data collection tool; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id33a8d8ddf4e04304ba7dc4e428664ba8"><enum>(B)</enum><text display-inline="yes-display-inline">requiring that individuals are offered an opportunity to direct the use of their health data for health care research; and</text></subparagraph></paragraph><paragraph id="id0253abc1ee204351a7bce4b1c676875f"><enum>(2)</enum><text>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—</text><subparagraph commented="no" display-inline="no-display-inline" id="id9fc67ee9d91c4ec79453d82034f032e2"><enum>(A)</enum><text display-inline="yes-display-inline">the United States Core Data for Interoperability; </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id759f651731fc4f549e7dda245a1b627b"><enum>(B)</enum><text display-inline="yes-display-inline">the Fast Health Interoperability Resources; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd779d34c6e234a1799e3fe3573bed0e9"><enum>(C)</enum><text display-inline="yes-display-inline">the Trusted Exchange Framework and Common Agreement.</text></subparagraph></paragraph></subsection><subsection id="id751f48975d57475a8f903dcf106c1ded"><enum>(b)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to the National Coordinator for fiscal year 2025—</text><paragraph commented="no" display-inline="no-display-inline" id="idbafb4a5cffaa4809b9f970f85f85fceb"><enum>(1)</enum><text display-inline="yes-display-inline">$10,000,000 to carry out subsection (a)(1); and</text></paragraph><paragraph id="iddf62a66d55334b829addd8c7ab18c044"><enum>(2)</enum><text>$50,000,000 to carry out subsection (a)(2).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="id4dd13800818e42ac8ce83212e732b4fa"><enum>(c)</enum><header>Medicare requirement for hospitals relating to use of electronic health records data for biomedical research purposes</header><text display-inline="yes-display-inline">Section 1866(a)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395cc">42 U.S.C. 1395cc(a)(1)</external-xref>) is amended—</text><paragraph id="id5c3e6470945f4415b05c060824b78cd4"><enum>(1)</enum><text>by moving the indentation of subparagraph (W) 2 ems to the left;</text></paragraph><paragraph id="id1c1bc4d26485429e9f7336d93fea9550"><enum>(2)</enum><text>in subparagraph (X)—</text><subparagraph id="ide1500bc395134f04907d8f39d06860bd"><enum>(A)</enum><text>by moving the indentation 2 ems to the left; and</text></subparagraph><subparagraph id="idc07f383560364cb08fbafd69a45b1926"><enum>(B)</enum><text>by striking <quote>and</quote> at the end;</text></subparagraph></paragraph><paragraph id="iddfbc7a5bcd0044eb9877c3bbb8d62343"><enum>(3)</enum><text>in subparagraph (Y), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="idc241f8d1e29043b89964078f521d02a1"><enum>(4)</enum><text>by inserting after subparagraph (Y) the following new subparagraph:</text><quoted-block id="ida972d8c64a4b471b869725fb95e0a313" display-inline="no-display-inline" style="OLC"><subparagraph id="id862c8082c10b40638e893ac7450167ad"><enum>(Z)</enum><text>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—</text><clause id="id75e7d674374148f88e1b1669f338fc71"><enum>(i)</enum><text>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</text></clause><clause id="id53d23d5f5c6c4a559216f592af0e3986" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text>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.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="ida86103c4fabe4199b4c3330a340bd001"><enum>(d)</enum><header>Sense of the Senate</header><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/15/9413">15 U.S.C. 9413</external-xref>) shall include an officer or employee of the National Institutes of Health. </text></subsection><subsection commented="no" display-inline="no-display-inline" id="id06c6e3ad8b814cf49265f75a4a3d26c1"><enum>(e)</enum><header display-inline="yes-display-inline">National Library of Medicine</header><paragraph commented="no" display-inline="no-display-inline" id="id4b2288f828694290b0979ea9472bb018"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 465(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/286">42 U.S.C. 286(b)</external-xref>) is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="idf19aed98d20043638f2958b23c7e9ad3"><enum>(A)</enum><text>in paragraph (7), by striking <quote>and</quote> after the semicolon;</text></subparagraph><subparagraph id="id32b69777c416447180bb943356125b92"><enum>(B)</enum><text>by redesignating paragraph (8) as paragraph (10); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide84fb043eff045ae913a6ba85f47b5c1"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after paragraph (7) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idC05BF11CD6B14A6DA233CEE214F717E1"><paragraph id="idd5c36b99b3b04240b4fe934bf88b15aa"><enum>(8)</enum><text>establish facilities so that the Library serves as the central exchange center of federated data sharing; </text></paragraph><paragraph id="id39f28e4606a147f0917db5040bb5276d"><enum>(9)</enum><text>establish a core data science program to guide and enable a diverse and comprehensive community of health-related research data users; and</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida663c099eafc4c198788bceb63209dda"><enum>(2)</enum><header>Authorization of appropriations</header><text>Subpart 1 of part D of title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/286">42 U.S.C. 286 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block id="idC54DC7B3D7074D36B6608EAB7BBE8F93" display-inline="no-display-inline" style="OLC"><section commented="no" display-inline="no-display-inline" id="idfb923660ec744a9696b672cf287ba90f"><enum>468.</enum><header>Authorization of appropriations</header><text display-inline="no-display-inline">There are authorized to be appropriated to the Secretary for fiscal year 2025—</text><paragraph id="idd29139ccecfe482d9a09c1281696ee17"><enum>(1)</enum><text>$100,000,000 to carry out section 465(b)(8); and</text></paragraph><paragraph id="id6199ed636e194f188a09f548866d30f4" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>$100,000,000 to carry out section 465(b)(9).</text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section></legis-body></bill> 

