I
119THCONGRESS
1
STSESSION H. R. 238
To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial
intelligence and machine learning technologies can qualify as a practi-
tioner eligible to prescribe drugs if authorized by the State involved
and approved, cleared, or authorized by the Food and Drug Administra-
tion, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY7, 2025
Mr. S
CHWEIKERTintroduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
clarify that artificial intelligence and machine learning
technologies can qualify as a practitioner eligible to pre-
scribe drugs if authorized by the State involved and
approved, cleared, or authorized by the Food and Drug
Administration, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Healthy Technology 4
Act of 2025’’. 5
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•HR 238 IH
SEC. 2. PRESCRIPTION OF DRUGS BY ARTIFICIAL INTEL-1
LIGENCE OR MACHINE LEARNING TECH-2
NOLOGIES. 3
Section 503(b) of Federal Food, Drug, and Cosmetic 4
Act (21 U.S.C. 353(b)) is amended by adding at the end 5
the following: 6
‘‘(6) In this subsection, the term ‘practitioner li-7
censed by law to administer such drug’ includes artificial 8
intelligence and machine learning technology that are— 9
‘‘(A) authorized pursuant to a statute of the 10
State involved to prescribe the drug involved; and 11
‘‘(B) approved, cleared, or authorized under 12
section 510(k), 513, 515, or 564.’’. 13
Æ
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