Bill Details
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This bill would change federal drug law so that artificial intelligence and machine learning systems could be allowed to prescribe certain drugs, but only in limited cases. For this to happen, the AI system would need to be permitted by the state where it is used, and it would also need to be approved, cleared, or otherwise authorized by the Food and Drug Administration. In simple terms, the bill would make it clearer that, under the right legal and regulatory conditions, AI tools can count as a type of practitioner for prescribing medicine.
- It updates the federal law that defines who can be treated as a “practitioner” allowed to prescribe drugs.
- AI or machine learning systems could only prescribe if state law allows them to do so.
- They would also need FDA approval, clearance, or authorization through existing FDA pathways.
- The bill is meant to create clearer rules for using advanced technology in health care and prescription decisions.
Official Summaries
Healthy Technology Act of 2025
This bill establishes that artificial intelligence (AI) or machine learning technology may be eligible to prescribe drugs.
Currently, certain drugs may be dispensed only upon a prescription provided by a practitioner licensed by law to administer the drug. Under this bill, an AI or machine learning technology may qualify as such a prescribing practitioner if the technology is (1) authorized by state law to prescribe the drug involved; and (2) approved, cleared, or authorized under certain federal provisions pertaining to medical devices and products.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 238 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
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 practitioner eligible to prescribe drugs if authorized by the
State involved and approved, cleared, or authorized by the Food and
Drug Administration, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 7, 2025
Mr. Schweikert introduced the following bill; which was referred to the
Committee on Energy and Commerce
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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 prescribe 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Healthy Technology Act of 2025''.
SEC. 2. PRESCRIPTION OF DRUGS BY ARTIFICIAL INTELLIGENCE OR MACHINE
LEARNING TECHNOLOGIES.
Section 503(b) of Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353(b)) is amended by adding at the end the following:
``(6) In this subsection, the term `practitioner licensed by law to
administer such drug' includes artificial intelligence and machine
learning technology that are--
``(A) authorized pursuant to a statute of the State
involved to prescribe the drug involved; and
``(B) approved, cleared, or authorized under section
510(k), 513, 515, or 564.''.
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