Amends the Federal Food, Drug, and Cosmetic Act to include AI and machine learning technologies as eligible drug prescribers if they are state-authorized and FDA-approved, cleared, or authorized by the FDA and other purposes.
Revises the Federal Food, Drug, and Cosmetic Act to include 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.
Requires section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) to be amended by adding the following at the end.
Requires that any artificial intelligence or machine learning technology included as a “practitioner licensed by law to administer such drug” be authorized pursuant to a statute of the State involved to prescribe the drug involved.
Mandates that the artificial intelligence or machine learning technology be approved, cleared, or authorized by the Food and Drug Administration under section 510(k), 513, 515, or 564.
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This document has not been enacted or otherwise finalized and is subject to change. This summary is based on a copy of the document collected 2025-04-21 - refer to the official source for the most current version.
Key facts
🏛️ This document has been proposed by the United States Congress, but is not yet enacted.
For authoritative text and metadata, visit the official source.
🎯 This document primarily applies to the government, rather than the private sector.
📜 This document's name is Healthy Technology Act of 2025.
Themes AI risks, applications, governance strategies, and other themes addressed in AGORA documents.
This document has not been enacted or otherwise finalized and is subject to change. This summary is based on a copy of the document collected 2025-04-21 - refer to the official source for the most current version.
Thematic tags are in progress.
Full text
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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”.
Amends Federal Act to qualify AI as drug prescriber if FDA-approved and state-authorized.
Amends Federal Act to qualify AI as drug prescriber if FDA-approved and state-authorized.
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.”.
Amends law to authorize AI/ML technologies, licensed by states, to prescribe drugs if federally approved.
Amends law to authorize AI/ML technologies, licensed by states, to prescribe drugs if federally approved.