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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Healthy Technology Act of 2025
ETO AGORA · U.S. federal laws · 2025
Summary
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.
Amends Federal Act to qualify AI as drug prescriber if FDA-approved and state-authorized.
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 law to authorize AI/ML technologies, licensed by states, to prescribe drugs if federally approved.
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.”.