Authorizes artificial intelligence and machine learning technologies to prescribe pharmaceutical drugs if approved by the State involved and the Food and Drug Administration
Amends the definition of 'practitioner licensed by law to administer such a drug' in Section 503(b) of the Federal Food, Drug and Cosmetic Act, to include artificial intelligence and machine learning technology
Authorizes AI and ML technology to prescribe pharmaceutical drugs if approved by the State in question, and if approved by the Food and Drug Administration
Requires such AI and ML technology to be approved by the Food and Drug Administration through conventional channels, including having to provide 90 days' premarket notification if this is deemed a new device
This summary is awaiting validation (peer review by a second AGORA editor).
Key facts
🏛️ This document was proposed and/or enacted by the United States Congress but is now defunct.
For authoritative text and metadata, visit the official source.
🎯 This document primarily applies to the private sector, rather than the government.
📜 This document's name is Healthy Technology Act of 2023.
Themes AI risks, applications, governance strategies, and other themes addressed in AGORA documents.
Thematic tags for this document are awaiting validation (peer review by a second AGORA editor).
This is an unofficial copy. The document has been
archived and reformatted in plaintext for AGORA. Footnotes, tables, and
similar material may be omitted. For the official text, visit the original source.
Thematic tags for this document are awaiting validation (peer review by a second AGORA editor).
SECTION 1. SHORT TITLE.
This Act may be cited as the “Healthy Technology Act of 2023”.
Titles the Act as the “Healthy Technology Act of 2023”.
Titles the Act as the “Healthy Technology Act of 2023”.
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.”.
Defines AI as a licensed practitioner if state-authorized and federally approved to prescribe drugs.
Defines AI as a licensed practitioner if state-authorized and federally approved to prescribe drugs.