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
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Healthy Technology Act of 2023
ETO AGORA · U.S. federal laws · 2023
Summary
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
Titles the Act as the “Healthy Technology Act of 2023”.
SECTION 1. SHORT TITLE. This Act may be cited as the “Healthy Technology Act of 2023”.
Defines AI as a licensed practitioner if state-authorized and federally approved to prescribe drugs.
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.”.