H.R. 238

119th CONGRESS 1st Session

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 · Sponsor: Mr. Schweikert · Committee: Committee on Energy and Commerce

Table of contents

• H.R. 238
  • SEC. 1. Short title
  • SEC. 2. Prescription of drugs by artificial intelligence or machine learning technologies

SEC. 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 () is amended by adding at the end the following: 21 U.S.C. 353(b)
  • In this subsection, the term includes artificial intelligence and machine learning technology that are— practitioner licensed by law to administer such drug
    • authorized pursuant to a statute of the State involved to prescribe the drug involved; and
    • approved, cleared, or authorized under section 510(k), 513, 515, or 564.