Federal

Healthy Technology Act of 2023

Source: Congress.gov · 329 words in original text

What This Bill Does

This bill changes federal drug prescription rules to allow artificial intelligence and machine learning technology to prescribe drugs. These technologies can do so if their home state authorizes it and if the FDA approves, clears or authorizes the specific technology.

Who It Affects

States, the Food and Drug Administration, and developers of artificial intelligence and machine learning technologies used for drug prescribing.

Key Provisions

• Artificial intelligence and machine learning technologies can be considered a "practitioner licensed by law to administer" drugs under federal law if the state involved authorizes them by statute to prescribe drugs (Sec. 2) • These technologies must receive FDA approval, clearance or authorization through specific FDA review processes before they can prescribe drugs (Sec. 2)

What Changes

The definition of who can legally prescribe drugs under federal law expands to include artificial intelligence and machine learning technology, provided states allow it and the FDA approves the technology.

Important Definitions

The bill does not define "artificial intelligence," "machine learning technology," or "practitioner." It also does not define the specific FDA approval processes it references.

I 118TH CONGRESS 1ST SESSION H. R. 206 To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practi- tioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administra- tion, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 9, 2023 Mr. SCHWEIKERT introduced the following bill; which was referred to the Committee on Energy and Commerce 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 pre- scribe 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Healthy Technology 4 Act of 2023’’. 5 VerDate Sep 11 2014 03:08 Jan 19, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H206.IH H206 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 206 IH SEC. 2. PRESCRIPTION OF DRUGS BY ARTIFICIAL INTEL- 1 LIGENCE OR MACHINE LEARNING TECH- 2 NOLOGIES. 3 Section 503(b) of Federal Food, Drug, and Cosmetic 4 Act (21 U.S.C. 353(b)) is amended by adding at the end 5 the following: 6 ‘‘(6) In this subsection, the term ‘practitioner li- 7 censed by law to administer such drug’ includes artificial 8 intelligence and machine learning technology that are— 9 ‘‘(A) authorized pursuant to a statute of the 10 State involved to prescribe the drug involved; and 11 ‘‘(B) approved, cleared, or authorized under 12 section 510(k), 513, 515, or 564.’’. 13 Æ VerDate Sep 11 2014 03:08 Jan 19, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H206.IH H206 kjohnson on DSK79L0C42PROD with BILLS

Important: This plain English summary was generated by AI and is provided for informational purposes only. It is not legal advice. Always consult the official bill text on Congress.gov or a qualified attorney for legal matters.