Healthy Technology Act of 2025
Latest action (7 Jan 2025): Introduced
What this bill does
H.R. 238, the Healthy Technology Act of 2025, would amend the Federal Food, Drug, and Cosmetic Act to specify that artificial intelligence and machine learning technologies can be considered a "practitioner licensed by law" for purposes of prescribing certain drugs. Under the bill, such technologies could qualify as prescribers if two conditions are met: they are authorized under state law to prescribe the drug in question, and they have been approved, cleared, or otherwise authorized by the Food and Drug Administration through specified regulatory pathways (referencing sections 510(k), 513, 515, or 564 of the same Act, which cover various device clearance, approval, and emergency-use authorization processes).
The bill would affect the healthcare and pharmaceutical sectors, including drug manufacturers, prescribers, technology developers building AI/ML clinical tools, state licensing authorities, and ultimately patients who might receive prescriptions generated or issued through AI/ML systems. It would create a federal legal basis for such systems to act as prescribers, provided both state authorization and FDA clearance are in place, rather than changing FDA approval standards themselves.
The bill was introduced on January 7, 2025, by Rep. David Schweikert and referred to the House Committee on Energy and Commerce. It has not yet received a committee vote, floor action, or further congressional consideration.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
Healthy Technology Act of 2025
This bill establishes that artificial intelligence (AI) or machine learning technology may be eligible to prescribe drugs.
Currently, certain drugs may be dispensed only upon a prescription provided by a practitioner licensed by law to administer the drug. Under this bill, an AI or machine learning technology may qualify as such a prescribing practitioner if the technology is (1) authorized by state law to prescribe the drug involved; and (2) approved, cleared, or authorized under certain federal provisions pertaining to medical devices and products.
Common questions
- What does H.R. 238 do?
- H.R. 238, the Healthy Technology Act of 2025, would amend the Federal Food, Drug, and Cosmetic Act to specify that artificial intelligence and machine learning technologies can be considered a "practitioner licensed by law" for purposes of prescribing certain drugs. Under the bill, such technologies could qualify as prescribers if two conditions are met: they are authorized under state law to prescribe the drug in question, and they have been approved, cleared, or otherwise authorized by the Food and Drug Administration through specified regulatory pathways (referencing sections 510(k), 513, 515, or 564 of the same Act, which cover various device clearance, approval, and emergency-use authorization processes). The bill would affect the healthcare and pharmaceutical sectors, including drug manufacturers, prescribers, technology developers building AI/ML clinical tools, state licensing authorities, and ultimately patients who might receive prescriptions generated or issued through AI/ML systems. It would create a federal legal basis for such systems to act as prescribers, provided both state authorization and FDA clearance are in place, rather than changing FDA approval standards themselves. The bill was introduced on January 7, 2025, by Rep. David Schweikert and referred to the House Committee on Energy and Commerce. It has not yet received a committee vote, floor action, or further congressional consideration.
- Has H.R. 238 become law?
- Not yet. As of 7 Jan 2025, H.R. 238 is introduced.
- Who sponsored H.R. 238?
- H.R. 238 was sponsored by Rep. David Schweikert [R-AZ1] (Republican-AZ), with 0 cosponsors.
- What's the latest action on H.R. 238?
- Introduced (7 Jan 2025).
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