H.R. 238: Healthy Technology Act of 2025
Sponsor
David Schweikert
Republican · AZ-1
Bill Progress
Latest Action · Jan 7, 2025
Referred to the House Committee on Energy and Commerce.
Why it matters
Introduced on January 7, 2025, H.R. 238 would formally let certain artificial intelligence and machine learning tools count as drug prescribers under federal law if a State authorizes them and the FDA has already approved, cleared, or authorized them.
The immediate effect is legal recognition, not funding or a new federal program. There are no dollar authorizations, grant formulas, deadlines for implementation, age limits, civil penalties, or criminal penalties in the text provided. The practical impact would be on health care delivery and regulation: FDA-reviewed AI systems could potentially move from advisory roles into actual prescribing roles, but only where State law expressly allows it.
What does H.R. 238 do?
Amends federal drug law at 21 U.S.C. 353(b)
The bill changes section 503(b) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 353(b), to address who can count as a "practitioner licensed by law to administer such drug."
Creates new paragraph (6) for AI prescribing
H.R. 238 adds a new paragraph (6) to section 503(b) stating that a "practitioner licensed by law to administer such drug" includes artificial intelligence and machine learning technology if it meets the bill's conditions.
Requires State statute authorization
An AI or machine learning tool qualifies only if it is "authorized pursuant to a statute of the State involved" to prescribe the drug involved, meaning a State must pass a law before the technology can prescribe in that jurisdiction.
Requires FDA action under 4 pathways
The technology must also be "approved, cleared, or authorized" by the Food and Drug Administration under one of four listed sections: 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act.
Applies to AI and machine learning technologies
The bill specifically names "artificial intelligence and machine learning technology" as the covered category, rather than broadly covering all software or all automated tools.
No funding, penalties, or implementation deadline
The text provided includes no authorization of appropriations, no dollar amounts, no civil or criminal penalties, and no implementation deadline after the introduction date of January 7, 2025.
Who benefits from H.R. 238?
AI and machine learning developers with FDA-reviewed products
Companies whose products are approved, cleared, or authorized by the FDA under section 510(k), 513, 515, or 564 could gain a path to having their tools legally recognized as prescribers in States that pass authorizing statutes.
States that want to modernize prescribing rules
States keep control because the bill requires authorization "pursuant to a statute of the State involved," letting them decide whether and how AI can prescribe specific drugs.
Health systems and clinics using regulated digital tools
Hospitals, clinics, and other providers could potentially use FDA-reviewed AI or machine learning technologies for prescribing workflows, but only in States where the legislature has expressly allowed it.
Patients in States that authorize these systems
Patients could eventually get faster access to prescriptions through tools that have both State statutory authorization and FDA review under section 510(k), 513, 515, or 564.
Who is affected by H.R. 238?
State legislatures and regulators
They would have to decide whether to pass statutes authorizing artificial intelligence or machine learning technology to prescribe particular drugs, because the bill does not create automatic nationwide authority.
Food and Drug Administration
The FDA becomes a necessary federal gatekeeper because only technologies approved, cleared, or authorized under section 510(k), 513, 515, or 564 can qualify under the new paragraph (6).
Doctors, nurse practitioners, and other human prescribers
Their prescribing landscape could change if AI tools are recognized under section 503(b), although the bill does not remove human prescribers or change their licenses directly.
Drug manufacturers and pharmacies
They may need to adapt compliance and dispensing practices if prescriptions can come from AI or machine learning technologies that meet both the State-law requirement and the FDA requirement in H.R. 238.
What Congress Is Saying
H.R. 238 hasn't been debated on the floor yet.
This section updates when a legislator speaks about it on the floor or in committee.
HR238 Legislative Journey
House: Committee Action
Jan 7, 2025
Referred to the House Committee on Energy and Commerce.
About the Sponsor
David Schweikert
Republican, Arizona's 1st congressional district · 15 years in Congress
Committees: Joint Economic Committee, Ways and Means
View full profile →
Committee Sponsors
Energy and Commerce Committee
0 of 54 committee members cosponsored
No committee members have cosponsored this bill
30 Republicans across this committee haven't cosponsored yet. Mobilize their constituents
H.R. 238 Quick Facts
- Committee
- Energy and Commerce
- Chamber
- House
- Policy
- Health
- Introduced
- Jan 7, 2025
Referred to the House Committee on Energy and Commerce.
Jan 7, 2025
H.R. 238 Common Questions
Can AI prescribe medication under federal law
Yes, under the Healthy Technology Act of 2025 (Section 2), AI and machine learning could count as a drug prescriber under federal law if state law authorizes it and the FDA has approved, cleared, or authorized the technology.
Which FDA pathways would let AI prescribe drugs under HR 238
According to H.R. 238 Section 2, the AI or ML tool must be approved, cleared, or authorized by FDA under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act.
Does HR 238 require a state law before AI can prescribe drugs
Yes. Under the Healthy Technology Act of 2025 (Section 2(6)(A)), an AI system can qualify only if it is authorized by a statute of the state involved to prescribe the specific drug.
What are the requirements for an AI tool to qualify as a drug prescriber
Under the Healthy Technology Act of 2025 (Section 2), the tool must be authorized by state statute and also be FDA approved, cleared, or authorized under 510(k), 513, 515, or 564.
Can a state allow AI to prescribe some drugs but not others
Yes. According to H.R. 238 Section 2(6)(A), the AI must be authorized by state statute to prescribe the drug involved, which ties authorization to the specific drug at issue.
Does the Healthy Technology Act apply to all health software
No. Under the Healthy Technology Act of 2025 (Section 2), the bill specifically covers artificial intelligence and machine learning technologies, not all software or automated tools.
Is FDA approval alone enough for AI to prescribe drugs under HR 238
No. Under the Healthy Technology Act of 2025 (Section 2), FDA approval, clearance, or authorization is required, but the AI also must be authorized by a state statute.
Can AI be treated as a practitioner licensed by law to administer a drug
Yes. Under the Healthy Technology Act of 2025 (Section 2), AI and machine learning technology would be included in the term "practitioner licensed by law to administer such drug" if the bill’s conditions are met.
What federal law would HR 238 change to recognize AI prescribers
According to H.R. 238 Section 2, it would amend section 503(b) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 353(b), by adding a new paragraph (6).
Does HR 238 create federal penalties or funding for AI prescribing
No. According to H.R. 238 Section 2, the bill text adds legal recognition for qualifying AI prescribers but does not include funding, civil penalties, criminal penalties, or an implementation deadline.
Based on H.R. 238 bill text
H.R. 238 Bill Text
“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.”
Source: U.S. Government Publishing Office
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