H.R. 238: Healthy Technology Act of 2025

Introduced Jan 7, 20250 cosponsors

Sponsor

David Schweikert

David Schweikert

Republican · AZ-1

Bill Progress

IntroducedJan 7
Committee 
Pass House 
Pass Senate 
Signed 
Law 

Latest Action · Jan 7, 2025

Referred to the House Committee on Energy and Commerce.

Bill would let AI prescribe drugs

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?

1

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."

2

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.

3

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.

4

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.

5

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.

6

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.

On the Record

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

1 actions

House: Committee Action

Jan 7, 2025

Referred to the House Committee on Energy and Commerce.

About the Sponsor

David Schweikert

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

24D30R
|0 signed54 not yet

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

Cosponsors
0
Committee
Energy and Commerce
Chamber
House
Policy
Health
Introduced
Jan 7, 2025

Referred to the House Committee on Energy and Commerce.

Jan 7, 2025

Constituent Resources

Get notified when this bill moves

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

PDF

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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