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119-hr-238119th CongressWALLET

Healthy Technology Act of 2025

Sponsored By: Representative Schweikert, David [R-AZ-1]

Introduced

Summary

Recognizes certain artificial intelligence and machine learning systems as eligible to prescribe drugs when both state law and FDA authorization are in place. This change adds AI/ML technologies to the federal definition of a practitioner eligible to provide prescriptions if the state authorizes the AI to prescribe the drug and the technology is approved, cleared, or authorized under specified FDA device authorities.

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  • Families and patients: May receive prescriptions written by qualifying AI systems when the state has authorized AI prescribing and the product meets FDA device requirements.
  • Health care providers: Qualifying AI/ML systems are treated under federal drug law as a type of "practitioner" for purposes of prescription-only dispensing rules, affecting who can legally issue prescriptions.
  • States and regulators: A state statute must authorize AI prescribing for the federal change to apply in that state.
  • Developers and manufacturers: AI/ML products must be approved, cleared, or authorized under sections 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act to qualify.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

AI could prescribe drugs in some states

If enacted, some AI tools would count as prescribers for medicines. This would only apply if your state lets AI prescribe the drug and the AI is approved, cleared, or authorized by the FDA. The FDA pathways listed are sections 510(k), 513, 515, or 564. Clinics and device makers could use these tools where both rules are met. Patients could see easier access to some prescriptions in those settings.

Sponsors & CoSponsors

Sponsor

Schweikert, David [R-AZ-1]

AZ • R

Cosponsors

There are no cosponsors for this bill.

Roll Call Votes

No roll call votes available for this bill.

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