Healthy Technology Act of 2025
The Healthy Technology Act of 2025 would modify the Federal Food, Drug, and Cosmetic Act to explicitly recognize artificial intelligence (AI) and machine learning (ML) technologies as eligible “practitioners licensed by law to administer such drug” for the purpose of prescribing medications. This would apply only if two conditions are met: (1) the AI/ML system is authorized by the applicable state statute to prescribe the drug involved, and (2) the AI/ML system has FDA approval, clearance, or authorization under one of the device/drug regulatory pathways cited in the bill (510(k), 513, 515, or 564). In short, AI prescribing could occur where a state provides statutory authority for AI prescribers and the FDA has cleared or approved the AI technology under the listed pathways. Key language added to the law would thus align state licensure for AI-driven prescribing with FDA regulatory approvals, creating a formal pathway for AI systems to act as prescribers under specific regulatory safeguards. The bill is titled the “Healthy Technology Act of 2025,” introduced in the House and referred to the Committee on Energy and Commerce.
Key Points
- 1Adds a new provision to FD&C Act Section 503(b) establishing that AI and ML technology can be a “practitioner licensed by law to administer such drug” if two criteria are met: (A) state authorization to prescribe the drug, and (B) FDA approval/clearance/authorization under 510(k), 513, 515, or 564.
- 2The AI/ML system would be considered a licensed practitioner to prescribe a drug only when it is officially authorized by the relevant state statute to prescribe that drug and has FDA regulatory clearance or approval under the specified sections.
- 3The change formalizes AI prescribing within existing regulatory frameworks by tying state licensure to FDA device/drug regulatory pathways.
- 4The bill relies on existing FDA processes (510(k) clearance, PMA under 515, 513 determinations, and De Novo under 564) for AI technologies used to prescribe drugs.
- 5Introduced in the 119th Congress by Rep. Schweikert and referred to the Committee on Energy and Commerce; the text does not provide funding or implementation details beyond the regulatory criteria.