Healthy Technology Act of 2025
The Healthy Technology Act of 2025 amends Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) to expand the definition of 'practitioner licensed by law to administer such drug' to include artificial intelligence and machine learning technologies. Under the bill, an AI or ML technology qualifies as such a practitioner if it meets two conditions: (1) it is authorized under the relevant state's statute to prescribe the drug in question, and (2) it has received FDA approval, clearance, or authorization under one of the specified regulatory pathways—section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act. In effect, this legislation would allow AI and ML systems that satisfy these state and federal requirements to legally prescribe drugs.
Status history
Current status as of 2025-01-07
In committee
2025-01-07
observed 2026-06-16
Impact areas
- Quality Assurance
- Certifications & Standards
- AI Policy