AI Frontier Institute

Healthy Technology Act of 2025

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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 (AI/ML) technologies. Under the bill, an AI/ML technology qualifies as such a practitioner only if it meets two conditions: (A) it is authorized under the relevant state's statute to prescribe the drug in question, and (B) it has received FDA approval, clearance, or authorization under one of the specified pathways—section 510(k), 513, 515, or 564 of the Act. In effect, the bill creates a legal pathway for AI/ML systems to prescribe prescription drugs, subject to both state-level authorization and federal FDA regulatory clearance.

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