Dr. Richard Watson

Chief Science Officer and Co-Founder, RecovryAI

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Last updated Oct 17, 2026

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FDA begins charting a regulatory path for generative AI in patient care

Rule Changes

Leading FDA submission preparation

In August 2026, the FDA's device center published a discussion paper on how to regulate generative AI medical devices and asked for public comment. The paper is the agency's most concrete step toward formal rules for a technology it has never authorized in a commercial device.

Updated Oct 17