Regulating Generative AI: Insights From the FDA’s First DHAC Meeting
The FDA’s new Digital Health Advisory Committee (DHAC) convened for the first time on November 20-21, 2024. The topic of discussion was medical devices that rely on generative AI (GenAI) models, which hold transformative potential for healthcare but pose unique regulatory challenges. For example, how to define the device’s intended use, manage errors like hallucinations…