FDA Takes on Generative AI in Healthcare

The FDA's Digital Health Advisory Committee held its first meeting on November 20-21, 2024 in Gaithersburg, MD, streamed live online. Led by Commissioner Robert Califf, the nine-member panel debated regulating generative AI in medical devices, focusing on lifecycle evaluations and risk management.

Industry input was gathered, and the public docket is open until January 21, 2025. With AI-generated clinical notes approved 85% by providers, the FDA's moves could revolutionize digital health oversight—exciting times ahead!