FDA Regulation and the Dynamic Nature of AI September 15, 2026

Episode 15, AI Series: Dr. Brian Miller has seen medical technology regulation from every side — as a hospitalist, a former FDA official, and now an associate professor at Johns Hopkins University, where he leads a research group on market-driven approaches to FDA regulation and Medicare payment policy. In this episode, Chip talks with Miller about what happens when the FDA applies its 1976 medical device framework to AI — a technology that learns and changes. Miller’s argument may surprise you: the manual system of medicine we have today is already less safe and less consistent than most people assume. What keeps him up at night isn’t the speed of AI — it’s the risk that fear-driven regulation will cost us the opportunities AI offers. The conversation was recorded shortly before the FDA released a discussion paper outlining possible regulatory approaches and inviting stakeholder feedback. Chip weighs in on the paper at the end of the episode. https://www.kff.org/other-health/fda-regulation-and-the-dynamic-nature-of-ai/