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.
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