The Business of Health with Chip Kahn
FDA Regulation and the Dynamic Nature of AI
September 15, 2026
Video
Audio
About this Episode
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.
The Host
Charles N. Kahn III is a senior visiting fellow at KFF. He is also a visiting senior fellow at the American Enterprise Institute and a nonresident senior scholar at the University of Southern California’s Schaeffer Center for Health Policy & Economics. He serves as co-chair of the international Future of Health collaborative.
Guest
Brian Miller, MD, FACPM
Associate Professor of Medicine at the Johns Hopkins University School of Medicine; Visiting Fellow, Hoover Institution
Brian Miller, MD, MBA, MPH, is a practicing hospitalist at the Johns Hopkins Hospital, an Associate Professor of Medicine and Business (courtesy) at Johns Hopkins University, and a Visiting Fellow at the Hoover Institution. Dr. Miller runs a multi-disciplinary, twenty-person research group that analyzes market-driven solutions in FDA regulatory policy and Medicare payment policy. He has broad regulatory experience at the Centers for Medicare & Medicaid Services, the Federal Trade Commission, the Federal Communications Commission, and the U.S. Food and Drug Administration and is familiar with merger review, software and medical device product review, and payment policy.
Dr. Miller serves as a Commissioner on the Medicare Payment Advisory Commission which advises Congress on the $1 trillion Medicare program and as a Trustee for the North Carolina State Health Plan, a $4.5 billion health plan covering over 750,000 state employees, dependents and retirees. He serves as an advisor to members of Congress and other elected officials and lives in Washington, D.C.
SERIES
This weekly podcast features insightful conversations between host Chip Kahn and his guests, who discuss the business of health care, connecting the dots between the health care business, policy, and patients.
The podcast’s first series on AI in health care illuminates how AI is changing health care, and features guests who are deploying this technology, managing its consequences, and designing policy around it.