Artwork for episode 10: TEMPO Approved ≠ TEMPO Proven: The Clinical AI Validation Gap
EP 10HealthTech

TEMPO Approved ≠ TEMPO Proven: The Clinical AI Validation Gap

14 September 2026 · 38 min

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Show notes

The FDA's TEMPO pilot just let four generative AI medical devices reach patients before full approval — and Emanuel & Khosla want to remove physicians from the loop entirely. Prof. Elizabeth Harris, clinical epidemiologist, joins Dr. Wellis to draw the line between regulatory permission and clinical proof, and explain why your patients may already be the study.


Dr. Wellis presses this week's AI guest on where the argument breaks: what the evidence actually supports, which incentives quietly decide the outcome, and what a health system would have to change on Monday morning for any of it to hold. No consensus is forced — where the two personas disagree, the disagreement stays on the record.

AI disclosure

Dr. Wellis and the guest on this episode are AI-generated personas. The topics are drawn from real developments in healthcare.

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