FDA Asks How to Judge Medical AI; Yale's Krumholz: Get the Comparator Right
zakkohane · x · 2026-10-20
Responding to an FDA request for input, Yale's Harlan Krumholz argues the core question is choosing the right comparator: medical AI systems should be judged against the health care systems we actually have, not the ones we wish we had, as an NEJM piece puts it.
Context: 3 in 10 U.S. adults use AI chatbots for health information, and nearly 1 in 5 say they cannot afford to see a provider — making the comparator question central to regulatory judgment. The FDA comment window closed the same day.
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