Why AI doctors should not be FDA regulated

The FDA is a sacred cow in medicine. Thus, it was refreshing when I saw a recent critique of the FDA’s current system for AI regulation published in PLOS: Digital Health. The authors include medical researchers from the Harvard T. H Chan School of Public Health, Beth Israel Deaconess Medical Center, and the UK’s National Institute for Health and Care Excellence. They are a bit shy about how they state it, but their proposal is rather radical — they call for a major curtailment of the FDA’s role in AI regulation and a shift towards decentralized systems for AI oversight.

moreisdifferent.substack.com