Vital Signs with Jacob Effron and Nikhil Krishnan cover image

Ep 23: Stanford Professor James Zou on the Economics, Regulation and Applications of AI in Healthcare

Vital Signs with Jacob Effron and Nikhil Krishnan

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How the FDA Approval Process Works

The FDA is thinking about how to revamp their approval system for medical AI system. The idea is that previously, like, basically, a self-end of 2022, right? Now they're seriously working on moving towards a process whereby you don't just get approved for the algorithm but an algorithm plus a plan to find, tune and update your model over time. And if you get approved for that whole plan, then as long as you follow that updating plan over time, then that becomes inferior in terms of efficiency.

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