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Robert Califf: Clinical care should drive AI adoption
It’s day two of the FDA’s advisory committee meeting on regulating generative artificial intelligence tools. Day one, as you might expect, was extremely technical, but it kicked off with provocative remarks from commissioner Robert Califf.
FDA faces a difficult task in ensuring the safety and effectiveness of AI devices under its purview. While it’s a given that any product may perform differently in the real world than in clinical trials, this challenge is magnified in the case of AI, where data models underlying the tools can be continually updated. And where the data inputs flowing into tools can be influenced by the existence of the tools themselves, potentially impacting performance over time.
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