FDA chief: AI adoption driven by financial reasons, not patient benefits

Anne Thompson

akstanwyck

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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Mario Aguilar
Health Tech Correspondent
Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech’s promise. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter.