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BioWorld - Sunday, April 12, 2026
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Home » FDA regulation of AI complicated by hospital’s use of in-house algorithms
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FDA regulation of AI complicated by hospital’s use of in-house algorithms

April 9, 2021
By Mark McCarty
The authors of a recent journal article see problems with the FDA’s approach to premarket review of artificial intelligence (AI) algorithms, including an undue reliance on single-site algorithm development. Regulatory attorney Brad Thompson told BioWorld, however, that hospital administrators want algorithms that maximize accuracy for their populations and are not averse to in-house development of just such an algorithm, thus creating a source of tension between what hospitals want and what the FDA expects.
Medical technology Regulatory Artificial intelligence Digital health Algorithm U.S. FDA

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