Evaluating Translational AI: A Two-Way Moving Target Problem.
PMID: 41613162 ·
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Predictive artificial intelligence models are being deployed across health systems with dangerously inconsistent oversight, creating two critical gaps: a compliance gap, where clinical tools that likely qualify as software as a medical device are implemented without seeking U.S. Food and Drug Administration authorization; and a regulatory gap, where administrative and operational models are deployed without any external review despite their potential to influence care and widen disparities. Give
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