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After Clearance - Continuous Monitoring as the Foundation of Clinical AI Oversight
Ank A Agarwal1,2,3, Alia N Sajjadian1, Kavita Patel4
1Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, CA, USA.
NEJM AI
|October 26, 2026
Abstract:
AbstractWhile U.S. Food and Drug Administration clearance of clinical AI tools relies overwhelmingly on retrospective evidence, these tools frequently fail when deployed in clinical environments. We argue that continuous monitoring and real-world evaluation should be integrated into regulatory oversight to ensure optimal patient safety and care.
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