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AI Standard of Care
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Standard of Care

AI Medical Device Adverse Events & Liability

··22 mins
Healthcare Medical Devices FDA MAUDE Database Radiology AI Sepsis Prediction Dermatology AI Product Liability Malpractice Standard of Care
Executive Summary # AI medical devices are proliferating faster than regulatory infrastructure can track their failures. With over 1,200 FDA-authorized AI devices and a 14% increase in AI-related malpractice claims since 2022, understanding the liability landscape has never been more critical.