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AI Standard of Care
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Medical Devices

The Learned Intermediary Doctrine and AI Medical Devices

·14 mins
Resources Learned Intermediary Medical Devices FDA AI Diagnostics Physician Liability Product Liability Duty to Warn Medical AI
The Doctrine That Once Shielded Medical Manufacturers # For decades, the learned intermediary doctrine provided pharmaceutical and medical device manufacturers with a powerful liability shield. The principle was elegant: manufacturers need not warn patients directly because physicians, as “learned intermediaries”, stand between manufacturer and patient. Warn the doctor adequately, and the duty to warn is satisfied.

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.