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AI Standard of Care
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Medical AI

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.

Healthcare AI Standard of Care

··10 mins
Industries Healthcare Medical AI Diagnostic AI FDA SB 1120 Radiology AI Sepsis Prediction Standard of Care
Healthcare represents the highest-stakes arena for AI standard of care questions. When diagnostic AI systems, clinical decision support tools, and treatment recommendation algorithms are wrong, patients die. With over 1,250 FDA-authorized AI medical devices and AI-related malpractice claims rising 14% since 2022, understanding the evolving standard of care is critical for patients, providers, and institutions.