AINeutralarXiv – CS AI · 5h ago7/10
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Evaluating Patient Safety Risks in Generative AI: Development and Validation of a FMECA Framework for Generated Clinical Content
Researchers developed and validated the first FMECA (Failure Mode, Effects, and Criticality Analysis) framework to systematically assess patient safety risks in clinical summaries generated by large language models. Testing with GPT-OSS 120B on real hospital discharge summaries demonstrated moderate-to-substantial inter-rater agreement and identified 14 distinct failure modes, establishing a reproducible methodology for evaluating AI-generated clinical content safety.