AI Morbidity and Mortality: A Framework for Clinical AI Failure Review
TL;DR
AI Morbidity and Mortality (AI M&M) is intended to complement, rather than replace, model monitoring, patient safety reporting, and regulatory oversight by converting individual AI-in-workflow failures into actionable institutional learning.
Abstract
Clinical artificial intelligence is increasingly embedded in real-world care, yet existing safety mechanisms are poorly suited to reconstructing and learning from individual AI-related errors and near-misses. Aggregate model monitoring can identify performance changes, and traditional patient safety reporting can capture adverse events, but neither is designed to explain how risk emerges across the interaction among AI systems, clinicians, workflows, and institutional controls. We propose AI Morbidity and Mortality (AI M&M), a structured, blameless framework for case-based review of clinical AI failures. The framework combines standardized case intake, evidence preservation and investigator-level reconstruction, tool-in-loop attribution, and corrective-action tracking. Each event is classified across four linked dimensions: Trigger - Mechanism - Clinical Pathway - Corrective Action, separating the condition that exposed a vulnerability from the process that produced risk, its consequence for care, and the remediation assigned. We demonstrate the framework using five illustrative outpatient medication and clinical decision-support cases; two clinician reviewers independently applied all four classification axes and reached agreement across all 20 axis-level classifications. AI M&M is intended to complement, rather than replace, model monitoring, patient safety reporting, and regulatory oversight by converting individual AI-in-workflow failures into actionable institutional learning. Prospective evaluation across institutions, AI systems, and clinical settings is needed.
