Paulius Mui, Dean F. Sittig, Steve Labkoff +1cs.AI cs.HC
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.
Diagnostic error is a major threat to patient safety, yet current large language model (LLM) systems often treat diagnosis as a one-shot prediction task, lacking safeguards against missed high-risk alternatives or rigorous verification of their reasoning. Here, we present AegisDx, a safety-oriented framework for hypothetico-deductive clinical reasoning. AegisDx coordinates specialized LLM components through role-specific contracts, structured intermediate outputs, evidence-retrieval interfaces, and verification gates to generate broad differential diagnoses, enforce explicit screening for dangerous "must-not-miss" conditions, verify reasoning against grounded medical evidence, and structure actionable next steps. We evaluated AegisDx across three layers. On literature-derived case reports from NEJM and JAMA, with GPT-oss-120B as the shared backbone, Top-3 diagnostic accuracy was 59.9% versus 52.1% for the standalone LLM on JAMA cases and 62.7% versus 51.4% on NEJM cases. On cases from Annals of Emergency Medicine, Top-3 accuracy was 85.7% versus 68.6%; against physician-consensus must-not-miss diagnosis sets, AegisDx captured at least one such condition among its top three diagnoses in 78.0% of cases versus 52.0%. In a blinded physician evaluation of 43 real-world emergency department notes from the Yale New Haven Health System compared against GPT-5, AegisDx improved the physician-rated composite safety score from 4.31 to 4.55 on a 5-point scale (adjusted p = 2.1x10^-4), with qualitative gains in must-not-miss identification and reasoning safety. Our findings suggest that engineering diagnostic AI as a safety-oriented reasoning framework, rather than optimizing raw predictive accuracy alone, can provide a safer, more transparent, and clinically meaningful layer of bedside decision support for acute care workflows.
Patient safety event triage, determining whether a clinical event is reportable under jurisdiction-specific policy, is a high-stakes task typically performed manually by patient safety experts. Although LLMs may support this workflow, reliable evaluation is limited by the lack of benchmarks to capture evidence-grounded policy reasoning, proactive information seeking for incomplete reports, and principled abstention in irreducibly ambiguous cases. We address this gap with a policy-grounded construction methodology centered on the clause card, a structured representation that factorizes regulatory text into auditable decision specifications. Combining clause cards with anchor-driven instantiation and closed-loop verification, our scalable pipeline produces narratives with by-construction ground truth and naturally supports generating missing information and uncertain variants. We instantiate this method on Minnesota's 29 Reportable Adverse Health Events, producing PSEBench, a 5,074-case benchmark with an agentic evaluation environment. Evaluation on 15 representative LLMs reveals consistent capability trends, demonstrates the benchmark's utility, and identifies actionable gaps toward reliable LLM-based patient safety event triage.