# Evaluating Patient Safety Risks in Generative AI: Development and Validation of a FMECA Framework for Generated Clinical Content

arXiv: https://arxiv.org/abs/2605.04085 · HTML: https://mlsanity.com/paper/2605.04085/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 7 of its 32 references that are in the map.
- First posted on arXiv 23 Apr 2026.

## Builds on (most cited first, 7 of 7)

- [GPQA: A Graduate-Level Google-Proof Q&A Benchmark](https://mlsanity.com/paper/2311.12022/) (2023)
- [MMLU-Pro: A More Robust and Challenging Multi-Task Language Understanding Benchmark](https://mlsanity.com/paper/2406.01574/) (2024)
- [Large Language Models Encode Clinical Knowledge](https://mlsanity.com/paper/2212.13138/) (2022)
- [A Survey of Hallucination in Large Foundation Models](https://mlsanity.com/paper/2309.05922/) (2023)
- [MEDIC: Comprehensive Evaluation of Leading Indicators for LLM Safety and Utility in Clinical Applications](https://mlsanity.com/paper/2409.07314/) (2024)
- [Prompt engineering paradigms for medical applications: scoping review and recommendations for better practices](https://mlsanity.com/paper/2405.01249/) (2024)
- [Development and Validation of the Provider Documentation Summarization Quality Instrument for Large Language Models](https://mlsanity.com/paper/2501.08977/) (2025)

## Abstract (arXiv)

Objectives: Large language models (LLMs) are increasingly used for clinical text summarization, yet structured methods to assess associated patient safety risks remain limited. Failure Mode, Effects, and Criticality Analysis (FMECA) provides a proactive framework for systematic risk identification but has not been adapted to LLM-generated clinical content. This study aimed to develop and validate a novel FMECA framework for the prospective assessment of patient safety risks in LLM-generated clinical summaries. Materials and Methods: An interdisciplinary expert panel (n = 8) developed a taxonomy of failure modes through literature review and brainstorming. Standard FMECA dimensions (occurrence, severity, detectability) were adapted into 5-point ordinal scales. The framework was applied to 36 discharge summaries from four patients, generated by an open LLM (GPT-OSS 120B) using real-world clinical data from the Geneva University Hospitals. Reviewers independently annotated the summaries across two rounds. Inter-rater reliability was assessed at failure mode, severity and detectability score levels. Usability and content validity were evaluated using an adapted System Usability Scale and structured feedback. Results: The final framework comprised 14 failure modes organized into categories. Inter-rater agreement improved between rounds, reaching moderate-to-substantial agreement for failure mode identification and good agreement for severity and detectability scoring. Usability was rated as good (mean SUS: 79.2/100), with high evaluator confidence. Discussion and Conclusion: This study presents the first FMECA-based framework for systematic patient safety risk assessment of LLM-generated clinical summaries. The framework provides a structured and reproducible method for identifying clinically relevant risks caused by these summaries.