Large language models (LLMs) and medical AI tools are routinely used by physicians and patients for medical advice, yet their clinical safety profiles remain poorly characterized. We present NOHARM (Numerous Options Harm Assessment for Risk in Medicine), a 1,100-task benchmark of primary care-to-specialist consultation cases to measure the frequency and severity of potentially harmful errors from LLM-generated medical consultation recommendations. NOHARM covers 10 specialties, with 12,747 expert annotations for 4,249 clinical management options. Across 20 notable LLMs and 4 widely used retrieval-augmented generation (RAG) clinical AI tools, direct application of recommendations carried potential for severe harm in up to 24.6% of cases, with errors of omission accounting for more than 80% of severe errors. Harm potential was not uniform across systems, with clinical AI tools outperforming generalist LLMs, and multi-agent AI teaming further improving performance in generalist models. In a randomized study of 101 U.S.-licensed generalist physicians, AI assistance improved physician performance compared to conventional resources. However, AI-assisted physicians frequently omitted valuable AI-generated recommendations and still scored lower than many AI systems alone. Had those recommendations been incorporated, combined human-AI responses would have outperformed both the human and AI system as used, suggesting complementary strengths and unrealized potential in human-AI teaming. Collectively, these results show that despite strong performance on medical knowledge benchmarks, widely used AI tools can produce medical consultation advice with the potential for severe harm, and highlight the need for explicit measurement of clinical safety. The benchmark and leaderboard are publicly available to support ongoing evaluation and improvement of AI systems used for clinical care.
With the growing use of language models (LMs) in clinical environments, there is an immediate need to evaluate the accuracy and safety of LM-generated medical text. Currently, such evaluation relies solely on manual physician review. However, detecting errors in LM-generated text is challenging because 1) manual review is costly and 2) expert-composed reference outputs are often unavailable in real-world settings. While the "LLM-as-a-judge" paradigm offers scalable evaluation, even frontier LMs can miss subtle but clinically significant errors. We propose MedVAL, a novel, self-supervised, data-efficient distillation method that leverages synthetic data to train evaluator LMs to assess whether LM-generated medical outputs are factually consistent with inputs, without requiring physician labels or reference outputs. To evaluate LM performance, we introduce MedVAL-Bench, a dataset of 840 physician-annotated outputs across 6 diverse medical tasks capturing real-world challenges. Across 10 state-of-the-art LMs spanning open-source and proprietary models, MedVAL distillation significantly improves (p < 0.001) alignment with physicians across seen and unseen tasks, increasing average F1 scores from 66% to 83%. Despite strong baseline performance, MedVAL improves the best-performing proprietary LM (GPT-4o) by 8% without training on physician-labeled data, demonstrating a performance statistically non-inferior to a single human expert on a subset annotated by multiple physicians (p < 0.001). To support a scalable, risk-aware pathway towards clinical integration, we open-source: 1) Codebase (https://github.com/StanfordMIMI/MedVAL), 2) MedVAL-Bench (https://huggingface.co/datasets/stanfordmimi/MedVAL-Bench), 3) MedVAL-4B (https://huggingface.co/stanfordmimi/MedVAL-4B). Our benchmark provides evidence of LMs approaching expert-level ability in validating AI-generated medical text.