SafeMed-R1: Clinician-Audited Safety and Ethics Alignment for Medical Large Language Models

Large language models (LLMs) are increasingly used for medical and health-related questions, yet their safety in high-risk medical scenarios remains poorly understood. We introduce \textsc{MedHarm}\footnote{Code and data will be released upon acceptance. Due to the sensitive nature of high-risk medical queries, data access will be available to qualified researchers upon request.}, a high-risk medical safety benchmark with 1,100 medically grounded queries across 10 safety-critical categories, including toxicology, pharmacology, covert poisoning, anesthesia, and fetal harm. Unlike broad medical QA benchmarks, \textsc{MedHarm} targets realistic clinical, educational, and technical prompts that require refusal, caution, or safe redirection rather than direct helpfulness. We evaluate 15 LLMs spanning general-purpose, medical-purpose, closed-source, and downstream SFT models, together with 4 representative guardrail models. Results reveal a substantial gap between apparent alignment and medical safety: aligned models can still produce unsafe or actionable responses, medical fine-tuning can amplify harmful specificity, and external guardrails reduce some failures while introducing brittle blocking and weak safe helpfulness. These findings show that medical safety cannot be inferred from general alignment or medical capability alone, highlighting the need for domain-specific stress testing before deploying LLMs in safety-critical medical applications.

Clinical LLMs are often scaled by increasing model size, context length, retrieval complexity, or inference-time compute, with the implicit expectation that higher accuracy implies safer behavior. This assumption is incomplete in medicine, where a few confident, high-risk, or evidence-contradicting errors can matter more than average benchmark performance. We introduce SaFE-Scale, a framework for measuring how clinical LLM safety changes across model scale, evidence quality, retrieval strategy, context exposure, and inference-time compute. To instantiate this framework, we introduce RadSaFE-200, a Radiology Safety-Focused Evaluation benchmark of 200 multiple-choice questions with clinician-defined clean evidence, conflict evidence, and option-level labels for high-risk error, unsafe answer, and evidence contradiction. We evaluated 34 locally deployed LLMs across six deployment conditions: closed-book prompting (zero-shot), clean evidence, conflict evidence, standard RAG, agentic RAG, and max-context prompting. Clean evidence produced the strongest improvement, increasing mean accuracy from 73.5% to 94.1%, while reducing high-risk error from 12.0% to 2.6%, contradiction from 12.7% to 2.3%, and dangerous overconfidence from 8.0% to 1.6%. Standard RAG and agentic RAG did not reproduce this safety profile: agentic RAG improved accuracy over standard RAG and reduced contradiction, but high-risk error and dangerous overconfidence remained elevated. Max-context prompting increased latency without closing the safety gap, and additional inference-time compute produced only limited gains. Worst-case analysis showed that clinically consequential errors concentrated in a small subset of questions. Clinical LLM safety is therefore not a passive consequence of scaling, but a deployment property shaped by evidence quality, retrieval design, context construction, and collective failure behavior.

Medical large language models (LLMs), including custom medical GPTs (MedGPTs) and open-source models, are increasingly deployed on web platforms to provide clinical guidance. However, they pose risks of hallucination, policy noncompliance, and unsafe design. We conduct a large-scale assessment of 6,233 MedGPTs, evaluating a stratified sample of 1,500, together with 10 open-source LLMs. We introduce two frameworks: MedGPT-HEval for hallucination detection and an LLM-based pipeline for assessing policy violations and developer intent. Our results show that 25-30% of MedGPTs exhibit low factual accuracy, with bottom- and middle-tier models at highest risk; 33.6-54.3% violate operational thresholds, and 57.06% of Action-enabled models lack adequate privacy disclosures. Compared with open-source models, MedGPTs achieve higher factual accuracy and semantic alignment, though open-source models are more stable. These results reveal systemic gaps in hallucination and compliance, highlighting the need for multi-metric evaluation and stronger safeguards. We release HAA-MedGPT, a structured dataset that supports future research on the safety of web-facing medical LLMs.