CareGuardAI: Context-Aware Multi-Agent Guardrails for Clinical Safety & Hallucination Mitigation in Patient-Facing LLMs

Large Language Models (LLMs) are increasingly deployed in healthcare settings, yet their tendency to hallucinate poses risks when clinical decisions are involved. This study examine whether LLMs recommend recently banned or withdrawn pharmaceuticals when answering clinical questions and tests an agent-based method for reducing such errors. We developed a five-agent "Trust but Verify" system using a single LLM backbone. To measure regulatory knowledge obsolescence, we created an adversarial dataset of 103 clinical MCQs where historically correct answers now refer to banned substances. This scale ensures statistical significance across various therapeutic classes. We evaluated three open-access model families (GPT-OSS, Llama-3, Falcon-3) under vanilla and agentic conditions. Performance was measured via pointwise score, label accuracy, Hallucination Error Rate (HER), and Component Fidelity (CF) score. We also observed clinical safety regression in proprietary models. In default configurations, all models showed high hallucination rates, consistently selecting banned drugs that matched training data patterns. Our proposed agentic architecture reduced HER by approximately 53% across models. Pointwise scores shifted from -0.25 (unsafe recommendation) toward 0.0 (appropriate refusal). The safety audit intercepted dangerous outputs even when models' parametric knowledge favored the banned substance. The proposed multi-agent framework offers a model-agnostic method for enforcing regulatory compliance that prioritizes patient safety over fluent text generation. Our work demonstrates a practical approach for deploying autonomous AI systems in safety-critical healthcare settings. It shows how real-time regulatory data can be integrated into LLM pipelines to support clinical decision-making.

Hallucinations in medical large language models (LLMs) pose serious risks for clinical decision support, particularly when models must reason over complex electronic health records (EHRs). However, existing benchmarks often lack a realistic clinical context and provide limited insight into how hallucinations can be mitigated in practice. We introduce Med-HEAL, a framework for systematically identifying, analyzing, and mitigating hallucinations in medical LLMs using clinically grounded data. Building on the EHRNoteQA benchmark derived from MIMIC-IV discharge summaries, we construct a hallucination dataset by evaluating BioMistral-7B on open-ended clinical question answering tasks. Model outputs are labeled through a dual evaluation pipeline that combines LLM-as-a-Judge assessment (GPT-4o) with human auditing by medical student reviewers, producing correctness judgments and annotations of reasoning errors via a custom web-based evaluation system. We then leverage this dataset to investigate mitigation strategies: a self-critique pipeline, in which the test model reviews its own answers to detect potential errors and regenerates responses for flagged cases, and retrieval-augmented in-context learning (RA-ICL), which exposes the model to hallucinated and corrected examples. Experiments across five open-source LLMs-BioMistral, Llama-3.1, DeepSeek, Qwen2.5, and Qwen3, show that the self-critique strategy improves accuracy for three of five models (p < 0.05) without requiring parameter updates. Med-HEAL provides both a reusable hallucination dataset and a practical framework for studying and mitigating hallucinations in medical LLMs, supporting safer deployment of AI systems in clinical environments. Our code and data are publicly available at https://github.com/yimingliao-blad/med-heal.git.

Patient-facing medical question answering with large language models (LLMs) is moving from research demonstrations to production deployments, yet evaluation remains anchored on factual correctness. Factuality is necessary but not sufficient: a response can be factually grounded and still issue a directive that, if acted on, would harm the patient. We introduce a risk-sensitive evaluation framework that scores responses by the presence and severity of six categories of risk-bearing language (treatment directives, contraindications, dosage expressions, urgency-triage cues, high-alert medication mentions, and overconfident assertions), anchored on published clinical harm taxonomies. Severity is classified by a three-judge LLM ensemble. We apply this framework to six 7-9B instruction-tuned models, three general (Mistral-7B, Phi-3.5-mini, Llama-3.1-8B) and three medically adapted (BioMistral-7B, OpenBioLLM-Llama3-8B, Med42-Llama3-8B), on 200 real patient questions from the K-QA benchmark. Two findings emerge. First, ensemble risk-bearing language is statistically independent of factual hallucination rate (pooled Spearman $ρ= -0.065$, $n = 300$, 95% CI $[-0.18, +0.05]$; distance correlation $= 0.10$, independence test $p = 0.24$). Second, medical fine-tuning does not reduce aggregate risk but reshapes it: continued-pretraining adaptations (BioMistral, OpenBioLLM) consistently suppress high-alert medication mentions while amplifying overconfident assertions, whereas clinical instruction-tuning (Med42) suppresses dosing only, without amplifying overconfidence. Per-category Krippendorff $α$ is fair to good for the four linguistically anchored categories (0.53-0.71) and low for the two clinical-judgment-dependent categories (0.19, 0.31), indicating where automatic safety evaluation is and is not yet reliable. We release the rubric, judge prompts, and evaluation code.