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

Abstract

Integrating large language models (LLMs) into patient-facing healthcare systems offers significant potential to improve access to medical information. However, ensuring clinical safety and factual reliability remains a critical challenge. In practice, AI-generated responses may be conditionally correct yet medically inappropriate, as models often fail to interpret patient context and tend to produce agreeable responses rather than challenge unsafe assumptions. Unlike clinicians, who infer risk from incomplete information, LLMs frequently lack contextual awareness. Moreover, real-world patient interactions are open-ended and underspecified, unlike structured benchmark settings. We present CareGuardAI, a risk-aware safety framework for patient-facing medical question answering that addresses two key failure modes: clinical safety risk and hallucination risk. The framework introduces Clinical Safety Risk Assessment (SRA), inspired by ISO 14971, and Hallucination Risk Assessment (HRA) to evaluate medical risk and factual reliability. At inference time, CareGuardAI employs a multi-stage pipeline consisting of a controller agent, safety-constrained generation, and dual risk evaluation, followed by iterative refinement when necessary. Responses are released only when both SRA and HRA are less than or equal to 2, ensuring clinically acceptable outputs with bounded latency. We evaluate CareGuardAI on PatientSafeBench, MedSafetyBench, and MedHallu, covering both safety and hallucination detection. Across these benchmarks, the framework consistently outperforms strong baseline models, including GPT-4o-mini, demonstrating the importance of context-aware, risk-based, inference-time safety mechanisms for reliable deployment in healthcare.