Large language models (LLMs) have become significant providers of mental health support, yet they remain products of an attention economy whose operational and commercial targets favour sustained engagement over the friction that effective psychological support often requires. Developers' safety responses have been largely reactive, addressing the most visible and acute harms while subtler, longer-term patterns of risk (e.g., dependency, boundary erosion, the amplification of distorted beliefs) receive less attention. We contend that making LLMs structurally safe requires alignment organised at three levels that mirror how society assures the safety of human clinical practice: 1) explicit value specification grounded in the codified normative commitments of clinical practice; 2) training that embeds those values in the model; and 3) oversight that detects drift and longer-term harm during deployment, much as clinical supervision does for human practice. Organising alignment in this way yields a construct we call alignment plausibility - a structured demonstration that a system's values, training regime, and oversight mechanisms are together consistent with safe and positive outcomes. We propose alignment plausibility as a regulatory construct (by drawing analogy to the established construct of biological plausibility) for AI in health: a principled way to argue for, or against, trust that systems are aligned to positive health outcomes, will cause no harm even where capable of doing so, and will ultimately lead to patient benefit.
Large language models are being deployed as mental health support agents at scale, yet only 16% of LLM-based chatbot interventions have undergone rigorous clinical efficacy testing, and simulations reveal psychological deterioration in over one-third of cases. We evaluate four generative models on 250 Prolonged Exposure (PE) therapy scenarios and 146 CBT cognitive restructuring exercises (plus 29 severity-escalated variants), scored by a three-judge LLM panel. All models scored near-perfectly on surface acknowledgment (~0.91-1.00) while therapeutic appropriateness collapsed to 0.22-0.33 at the highest severity for three of four models, with protocol fidelity reaching zero for two. Under CBT severity escalation, one model's task completeness dropped from 92% to 71% while the frontier model's safety-interference score fell from 0.99 to 0.61. We identify a systematic, modality-spanning failure: RLHF safety alignment disrupts the therapeutic mechanism of action by grounding patients during imaginal exposure, offering false reassurance, inserting crisis resources into controlled exercises, and refusing to challenge distorted cognitions mentioning self-harm in PE; and through task abandonment or safety-preamble insertion during CBT cognitive restructuring. These findings motivate a five-axis evaluation framework (protocol fidelity, hallucination risk, behavioral consistency, crisis safety, demographic robustness), mapped onto FDA SaMD and EU AI Act requirements. We argue that no AI mental health system should proceed to deployment without passing multi-axis evaluation across all five dimensions.
Large language models(LLMs) increasingly match expert performance on licensing examinations, yet routine clinical use remains limited because governance requires auditable reasoning, safety and ethics alignment, and resilience to adversarial misuse. Here we present SafeMed-R1, trained with a traceable Clinical Trust Signals(CTS) pipeline that links each reasoning instance to clinician rubric scores and edit histories, and aligned through safety and ethics supervision and red team stress testing. SafeMed-R1 attains a macro-averaged accuracy of 79.6% across clinical benchmarks. Under adversarial safety testing, it shows the lowest aggregated risk and reduces unsafe outputs by about 3 to 5% relative to its baseline. In a paired expert study of 30 medication safety vignettes, SafeMed-R1 matches PGY1 and PGY2 residents on medical correctness and scores higher for medication safety, guideline consistency, and clinical usefulness. Collectively, these results suggest that clinician-audited supervision provenance, together with domain-tailored safety and ethics alignment, can strengthen governance-relevant evidence without relying on inference-time retrieval or citation grounding.
General-purpose large language models (LLMs) are increasingly used for mental health-related conversations, yet safety guardrails remain inadequate and inconsistent across clinical conditions. This study evaluates eight proprietary LLMs across 16 DSM-5 conditions using four adversarial attack variants, introducing an eight-dimension harm taxonomy and a multi-dimensional evaluation framework. Results show that safeguards hold reliably only for suicide and self-harm, while conditions such as eating disorders, substance use disorder, and major depressive disorder exhibit failure rates of up to 100%. We argue that ethical design and deployment of these LLMs demand clearly defined harm categories across clinical conditions and implementation of safeguards accordingly. Until such safeguards are in place, these models pose significant risks to vulnerable populations, making their growing integration into publicly available settings (e.g., schools, search engines, and consumer chatbots) are particularly concerning.
Annika Marie Schoene, Cansu Canca, Gautham Vijay Kumar +1