JMIR Publications

ABSTRACT

Artificial intelligence is increasingly entering psychiatric care through decision-support systems, digital phenotyping tools, suicide-risk prediction models, documentation assistants, and conversational agents. These technologies may improve access, consistency, and personalised care, yet they also redistribute clinical authority and complicate liability when harm occurs. This article examines how European law and psychiatric ethics should respond to this shift. It argues that liability in AI-driven psychiatry cannot be understood only as a product-defect issue or only as a malpractice problem. Because psychiatric practice depends on interpretation, testimony, contextual judgment, and therapeutic alliance, the relevant standard of care must remain human, even when technologically augmented. The article advocates an augmented-clinician model in which AI informs but does not replace psychiatric reasoning. After outlining the European regulatory framework, including the AI Act, the Medical Device Regulation, the General Data Protection Regulation, the revised Product Liability Directive, and the European Health Data Space Regulation, the article analyses the implications of the withdrawal of the proposed AI Liability Directive and the persistence of divergent national tort regimes. It then examines psychiatric risk vectors, including automation bias, testimonial injustice, bias in mental health datasets, therapeutic chatbots, suicide prediction tools, passive monitoring, and large language model documentation. The discussion proposes a layered accountability model that links developers, deployers, and clinicians while preserving therapeutic integrity, patient rights, and legal clarity.