ChatGPT Health and other health-focused generative AI chatbots increasingly function as alternative first points of contact that may mediate – and in some cases substitute – engagement with regulated healthcare systems. At scale, these systems can shape care-seeking behavior, system capacity, trust in clinical expertise, and health equity. We describe this development as the emergence of shadow health systems: privately governed infrastructures that perform health-system functions without being subject to healthcare-specific safeguards. EU law currently regulates such tools based on declared medical purpose rather than their real-world effects, creating gaps in legal protection. We propose the adoption of stronger consumer and health data safeguards alongside extension of the scope of the Medical Devices Regulation and AI Act.

Please cite as: van Kolfschooten, H. & Petročnik, T. ‘Emerging Shadow Health Systems: Regulating Health-Focused Generative AI Chatbots from a European perspective’ (Zenodo 2026) doi:10.5281/zenodo.19094764