Bridging Innovation and Regulation: A Regulatory Mapping for Designing Digital Mental Health Interventions

As digital mental health interventions such as AI chatbots rapidly expand, integrating regulatory frameworks into their design remains essential yet challenging. This project maps six key EU regulations onto the development framework for complex health interventions to explore how policy requirements influence each stage of design. The study identifies tensions between regulation and innovation while revealing opportunities to embed compliance and ethical principles early in the design process, ultimately bridging innovation and regulation in digital mental health.