Exploring a regulatory mapping approach for designing digital mental health interventions within the EU context

ABSTRACT:

As digital mental health interventions expand, integrating EU regulations into the design process remains essential but challenging due to their complexity. This study explores how the GDPR, AI Act, EHDS, HTA, MDR, and IVDR influence the design of AI-based mental health chatbots by mapping them onto a framework. The proposed mapping approach provides an overview of the regulatory landscape at each stage, revealing tensions between innovation and compliance as well as opportunities to use regulatory principles as structured checkpoints that guide responsible digital mental health design.