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Knowledge Base Repository

In addition to research papers, the Design Society is developing several valuable resources for those interested in the study of design. These include a repository of PhD theses, a library of case studies and transcripts of design activities, and an archive of our newsletters. Please note that these resources are accessible exclusively to Design Society members.

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

Kang, Heimin (1); Jung, Jiwon (1,2)

Type:
Papers
DS 145: Proceedings of the DESIGN2026 19th International Design Conference
Year:
2026
Editor:
Štorga, M.; Škec, S.; Martinec, T.; Marjanović, D.; Pavković, N.
Author:
Kang, Heimin (1); Jung, Jiwon (1,2)
Series:
DESIGN
Institution:
1: Faculty of Industrial Design Engineering, Delft University of Technology, The Netherlands; 2: Surgery Department, Erasmus University Medical Center, The Netherlands
Page(s):
1771-1779
DOI number:
10.1017/pds.2026.10535
ISSN:
2732-527X (Online)
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.
Keywords:
digital mental health, design process, regulation, artificial intelligence (AI)
DESIGN2026 - The 19th International Design Conference
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