About the Authors

Cindy Welzel

Roles Conceptualization, Writing – original draft

Affiliation Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology; Dresden, Germany

Stefanie Brückner

Roles Writing – review & editing

Affiliation Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology; Dresden, Germany

Celia Brightwell

Roles Writing – review & editing

Affiliation Chair of Digital Cultures, TUD Dresden University of Technology; Dresden, Germany

Matthew Fenech

Roles Writing – review & editing

Affiliation Una Health GmbH, Hamburg, Germany

Stephen Gilbert

Roles Conceptualization, Writing – original draft

stephen.gilbert@tu-dresden.de

Affiliation Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology; Dresden, Germany

Competing Interests

Author SG declares a nonfinancial interest as an Advisory Group member of the EY-coordinated “Study on Regulatory Governance and Innovation in the field of Medical Devices” conduced on behalf of the DG SANTE of the European Commission. Author SG declares the following competing financial interests: he has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd., Flo Health UK Limited, Thymia Ltd., FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, and Ada Health GmbH and holds share options in Ada Health GmbH. Author MF declares no Non-Financial Interests and the following Competing Financial Interests: he is a Managing Director of and holds equity in Una Health GmbH, and he has a consulting relationship with Flo Health UK Limited. Authors CW, SB and CB declare no Non-Financial Interests and no Competing Financial Interests.