A roadmap for safe, regulation-compliant Living Labs for AI and digital health development.

Journal: Science advances
PMID: 40367163

Abstract

Safe and agile experimentation spaces are essential for developing AI-enabled medical devices and digital health innovations. "Living Labs" offer a collaborative environment for testing technologies in near-real-world settings, capturing user perspectives and outcomes, often missed in traditional testing. However, the flexibility of Living Labs often clashes with the European Union's rigid regulatory frameworks for medical devices that were not designed for digital technologies. We examine this intersection, showing how flexibility in evaluation and patient interaction can coexist with safety guardrails. Our approach integrates technology readiness, preemptive planning, and iterative modifications to bridge innovation and regulation, fostering adaptive health care technology development.

Authors

  • Stephen Gilbert
    Ada Health GmbH, Berlin, Germany.
  • Rebecca Mathias
    Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Fetscherstr. 74, 01307 Dresden, Germany.
  • Anett Schönfelder
    Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Fetscherstr. 74, 01307 Dresden, Germany.
  • Magdalena Wekenborg
    Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany.
  • Julia Steinigen-Fuchs
    Member of the ethics committee at TUD Dresden University of Technology, Fetscherstr. 74, 01307 Dresden, Germany.
  • Anja Dillenseger
    Center of Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.
  • Tjalf Ziemssen
    Technische Universität, Dresden, Germany.

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