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Regulation for innovation or innovation despite regulation? Lessons from Germany’s DiGA Fast-Track for digital health innovation
Citation Link: https://doi.org/10.15480/882.18134
Publikationstyp
Doctoral Thesis
Date Issued
2026
Sprache
English
Author(s)
TORE-DOI
Citation
Technische Universität Hamburg (2026)
Germany’s Digital Health Applications (DiGA) Fast-Track represents one of the first regulated pathways for integrating digital health applications into reimbursed healthcare. It provides a unique setting for examining how regulation shapes innovation in digital health. This dissertation explores the development of the DiGA market and examines two innovative elements of its regulatory framework: patient-relevant structural and procedural improvements (pSVV) as a novel concept of value, and the use of real-world data (RWD) for evaluating the effectiveness of digital health technologies. Combining market and regulatory data, qualitative stakeholder research, innovation systems analysis, and a systematic scoping review, the findings show that regulation can successfully create and structure markets for digital health innovation. At the same time, realizing the potential of novel value concepts and evidence approaches depends on methodological clarity, aligned incentives, and supportive institutional conditions.
Subjects
Digital Health Applications (DiGA)
digital health
regulation
innovation
reimbursement
patient-relevant structural and procedural improvements (pSVV)
real-world data (RWD)
evidence generation
DDC Class
610: Medicine, Health
330: Economics
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Name
202609_Gehder_Sara-Regulation_for_Innovation.pdf
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33.47 MB
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Adobe PDF