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Item type:Publication, Access status: with files , Regulation for innovation or innovation despite regulation? Lessons from Germany’s DiGA Fast-Track for digital health innovation(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.Publicationtype: Doctoral Thesis43 27