Business model innovation in mHealth applications under public reimbursement: evidence from Germany's DiGA
Ramon Davi de Souza Rodrigues, Vivek K. VelamuriObjective
Germany has emerged as a frontrunner in digital health reimbursement through the Digital Health Applications (DiGA) framework, which provides a formal public reimbursement pathway for mobile health applications. This study examines how the DiGA framework influences business model innovation among providers of mobile health applications in Germany.
Methods
This study used an inductive, theory-sensitised qualitative design based on 25 semi-structured interviews with digital health executives and experts. Interviews were conducted in Germany between January and November 2025. Data were analysed inductively using the Gioia methodology, with business model dimensions serving as sensitising concepts.
Results
The findings indicate that participants perceived public reimbursement as both an enabler and a challenge for business model innovation. Participants described the DiGA framework as reshaping value propositions by strengthening patient-centricity, evidence-based value, and stakeholder value creation; transforming revenue models by creating new revenue streams and market segments, while introducing statutory health insurance funds as central payers and new pricing dynamics; and reshaping cost models by requiring manufacturers to develop technical, regulatory, commercial, and market access capabilities.
Conclusions
By conceptualising the DiGA public reimbursement pathway as an institutional mechanism that both enables and challenges business model innovation, this study advances understanding of how regulatory and reimbursement frameworks help shape business models in digital health markets. The findings offer insights for digital health entrepreneurs and healthcare stakeholders seeking to design sustainable, evidence-based digital health solutions within regulated reimbursement environments.