Digital health applications in Germany: Explorative pilot study on the challenges of approval from the perspective of manufacturers

Objective
Digital health applications are digital medical products (e.g. apps and web applications) that are prescribed by healthcare service providers and reimbursed by health insurances. Before digital health applications can be prescribed, manufacturers must fulfill the requirements of the approval process. The aim of this study is to identify the challenges faced by digital health applications manufacturers in the German fast-track process.

Methods
Use of a questionnaire-based online survey with 10 digital health applications manufacturers from March to October 2023. The survey design is based on the German digital health application regulation and the digital health application guideline. Data collection via LimeSurvey and HubSpot and data visualization in bar charts.

Results
Digital health applications manufacturers see the fast-track process as a challenge, especially in terms of demonstrating positive care effects and compliance with regulatory standards. Challenges include conducting clinical trials, negotiating pricing and improving market acceptance even with innovative approaches. Views on the profitability and relevance of the digital health application model are varied, with concerns over pricing and market strategies predominating.

Conclusions
The fast-track approval of digital health applications in Germany is a significant barrier to innovation and market entry. Collaboration between stakeholders is essential to optimizing processes while ensuring safety and accessibility for patients. However, even with the limitations, the results provide insights for future research and policy refinements that are necessary to improve the implementation of digital health applications in healthcare.