BfArM's application portal for digital health applications

The BfArM application portal for digital health applications (DiGA) was already launched on 27 May 2020. A further completion guidance for answering the comprehensive catalogue of questions was added during June.

The formal process of application submission takes place exclusively via the released application portal, which also serves as a central communication platform for the entire application and evaluation process. DiGA manufacturers or authorized applicants can independently start application procedures by creating a user profile and successively complete the application, as an intermediate status can be saved at any time. The actual format of the application follows the logic of a questionnaire in which specified questions according to the DiGA-V must be answered. The application is thereby structured in three categories:

1. The main application form for inclusion in the DiGA directory according to §139e SGB V
2. Appendix I – as a questionnaire according to §4 para. 6 of the DIGA-V on requirements for data protection and data security
3. Appendix II – as a questionnaire according to §§ 5 and 6 of the DIGA-V on quality and interoperability requirements

A total of 172 questions must be answered by DiGA manufacturers in the application procedure. The completion guidance provides a structured overview of all input steps, the individual fields, the information required for each input field and the necessary documents. As the BfArM already clarified in the published guideline, the completion guidance is only an optional support, however, manufacturers should take the recommendations into account to ensure a formally complete application. Yet if problems in answering individual questions remain, there is always the possibility of an advice meeting.

The new fast-track procedure is revolutionizing existing reimbursement pathways for digital healthcare applications, however, DiGA manufacturers should not underestimate the new arising strategic challenges. Although the BfArM guideline and the completion guidance provide comprehensive assistance, the "question-answer logic" of the application process can quickly cause the red thread and the overall concept to get lost. Several components of the application from require a detailed illustration and value-based argumentation, which can only be achieved if the application underlies a convincing value story. We therefore advise manufacturers to deal intensively with the argumentation of the respective value advantages against the background of the present care situation to maximize the chances of success. Applications for the admission of a DiGA into the DiGA register according to §135e are required to be written in German. Until further notice, the BfArM guideline and the completion guidance are also only available in German.

In a series of blogs, SKC provides manufacturers with comprehensive information about the general requirements and new strategic challenges surrounding the application process for digital health applications. SKC offers strategic support throughout the various steps of the DiGA process. We have a lot of experience regarding the preparation of advice meetings with the BfArM or the creation of application documents. For more detailed information, please also read the first and second part of our blog series.