How do you get your health app listed as a DiGA in the BfArM directory?

A DiGA must pass three assessment logics at once, each drawn from a different body of rules: first, it is a medical device in Class I or IIa with CE marking under EU 2017/745, second, it is a system that demonstrably meets data protection and data security requirements under the GDPR (EU 2016/679) and BSI TR-03161, and third, it is a statutory health insurance benefit under Sec. 33a SGB V whose positive healthcare effect must be demonstrated quantitatively. The first two strands can be worked through. The bottleneck is almost always the third: a healthcare effect that was not defined as a measurable endpoint with a suitable comparator group from the outset can hardly be demonstrated after the fact.

This dictates the sequence: first the eligibility check covering risk class, intended purpose and a recognizable healthcare effect, then the choice of procedure between fast-track and the regular route, and only after that the application and the study. The 12-month trial period of provisional listing forgives no methodological corrections, and since the DiGAV amendment of 01.02.2026 pure usage data is no longer sufficient for the application-accompanying outcome measurement. Locking down the evidence strategy before the application shifts the effort to where corrections are cheap, rather than into the trial period, where time runs against the product.