Is your app a DiGA? Definition criteria of digital health applications
So-called DiGA (digital health applications) can be reimbursed by statutory health insurance companies. This became possible for the first time when the Digital Supply Act (DVG) came into force on December 19, 2019. However, not every health app or medical software...
BSI TR-03161 for DiGA: Data Security Certification
Since January 1, 2025, manufacturers of digital health applications (DiGA) must prove compliance with data security requirements by means of an official certificate. The basis for certification is BSI TR-03161, which was first published in 2020. The BfArM checks...
DiGA Guide: History of all changes
The BfArM updates the DiGA guidelines regularly. Unfortunately, there is no detailed change history available for this yet. We therefore continuously review all changes to the DiGA guidelines and prepare them for you. We present all changes here with comments in a...
DiGA: Guidelines for demonstrating positive supply effects
What is the point of a DiGA if it does not improve patients’ lives? There is none! This is why DiGAs are only justified when their positive supply effect has been proven. Only then do you have a chance of being permanently included in the BfArM register....
DiGA in Austria: Approval of digital health applications (2026)
Since 2020, there have been increasing efforts in Austria to integrate digital health applications (DiGA) into regular healthcare. So is the “app on prescription” now coming to Austria? In this article we give you an overview of: the planned approval...
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