On January 29, 2026, the Second Ordinance Amending the Digital Health Applications Ordinance (DiGAV) was published in the Federal Law Gazette (BGBl. 2026 I No. 22). It has been in force since February 1, 2026.
An overview of the key changes:
- Application-accompanying performance measurement (AbEM): manufacturers of permanently listed DiGA will in future have to collect quarterly data on extent of use, duration of use and discontinuation of use, and report it to the BfArM every six months. The first reporting deadline is April 15, 2027. Data on patient-reported health status and satisfaction must then be reported for the first time on April 15, 2028, with additional AbEM results from April 15, 2029. Participation in the survey is voluntary for patients.
- Preservation of the ability to work can be demonstrated in addition to the positive healthcare effects. Some DiGA manufacturers achieve only small effects on the positive healthcare effect. Additionally demonstrating the preservation of the ability to work now allows functional effects to be captured better.
- AI Regulation: manufacturers will in future have to state whether their DiGA falls under the AI Regulation.
- Simplified change notifications: minor changes now only require a simplified notification with a fee of 150 euros.
- ePA integration: data exports must now also be available in human-readable form.
The ordinance has been criticised by an alliance of industry associations (including Bitkom, BVMed, vfa and SVDGV). The associations argue that the new documentation and reporting obligations mainly tie up resources without creating any discernible additional benefit for patient care. Instead, the requirements would slow down innovation and run counter to the declared goal of reducing bureaucracy.
The BfArM has already updated the application forms in the DiGA portal, in particular with regard to the AbEM requirements.
Read the report by Apotheke Adhoc on the topic: DiGA-Verordnung: Mehr Bürokratie statt besserer Versorgung
The ordinance can be read here: BGBl. 2026 I Nr. 22