As of July 1, 2026, Phase I of the in-use performance measurement (AbEM) applies to all permanently listed digital health applications (DiGA).
According to Section 23c(1) of the DiGAV, DiGA manufacturers must submit the following data for the third and fourth quarters of 2026:
“The results of the performance measurement conducted throughout the application period regarding the duration and frequency of use include an analysis of the data collected from the start of use through the end of the application period.”
- Regarding the scope of use,
- on frequency of use and
- “to discontinue use.”
For more detailed information on the required data sets, please refer to Appendix 4 of the DiGAV.
The first data submission to the BfArM is scheduled for April 15, 2027, followed by semi-annual submissions. In addition, starting in 2026, at least 20% of DiGA reimbursement must be performance-based.
Phase II of the real-world outcomes measurement (patient-reported health status, patient satisfaction) will begin on July 1, 2027.
Read more about this on the BfArM website: Digital Health Applications (DiGA)
Under the Statutory Health Insurance Contribution Rate Stabilization Act (GKV-BStabG) , a volume-based discount on DiGA reimbursement amounts will also take effect on January 1, 2027. The reduction is based on the annual volume of DiGA submissions and ranges from a minimum of 2% for more than 3,000 submissions to a minimum of 30% for more than 100,000 submissions per year.
The background to this is the Cost Structure of Digital Goods: High fixed costs for development are offset by low variable costs for reproduction and distribution; the low marginal costs associated with high sales volumes are to be accounted for through standardized discounts.
In addition, mandatory thresholds and a maximum amount are provided for DiGAs that cannot be assigned to a group of comparable applications. This catch-all amount is weighted based on the level of service utilization.
The text of the resolution is available here: Bundestag Resolution (PDF)