GKV report on the utilization and development of digital health application (DiGA) care in Germany

On April 1, 2025, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) published its report on the utilization and development of digital health applications (DiGA) covering the period from September 1, 2020, to December 31, 2024. The report presents GKV’s key findings along with recommendations aimed at optimizing the current framework for DiGA reimbursement and regulation.

Some of the key findings are provided below:

• During the reporting period, a total of 861,000 DiGAs were utilized, with cumulative reimbursement costs reaching €234 million. GKV expenditure on DiGA reimbursements increased by 71% between 2023 and 2024;
• As of December 31, 2024, 68 DiGAs were listed in the DiGA Directory maintained by the Federal Institute for Drugs and Medical Devices (BfArM). Of these, only 12 applications (18%) demonstrated proven benefits upon initial inclusion, resulting in 80% of DiGAs being granted provisional listing;
• Among the 56 provisionally listed DiGAs, 21 remain under ongoing evaluation by BfArM. Of the remaining 35, nine applications were fully removed from the Directory after failing to demonstrate a positive healthcare effect.

GKV recommends the following legislative changes:

• Restriction of reimbursement eligibility to DiGAs that present sufficient evidence of clinical benefit, quality, and medical necessity, with the Federal Joint Committee (G-BA) assuming responsibility for the evaluation process;
• Ensuring that negotiated prices between GKV-Spitzenverband and manufacturers' associations apply from the first day of a DiGA’s inclusion in the Directory, eliminating the current provisional pricing phase;
• For DiGAs associated with a higher patient risk potential, the application of established G-BA procedures for comprehensive benefit-risk assessments at the outset of market access should be mandated.

The full details in German can be found here and here.

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