Berlin – Many Digital Health Applications (DiGA) are prescribed by doctors and paid for by health insurance companies, even though their benefits are not sufficiently proven. The fast-track procedure of the Federal Institute for Drugs and Medical Devices (BfArM) allows for provisional approvals, enabling manufacturers to charge high prices – at the expense of contributors.
According to the DiGA report of the National Association of Statutory Health Insurance Funds for 2025, a total of 74 applications were included in the directory by the end of the year. Only 14 of them – around 19 percent – could provide complete proof of a positive care effect at the time of inclusion. A large portion started provisionally for testing. At the end of 2025, ten apps were still in this phase, while 48 were permanently listed and 16 were removed.
The system provides for: In case of incomplete proof, provisional inclusion is possible for up to 12 months, extendable to 24 months. During this time, the apps can be prescribed at the expense of statutory health insurance funds. Manufacturers can largely set the price themselves in the first year – often significantly higher than for permanently approved applications. Provisional DiGA cost an average of around 600 euros per quarter, while permanent ones were cheaper. Total expenses of the GKV: By the end of 2024, already over 230 million euros, with a strongly increasing trend.
Criticism of Evidence and Costs
Independent analyses and the National Association of Statutory Health Insurance Funds sharply criticize the quality of the studies. Many approval studies show methodological weaknesses: lack of blinding, high dropout rates, or insufficient control groups. Even with permanently approved DiGA, there are doubts about their transferability to real-world care. Provisionally approved apps start with even less evidence – proof is only supposed to be provided during the trial period.
"In many cases, the prices and benefits are not in an appropriate ratio," the report from the National Association of Statutory Health Insurance Funds states. Provisional DiGA are more expensive, even though proof of efficacy is lacking. Some apps were removed from the directory again after the trial phase.
Consequences for Patients
For those affected, this carries risks: they invest time and motivation in applications whose benefits are unclear or minimal – for example, for depression, back pain, or diabetes. Instead of proven therapies, they receive an app that may not work. Frustration, treatment discontinuation, and lost treatment time can be the result. Older or less tech-savvy patients are particularly vulnerable.
In addition, all contributors finance a system that is intended to promote innovation but causes high costs with uncertain benefits. Data protection is mandatory, but with a lack of added value, the interference with sensitive health data is questionable.
The DiGA model is an international pioneer for access to digital therapies. However, experts are calling for a course correction: stricter evidence requirements before prescription, value-based prices, and better independent controls. From 2026, an accompanying success measurement is intended to create more transparency – whether it will be sufficient remains to be seen.
Conclusion: The "app on prescription" threatens to become an expensive experiment where patients and the solidarity community pay the bill without guaranteed value. Reform is overdue.
