Dear readers,

In the fourth year after its introduction, the successful model of digital health applications (DiGA) has continued to establish itself in German healthcare. DiGA stands for an evidence-based form of therapy independent of location and time, which fills gaps in care and strengthens patients' sovereignty. DiGA also relieves the health care system and contributes to cost savings. They make it possible to treat illnesses at an early stage and to expand treatment options for patients and therapists.

As this second DIGA report shows, at the time of publication, patients were able to benefit from the benefits of DiGA almost one million times. At the same time, the DIGA offering has become even wider and more diverse.

DiGA also set standards worldwide as an “Innovation Made in Germany”, as Germany was the first country to include digital treatment methods in standard care. Other countries such as France and Belgium are now following this example.

On the one hand, the legal framework for DiGA gives doctors and psychotherapists the certainty that they can prescribe certified medical devices with proven supply benefits and an audit by the Federal Institute for Drugs and Medical Devices (BfArM). On the other hand, it regulates the unconditional reimbursement of DiGA costs by the statutory health insurance funds.

Contrary to positive developments over the past four years, however, there are several obstacles in the way of the DIGA concept. For example, a bureaucratic and out-of-date process for approval is blocking wider use of DIGA. In addition, the investments required to meet regulatory requirements are constantly increasing. As a result, fewer and fewer innovative products are reaching the supply.

With its second DIGA report, the National Association of Digital Health Care (SVDGV) takes stock of DIGA development, classifies groundbreaking developments over the past year and takes a look at the necessary steps for the future of digital healthcare:

The Digital Act brings some new features to DiGA.

With the Digital Act of March 2024, various regulations have come into force that change the framework conditions for DiGA. For example, statutory health insurance companies are required to issue activation codes more quickly, which the SVDGV had been demanding for a long time. In addition, by linking application-related performance measurement (ABem) to part of the DIGA remuneration, a step towards a concept of mandatory variable price components is being taken for the first time in Germany. However, the SVDGV's analysis shows how bureaucratic stumbling blocks significantly impede the practical implementation of these fundamentally progressive approaches.

The DIGA market continues to grow sustainably.

As of December 31, 2024, the number of redeemed activation codes continued to rise with significant double-digit growth rates. At the same time, with 59 listed DiGA, the selection has expanded by 20 percent compared to the previous year. The latest data also confirm the successful model of the DIGA fast-track process. This is because over two thirds of the DiGA, which was initially provisionally included in the BfArM directory, are now permanently listed. This means that in the fourth year, there are more permanent DiGAs available than provisionally recorded DiGA. At the same time, you can see that it was a difficult year, there were hardly any new admissions, the advantage is about to be gambled away — there is a need for action.

DiGA are becoming an international success model.

DiGA is now regarded as a “role model” for healthcare systems in other countries — in particular the unique DiGA fast-track process. Patients in France and Belgium can now also benefit from digital therapies as part of standard care. However, harmonised standards for the reimbursement of digital medical devices have so far been lacking across Europe. The SVDGV is therefore committed to harmonizing the regulatory framework.

Now is the right time to make political decisions.

In the last chapter of this DiGA report, the SVDGV makes concrete suggestions on how the framework conditions for DiGA can be improved in the next legislative period. This includes simplified access for patients as well as the removal of bureaucratic barriers that place a disproportionate burden on young and innovative DIGA companies in particular. It is also important to anchor DiGA's opportunities more firmly among patients and clinicians. Finally, the aim is to further develop the DIGA concept and anchor it as a third supply sector.

The new legislative period offers the opportunity to readjust the framework conditions for DiGA and thus have a lasting influence on its further development up to the end of this decade. The SVDGV appeals to those responsible to seize this opportunity and improve the regulatory conditions for DiGA. Only then can DiGA develop its full potential and make an even greater contribution to sustainable and patient-centered healthcare.

We wish you an insightful read.

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