The legal anchoring of DiGA in SGB V through the Digital Care Act (DVG, 2020) and the Digital Act (DigiG, 2024) has paved the way: Doctors and psychotherapists in Germany can prescribe certified medical devices with proven effectiveness on prescription, provided that they have successfully completed the DIGA fast-track procedure at the Federal Institute for Drugs and Medical Devices (BfArM). Statutory health insurance companies cover the costs for this, without prior approval. The success of this regulation is already evident today: DiGA demonstrably improves care for hundreds of thousands of people per year and ensures greater supply equity. DiGA also offer not only a proven positive care effect for patients, but also enormous savings potential for the healthcare system, for example by treating illnesses early on and reducing the number of unnecessary doctor visits.

Despite these positive developments, the DIGA model faces major challenges four years after its introduction. The bureaucratic approval process prevents widespread use and acceptance. Increasing regulatory costs and ever higher entry barriers mean that fewer and fewer innovative products reach the supply.

Now is the time to set the course for the next few years: The regulation of DiGA urgently needs to be optimized in order to enable healthcare strengthened by DiGA, which focuses on patients' needs. As a pioneer technology and “Innovation Made in Germany”, DiGA also strengthens innovative strength in Germany.

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1. Facilitate access

50% of patients do not reach care (SVDGV (2024): DIGA Report 2023; National Association of Statutory Health Insurance Funds (2024): DiGA report). They fail due to the cumbersome and paper-based redemption process of a DIGA regulation: Many process steps such as manual verification by health insurance companies, postal delivery and the error-prone manual entry of the activation code are unnecessary. Patients are still waiting several weeks for some health insurance companies to issue an activation code. Health insurance interfaces are completely cancelled several times a year. All of this is avoidable and would be much more patient-friendly.

We demand: DiGA must be just as quick and easy for patients as medicines. Flexible and barrier-free redemption channels could already enable immediate and automated activation of DiGA in accordance with medical prescription. It is therefore all the more important to set the right course for DiGA as part of the introduction of the e-prescription and to finally eliminate the weaknesses of the current process, which was originally designed as a short-term interim solution.

The e-prescription for DiGA must be designed in such a way that patients can start immediately after the prescription. Patients should have the freedom to use their DiGA flexibly and digitally and without manually entering an activation code — for example directly in DiGA, via the e-prescription app or the electronic patient record (ePA). Legally inadmissible control over the activation of DiGA by health insurance companies must also be prevented in the future. DIGA manufacturers are happy to assume the resulting billing risks in favor of improved patient friendliness.

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2. Reduce bureaucracy

Many laws in recent years have increased the hurdles to bringing innovative products to the supply. When it comes to data protection and data security, there are now several - largely overlapping - requirements and certificates. This results in high and unnecessary costs, which are borne by the solidarity community and do not benefit the supply.

The current language practice of the BfArM also makes it difficult to incorporate new applications and further develop existing DiGA. Requirements must finally be comprehensible, scientifically based and processed consistently in order to create planning security for manufacturers. Mandatory interpretations of the evidence requirements, a practical understanding of what constitutes a “significant change in accordance with DiGA-V” and compliance with legal deadlines are necessary so that DiGA can be continuously developed in the future. The current interpretation of the regulation by the BfArM punishes continuous development of the products — in stark contrast to the intention of the legislator. At the same time, the BfArM needs more resources in order to be able to speed up the DIGA recording process and the review of significant changes again.

When implementing European medical device regulations, Germany should refrain from taking special routes. For example, DiGA must still be able to be recognized as class I medical devices in order to ensure innovation-friendly framework conditions. There must also be a paradigm shift in data protection: The requirements must be streamlined in such a way that they maintain user-friendliness, remove hurdles for patients and enable more self-determination rights. This also applies to data security requirements: Software updates currently incur high recertification costs, which prevent agile product development.

‍It now takes the courage to simplify administrative processes with a de-bureaucratization law, to reduce existing barriers such as excessive data protection and data security certificates with overlapping requirements, and to adjust regulatory requirements. This is the only way for DIGA manufacturers to remain able to act.

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3. Enable sustainable financing

Fair and value-based compensation for DiGA is essential to make innovations financially viable in the long term and to ensure the quality of care. The current DIGA pricing approach is too undifferentiated and does not do justice to the individual benefits of DiGA, both for patients and for care. In addition, regulatory expenses for DIGA manufacturers continue to rise.

We therefore call for differentiated pricing based on parameters such as therapeutic benefit, indication and prevalence. This would enable fair remuneration and ensure economic viability for manufacturers. Particularly for specialized or less widespread indications, the price must be adjustable in such a way that the development of innovative applications remains cost-effective. This is the only way DiGA can develop its potential and contribute to the sustainable improvement of patient care.

In addition, there is a need for clear legal regulations for the creation and remuneration of new medical services in connection with a DiGA in order to close existing regulatory gaps and ensure that patients receive the necessary support without delay.

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4. Rethink the DIGA concept

In order for DiGA to fully develop their current potential, they must be integrated even better into care. France can set an example here: Basic knowledge of digital therapies should be integrated into education and continuing education programs for doctors, psychotherapists and other health professionals at an early stage.

DiGA also offer enormous potential that goes beyond its current application. This should be exploited through greater involvement of treatment providers in hybrid care models, the use of DiGA in rehabilitation, and through targeted funding measures for rare diseases and applications in risk class III areas.

Another key step is facilitating the privacy-compliant use of anonymized health data for clinical research. This data has enormous potential for developing new therapies and improving existing applications. This can make a significant contribution to strengthening Germany as a high-tech location and creating scalable innovation spaces that enable patient-centered healthcare in the long term.

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5. Promote European harmonization

With the DiGA Fast-Track, Germany has taken on a pioneering role and created an internationally recognized set of rules for the reimbursement of digital therapeutics. Establishing this successful concept across Europe requires harmonization of approval and regulatory requirements within the EU. This is the only way innovative products can gain a foothold throughout Europe and German manufacturers become European champions.

We call for mutual recognition of clinical trials and uniform approval requirements for DiGA and comparable digital therapeutics. This would strengthen the European market for digital health solutions, promote innovation and make DiGA an export hit “Made in Germany.”

Germany should actively work to position the DIGA model as a blueprint for digital therapeutic innovations in Europe. The aim is to simplify access to digital healthcare solutions and thus sustainably improve healthcare in Europe.

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