Paradoxically, in a place not exactly known for its digital legacy, in 2019, a major change in the approach towards the reimbursement of digital health solutions has been put forward. The German Digital Healthcare Act introduced the Digital Health Application program, known in German as ‘Digitale Gesundheitsanwendungen’ (DiGA). The program has established a model for integrating digital therapeutics (DTx) and digital diagnostics solutions into the German healthcare system with scalable and effective reimbursement strategies. Is this currently the most advanced digital health reimbursement framework in Europe? What results has DiGA brought in 6 years? Let us take a deeper look.

What qualifies as DiGA?

A DiGA is a CE-marked medical device that has the following properties:

• Medical device of the risk class I or IIa (according to the Medical Device Regulation (MDR) or the transitional regulation Medical Device Directive (MDD)).
• The main function of the DiGA is based on digital technologies.
• The medical purpose is mainly achieved by way of its digital function.
• The DiGA supports the recognition, monitoring, treatment or alleviation of diseases or the recognition, treatment, alleviation or compensation of injuries or disabilities.
• The DiGA is used by the patient alone or by the patient and the healthcare provider together.

From this definition, it is clear that both apps used directly for treatment as well as, for instance, an AI-based diagnostic solution for cardiovascular health could fall, and thus be reimbursed, under the DiGA framework.

Application and approval process: 3 months until preliminary decision

Application process for the inclusion in the DiGA list includes fast-track elements that ensure that the application gets assessed by the Federal Institute for Drugs and Medical Devices (BfArM) within 3 months at the latest, issuing a "Preliminary admission" or rejecting the application outright. The goal of this assessment is the examination of the manufacturer’s statements about the product features – including e.g. data protection, interoperability and UX - and the examination of the clinical and health economic evidence of the positive healthcare effect of the DiGA provided by the manufacturer.

As a prerequisite for Preliminary admission, the DiGA manufacturer presents a scientific evaluation concept for a clinical trial that must be created by an independent scientific institute and meet the BfArM’s quality requirements for demonstrating evidence of a positive healthcare effect. The ISO 14155 (good clinical practice)-compliant clinical trial should be carried out in the intended patient population and care settings, and the DiGA must be compared against existing standards of care, nontreatment, or to a DiGA already permanently listed. 

Within usually one year, a formal clinical study report should be submitted by the manufacturer to BfArM. The real-world evidence gained during this timeframe can inform the further enhancement of the DiGA and the design of future clinical trials. BfArM grants a permanent listing of the DiGA "Admission" in the directory if sufficient scientific evidence of a positive healthcare effect is demonstrated along the lines of patient-reported outcome measures, as well as endpoints related to medical outcomes and healthcare experience. The current list of devices that have been assessed under § 139e SGB V and thus have been included in the DiGA directory can be found here.

DiGA figures until 2025

As of June 2025, the DiGA directory listed 44 DiGAs with permanent and 14 DiGAs with provisional approval. Furthermore, 11 DiGAs had been delisted: six because no evidence of a positive healthcare effect could be provided, one because the clinical study for approval could not be completed, and four at the request of the manufacturer.

There were more than 1 million DiGA prescriptions issued Germany-wide by the end of 2024. Approximately 81% of these were actually used by patients, leading to cumulative expenditures of €234 million by the statutory health insurance funds between 1st of September 2020, to 31st of December 2024.

In 2024, the average price per DiGA prescription was €541, with prices per DiGA varying significantly, ranging from €119 to €2077 per use. The "use" is typically limited to 90 days but may extend to up to 365 days in certain cases.

Outlook

DiGA provides a nifty and fair way of entering the largest medtech market in Europe, and is well-balanced in terms of speed and gathering of necessary evidence for permanent inclusion. Indeed, RWE is an integral part of DiGA assessment and the final Admission to the list of reimbursed devices. This delicate balance makes DiGA likely the best digital health reimbursement framework in Europe, with other countries such as Austria in serious talks regarding the adoption of the framework.

A longer period of assessment will be needed to see the full health economic benefits of the digital health solutions reimbursed under DiGA; however, after 6 years, it seems that DiGA was clearly the right step forward.

Get in touch at info@ambiom.com to learn more about DiGA.

Sources

(1) Eurostat. Digitalisation in Europe – 2025 Edition. European Commission, 2025. https://ec.europa.eu/eurostat/web/interactive-%20publications/digitalisation-2025

(2) BfArM. “Interesting Facts — Digital Health Applications (DiGA).” Bundesinstitut für Arzneimittel und Medizinprodukte. https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/Interesting-facts/_artikel.html#:~:text=In%20addition%20to%20the%20prescription,prescription%20form%20(sample%2016).

(3) Schliess F., Affini Dicenzo T., Gaus N. et al. (2024). The German Fast Track Toward Reimbursement of Digital Health Applications (DiGA): Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes. Journal of Diabetes Science & Technology https://pmc.ncbi.nlm.nih.gov/articles/PMC10973846

(4) Schmidt L., Pawlitzki M., Renard B. Y., Meuth S. G., & Masanneck L. (2024). The three‑year evolution of Germany’s Digital Therapeutics reimbursement program and its path forward. npj Digital Medicine https://www.nature.com/articles/s41746-024-01137-1

(5) Steininger, Philipp. (2025, October 31). DiGA in Österreich: Vom politischen Versprechen zur gelebten Versorgung – jetzt braucht es gemeinsamen Willen. AUSTROMED. https://www.austromed.org/blog/diga-in-oesterreich-vom-politischen-versprechen-zur-gelebten-versorgung-jetzt-braucht-es-gemeinsamen-willen/

(6) Sippli, K., Deckert, S., Schmitt, J., & Scheibe, M. (2025). Healthcare effects and evidence robustness of reimbursable digital health applications in Germany: a systematic review. npj Digital Medicine, 8, Article 495. https://www.nature.com/articles/s41746-025-01879-6