When Germany introduced reimbursement for prescription digital health applications in 2020, it became the first country to create a national pathway for digital therapeutics to enter routine healthcare. The policy, embedded in the Digital Healthcare Act (Digitale-Versorgung-Gesetz), allowed physicians to prescribe certified medical apps (known as Digital Health Applications, or DiGAs) and have them reimbursed by statutory health insurance (SHI).
This marked a turning point in digital health. Software could now become a reimbursable medical intervention at national scale, potentially transforming the economics of digital health startups and the accessibility of digital therapeutics for patients.
Six years later, the DiGA programme offers valuable lessons about how digital therapeutics can move from startup innovation to regulated healthcare infrastructure. Early enthusiasm has gradually been followed by consolidation, growing scrutiny and more demanding evidence requirements. Understanding how the programme evolved, and how the latest regulatory amendments reshape the market, is essential for companies considering entry into the German digital health market.
The launch of the DiGA model
The DiGA pathway created a “fast-track” regulatory process managed by the Federal Institute for Drugs and Medical Devices (BfArM). Developers of low-risk medical software could apply to have their product listed in the national DiGA directory. Once listed, physicians could prescribe the application just like a medical device or medication, and SHIs would reimburse it for patients.
The key innovation of the German approach was the combination of rapid market access with evidence generation. Companies could enter the market with provisional approval even if full clinical evidence was not yet available. During a one-year evaluation period they were expected to generate proof that the application produced a measurable “positive healthcare effect,” either through improved clinical outcomes or through patient-relevant improvements in care processes such as adherence or disease management [1].
From the beginning, the model attracted considerable international attention. Germany effectively created the first national reimbursement pathway for digital therapeutics, and other countries, including France and Belgium, began exploring similar frameworks. The prospect of national reimbursement in Europe’s largest healthcare market quickly drew startups and established digital health companies to the DiGA programme.
Growth, but slower than early expectations
Despite the early excitement, adoption of DiGA applications has grown gradually rather than explosively. The first prescription apps became available in September 2020. In the first year of the programme, roughly 41,000 prescriptions were issued, reflecting both the novelty of the system and limited physician awareness [2].
Usage increased steadily over the following years. Between October 2022 and September 2023, prescriptions reached about 209,000 for the period, showing strong growth compared with earlier years [2]. By the end of 2024, cumulative prescriptions had exceeded one million, with approximately 861,000 of those prescriptions actually activated by patients [3]. This activation rate, around 81 percent, suggests that once prescribed, most patients do use the applications rather than abandoning them after receiving an access code [4].
Financially, the programme has also grown into a meaningful reimbursement category. SHIs had spent approximately €234 million on DiGA applications between 2020 and the end of 2024 [1]. Individual prescriptions typically cover a three-month treatment period, and manufacturers are allowed to set the price freely during the first year after market entry before negotiating a long-term reimbursement price with insurers.
Yet, uptake remains modest relative to the scale of the German healthcare system. While prescriptions have grown each year, they still represent a small fraction of total medical prescriptions nationwide. In addition, the market is highly concentrated: a small number of applications account for most prescriptions, with the top fifteen DiGAs generating roughly 82 percent of all usage [4].
Another limiting factor has been physician adoption. Surveys indicate that although many clinicians are open to digital therapeutics, relatively few prescribe them regularly. Limited familiarity with the applications, uncertainty about their clinical benefits and the additional effort required to integrate them into clinical workflows have all slowed adoption [4].
From “fast-track” innovation to stricter regulation
The early years of the DiGA programme prioritised innovation and rapid market entry. The relatively flexible evidence requirements allowed companies to launch products quickly while collecting data during the provisional listing period.
However, as the programme matured, regulators and health insurers began demanding stronger proof of clinical benefit and clearer justification for reimbursement. Several applications were removed from the DiGA directory after failing to demonstrate a measurable healthcare benefit during their evaluation period [1].
This shift reflects a broader transition from experimentation toward long-term sustainability. As the number of listed applications and the total reimbursement volume increased, policymakers became more focused on ensuring that public funds were spent on digital interventions that demonstrably improve patient outcomes.
The implications of recent amendments
Recent legislative amendments to Germany’s digital health framework signal a move toward a more evidence-driven model for digital therapeutics.
One key development is the growing emphasis on robust clinical evidence. Manufacturers must demonstrate that their application produces a “positive healthcare effect”, typically through well-designed clinical studies such as randomized controlled trials or rigorous observational studies [5]. Endpoints often include measurable improvements in health outcomes, quality of life or validated patient-reported outcome measures.
In practical terms, this means that companies seeking permanent listing in the DiGA directory must invest more heavily in clinical research and evidence generation. Early-stage digital health startups that previously relied on smaller pilot studies may now need trials comparable in design and methodological rigor to those required for many medical devices.
Policy discussions have also increasingly focused on linking reimbursement to measurable outcomes. Future developments in the framework may incorporate stronger performance-based elements, where long-term reimbursement levels are influenced by real-world effectiveness and patient engagement metrics [6].
Another significant evolution concerns the scope of the programme. Recent legislation allows higher-risk digital medical technologies, including certain class IIb software medical devices, to enter the reimbursement pathway. While this expands the potential impact of the DiGA system, it also introduces more demanding regulatory requirements for safety, evidence and post-market monitoring [7].
Taken together, these changes signal a shift in the DiGA market. The initial phase emphasised rapid innovation and market access; the current phase focuses on validation, real-world effectiveness and integration into healthcare delivery.
Six years after its launch, the German DiGA system remains one of the most advanced reimbursement frameworks for digital therapeutics anywhere in the world. It has demonstrated that medical software can be integrated into national healthcare systems and reimbursed at scale.
At the same time, the programme has revealed the challenges of translating digital health innovation into routine clinical practice. Physician adoption, patient engagement and rigorous evidence generation all play critical roles in determining whether a digital therapeutic ultimately succeeds.
The recent amendments reflect the natural maturation of the programme. As the market evolves, regulators and payers are shifting from encouraging experimentation to demanding proof of value. For developers, success in the DiGA ecosystem increasingly depends not only on technological innovation but also on clinical evidence, health-economic analysis and the ability to demonstrate measurable improvements in patient care.
The German market of reimbursable digital therapeutics is therefore entering a new phase, one where the promise of digital medicine must be supported by rigorous data. If the model succeeds, it may continue to shape how digital health solutions are evaluated and reimbursed across Europe in the years to come.
References
- Federal Institute for Drugs and Medical Devices. The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V – A Guide for Manufacturers, Service Providers and Users. Bonn: BfArM; 2024.
- Bundesministerium für Gesundheit. Digital Healthcare Act (Digitale-Versorgung-Gesetz – DVG). Berlin: German Federal Ministry of Health; 2019.
- German Federal Institute for Drugs and Medical Devices. DiGA directory and statistics on prescriptions and listed applications. Bonn: BfArM; 2024.
- German National Association of Statutory Health Insurance Funds. DiGA report: Utilisation and expenditure of digital health applications in statutory health insurance. Berlin: GKV-Spitzenverband; 2024.
- Goeldner M, Gehder S. Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024. J Med Internet Res 2024;26:e59013, URL: https://www.jmir.org/2024/1/e59013; DOI: 10.2196/59013
- IQVIA Institute for Human Data Science. Digital Health Trends 2025: Insights into the evolving digital health ecosystem. Parsippany, NJ: IQVIA Institute; 2025.
- European Commission. Medical Device Regulation (EU) 2017/745 and implications for software medical devices. Brussels: European Commission; 2017.
