Digital Health in Germany
Key Figures
84M
population in 2025
3rd
a global leader in the field of medical technology
12.6%
health care spending as a percentage of GDP
Shared Responsibilities in Health Care System Governance: Division of Roles Among the Federal Government, the Länder, and Professional Organizations
The German healthcare system is based on shared responsibility between the federal government and the federal states (Länder). The federal government is responsible for drafting the laws, regulations, and administrative provisions that govern the insurance system. The Länder are responsible for hospital planning and provide capital investments for hospitals.
Germany provides universal health coverage through two main systems: statutory health insurance (SHI; in German: Gesetzliche Krankenversicherung, GKV), which covers approximately 90% of the population, and private health insurance (PHI). Doctors bill the insurance companies directly, rather than the patients. These insurance funds also enter into contracts with various healthcare providers and play a key role in shaping the system, particularly by defining the scope of benefits under statutory health insurance.
Meet the Ambassadors
Matthias Mieves, Member of the German Parliament (Bundestag)
Germany ranks third in the world in terms of the medical technology industry, behind the United States and Japan
Germany is one of the pioneering countries in terms of rapid access to reimbursement for digital therapeutics (DTx). The innovative “fast track” procedure allows healthcare professionals to prescribe certain categories of digital health applications identified as “DiGA” (Digitale Gesundheitsanwendungen), pending evidence of a positive health effect and other product qualities. The Federal Institute for Drugs and Medical
Devices (BfArM) is responsible for assessing these applications’ eligibility for market access.
Germany is also accelerating its policy of facilitating patient continuity of care across healthcare providers using online health records.
Since April 29, 2025, the electronic health record “ePA für alle” has been rolled out nationwide across Germany and implemented by healthcare providers, hospitals, and pharmacies. As of March 2025, it covers nearly 70 million German citizens. Healthcare providers will be required to use the ePA starting October 1, 2025. The ePA is currently being implemented to serve as the central access point for data and the primary provider.
For more information on Germany’s “Digitalization Strategy for Health and Care,” click here.
How can I enter the German market?
1. Build closer ties with regional innovation hubs and clusters
Digital health in Germany is based on a system of innovation hubs that bring together developers and facilitate the incubation of new health technologies.
The federal “digital ecosystems” hub initiative lists several German digital innovation hubs. The digital health hubs are as follows:
- Zollhof, Nuremberg hub: specializes in developing business models for e-health, connected devices, and artificial intelligence
- 5-HT, Mannheim/Ludwigshafen hub: specializing in the digital transformation of the German healthcare system
- Medical Valley, Erlangen hub: specializes in developing innovations that address the challenges of today and tomorrow. It provides the Medical Valley GmbH platform, which markets the products of its member companies and offers them consulting services to help them enter the German market. It also operates the Dmac (Digital Medical Application Center), which supports innovators in developing their projects.
Other health-related clusters also exist in various cities:
- Life Science Nord: In the Hamburg and Schleswig-Holstein regions, this cluster offers startups services, networking opportunities, and business support in the fields of digital health, medical technology, and the pharmaceutical industry.
- DHCH, Hanover: This network of local healthcare stakeholders connects numerous public and private actors and coordinates projects in a rapidly growing sector.
- Health Navigator Cologne: This is the regional hub dedicated to digital innovation in healthcare in the Cologne/Bonn metropolitan area. Supported by KölnBusiness, the Cologne-Bonn health region, and local universities, it connects startups, SMEs, research institutes, clinics, investors, and industrial partners in the digital health sector to foster collaborative innovation.
- Berlin-Brandenburg Healthcare Cluster: A regional innovation hub that drives digital transformation in the healthcare sector in the German capital region. Ranked among Europe’s most attractive hubs in the life sciences sector, it brings together more than 670 companies specializing in biotechnology, medical technology, and pharmaceuticals, as well as 140 hospitals and major research institutes. It benefits from the support of incubators, accelerators, and public-private partnerships, including Bayer Grants4Apps, Pfizer Healthcare Hub, and Startupbootcamp.
2. Obtain reimbursement from health insurance providers
The prerequisites for entering the German market remain the mandatory CE marking—which is all a product needs to be sold in Germany—and the submission of a declaration of placing a medical device on the market to the BfArM in order to be eligible for reimbursement
However, the German health insurance system is decentralized: there are 95 public health insurance funds and 42 private ones. The two funds with the largest number of insured members are TK and Barmer. Health insurance funds select the products they agree to reimburse in addition to those approved by the BfArM. They often have their own innovation centers. This is the case with TK’s innovation portal, which provides support for innovation.
3. Submit for scientific evaluation for inclusion in the DiGA registry, if the product is a digital therapy
To be included in the DiGA directory (the official list of reimbursable digital therapies), a digital medical device must undergo a scientific evaluation by the BfArM. This process assesses interoperability, data protection, ease of use, and, above all, the application’s positive health effects.
Manufacturers must submit either:
- A clinical study (e.g., a randomized controlled trial or comparable real-world data) demonstrating the application’s positive impact on patient care, or
- A scientific evaluation plan, validated by an independent institute, if they are applying for temporary registration (pending the results of the clinical study).
This scientific evidence is essential for obtaining authorization under the accelerated procedure, and the BfArM’s evaluation period is limited to 3 months after receipt of a complete application.
If successful, the app may be admitted to the DiGA directory on a temporary or permanent basis. Temporary admission allows for a maximum period of 12 months (extendable to 24 months) to complete the study.
4. Obtain registration with the BfArM and national reimbursement
The BfArM is the federal authority responsible for evaluating health technologies related to digital medical devices. It issues marketing authorizations for various finished medical products.
To be eligible for reimbursement, a clinical study must demonstrate the product’s therapeutic efficacy and cost-effectiveness on the German market. For entrepreneurs who develop and market online health applications, the BfArM offers an accelerated evaluation procedure for faster market access, known as DiGA.
To be included in the directory of reimbursable e-health applications (the DiGA directory), you can follow an expedited procedure:
- Submit your application here, and declare the product’s quality, effectiveness, and impact on the German healthcare system
- After the evaluation period, patients will be able to access the DiGA upon presentation of a prescription or medical referral.
- If the comparative study has not yet been completed but the other conditions are met, the manufacturer may submit an application for “temporary admission.” In this case, the manufacturer must: provide an evaluation plan validated by an independent scientific body and conduct the study during a 12-month trial period (which may be extended to up to 24 months in exceptional cases).
In both cases, once listed in the DiGA registry, the e-health application is eligible for reimbursement by the GKV (health insurance).
For more information, click here.
5. Obtain reimbursement from the statutory health insurance funds (GKV) through the Joint Federal Committee (G-BA)
If your product is not eligible for the DiGA fast-track procedure, you must apply for reimbursement through the G-BA, which is the traditional route for inclusion in the standard care catalog. The fast-track application procedure cannot be successful for a product that has been rejected by the G-BA. The G-BA is a public legal entity composed of the four main coordinating organizations of Germany’s autonomous health care system:
- The national associations of physicians in the public health insurance system;
- The German Hospital Federation;
- The Federal Central Association of Health Insurance Funds; and the national associations of dentists in the public health insurance system.
The G-BA defines the specific health services covered by statutory health insurance (GKV). It is also responsible for funding projects on new forms of health care delivery and research. The G-BA’s Innovation Committee sets the priorities and funding criteria for projects.
Government agencies and platforms
Implement national digital health strategies and ensure the smooth operation of and cooperation within the health care system.
Organizations
Bring businesses together and facilitate their market access
Initiatives to Support Innovation
These initiatives bring together and facilitate the incubation of new technologies
Training Courses
Universities and institutes that train and support innovators in digital health
Expanding Internationally—Why Not Germany?
The German healthcare system is unique in Europe, characterized by a federal structure that closely links the national level with the Länder. Based on an insurance model, it relies on the coexistence of statutory health insurance and private health insurance, structured around health insurance funds that finance and regulate access to care. This model guarantees broad coverage of services and rapid access to high-quality medical care, whether provided in hospitals, doctors’ offices, or outpatient facilities. The division of responsibilities between federal and regional actors allows healthcare provision to be tailored to the needs of specific regions, while ensuring the overall coherence of the German healthcare system.
The operation of these health insurance funds, at the heart of the system, plays a decisive role in the organization of care and the integration of innovations. They define the terms for covering medical services, negotiate with physicians’ associations, and help structure care pathways. Healthcare professionals, whether they practice in private practices or within hospitals, operate within this regulated framework, ensuring a high level of quality in medical services. Compared to other European models, particularly the French one, the German system is distinguished by this shared governance and by the active role of payers, who directly influence access to care and the adoption of new solutions. This structure fosters a dynamic in which innovations must demonstrate their medical effectiveness and economic viability in order to be integrated.
In this context, healthcare innovation and the development of e-health are part of a process of gradual integration into the existing system. The diversity of stakeholders—such as health insurance funds, physicians, public institutions, research organizations, and companies—helps shape a cohesive ecosystem capable of fostering and deploying innovative solutions on a large scale. The specific characteristics of the federal structure, with distinct regional environments, require a detailed understanding of local dynamics to effectively access the German market. Projects must therefore align with the requirements of authorities, funding agencies, and healthcare professionals in order to be integrated into care pathways and service offerings.
G_NIUS supports project leaders in this process by providing them with a clear understanding of how the German healthcare system operates and the pathways to market access. Identifying key stakeholders—from health insurance funds to federal and regional authorities—enables a better understanding of decision-making processes and funding mechanisms. The resources provided help clarify the differences between statutory and private health insurance, the conditions for accessing medical care, and the expectations of healthcare professionals. With this support, innovators can structure their projects, secure their market entry, and integrate sustainably into a system that is demanding but particularly conducive to the development of digital health solutions.