eHealth in Germany
Key figures
83M
people
2nd
position in global MedTech
13.1%
health expenditure as a share of GDP in 2020
Division of decision-making powers between the 16 "Länder", the federal government and the statutory professional organisations
The federal government proposes draft laws, regulations and administrative provisions and the Länder are responsible for implementing them.
The health system is financed by a compulsory insurance system, 87.7% public and 10.5% private, organised around public health insurance funds. Doctors bill the health insurance funds directly, not the patients.
A la rencontre des ambassadeurs
Matthias Mieves, député au Parlement Allemand (Bundestag)
Germany has the second-largest industry in terms of medical technology after the United States.
Germany is one of the pioneer countries for early access to reimbursement for eHealth apps. The innovative "fast-track" procedure allows doctors to prescribe certain categories of eHealth applications identified as "DiGA" (Digitale Gesundheitsanwendungen), pending evidence of a positive effect on providing care.
Assessing whether these applications qualify for market access is a job assigned to the Federal Institute for Drugs and Medical Devices (BfArM).
By 2025, insured persons should have an electronic medical record (ePA). A central data access and coordination service will also be set up to provide access to health data from different sources. For more information on Germany's digital health policy, click here.
How do you access the German market?
1. Get closer to hub and innovation clusters
eHealth in Germany features a system of innovation hubs that bring developers together and facilitate the incubation of new healthcare technologies.
The”digital ecosystems” list several German digital innovation hubs. The digital health hubs are :
- Zollhof, Nürnberg hub: Specialising in the development of business models for eHealth, connected objects and artificial intelligence
- 5-HT, Mannheim/Ludwigshafen hub: Specialising in the digital transformation of the German healthcare system
- Medical Valley, Erlangen hub: Specialising in the development of innovations to meet the challenges of today and tomorrow. It provides its Medical Valley GmbH platform, which markets the products of its companies and offers advice to help them access the German market. It also offers the Dmac (Digital Medical Application Center) which supports innovators in the development of their projects.
2. Obtain reimbursement thanks to health insurance funds
The preconditions for this gateway to the German market remain the compulsory possession of the CE marking, which is all a product needs to be released in Germany, and the declaration of the release of a medical device to the BfArM, in order to receive reimbursement.
The German insurance system is decentralised. There are 97 public and 42 private health insurance funds. The two funds with the largest number of insured are TK and Barmer. The health insurance companies choose which products they agree to reimburse in addition to those that have been approved by the BfArM. They often have their own innovation hubs. This is the case of the TK innovation portal, which offers support for innovation.
3. Obtain the license of the BfArM
BfArM is the federal authority responsible for health technology assessment. It issues permits for the marketing of various finished medical products.
To qualify for reimbursement, there must be a clinical study to prove the therapeutic efficacy and cost-effectiveness of the product on the German market. This trial period lasts on average 18 months, during which time it is possible to get intermediate reimbursement from the regions if doctors request it. The support of health professionals and health insurance funds makes it easier to obtain a BfArM licence.
For entrepreneurs developing and marketing e-health applications, BfArM offers a fast-track assessment procedure for sooner market access called DiGA.
To be included in the directory of reimbursable eHealth applications (the DiGA directory), you can follow an accelerated procedure:
- Submit your application here, declaring the quality and efficacy of the product and its impact on the German health system
- In the event of a favorable evaluation by BfArM, your health solution will be included in the public DiGA directory.
- Patients will be able to benefit from the DiGA with a prescription or medical proof
For more information, click here
4. Obtain reimbursement by the compulsory health insurance fund (GKV) with the Joint Federal Committee (G-BA)
The G-BA is a public legal entity comprising the 4 main coordinating organisations of the German autonomous health system:
- The national associations of public health insurance doctors;
- The German Hospital Federation;
- The Federal Central Association of Health Insurance Funds and the national associations of public health insurance dentists
The G-BA defines the specific health care services that are covered by the 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 defines the priorities and criteria for funding projects.
Government authorities and platforms
Ensure efficient operation and cooperation within the healthcare system
Associations
They bring companies together and facilitate their incubation
Hubs and innovation clusters
They bring together and facilitate the incubation of new technologies
Training courses
Universities and their groups that offer training and support for digital health innovations