Digital Health in Germany

Facts & Figures

Recent legal initiatives are intended to increase the usage and reimbursement possibilities of digital applications. This is also paving the way forward for increased access to health data for research-based companies.  

As usage and reimbursement opportunities grow, digital health solutions – including smartphone apps, bio sensors and online physician consultation by app or website – turnover is growing. 

Digital Health Applications - DIGAs

The legislative framework provides access to digital health applications on prescription to 73 million insured Germans. Individuals with health insurance are entitled to coverage benefits for digital health applications (DIGAs) where those applications meet the following characteristics:

1. Medical products of class I, IIa pr llb under MDR
2. Main function is based on digital technologies
3. DIGAs assist the process of detection, monitoring, treatment and alleviation of injuries and compensate diseases and disabilities
4. DIGAs are used either by the patient or jointly by the patient and the care provider, which means application can solely be used for patient treatment 

DIGA Directory Fast Track Process

A “fast track” process has been created to bring digital health applications into the statutory health system.

The developer applies to the BfArM - the Federal Institute for Drugs and Medical Devices – which also advises the developer. If the application fulfils the general requirements (safety, quality, functionality, privacy, and data security) and positive care effects (medical benefits, structural & procedural improvements), it can be listed in the DIGA directory. Structural and procedural improvements include access to care, adherence, health literacy or overcoming gaps in transition from one type of care to another.

The developer can already provide evidence which shows the positive care effects. This process takes up to three months. The developer then negotiates a price with the umbrella organization of statutory health organizations. If the developer cannot yet provide evidence for the positive care effects a 12-month trial period is conducted.This can be used to provide a hypothesis and an evaluation concept for the expected positive care effects (producer bears cost).

The DIGA can then be listed in the directory for 12 months. During this time, the developer can collect data and show the DIGA positive care effects. The Federal Institute for Drugs and Medical Devices decides on the final listing and the producer negotiates a price with the umbrella organization of statutory health organizations.

Digital Applications for Long-term Care - DiPAs  

Digital long-term care applications, known as DiPAs, are intended to provide support to care recipients who are cared for at home. DiPAs are designed to help ease the care recipient’s loss of independence or capabilities or to prevent their need for care from progressing further. Those applications are available as apps or as web applications. To qualify for insurance cover, all digital care applications must be approved in advance by BfArM and listed in the DiPA directory. DiPAs can be used by care recipients alone or by care recipients together with their family carers, voluntary carers, or approved care services. 

They are intended to: 

• provide guidance and support on a daily basis to improve the independence or capabilities of the care recipient and seek to prevent their need for care from progressing further 

• help care recipients to organize and manage their own care on a daily basis 

• provide support in special care situations, e.g. by helping care recipients improve their own state of health – for example, apps with exercises to help reduce the risk of falls or memory training exercises for people with dementia 

Digital Act – DigiG  
In March 2024, the Act to Accelerate the Digitalisation of the Healthcare System (Digital Act – DigiG) entered into force. The aim is to improve healthcare in Germany using digital solutions such as electronic patient records (ePA).

Electronic patient record – ePA 
From January 2025 on, individuals with statutory health insurance (73 million) will automatically receive an electronic patient record (ePA) unless they object to having one set up for them. The ePA file system is accessed via the telematics infrastructure - a secure, self-contained network. The servers for processing data are located in Germany and are subject to European data protection regulations. All documents are end-to-end encrypted. Only insured persons themselves (or those they grant access to) can decrypt messages.

Health Data Use Act (GDNG) - strengthening Germany as a research location 
In December 2023, the German Bundestag adopted the Health Data Use Act (GDNG), which entered into force in March 2024. The act is intended to make health data accessible for research-based pharmaceutical and medical device companies so they can use the data for research and development of medicinal products, medical devices, and treatment methods. The GDNG specifies this use and aims to strike a balance between the interests of the individual and those of society. Legally insured persons will be able to object to the use of their data under the act. The act also allows the use of patient data for testing and training artificial intelligence (AI) applications. Such data will be made available to researchers by the Health Data Lab at the BfArM. This involves billing data that is transmitted to the HDL by the German National Association of Statutory Health Insurance Funds in pseudonymised form. Data from electronic patient records (ePA) will also be added. The center is currently being established and will begin accepting the first applications for data use starting in early 2025. Researchers will be able to test the reliability of AI tools more easily due to the larger database. This is expected to give a boost to medical AI research and AI applications in Germany.

Artificial Intelligence (AI) 
As the OECD has highlighted, “Germany has started meaningful action to advance AI in health, including legislative measures aimed at boosting the integration of digital health technologies and actively promoting AI applications in medicine”. Beyond legislation to enhance the availability and use of data, the government’s strategy includes significant funding for health-related AI projects. The aim is to improve health outcomes, system efficiency, and innovation - aligning with the EU’s health data space (EHDS) for better cross-border data collaboration.

Health AI Research & Development: Institutes and University Hospitals

German Research Center for Artificial Intelligence (DFKI) 
As the largest, independent AI research center worldwide, the DFKI develops product functions, prototypes and patentable solutions in the field of information and communication technology. Research and development projects are conducted in 27 research departments, ten competence centers and eight living labs.