Digital Health

Individuals with health insurance are entitled to coverage benefits for digital health applications (DIGAs) where those applications meet the following characteristics:

• Medical products of class I or IIa under MDR
• Main function is based on digital technologies
• DIGAs assist the process of detection, monitoring, treatment and alleviation of injuries and compensate diseases and disabilities
• 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

In order to bring digital health applications into the statutory health system, a  “Fast Track” process has been created to make sure that all of the 73 million Germans with public health insurance (90%) have access to these applications.

Fast Track into the DIGA Directory | © Federal Institute for Drugs and Medical Devices (BfArM); hih - health innovation hub 2020

The developer submits an application 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.

This means that 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, which can be used to provide a hypothesis and an evaluation concepts 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 producer can collect data and show the positive care effects its DIGA has. BfArM decides on the final listing and the producer negotiates a price with the umbrella organization of statutory health organizations.

Useful Links:

• BfArM - the Federal Institute for Drugs and Medical Devices

According to Arthur D. Little, the global market for digital health will grow to more than USD 200 billion through 2020.

The use of information and communications technology (ICT) in healthcare allows new business models to be established in order to enhance efficiency and, at the same time, maintain high quality in healthcare provision. The significant potential of digitalization to reduce healthcare costs has been proven by a number of studies. The Fraunhofer Institute for Systems and Innovation Research estimates that integrated digitalization of data and processes could achieve annual savings of EUR 9.6 billion in the German healthcare system alone.

Telemedicine combines telecommunication and information technologies to provide remote health care and other health-related services. A number of telemedicine initiatives have sprung up in recent years, with about 200 telemedicine projects currently active in Germany. Detailed information about ongoing and implemented projects is provided by Deutsche Telemedizinportal, part of the eHealth Initiative founded by the Federal Ministry of Health. The aim of the initiative is to pave the way for meaningful applications past the project phase into standard care.