The Digital Health Market in Germany
Germany's Digital Care Act (DVG) paves the way to broad usage and reimbursement of digital health applications - providing access to digital health applications on prescription to 73 million insured Germans.
The healthcare industry in Germany is undergoing massive digitalization. By 2025, the German digital health market is projected to be worth EUR 57 billion.
Digital Health Applications
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
“Fast Track” into the DIGA directory
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.
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.
Telemedicine
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.
“Time is Brain” - Telemedicine Closes Gaps in Health Care Provision
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