Doctor with a tablet in the hands and office background Doctor with a tablet in the hands and office background | © suedhang_gettyimages.com

Digital Health

Digital Solutions for Today’s Health Care Challenges

Since 2018, the German Ministry of Health has pushed forward a great amount of legislative actions to digitalize the health care system. In 2019, the German parliament passed the Digital Care Act (DVG) to accelerate digitalization and innovation within the German health care market. The act also paves the way to broad usage and reimbursement of digital health applications – so-called “DIGAs.” These steps open up the German health care market to a digital transformation that will provide 73 million insured Germans access to digital health application on prescription.

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.

Graphic: Fast Track into the DIGA Directory
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.

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Digital Health Market

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

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
One example that vividly illustrates how digital health is not just about saving money but also lives is the use of telemedicine solutions for the treatment of strokes. Germany has a dense network of stroke units and tele-stroke units. There are more than 300 hospitals with certified stroke units in Germany. Tele-stroke units complement the high quality and comprehensive medical care of strokes in areas where the admission to a hospital with a stroke unit would take too long. Since 2011, tele-stroke units are also certified to ensure the high quality of these telemedicine networks.

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