Health apps on prescription: Guide shows ways into the German market
The number of health apps on prescription in Germany is currently growing strongly. Many developers are waiting in the wings. IGES Digital's guide shows how market access and reimbursement of digital health apps work in Germany. The biggest challenge is primarily the studies that the company must submit in order for the digital health innovation to be reimbursed. This is because these studies must prove that the health app improves the medical care of its users.
The German market: around 73 million people with statutory health insurance
In Germany, there is a market of around 73 million people with statutory health insurance. These can have a medical app with proven benefits, also called digital health apps (DiGA), prescribed by their doctor. It is also possible to apply directly to one's own health insurer for reimbursement. This is regulated by the Digital Health Care Act (DVG), which came into force in December 2019. However, the app must first undergo an official review process at the responsible Federal Institute for Drugs and Medical Devices (BfArM) and be included in the so-called DiGA directory of the BfArM. In this process, the applicant must prove the existence of the so-called "positive Versogungseffekt" (positive effect on care). The studies required to prove the positive Versogungseffekt of a medical app are demanding, must be conducted in Germany, involve a manufacturer-independent institution and meet high methodological requirements. This is particularly challenging for international companies, as they are often not familiar with the medical care landscape in Germany.
Reimbursement options also for non-DiGAs
The 28-page brochure "Market Access and Reimbursement for Digital Health Apps" from IGES Digital describes the procedures for proving the positive effect on healthcare and the various options for submitting an application. The authors are experts in the fields of medical technology, clinical and health services research, and reimbursement. A special feature of the guide is that it also describes reimbursement options for digital health care products that are not DiGAs and for combined products, such as a DiGA and a medical device. The guide also provides general information on the German digital healthcare market and healthcare system.
DiPA - the new digital nursing application in Germany
Our guide contains an extensive chapter on DiPA, the new digital care applications designed to help patients better manage everyday care. DiPAs can be used by nursing patients to stabilize or improve their own state of health through exercises. They can also improve communication with family members and caregivers. DiPAs can be used either as an app on mobile devices (e.g., smartphone, tablet) or as a browser-based web application on a computer or laptop.
DiPAs are not available by prescription. For a digital care app to be reimbursed by the long-term care insurance fund, it must have been included in the directory for digital care aids (DiPA directory). Only DiPAs listed there will be reimbursed. Our guide explains which digital products can be listed as DiPAs, which studies are required and how the entry in the DiPA directory succeeds.
Market Access and Reimbursement for Digital Health Apps in Germany
36 pages, in English
Published by: IGES Institute, 2020
The guide can be requested here:
Contact: Agata Daroszewska
Phone: +49-(0)30-23 08 09 40