Market access for medical apps

We pave the way to reimbursement for your medical app

With the Digitale-Versorgung-Gesetz (DVG), digital health applications can be reimbursed by health insurance companies for the first time in Germany. For this purpose, manufacturers must submit an application to the Federal Institute for Drugs and Medical Devices (BfArM), whereby the BfArM examines safety, functional capability, quality, data protection and data security. In addition, positive effects on health care must be proved. If the test is positive, the app is included in the Directory of Digital Health Applications (DiGA) in accordance with section 139e of the SGB V, and the app becomes reimbursable.

For the market success of your medical App, inclusion in the DiGA directory is essential. On the journey there, we provide comprehensive support in the application process, conduct preparatory literature research and formulate convincing evidence for your product.

How you can benefit from our services:

  • Comprehensive support in the application process to enable reimbursement of your medical app
  • Preparatory literature research
  • Convincing presentation of safety, functional capability, quality, data protection and data security as well as positive effects for health care
  • Assistance in the statement procedure at the BfArM