Research2Guidance (R2G) has published a new report on the new, and faster, German regulations for obtaining approval for digital health applications. 2019’s Digital Healthcare Act (DVG) introduced measures to speed up approvals for digital apps so that they can be prescribed by German doctors and reimbursed through German public health insurance, which covers 90 percent of the population.
The Digital Health Applications process (DiGA) requires a review by the German Federal Institute for Drugs and Medical Devices (BfArM) to prove that apps and digital tools improve patient care. Other criteria include:
- Data protection legislation and information security conformance
- CE-certification as a medical product (in the lowest-risk class for now)
The R2G report details not only the DiGA Fast Track process and the current status of DiGA adoption, but also what it takes to create a successful German market entry strategy with innovative distribution channels. If you have a digital health app or tool, and you’re targeting 80 million Germans, this report is a Must Read. R2G page, Mobihealthnews, HealthcareITNews