Digital Health Technology Approval and Evidence in Germany

The previous approach to digital health technology assessment in Germany was considered rigid by many in the industry. However, with the passage of the Act to Improve Healthcare Provision through Digitalization and Innovation (Digital Healthcare Act, DVG) in late 2019, the process was accelerated. Digital health applications now can get results from the Federal Office for Drugs and Medical Devices (BfArM) much earlier.

According to an article on Xcenda, “The BfArM assessment procedure is referred to as the fast-track process as manufacturers receive notification of the result within 3 months after submitting an application. The assessment determines whether the DiGA fulfills all requirements regarding necessary product qualities (eg, data protection specifications) and whether the use of the DiGA results in a positive healthcare effect.”

Find out more about the process by clicking here.

(Source: Xcenda, November 23^rd, 2021)