In this interview with MEDICA-tradefair.com, Prof. Dr. Broich talks about the fast-track admission procedure for digital health apps and the impact these products have during the corona pandemic.
Prof. Dr. Broich, what does Germany's new “Digital Health Applications Ordinance (in German “DiGAV”)” regulate?
Prof. Dr. Karl Broich: The number of digital health applications, or "DiGA" for short, has increased enormously in recent years: For example, apps or web applications can help to better control the course of therapy through a diary function or provide dosage recommendations based on current vital parameters.
With the coming into force of the Digital Supply Act in December 2019, the "app on prescription" for patients was finally introduced into healthcare. This means that around 73 million people insured under the statutory health insurance scheme are entitled to be provided with DiGA. These can be prescribed by doctors and psychotherapists and reimbursed by the health insurance companies.
The BfArM has been involved in shaping this important part of the digitization strategy of the German government and the Ministry of Health from the very beginning. In connection with the "apps on prescription", we are responsible for the evaluation procedures for the applications, as well as for the directory of digital applications that are listed as reimbursable health applications after successful testing.
Within a very short period of time, we have set up an appropriate test procedure for this purpose. This is designed as a "fast track": The evaluation time by the BfArM is a maximum of three months after receipt of the complete application.