With the new Digital Healthcare Act (DVG), Germany is opening up to digital innovation in healthcare. Starting September 2020 doctors in Germany can prescribe digital health applications approved by BfArM.
What is DiGA?
- Low risk MDR approved medical device class I and IIa
- Main functionality relies on digital technology
- Supports disease detection, monitoring, treatment or relief as well as provides support for compensation of diseases, injuries and disabilities
- DiGA is used by a patient or by patients and a medical provider together.
"DiGA are digital helpers in the hand of a patient"
Requirements for DiGA
To be listed as DiGA your medical application has to go through BfArM approvement process and fulfill the requirements around:
The DiGA assessment is designed as a fast-track process. Within three months after receiving the application, the BfArM has to assess the DiGA and examine the product's technical features and evidence of its positive healthcare effect.
The assessment process is shown in the scheme below: