Digitale Gesundheitsanwendungen (DiGA)

Digitale Gesundheitsanwendungen (DiGA), often translated as "apps on prescription" is a legal term used in Germany for digital health applications designed to support the detection, monitoring, treatment, or alleviation of diseases or disabilities. DiGA are regulated under the German Digital Healthcare Act (DVG) and must be certified as medical devices under the EU Medical Device Regulation (MDR).

These applications range from mobile apps to web-based platforms and are prescribed by healthcare professionals or accessed directly by patients via statutory health insurance. DiGA provide evidence-based support, such as digital therapy plans, symptom tracking, or cognitive behavioral therapy.

Before approval, DiGA must demonstrate safety, data protection, and positive healthcare effects through evaluation by the Federal Institute for Drugs and Medical Devices (BfArM).