Digital health applications (Digitale Gesundheitsanwendungen, DiGA) are software applications with a medical purpose. A DiGA is therefore a CE-marked medical device. In the German health system, the decisive factor for a DiGA is that the core medical function is essentially provided by the application, i.e. it is based on digital technology.
A DiGA as a medical device supports the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities.
In the German healthcare system, it is possible for patients to have the costs of a DiGA reimbursed by the health insurance funds. Manufacturers can have their DiGA included in the DiGA register via an application procedure at the (German) Federal Institute for Drugs and Medical Devices (BfArM) .
Like DiGA software applications, digital care apps (Digitale Pflegeanwendungen, DiPA) have a medical purpose and are therefore also CE-marked medical devices. Their core nursing medical function is essentially based on digital technology. The apps support the long-term care of patients. Manufacturers in Germany can apply to the BfArM to have their products included in the DiPA list.
