What are DiGA?

DiGA refers to digital health applications, so-called "medical apps on prescription". These are medical devices with a CE mark and a low risk class whose main function is provided by digital technologies. In addition to high requirements for data protection and data security, they must also have demonstrated their benefits as a so-called "positive care effect" and their safety in a clinical trial. If they meet these requirements, they are reimbursed by health insurance companies in Germany. For example, they can monitor vital signs (blood pressure, blood sugar, heart rate), remind people to take their medication or provide therapy recommendations.

1. definition: DiGA are digital products that are used to support health objectives or manage medical conditions. According to the Digital Healthcare Act (DVG), they are intended to promote health and to support the detection, monitoring and treatment of diseases and disabilities. They can be used on smartphones, tablets, PCs or other electronic devices.

2. reference to the European Medical Device Regulation (EU) 2017/745 (MDR): DiGA are medical devices in risk classes I or IIa and are subject to the Medical Device Regulation (MDR 2017), which aims to ensure that they are effective and safe. DiGA are always also used by patients and can be combined with other (for example) medical services.

3. other laws: DiGA are further regulated in Germany by the Medical Devices Implementation Act (MPDG) and the Digital Healthcare Act (DVG) in order to implement the requirements of the MDR.

4. fast-track procedure of the BfArM: The Federal Institute for Drugs and Medical Devices (BfArM) offers an accelerated procedure (fast track) for the approval of DiGA in order to enable rapid access to innovative digital solutions. DiGA and digital care applications (DiPA) are tested by the BfArM on the basis of test criteria prior to listing.

5. quality requirements: DiGA must meet certain quality and safety standards in order to be prescribed by doctors. These include: Functionality, data protection, information security, technical quality, interoperability, consumer protection and fairness, quality of medical content, patient safety, user-friendliness and connection to the healthcare system.

6. proof of the positive effect on care: DiGAs must have a proven benefit for patients in order to be approved. This can be done either through the medical benefit or patient-related and patient-relevant structural and procedural improvements in a systematic data analysis (provisional inclusion for testing) or clinical trial (final inclusion in the DiGA list).

The integration of DiGA into healthcare enables a more modern, patient-centered approach and highlights the use of digital technologies to improve healthcare.