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 to medium risk class whose main function is provided by digital technologies.

In addition to meeting high data protection and data security requirements, they must also have demonstrated their benefit as a so-called "positive healthcare effect" and their safety in a clinical investigation. If they fulfil 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.

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 support the detection, monitoring and treatment of diseases and disabilities. They can be used on smartphones, tablets, PCs or other electronic appliances.

Reference to the European Medical Device Regulation (EU) 2017/745 (MDR):

DiGA are medical devices in risk classes I to IIb and are subject to the Medical Device Regulation (MDR 2017), which aims to ensure that they are effective and safe. DiGA are always used by patients and can be combined with other (for example) medical performances.

Other laws:

DiGA are further regulated in Germany by the Medical Devices Implementation Act (MPDG), the Digital Care Act (DVG) and the Digital Act (DigiG) in order to implement the requirements of the MDR.

Fast-track procedure of the BfArM:

The Federal Institute for Drugs and Medical Devices (BfArM) offers an accelerated procedure (Fast Track) for the authorisation of DiGA to enable rapid access to innovative digital solutions. DiGA and digital care applications (DiPA) are tested by the BfArM on the basis of investigator criteria prior to listing.

Quality requirements:

DiGA must fulfil certain quality and safety standards in order to be prescribed by doctors. These include: Functional suitability, 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.

Proof of the positive healthcare effect:

DiGAs must have a proven benefit for patients in order to be authorised. This can be either through medical benefit or patient-centred and patient-relevant structural and procedural improvements in a systematic data analysis (provisional listing) or clinical investigation (final inclusion in the DiGA Directory).

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

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