Requirements of the BfArM for DiGA

The Federal Institute for Drugs and Medical Devices (BfArM) places high demands on digital health applications (DiGA) before they can be provisionally or even definitively listed in the DiGA Directory.

Regulatory framework

The BfArM sets the requirements for DiGA in accordance with the provisions of the Digital Health Care Act (DVG) and the Digital Health Applications Ordinance (DiGAV). These requirements include safety, functional suitability, data protection, data security and proof of a positive healthcare effect. The legal basis for this is anchored in the Fifth Book of the German) Social Code Book V (SGB V), in particular in Section 139e SGB V, which was amended in 2024 by the Act to Accelerate the Digitisation of the Healthcare System (Digital Act - DigiG).

Requirements for DiGA

The requirements as part of the test procedure that DiGA must undergo in order to be included in the DiGA Directory include

• Safety and functional suitability: as medical devices, DiGAs must fulfil the basic requirements for safety and performance.
• Data protection and data security: DiGA must fulfil strict data protection criteria. The BfArM has developed specific test criteria for data protection that DiGA manufacturers must demonstrate.
• Interoperability: DiGAs should be interoperable and use open interfaces to enable data exchange with other systems.
• Robustness: DiGAs must be robust against interference and tampering attempts.
• Consumer protection: DiGA must fulfil consumer protection requirements, including accessibility and age-appropriate usability.
• Quality: DiGAs must fulfil quality requirements relating to development, testing and use.
• Positive healthcare effect: DiGAs must demonstrate a patient-relevant positive healthcare effect. This can be either a medical benefit or a patient-relevant improvement of structure and processes in care.
• Proof of evidence: DiGA manufacturers must provide scientific evidence of the effectiveness of their users.

Only when these requirements are met is medical software included in the DiGA Directory as a DiGA.

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