§ 374a SGB V: Medical Aid Data Becomes Part of Digital Care
What manufacturers need to know about implementing § 374a SGB V and the binding HDDT technical specifications
§ 374a SGB V has been in force since 2021, with its implementation deadline adjusted several times since due to missing technical specifications. The specifications – Health Device Data Transfer (HDDT) has been published by gematik in October 2025 for stakeholder commenting and are available since April 2026 as normative version 1.0.1. In parallel, BfArM has published interfaces and registration processes for the new device registry. With the upcoming GeDIG, the binding nature of these requirements are even strengthened, particularly by requesting the Establishment of a structured sanctions regime for non-compliance through the GKV-Spitzenverband. Having this organizational and technical ecosystem in place, it is now up to the manufactures of medical aids and implants to implement the requested services for sharing data with registered health apps (DiGA) by January 2028:
- All platforms and other backend systems which gather data from personal health devices and implants reimbursed in the first healthcare market – starting with glucometers, rtCGM, AID systems, blood pressure monitors, peak flow meters, and spirometers – must provide an open interface according to the HDDT specification.
- These systems must also be registered in the Directory of Medical Device and Implant Interfaces (HIIS) maintained by BfArM.
- Manufacturers are also legally required to provide technical support and testing abilities for DiGA manufacturers to connect and integrate their solutions.
For medical device manufacturers, § 374a SGB V and the HDDT specifications represent a fundamental paradigm shift: until now, medical aids and their associated apps have existed in isolation within a manufacturer-specific ecosystem, focused on measuring patient data. Through HDDT, medical aids become part of a connected, cross-manufacturer ecosystem that also includes DiGA, practice IT systems, and the telematics infrastructure – covering the entire process chain from data collection through patients‘ self-management to physicians‘ care processes.
The decisive challenge for manufacturers is how quickly and successfully they can turn this legally mandated interoperability and openness to their advantage.
To explore these opportunities and their practical implications for manufacturers and other stakeholders, the event will cover the following topics:
- § 374a SGB V: Medical Aid Data as Part of Connected Digital Healthcare
Jana Venhaus-Gießmann (Referatsleiterin „Digitale Versorgungsprozesse und Anwendungen“ im Bundesministerium für Gesundheit)
- Registration of Medical Aids with the BfArM Device Registry
angefragt: Dr. Armin Grünewald/Leonie Reick (Bundesinstitut für Arzneimittel und Medizinprodukte) - Health Device Data Transfer: Implementation and Support Offerings
Sergej Reiser (_fbeta GmbH) - Device Interoperability: What comes next?
angefragt: Sophia Lückhoff (Kompetenzzentrum für Interoperabilität im Gesundheitswesen)
Who should attend: Manufacturers of medical aids and implants, DiGA manufacturers, and anyone with regulatory or technical responsibility for the implementation of HDDT and § 374a SGB V.
Please don’t hesitate to reach out with any questions:
phone: +49 (0) 30 610 769 16 or email: event@fbeta.de