Development of a Cross-Border Gateway

DACO is actively working on the development of a Cross-Border Gateway, a key component of the HealthData@EU network within the EHDS. This gateway will allow secure exchange of metadata and application-related information between national and European services.

Functions of the Cross-Border Gateway

• Transmitting the national metadata catalog to a central European metadata repository.
• Forwarding applications from the European Commission to national data access bodies.

Participation in the EU Community of Practice

DACO is part of the Community of Practice, a European forum for the Competent Authorities and Affiliated Entities involved in EU-funded projects for the establishment of Health Data Access Bodies (HDABs). In this forum, institutions such as the BfArM collaborate to develop best practices for health data access.

Tasks of the Community of Practice

• Strengthening Collaboration: Improving cooperation between national health data access bodies.
• Creating an Information Exchange Platform: Facilitating the sharing of knowledge and alignment of strategies.
• Technical Knowledge Sharing: Promoting the exchange of expertise and best practices.
• Efficient Solutions: Developing and promoting sustainable approaches based on the 3R principle – Reduce, Reuse, Recycle.
• Harmonization and Standardization: Encouraging unified standards and better technical interoperability.
• Dissemination Strategies: Developing effective communication strategies for sharing results.

HDP4Germany (Improving HealthData@EU Preparedness for Germany) is an EU-funded project that significantly contributes to DACO.

As part of HDP4Germany, DACO actively participates in the Community of Practice of the European Commission. This network brings together European health data access bodies to exchange best practices and develop common standards for secure and efficient health data access.

More information on HDP4Germany can be found at EU Projects - HDP4Germany.

Participation in TEHDAS2

DACO actively contributes to TEHDAS2, the Second Joint Action Towards the EHDS, which develops concrete guidelines and technical specifications for the implementation of the EHDS regulation.

TEHDAS2 focuses on developing guidelines and technical specifications to support the implementation of the EHDS. The key goals of TEHDAS2 include:

• Creating harmonized guidelines and technical frameworks for health data access and usage.
• Facilitating the secure and cross-border secondary use of health data to support research, innovation, and policymaking.
• Assisting the European Commission in drafting implementing acts for the EHDS Regulation to ensure consistent application across member states.

DACO’s role in TEHDAS2

DACO is particularly engaged in the Safe and Secure Processing work package, focusing on data minimization, de-identification, and secure processing environments, in collaboration with the French Health Data Hub.

More information about TEHDAS2 can be found on the official website: TEHDAS.

The BfArM was also actively involved in the predecessor project, TEHDAS1, particularly in Work Package 7 ("Connecting the Dots"), which focused on designing the infrastructure for the EHDS. Further information on TEHDAS1 can be found at the archive of TEHDAS1 .

Why is EU Integration important?

Collaboration at the European level brings numerous benefits:

• Harmonization of procedures: Establishing unified processes for the secondary use of health data across Europe.
• Promotion of research and innovation: Advancing scientific and medical innovation through improved access to health data.
• Improved healthcare in Europe: Strengthening healthcare systems by enabling data-driven decisions and cross-border cooperation.