Medical Informatics Initiative and the German Portal for Medical Research Data: Alignment with EHDS Regulation.

Area of Science:

• Health Informatics
• Data Governance
• Medical Research

Background:

• The European Health Data Space (EHDS) mandates harmonized regulations and infrastructure for EU-wide secondary health data sharing.
• Germany has established national data sharing capabilities through the Medical Informatics Initiative (MII) and the German Portal for Medical Research Data (FDPG).

Purpose of the Study:

• To compare the German MII/FDPG framework with the EU EHDS regulation.
• To assess the readiness of Germany's national infrastructure for the EHDS, focusing on data holder and data access body responsibilities.

Main Methods:

• Comparative analysis of the German MII/FDPG framework against the stipulations of the EU EHDS regulation.
• Focus on the roles and responsibilities of data holders and data access bodies within both frameworks.

Main Results:

• The established national secondary use research infrastructure, developed over a decade by the MII, provides a solid basis for Germany's EHDS implementation.
• The German framework demonstrates alignment with key EHDS requirements, particularly concerning governance and data access.

Conclusions:

• Germany's existing infrastructure is well-positioned to meet the requirements of the European Health Data Space.
• The MII and FDPG serve as a robust foundation for Germany's participation in the EHDS, facilitating secure and harmonized health data sharing for research.