The European Health Data Space as 3LGM2-Based Enterprise Architecture Model.

Area of Science:

• Health Informatics
• Enterprise Architecture
• Data Governance

Background:

• The European Health Data Space (EHDS) regulation mandates new frameworks for health data management across Europe.
• Developing compliant European health information systems necessitates robust architectural blueprints.
• Enterprise Architecture Models (EAM) are crucial for designing complex information systems.

Purpose of the Study:

• To propose an Enterprise Architecture Model (EAM) tailored for the European Health Data Space (EHDS) regulation.
• To leverage the three-layer graph-based metamodel (3LGMš) for structuring EHDS-compliant health information systems.
• To provide a freely accessible model and tool for implementing EHDS data management strategies.

Main Methods:

• Development of an Enterprise Architecture Model (EAM) based on the three-layer graph-based metamodel (3LGMš).
• Description of stakeholder tasks, data processing requirements, and application systems/services within the EHDS context.
• Integration of primary and secondary data use considerations into the architectural model.

Main Results:

• A comprehensive EHDS 3LGMš model detailing stakeholder roles, data flows, and system components.
• The model addresses both primary (patient care) and secondary (research, policy) data use.
• The EHDS 3LGMš model and associated tool are made publicly available.

Conclusions:

• The presented EHDS 3LGMš model provides a foundational architecture for European health information systems.
• This model facilitates compliance with the EHDS regulation by defining necessary components and data governance.
• The availability of the model and tool supports the practical implementation of the European Health Data Space.