Integration between
Two Data Spaces

Summary This document discusses the technical and governance aspects required to integrate existing federated healthcare data networks into the European Health Data Space (EHDS), focusing on the Clinnova project as a case study. It highlights the challenges and necessary adaptations for compliance with EHDS regulations to enable secure, interoperable, and cross-border health data sharing.

Federated healthcare networks and EHDS alignment: Federated networks retain data locally while enabling distributed analytics and collaboration. Aligning these networks with EHDS infrastructure and governance is essential for lawful cross-border secondary health data use in Europe.

Existing federated network initiatives: Projects like HealthData@EU, IDERHA, EHDEN, and BBMRI-ERIC exemplify efforts to create interoperable, EHDS-compatible health data infrastructures with standards for metadata, data access, and common datamodels.

Clinnova project overview: Clinnova is a cross-border federated network focusing on immune-mediated diseases, employing a federated architecture that keeps data locally while sharing metadata and governance information through standardized interfaces.

DS-PACK for federated data governance: Clinnova uses the DS-PACK suite, including DAISY, REMS, the Elixir Data Catalogue, and Keycloak with OIDC, to manage metadata, data access requests, and authentication across partners, supporting privacy-preserving governance.

Data harmonization and common data model: Clinnova harmonizes heterogeneous clinical data using REDCap and openEHR, with a pipeline for transforming institutional data into interoperable formats, facilitating shared analytics.

Roadmap for EHDS compliance: To align with EHDS, Clinnova must enhance metadata catalogues to comply with Health DCAT-AP standards, extend REMS to integrate the Common European Data Access Application Form and national systems, adopt or subscribe to EHDS-certified secure processing environments, integrate eIDAS 2.0-compliant authentication, and map its data models to OMOP CDM and HL7 FHIRstandards.

Blueprint for federated network integration: The document proposes that the approach for evolving Clinnova into an EHDS-compliant data space can serve as a model for other federated research networks to interconnect with European health data spaces, unlocking broader research and policy opportunities.