Dataspace4Health Reference Architecture
Muhammad SHOAIB, Zia ALBORZI
Architecture Purpose and Vision
The Dataspace4Health Reference Architecture v1.0 provides a comprehensive blueprint for implementing secure, sovereign health dataspaces based on European dataspace frameworks and Gaia-X principles. It addresses health data fragmentation by enabling trusted, federated data exchange between healthcare organizations while preserving data sovereignty and regulatory compliance.
This architecture transforms isolated healthcare systems into a collaborative ecosystem where hospitals, research institutions, and laboratories can securely share data while maintaining full control. It unlocks capabilities for personalized medicine, clinical decision support, and collaborative research without compromising patient privacy.
Core Architectural Principles:
The architecture is built on five fundamental principles:
Data Sovereignty: Data remains under originating organization control with explicit consent policies
Federated Architecture: Decentralized approach enabling secure, policy-driven access
Semantic Interoperability: Standardized data models (FHIR, OMOP, openEHR) ensure consistent interpretation
Compliance by Design: Built-in mechanisms for GDPR, EHDS, and European health regulations
Trust and Transparency: Cryptographic identity management and immutable audit trails
The technical implementation follows a proven five-layer model:
Business Layer: Governance frameworks and compliance mechanisms
Functional Layer: Clinical dashboards, patient applications, and research portals
Information Layer: Semantic harmonization and metadata management
Process Layer: Digital-twin engines and AI-powered decision support
System Layer: Eclipse Dataspace Connectors, identity services, and policy enforcement
A key innovation lies in the integration of digital-twin services as a cross-layer capability, enabling personalized, AI-driven patient health models that support real-time clinical decision-making.
Value and Strategic Impact
Healthcare Providers gain secure access to external data sources while maintaining control, enabling AI-powered clinical support and federated research participation without data movement.
Research Institutions access harmonized, multi-institutional datasets with built-in compliance, supporting collaborative AI development without exposing sensitive data.
Technology Implementers benefit from standardized APIs and modular components that integrate with existing healthcare IT systems while minimizing operational disruption.
Regulators receive comprehensive audit trails and policy enforcement ensuring compliance with current and anticipated requirements including GDPR and EHDS.
Standards Foundation
The architecture leverages established international standards: HL7 FHIR for clinical data exchange, OMOP CDM for research analytics, openEHR for longitudinal records, and SNOMED CT/LOINC for terminology. Identity management uses eIDAS frameworks and self-sovereign identity standards, while Eclipse Dataspace Connectors enforce data sovereignty aligned with Gaia-X specifications.
Strategic Positioning
This reference architecture positions organizations within the emerging European health data ecosystem, ensuring compatibility with the European Health Data Space (EHDS) initiative and Gaia-X principles. Implementers will be prepared for cross-border health data sharing, European research participation, and compliance with evolving digital health regulations.
The Dataspace4Health Reference Architecture serves as a practical blueprint for healthcare ecosystems seeking sovereign, secure, and interoperable data sharing capabilities while maintaining European data protection compliance.