CARDIO-HUB

Enabling Real-World Evidence for Elderly Heart Failure through EHDS-Aligned Data Spaces and Remote Care.
European health systems face a dual challenge: generating high-quality evidence from real-world health data while ensuring that data can be accessed, understood and reused safely across organisational and regional boundaries. This project prioritises advancing European Health Data Space (EHDS) readiness through a federated, standards-based data infrastructure that enables the secondary use of harmonised real-world data (RWD) for research, innovation and policy-relevant evaluation, using elderly heart failure care as a high-impact clinical use case. Building on the eHealthPass ecosystem, the project will deploy eHealthPass.CDR as an EHDS-ready clinical data backbone to collect, structure and harmonise multimodal data streams across pilot sites, including clinical records, patient-reported outcomes, and device-based measurements. Clear governance for consent, access control, data quality, and privacy-preserving processing will support compliant data reuse for research. The project will produce reusable data specifications and methodological guidance aligned with EHDS principles and interoperability standards.

In parallel, remote care and virtual ward services will be implemented as a real-world data generation and validation environment. Wearables and point-of-care measurements will support longitudinal monitoring and facilitate the development and validation of predictive and analytic models, while providing tangible benefits to care delivery. Two pilots (Greece and Italy) will demonstrate cross-regional feasibility, data harmonisation in practice, and research-grade data availability. The project will deliver an operational EHDS-aligned RWD infrastructure, validated datasets and model evidence, and a replication roadmap for scaling to other chronic diseases and cross-border scenarios.