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 accessible, cross-border reuse. This project prioritises advancing European Health Data Space (EHDS) readiness through a federated standards- based data infrastructure enabling 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 use case. Building on the eHealthPass ecosystem, the project deploys eHealthPass.CDR as an EHDS- ready backbone to harmonise large-scale retrospective registries and multimodal prospective data streams across pilot sites, collecting clinical records, patient-reported outcomes, and device-based measurements. Clear data governance supports EHDS-compliant interoperability and reuse. Moreover, the development of a privacy-safe synthetic data factory will establish a replicable model of an interregional health data clearinghouse, enabling immediate open innovation and cross-border research. In parallel, remote care and virtual ward services function as a living lab for real-world data generation and validation. 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. Beyond standard remote monitoring, the project implements a deep tech translation loop: context-aware AI models, pre-trained on historical cohorts to recognize structural phenotypes, are deployed to filter real- time pilot data and continuously fine-tune risk stratification. Two clinical pilots (Greece and Italy) will demonstrate cross-regional feasibility (including patient mobility), data harmonisation, and research-grade data availability. The project delivers an operational EHDS- aligned infrastructure, validated datasets, and a replication roadmap.