Working documents

This draft deliverable report presents the initial xShare proposal for a Care Plan HID within the EHDS ecosystem. The proposal is based on the observation that healthcare systems across Europe are increasingly required to support patients with chronic diseases, multimorbidity and long-term care needs.

The workshop titled “Connecting primary and secondary use of data in the EHDS: creating the conditions for real data fluidity” offers a rich, multi-perspective exploration of long COVID as both a clinical and data governance challenge.

Summary of the xShare WP4 workshop findings held in Brussels in March 2026 during the IHE Connecthaton

The xShare Industry Label is an experimental, voluntary, pre-regulatory certification designed to help EHR systems and wellness app manufacturers demonstrate their technical readiness for the European Electronic Health Record Exchange Format (EEHRxF).

Key insights from xShare’s first data collection round, focussing on uptake of standards related to the European EHR Exchange format. Based on Survey with 38 replies from 17 Member States, status August 2025.

Key insights from xShare’s first data collection round, focussing on quality and integration of EHR data. Based on Survey with 38 replies from 17 Member States, status August 2025.

Between February and March 2025, we interviewed 9 experts representing diverse healthcare-related institutions from seven different EU countries. We used a semi-structured format aligned with three core themes: (1) uptake of standards, (2) data quality, and (3) the current state and implementation of EHRs.

The adoption of the European Health Data Space Regulation across the European Union provides enormous momentum to the provision of electronic health data access services to natural persons and their representatives.

This working paper presents the refined modular architecture and updated xShare toolbox enabling GDPR-aligned health data portability and interoperability under EHDS. It introduces open-source tools such as the CDA2FHIR converter, visualization utilities, and synthetic data support, validated through IHE Plugathon-style testing. This interim version lays the foundation for full interoperability and future certification, while identifying areas, such as consent management, that require further development.

This working paper (D5.1) reports on an analysis of the data elements from a number of sources to identify and to some degree align the healthcare/IPS data elements of greatest research value and proposes the data elements that could usefully be added to the existing IPS in order to maximise its value for public/population health and clinical research in addition to its primary value for healthcare. This core data element set will be subject to consultation by stakeholders, and then, aligned CDISC and HL7 FHIR implementation guides will be produced. This will set the groundwork for IPS+R and for additional health information domains, new or extended priority data categories in the EHDS.

This working paper presents nine use cases that illustrate how a common data format and a direct link between data with collected for primary use can support public health purposes. These use cases vary in terms of citizen involvement and the use of tools like the Yellow Button. They aim to address objectives such as administrative simplification, improved data quality, real-time monitoring, patient identification, and knowledge generation.

The xShare Industry Label is a voluntary certification developed to help the digital health industry align with upcoming European Health Data Space (EHDS) requirements. It provides a pathway for manufacturers to demonstrate technical compliance with interoperability standards, supporting early readiness for the EHDS and fostering cross-border health data exchange.