Working documents

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.

The European Electronic Health Record Exchange Format (European EHRxF), introduced by the European Commission in 2019, aims to ensure secure, interoperable, cross-border access to electronic health data across the EU. To enhance public understanding, “EHRxF in a Nutshell” was developed, illustrating its benefits through eight storylines based on perspectives of citizens, workforce, health system, and market.

This document summarises major current strategic and priority secondary use data collection initiatives and analyses them with the aim of bridging the gap between primary and secondary data use for better healthcare outcomes and policymaking. It documents important lessons learnt from “only once” initiatives and discusses the need of a better alignment between resources used in care, research, epidemiology and decision support.

Finland boasts comprehensive, high-quality information resources and advanced digital service infrastructure, anchored by the extensive Kanta services system. The implementation of the Act on the Secondary Use of Health and Social Data in 2019, along with the establishment of Findata as a centralized access point for secondary use of health and social data, solidifies Finland’s position as a global leader in health data management and accessibility. Moreover, its robust health information system, combined with active participation in European initiatives, positions Finland as a key player in shaping and preparing for the European Health Data Space (EHDS).