The xShare project promotes an industrial label as a guarantee of data protection and interoperability across Europe

The xShare project

aims to make it easier for European citizens to download and transfer their health data using the well-known yellow button. Inspired by the blue button of La Meva Salut in Catalonia, this functionality will enable easy access to health data from various EU healthcare systems, enhancing the patient experience and supporting collaboration with healthcare professionals in other countries.

Data sharing is based on international standards such as the International Patient Summary (IPS) and the European Electronic Health Record Exchange Format (EEHRxF), ensuring structured, secure and understandable data exchange across systems.

xShare thus puts into practice the strategy of the European Health Data Space,

by safeguarding the right to access and reuse personal data. These data can serve primary purposes (direct care such as diagnosis, treatment or monitoring) or secondary purposes (research, healthcare management, resource planning or public policy). In both cases, data quality and structure are critical to ensuring their value and impact.

An industrial label to foster interoperability and regulatory compliance

To support the adoption of the yellow button, the xShare project has developed an Industry Label. This certification serves as a quality and excellence marker for companies and organisations that meet the technical and regulatory requirements of the EHDS.

The xShare label is divided into three levels, reflecting different stages of technological maturity:

• Bronze: Based on a self-assessment, it helps organisations understand their level of alignment with the EHDS. Certification is issued automatically upon submission of a technical form.

• Silver: Assesses compliance with the IPS standard, including technical validations and functional tests of the yellow button, through a mix of automated and manual reviews.

• Gold: The highest level, reserved for solutions fully integrated into healthcare environments. It requires a comprehensive evaluation by a healthcare authority (such as the TIC Salut Social Foundation) covering technical, usability, accessibility and content aspects.

The xShare industry label demonstrates the industry’s commitment ti implementing the EEHRxF

According to Carme Pratdepàdua, Head of Digital Assets at the TIC Salut Social Foundation, “the industry label defines a common framework with clear indicators to measure the degree of adoption of EEHRxF and to establish a rigorous assessment system for organisations wishing to implement it”.

This label aims to align all key actors—healthcare industry, regulators, patients, data users, policymakers and standardisation bodies—by laying the groundwork for its viability and recognition at the European level.

Pilot phase and next steps: Catalonia leads the way

The xShare industry label will ensure that citizens and patients can share their health data securely and interoperably across platforms.

Implementation will begin with a pilot phase in eight project adoption centres, including Catalonia, represented by the TIC Salut Social Foundation.

Centres will be required to implement the latest version of the HL7 FHIR IPS Implementation Guide (version 1.1.0), which ensures the proper structuring of health data. This phase will help gather key insights to improve tools and consolidate adoption of the EEHRxF model, in line with the EHDS regulation (notably Article 23 on EHR systems and Article 14.3 on digital health technologies).

The rollout of the xShare label will be informed by the project’s results, regulatory developments and the ecosystem’s needs. In addition, resources and technical support will be provided to encourage semantic interoperability and foster healthcare research and innovation.

Finally, Carla Álvarez, Head of Public Programmes at the TIC Salut Social Foundation, explained that “Catalonia will be the first adoption centre to assess two healthcare organisations that have already implemented the HL7 FHIR IPS. This positions us as a European reference in the implementation of this standard and in the evaluation of the EEHRxF model.”