Innovation is perceived as one of the key areas of potential in the European Health Data Space (EHDS). At the centre of the 2025 EHDS regulation’s three main aims is for Europe to better achieve purposes that involve the use of electronic health data in the healthcare and care sectors that would benefit society. Innovation is one of the several societal benefits mentioned. In health and care, artificial intelligence (AI) surely provides one of these areas of opportunity.

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Throughout 2023-2026, the Xt-EHR joint action worked to enhance the interoperability and exchange of healthcare data between European countries, and to pave the way for implementation of the EHDS regulation.

As part of the joint action’s work, together with EHTEL, the project produced a Briefing Paper on how findable, accessible, interoperable, and reusable (FAIR) data structures can enable communication with EHDS-compliant electronic health record (EHR) systems and algorithm-based tools. The Briefing Paper is inspired by the remit of Xt-EHR Work Package (WP)5 deliverables on General Requirements for EHRs and System Interfaces.

Contributions by the EHDS on the FAIRification of data

The EHDS is eagerly expected to make a significant contribution to the FAIRification of health data. This progress is anticipated to take place through the interoperability specifications defined for six priority information domains listed in article 14 of the EHDS regulation. By promoting common formats, identifiers, and exchange mechanisms, the EHDS establishes an essential foundation for making health data FAIRer across both borders and systems.

Specifications on their own, however, are not enough to support the safe, scalable, and trustworthy integration of more advanced algorithm-based tools (especially AI-driven clinical decision support systems (AI-CDSS)). Data can remain difficult to interpret, reuse, and validate.

Instead, a critically important pre-requisite to ensure meaningful communication between EHR systems and algorithmic tools is a more in-depth implementation of semantic interoperability. Achieving this level of FAIRness in Europe requires strategies to be coordinated across the entire health data value chain.

The role of AI and algorithm-based tools

AI is increasingly becoming part of the solutions with which to face remaining FAIRification challenges. AI-based tools can support the structuring, coding, validation, and enrichment of health data. From a FAIR perspective, however, human oversight remains essential to the maintenance of quality, transparency, explainability, and trust in data and algorithmic outputs.

In this field of activity, it is important to work with the EHR industry and EHR platforms. Indeed, the Briefing Paper already shows – in its Annex 2 – 10 types of AI- and algorithm-based tools that are already functioning and/or on the market. They range from AI-CDSS through to virtual health assistants.

As the briefing paper concludes:

What the Briefing Paper offers

This 85-page Xt-EHR/EHTEL Briefing Paper deep dives into potential European-level expectations for data structures that would enable communication between EHR systems and algorithm-based tools. It highlights that the data structures should be in line with FAIR data principles. The paper contains plenty of insights into data fluidity, FAIR data,  and AI-based algorithms. Practically, it outlines use cases, typologies and samples of tools, and lists the involvement of members of a wide  spectrum of 13 actors/stakeholders.

Chiefly, the Briefing Paper offers 10 key recommendations. Among them are these three:

• Leveraging AI for progressive FAIRification.
• Balancing transparency, explainability, and seamless AI
• Investing in stakeholder-specific digital literacy, including on AI.

Two 2025 webinars provided content which formed the origins of the Briefing Paper. They were part of EHTEL’s series of EHDS implementers’ task force meetings. Brief public reports on the event are available. 

EHTEL’s own reflections on next steps in the journey

EHTEL is  proud of the confidence  that Xt-EHR placed in EHTEL’s capacity to engage stakeholders in reflecting on this forward-looking aspect of the EHDS.

This Briefing Paper is not the end of the journey. Rather, it is a key milestone in a conversation that EHTEL is holding with implementers on how to advance digital health and care transformation.

For more information

• Download the Briefing Paper 
• Europe’s thinking on health data use and AI
  
• News from Cyprus: Health data uses and AI
  
• A leaflet on the background on the Xt-EHR joint action
• EHTEL EHDS implementers’ task force meeting of 16 October 2025. 
• EHTEL EHDS implementers’ task force meeting of 5 December 2025.