The Helpdesk will acknowledge the receipt of your question within 5 working days. We will give you an answer via email within 20 working days.

An internal expert team within the xShare project will answer your question. Occasionally, we might direct you to experts from other EU projects related to the EHRxF, if their expertise fits more.

The EHRxF is not a platform, central repository, or piece of software.

According to Article 14(1) EHDS, the format applies to the following priority categories of personal electronic health data:

• a) Patient summaries;
• b) Electronic prescriptions;
• c) Electronic dispensations;
• c) Medical imaging studies and related imaging reports;
• d) Medical test results, including laboratory and other diagnostic results and related reports; and
• e) Discharge reports

These categories must be exchanged in compliance with EHRxF when shared within or across Member States.

The following actors are required to implement and support the format:

• Healthcare providers and facilities
• EHR system manufacturers, who must ensure their products are compliant with the common specifications in Art. 36, EHDS
• Digital health authorities in Member States, responsible for supervision and certification

The format enables semantic and technical interoperability across systems and Member States. This ensures that data generated in one country can be understood and used in another, improving continuity of care for mobile EU citizens and cross-border treatment scenarios.

No – the EHRxF is also for national level health-data exchange.

Yes. Detailed requirements are laid out in Art. 30 and Annex II of the EHDS Regulation

EHR manufacturers shall ensure that EHR systems  satisfy the essential requirements laid down in Annex II and conform with the common specifications (Article 36, EHDS Regulation).

EHR systems  need to comply with software components and specifications.

The requirements for software components relate to a logging and an interoperability component. They are outlined in Chapter III, Section 1, EHDS Regulation.

The specifications for the conformity of the harmonised software components of EHR systems are outlined in Chapter III, Section 3, EHDS Regulation.

Both components and specifications will be further defined via Implementing Acts.

Not yet. By 26 March 2027, the European Commission is expected to define via Implementing Acts the requirements and specifications that various stakeholders must comply with to meet the interoperability requirements that the EHDS Regulation demands.  The use of the EHRxF will be mandatory for patient summaries, electronic prescription and dispensation from 2029 onwards, and for medical images, test results and discharge reports from 2031 onwards.

To get a better idea of the upcoming Implementing Acts, check out the Joint Action Xt-EHR (2023-2026). It develops guidelines, implementation guides, and a conformity assessment framework for EHR systems. You can find out about their ongoing work and stakeholder engagement activities on the project website. The Deadline for the final Implementing Acts is 26 March 2027.

Yes. The European Commission, assisted by EU agencies and stakeholders, may update and extend the EHRxF specifications to incorporate new data categories or technical standards. These updates will be done via new Implementing Acts.

In the X-Bundle Registry, you can find examples of X-Bundles for the EHRxF priority categories and  the business use cases identified by the xShare project, including the Yellow Button. Please note that these resources are under development and are kept continuously updated.

The X-Bundles are and artefact of xShare and not part of the Implementing Acts. Yet, they provide a mean for better supporting the EHRxF adoption.

The Hub serves three principal functions: 

1. Managing and supporting users of interoperability assets relevant to their business use cases.
2. Co-Creation Environment: Providing a neutral space for collaborative design and innovation.
3. Adoption Promotion: Facilitating and encouraging the adoption of the European EHRxF across various stakeholders.

With its work, it supports Member States, organisations and vendors in the implementation of EHDS-ready  and compliant solutions.

The Hub sees itself as a one-stop-shop providing the following services:

• interoperability specifications and tools, adoption and implementation kits;
• a Community of Excellence;
• the xShare Industry Label as a mark of EHDS readiness.

The Hub is a joint initiative involving Standards Development Organizations (SDOs) (e.g. CDISC, CEN/TC 251, HL7 Europe, IEEE, IHE-Europe, and SNOMED International), industry representatives, policymakers and regulators, research organisations and others. The European Commission and other international organizations are invited as observers to ensure broad alignment and oversight.

Stakeholders can engage with the Hub through:

• Participating in co-creation and design-thinking activities.
• Utilizing the Hub’s resources and interoperability assets for their specific use cases.
• Contributing to the development and maintenance of EHRxF specifications.
• Collaborating with other stakeholders to promote the adoption of European EHRxF

For more information or to get involved with the European EHRxF Standards and Policy Hub contact the Hub’s coordinators: Robert Stegwee (robert[at]trace-health.nl) and Catherine Chronaki (chronaki[at]hl7europe.org).

In the coming months we develop the legal entity, business model and membership conditions. Then, we will welcome SDOs, interoperability competence centres, stakeholder associations and other organisations to join ESHIA. More information will be available soon.

The seventeen founding members (in alphabetical order) are: CEN/TC 251, Berlin Institute of Health @ Charité (DE), Datawizard (IT), DNV AS (NO), ECHAlliance – The Global Health Connector (IE), EHTEL (BE), empirica (DE), Fondazione Toscana Gabriele Monasterio (IT), Foundation for Research and Technology FORTH (GR), Fundació TIC Salut Social (ES), Gnomon (GR), HL7 Europe, IEEE, IHE-Europe, IHE Catalyst, MedCom (DK), and Uninova (PT)

The members of the inaugural ESHIA Board of Directors are: Carla Alvarez Costa (Fundació TIC Salut Social), Giorgio Cangioli (HL7 Europe), Marc Lange (EHTEL), Karolina Mackiewicz (ECHAlliance – The Global Health Connector), Maria Palombini (IEEE), Claudio Saccavini (IHE Catalyst), Robert Stegwee (CEN/TC 251), Sylvia Thun (Charité), and Janos Vincze (IHE-Europe)

To find out more about ESHIA, check out our press release and the ESHIA website: http://www.eshia.eu/

For specific inquiries, contact Karolina Mackiewicz, xShare Communications Lead, and ESHIA Vice President:  karolina[at]echalliance.com

The label is designed for:

• Digital health manufacturers and solution providers;
• Stakeholders across the healthcare data ecosystem;
• Policy and technical decision-makers who want to demonstrate or evaluate EHDS readiness.

There are three progressive levels in the xShare Industry Label system:

• Bronze: Entry-level recognition, typically following a self-assessment
• Silver: Mid-level recognition, may involve more structured evaluation
• Gold: Advanced recognition, typically based on independent third-party validation

These levels allow organisations to evolve over time and prepare for full EHDS compliance by 2029/2031.

Yes. xShare’s eight adoption sites in Cyprus, Denmark, France, Greece, Ireland, Italy, Portugal and Spain already use the Yellow Button. Via the xShare Open Calls, we aspire that the Yellow Button is featured in close to 100 settings by the end of 2026. Ultimately, our vision is to bring the button to all  citizens in the EU.

xShare is an EC-funded project that supports the implementation of the EHDS, particularly the EHRxF. It helps develop standards, tools, and guidance and provides early pilots (like the Yellow Button) to test interoperability in real-world settings.

The open call aims to support real-world integration of the Yellow Button in healthcare and wellness scenarios. Proposals should demonstrate how one-time health data sharing can enhance care delivery, personal health management, or research. Proposals must utilize the HL7 FHIR xShare Implementation Guide and are expected to prioritize EHDS Regulation categories such as:

• Patient summaries
• ePrescriptions and eDispensations
• Laboratory results
• Medical imaging and reports
• Hospital discharge summaries

Additional categories proposed by xShare include:

• IPS+R (an extension of the International Patient Summary for research)
• Care Plans

The call is open to a wide range of actors in the digital health ecosystem, including:

• Health tech startups
• Electronic Health Record (EHR) or Personal Health Record (PHR) vendors
• Digital therapeutics and wellness app developers
• Healthcare providers and system integrators
• Patient associations
• Hospitals
• National agencies and public authorities

Applicants may apply individually or as part of a consortium and should be capable of delivering a working demonstrator or Minimum Viable Product (MVP) during the call period.

Proposals should focus on:

• Enhancing patient control over their data
• Demonstrating clear real-world value
• Improving productivity for providers or systems

Examples include:

• Personal health apps that combine official records and wearable data
• EHR portals offering FHIR-based data downloads
• Tools to facilitate research data contributions directly from patients
• Services enabling patients to match with clinical trials using their own data

Creative combinations of official health data, patient-generated data, and other sources are encouraged.