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.

The EEHRxF does not mandate one single standard, rather, a set of common standards is envisioned (including HL7 FHIR) to encompass a broad range of applications, usages and practices, and to avoid creating a new standard on top of the numerous existing ones.

The exact specifications around the EEHRxF are still in development (e.g., in Joint Action Xt-EHR) and are expected to be published as Implementing Acts in 2027. The documents prepared by the Joint Action Xt-EHR which are meant to prepare the implementing acts are however pointing to HL7 FHIR as the key reference standard.

The EEHRxF mandates not one new standard, but a set of common standards to encompass a broad range of applications, usages and practices. For example, HL7 FHIR is expected to play a pivotal role in the EEHRxF.

The EEHRxF’s requirements will evolve to permit adaptation to evolving landscapes of standards, healthcare practices, health systems and of digital health solutions including with the integration of new technologies. At the level of data, the use of controlled vocabularies such as SNOMED-CT, LOINC, UCUM or ICD need also to be considered. Those standards will increasingly need to be able to ‘talk” to each other.

Note also that standards are created at various points in time to serve different purposes and use cases. As part of their lifecycle, all data standards undergo continuous maintenance, which involves collecting items for review, updating existing frameworks, and extending their capabilities. Over time, advancements in technology and evolving use cases, may require the development of new standards and may make it necessary to align with other standards, driving updates to existing standards to ensure that published standards remain relevant and adaptable to these new conditions.

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.

For non-technical people:

The EHRxF covers health data types that help you get adequate treatment when you are not with your main doctor and avoid repetitive exams, testing etc.

1. Patient Summary: Think of it as a medical “snapshot” of your most important health information. It helps doctors quickly understand your health situation – in your country and abroad.

It includes:

• Your current health problems (like diabetes, asthma),
• Allergies, to avoid dangerous reactions,
• Medications you are taking,
• Recent surgeries or treatments,
• And more.

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.

The  EEHRxF is first of all meant to support continuity and quality of care. However, the capacity to reuse those structured data for other finalities is also of major importance. The core data supported by the five priority categories of health data are also present in the vast majority of datasets for secondary use. Both public health analysts and clinical research officers can build on the EHRxF to define their data collection process paving the way to very innovative new use cases (see the Business Use Case Repository)

In the past, each (health) data ecosystem has been working in silos and has selected or even developed its own standards, without taking into consideration other initiatives working on similar standards or terminologies. . This is true for the data models and the controlled vocabularies. Simplification and better alignment is possible and beneficial. SDOs have already taken major initiatives to create governance and mappings between major international resources.  By referring to a common standard for describing datasets, HealthDCAT-AP, the EHDS greatly facilitates the capacity to identify and reuse existing datasets. HealthDCAT-AP is not a data standard itself, but a way to describe datasets and their metadata. It does not replace medical terminologies like SNOMED CT or ICD-10, or data standards such as FHIR, CDISC, or OMOP CDM. Those are still needed to label, organise, and structure the actual data, and should be referenced in the metadata. HealthDCAT-AP’s role is to make datasets easier to find and describe in a consistent way, without defining how the data itself is stored or formatted.  The EEHRxF provide a first robust reference to be used by all actors of the healthcare value chain. 

The European Health Data Space (EHDS) Regulation does not require hospitals or healthcare providers to make all retrospective (past) data available by default. However, it does allow and encourage Member States to include historical data if they wish — under certain conditions.

Article 8 of the EHDS Regulation refers to the mandatory use of the European Electronic Health Record Exchange Format (EEHRxF) for newly generated data.

Without strong support for infrastructure and workforce training, smaller hospitals will struggle to implement FHIR. The EHDS directly mandates both national and EU-level assistance to prevent these gaps from widening. It explicitly addresses training in Articles 83 and 84.

On this topic, check out the EU-co-funded project XiA which aims to build capacity comprehensively in the health workforce for adopting the EEHRxF.

The use of the EEHRxF and of the proposed extension of the International Patient Summary (IPS+R) will have a direct impact on the following use cases:

• Administrative simplification (avoidance of data duplication),
• Real time monitoring of key variables,

Patient discovery (identification of patients meeting specific criteria),

• Improved knowledge consolidation.

xShare’s work has identified that the clinical domains of infectious diseases, cancer monitoring and control of antimicrobial resistance are the ones that could mostly benefit from the implementation of the EEHRxF.

The Patient summary is one of the five priority categories of personal electronic health data listed by the EHDS. The IPS, International Patient Summary, has been defined at an international level and is aligned with the EU specifications. xShare has studied how the IPS could support critical use cases related to clinical research and public health and created a new specification called the IPS+R (International Patient Summary + Research). Only adding a few variables to the existing ones would make a huge difference and would allow an extended use of the data produced. EHR Systems which have implemented IPS+R facilitate planning of clinical studies (e.g. eligibility criteria, assumption testing), sparing both time and resources. This fosters innovative use cases.

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.

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.

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.

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.

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.

xShare’s focus is to make data available to the patient and enable a smooth reuse of those data for different purposes, via its Yellow Button. The project paves the way to implementing consent mechanisms for health data sharing as foreseen in the EHDS Regulation. Under the EHDS regulation, consent is considered to be granted a priori. Under certain circumstances, citizens may opt out. For primary use, the EHDS regulation also foresees the right of patients to restrict access to specific data. Beyond this right, it is up to each Member State to pass national law to allow total opt-out. As a result, health data of people who have opted out will not be accessible by third parties, other than the healthcare provider who provided the treatment.

For secondary use, the EHDS Regulation (Art. 71) gives all individuals the right to opt out from secondary use of their personal electronic health data – i.e. without specific legislation from Member States. Member States need to provide easily understandable information about the opt-out process.  

Both opt out mechanisms are thus enforced by each Member State which develops all components required for their tracking and auditing.

The Yellow Button is to be coupled with a secure authentication method.

Health professionals (like doctors or nurses) will use trusted national ID systems that are recognized across Europe  to access patient data. Many countries in the EU already provide such digital IDs to licensed health professionals. These IDs are usually the same ones people already use to log into public or private services online (like government websites or banking apps). They can keep using them as long as they meet common EU standards, which will be officially set in the near future.

However, just using a digital ID is not enough to confirm that someone is a qualified health professional. These IDs usually only confirm someone’s identity – like proving that a person is really “Jacques  Durand.” But they don’t always confirm that Jacques Durand is a nurse or works at a specific hospital.

To solve this, more advanced ID systems – like the EU Digital Identity Wallet – may also include details such as a person’s professional role and qualifications. Countries may choose to use this feature to help confirm that a user is not only who they say they are, but also that they are truly qualified to access health data. This requires that Member States have implemented a digital registry of healthcare professionals operating in the country.

The yellow button is to be coupled with a secure authentication method.

There are quite a few trustable apps which can already retrieve lab results on real time in different EU Member States. But in order to do this, the App must be able to communicate seamlessly either with each Lab or with the Regional/National EHR to which all the labs are connected. This is not specific to xShare. But thanks to the Yellow Button, the lab results can be retrieved in a structured way following the specifications of the EEHRxF. This will allow the App to show the information to the patient in a more comprehensive, intuitive and dynamic way and possibly also to support the “translation” of the results in lay language

The EHDS does not automatically authorise sharing your health data with non-healthcare entities like the army or border control officers. But the EHDS Regulation guarantees a right to data portability. This means that the citizen can download  his/her data and can share them with third parties if he/she wishes so. You as a natural person remain in full control.

The xShare Yellow button has precisely this objective in mind. The EU digital identity wallet will also be a very convenient tool to store essential and certified data that need to be shared with third parties.

The maturity of national digital health infrastructure can be very different from country to country in the EU. In some countries, the documents and data produced by each professional or hospital are already shared via a regional or national EHR. In this case, downloading data with the yellow button can be done easily through an App or a web portal leaving the patient select the download criteria (e.g. all lab reports for a selected period).

If the infrastructure is not yet mature, then indeed the patient might have to download data from each individual hospital or professional via a secured data processing environment or protocol (such as e.g. Bluetooth for simple transactions such as prescriptions or dispensations).

When the data sharing is made via a secured unique link, the person (data owner) clicks on the xShare Yellow Button and selects the one-time share functionality. He/she visualises and selects the health data available to share and indeed creates a static document. The xShare Yellow Button might suggest several  options such as data transformation: anonymisation, translation, and digital signature. The data are then visible both in EEHRxF and the original data in human readable format. The  person requests then a shareable link and provides the shareable link to the Authorised Data Recipient. The period of validity of the link can be customised.

Another option foreseen by  the Yellow Button is the “linked option” where the person can share selected data during a selected period of time. All data which meet the set criteria are then shared with the external party  during this period.

Start-Up are most welcome to integrate the Yellow Button functionality. This is also the purpose of the Open Call organised by xShare.  The Yellow Button FHIR implementation guideline has been published and a first plugathon has been successfully  organised in Vienna in June 2025. There is no cost of access to the specifications but using the testing environment might be subject to limited fees.

The xShare Yellow Button also includes an upload functionality which can thus allow to insert data into specific EHR systems. The Yellow Button is however for now only covering the data included in the EEHRxF; other types of data such as those provided by wellness app might also be shared but this might lead to interoperability issues.

The Yellow Button is closely connected to the EEHRxF while Medmij relies on its own national specifications. The Yellow Button might thus not replace Medmij but Medmij might integrate the Yellow Button specifications to cover an extended number of use cases – in particular in a cross-border context.

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.

Under the European Health Data Space (EHDS), the health record you can insert your data into is your Electronic Health Record (EHR), maintained within the healthcare system by healthcare providers, but accessible to you via official national or regional electronic health data access services established by your Member State

 More precisely:

1. The health record is not directly maintained by you, nor by the EHDS itself.
   It remains operated by healthcare providers (hospitals, clinics, doctors, etc.) who register and update your personal electronic health data when delivering care.
2. The EHDS sets common EU rules and technical standards for how these EHR systems work and interoperate.
   The EHDS creates the legal and technical framework, but does not itself host or own your health record.
3. You can insert data into your EHR via national electronic health data access services or apps linked to them.
   Article 5 gives you the right to insert information into your own EHR through these official access services or connected applications. This data will be clearly marked as “provided by you”, and you cannot directly modify the information entered by health professionals.
4. In addition, you may also keep personal health records that are separate from the EHR.
   Recital (12) explains that citizens may store additional health information in personal health records, but these have a different legal status than the official EHR maintained by healthcare providers

In summary:

• You insert your data into your official EHR via authorised national electronic health data access services.
• You do not manage the EHR directly.
• The EHDS does not maintain or host your record but regulates the system.

 For reference: Articles 1(1), 5 and Recitals 1, 7, 11 and 12.

Under the European Health Data Space (EHDS), you cannot directly “opt out of a country.” The regulation doesn’t allow an individual to selectively exclude a specific Member State or third country from having access to their data.

 However, you have multiple rights to limit access in general:

1. Right to restrict access for primary use (care purposes)
   You can restrict which health professionals and healthcare providers see parts of your data (e.g. specific treatments, diagnoses) — but this applies to any professional regardless of country, not country-specific
2. Right to opt-out entirely from primary use sharing (if your country allows it)
   Some Member States may allow you to fully opt-out of sharing your data beyond the healthcare provider that originally treated you. This means no cross-border sharing at all — but again, not selectively by country
3. Right to opt-out from secondary use (research, policy, public health, etc.)
   You can fully opt out of having your data used for secondary purposes (like research, statistics, public health monitoring). This opt-out applies generally — again, not selectively by country.
4. International transfers to third countries
   Transfers to non-EU countries are strictly regulated under international agreements and GDPR rules. These are not something you as an individual can directly control, but there are high legal safeguards in place.

For reference: Articles 8, 10, 71, 90-91; Recitals 17, 18, 54