The European patient summary – a long evolving journey

Susan Sverin, Anna Adelöf Kragh

Socialstyrelsen

20260923

The journey��- Where it began�- The introduction of EHDS�- Xt-EHR and connecting initiatives�- Current status�

eHealth Network

• Patients rights directive
• eHealth Network initiation
• Projects

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epSOS – European Patients Smart Open Services

• 31 partners (public and private)
• Growing set of member states
• One target to test the possibilities of sharing data across borders
• Patient summary and E-prescription/e-dispensation
• Finished in 2014

• The epSOS ‘Patient Summary’ is a standardised set of basic medical data that includes the most important clinical facts required to ensure safe and secure healthcare. This short version gives health professionals the essential information they need to provide care in the case of an unexpected or unscheduled medical situation (e.g. emergency or accident).��The epSOS ePrescriptions  contain the currently available ePrescriptions for the medications, i.e. all prescriptions that could also be dispensed in the patient’s home country at that moment. However with epSOS they are electronically transmitted to pharmacies in epSOS partner countries. It means that if a prescribed medical product is not available abroad, the participating pharmacist may, depending on the circumstances, dispense a different brand or package size of a comparable product to the patient.

What followed?

• Services remained
• Central services housed with the EC
• A new set of organisation linked to eHN
• A number of new projects
• EHDS was proposed and

negotiations initiated

Actions related to the European electronic health record exchange format (EEHRxF)

Xt-EHR (Joint Action 09 under EU4Health WP2022)

Further actions

MyHealth@EU current and future services

XpanDH

Patient Summary and ePrescription

• HL7 CDA for structured content
• PDF available (except eDispensation)
• IHE XDS profiles for content transmission

• Use cases, data sets, principles
• Adopted by Member States in the eHN

• Development of the MyHealth@EU infrastructure

epSOS, EXPAND, JAseHN, eHAction

X-eHealth

Original Clinical Documents

• HL7 CDA header, no further structured content
• PDF for content representation
• IHE XDS profiles for content transmission

Lab results, hospital discharge reports, medical imaging

• To be based mostly on HL7 FHIR
• DICOM for medical imaging studies

• Work on lab results, hospital discharge reports, medical imaging
• Defined use cases, data sets, data models
• Implementation guides for CDA and FHIR

• Further elaboration of the format
• Pilots, verification of implementability
• Set-up of the ecosystem

• Work on the formalisation of the format
• Requirements for the certification of EHR systems

(recommendations for possible future implementing acts under EHDS)

• Practical implementation of patient-mediated workflow for data portability
• Further development of the exchange format (e.g. care plans, telemonitoring)

Work by MyHealth@EU Solution Provider

Work on the eHealth Network guidelines

• Implementable specifications, other artefacts
• Implementation in OpenNCP for MyHealth@EU
• Adopted by Member States in the eHMSEG

Further data categories

• Not defined yet

Implementing Decisions under the upcoming EHDS

• Legally binding requirements and specifications for the European health record exchange format
• Legally binding requirements for the certification of EHR systems

Innovation, experimentation

Formalisation

Infrastructure, deployment

xShare

• Xt-EHR represents a significant, collaborative step toward establishing a truly interoperable, secure, and patient-centred European Health Data Space (EHDS
• Active involvement of all EU Member States and Norway
• The project brought together experts from more than 50 Competent Authorities and Affiliated Entities across Europe.
• Ran between 2023 and 2026

Patient summary

• The first approved eHN guideline
• One of two initial EHDS services – some infrastructure in place
• One of many focus areas of xt-EHR
• Readiness higher in most countries compared to the new services

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Patient summary – work process

• Reviewed and assessed:
• Guideline
• EEHRxF
• FHIR models
• International Patient summary
• MyHealth@EU
• Compliance data

Logical Models Browsable - Xt-EHR

Main result

So whats now?

• Negotiations remain within comitology
• All member states are involved and the EC
• Implementing acts are to be decided
• Format is part of this
• Once the articles are formally decided upon we will know what to implement

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Thank you