Scope and Usage
Problem Statement
When patients travel, work, or live in a European country other than their country of affiliation, treating health professionals in the country of treatment (Country B) have no reliable, structured access to the patient's medical background. Critical clinical facts — allergies, current medications, implanted devices, rare disease diagnoses — are unavailable at the point of care. Language barriers, differing national healthcare systems, and fragmented clinical vocabularies compound the risk. This Implementation Guide (IG) addresses that gap.
The IG is grounded in Directive 2011/24/EU on patients' rights in cross-border healthcare and the eHealth Network Guidelines on Patient Summary (Release 3.4, November 2024). Its goal is to define a FHIR R4 representation of the eHN Patient Summary dataset that enables structured, semantically interoperable, and secure electronic exchange of a Patient Summary from a patient's country of affiliation (Country A) to a treating health professional in another EU country (Country B), covering both unplanned/emergency and planned care encounters.
Actors and Systems
Six principal actors participate in the cross-border exchange:
Originating Health Professional — Country A (OHP-A) authors and maintains the Patient Summary within the Country A EHR or national health record system. OHP-A is responsible for the clinical accuracy of all PS body sections and triggers creation or update before planned care episodes.
Legal Authenticator (typically the same system as OHP-A) legally signs and timestamps the Patient Summary, providing the attestation required for cross-border use.
National Contact Point — Country A (NCP-A) is the FHIR server / document source. It receives identity-resolved PS queries from NCP-B, assembles the Patient Summary from Country A health record systems, and returns a FHIR Document Bundle or an OperationOutcome on error.
National Contact Point — Country B (NCP-B) is the FHIR client proxy. It receives PS retrieval requests from THP-B's EHR, forwards patient identity to NCP-A, and relays the returned PS Bundle back to the requesting EHR.
Treating Health Professional — Country B (THP-B) is the clinician who initiates the PS retrieval from within their clinical workstation or EHR and acts on the received data to provide care.
Identity Provider — Country A (IdP-A) confirms patient identity cross-border (via eIDAS or the national identity federation) and returns a confirmed identity token to NCP-A, enabling accurate patient matching.
The Patient / Citizen is the subject of the summary and may supply patient-provided data (travel history, advance directives) but does not directly consume the PS; it is consumed on their behalf by THP-B.
The high-level data flow is:
THP-B EHR --> NCP-B --> NCP-A --> IdP-A (identity confirmation)
--> OHP-A EHR (PS assembly)
THP-B EHR <-- NCP-B <-- NCP-A (PS Bundle or OperationOutcome)
In Scope
- FHIR R4 (4.0.1) representation of the full eHN Patient Summary dataset (header + all body sections, eHN PS Release 3.4, section 4).
- Profiles for all PS body sections: alerts (allergies, intolerances, medical alerts), vaccinations, resolved/inactive problems and medical history, current problems and diagnoses (including rare diseases via Orphacode), medical devices and implants, procedures, functional status, medication summary, social history, pregnancy history, patient-provided data (travel history, advance directives), results (lab, imaging, vital signs, other observations), and plan of care.
- PS header profiles: patient identification, contact information, insurance, document metadata, author/authenticator, and knowledge resource references.
- Terminology bindings: SNOMED CT GPS, ICD-10, LOINC, ATC, EDQM Standard Terms, UCUM, ISO 3166, BCP-47, HL7 Administrative Gender, HL7 RoleClass/RoleCode, ICF, Orphacode, EMDN, and EMA PMS/SPOR.
- Document-exchange interaction pattern (FHIR Document Bundle) aligned with MyHealth@EU / eHDSI infrastructure.
- Cross-border use cases: occasional visitor (unplanned emergency care, planned care), and regular cross-border worker (retrieval only).
- Graceful handling of PS-not-available responses via
OperationOutcome. - Conformance alignment with ISO 27269:2021 (International Patient Summary) and the HL7 IPS FHIR IG.
- Dual-language support: coded content plus narrative in the Country A language with a Country B language or English fallback.
Out of Scope
- Authentication and authorisation infrastructure (eIDAS, NCP-level security protocols) — referenced but not profiled.
- Internal architecture of national or regional health record systems.
- Patient-facing direct data injection into the PS (reserved for a future revision).
- Mandatory vs. optional cardinality decisions at national level — deferred to derived national IGs.
- Country B record update or merge for regular cross-border workers.
- Full ISO IDMP-based medicinal product identification — ATC is used as the interim standard; IDMP profiled as a future extension.
- Prescription and dispensation workflows.
- Consent management infrastructure.
FHIR Version and Key Resources / Profiles
This IG targets FHIR R4 (4.0.1). The Patient Summary is exchanged as a FHIR Document Bundle whose Composition resource structures the header and organises references to all clinical entries.
The headline profiles defined by this IG correspond directly to the eHN data model entities:
| Profile | Primary FHIR Resource | eHN Section |
|---|---|---|
| PatientIdentification | Patient |
A.1.1 |
| DocumentMetadata | Composition |
A.1.4 |
| AuthorAndOrganisation | Practitioner / PractitionerRole / Organization |
A.1.5 |
| InsuranceInformation | Coverage |
A.1.3 |
| ContactPersonOrGuardian | RelatedPerson |
A.1.2.3 |
| PreferredHealthProfessional | PractitionerRole |
A.1.2.2 |
| KnowledgeResource | DocumentReference |
A.1.6 |
| Allergy | AllergyIntolerance |
A.2.1.1 |
| MedicalAlert | AllergyIntolerance / Flag |
A.2.1.2 |
| Vaccination | Immunization |
A.2.2.1 |
| ResolvedProblem | Condition |
A.2.2.2 |
| MedicalHistory | Condition / Composition.section.text |
A.2.2.3 |
| CurrentProblem | Condition |
A.2.3.1 |
| MedicalDevice | Device / DeviceUseStatement |
A.2.3.2 |
| Procedure | Procedure |
A.2.3.3 |
| FunctionalStatus | Observation / ClinicalImpression |
A.2.3.4 |
| MedicationSummaryEntry | MedicationStatement |
A.2.4 |
| SocialHistoryObservation | Observation |
A.2.5 |
| PregnancyStatus / PreviousPregnancy | Observation |
A.2.6 |
| TravelHistory | Observation |
A.2.7.1 |
| AdvanceDirective | Consent |
A.2.7.2 |
| ResultObservation | Observation |
A.2.8 |
| PlanOfCare | CarePlan |
A.2.9 |
The logical model EHNPatientSummary (and per-section logical models) formally captures the eHN dataset structure. ConceptMaps are provided for each section to document the mapping between eHN logical model elements and the corresponding FHIR profile elements. The NatureOfPS-lm CodeSystem and ValueSet capture the document generation approach (human / automatic / mixed) pending formal eHN value set publication.