IE Medication Events Implementation Guide
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Cross-Border ePrescription (reference examples)

Reference examples, for illustration only. This material was first published in IE Core 0.2.0 and moved here with the ePrescription and eDispensation profiles (IE Core ADR-009). The scenarios, payloads and foreign product codes are illustrative: all people, organisations and identifiers are fictional, and the cross-border flows are not specified by HIQA. They show how the IE MPD profiles can be used; they are not normative.

Cross-Border ePrescription (MyHealth@EU)

Illustrative. The actors, flows and payloads in this section describe how a cross-border exchange could work. They are not a description of any live HSE, NePS or National Contact Point system. For the conformant HIQA-aligned cross-border example, see scenario 6 on the HIQA 2026 Alignment page.

This section covers Ireland's participation in the EU cross-border ePrescription and eDispensation infrastructure under MyHealth@EU and the European Health Data Space (EHDS) Regulation 2025/327.

IE MPD provides dedicated FHIR R4 profiles for the full ePrescription lifecycle — from prescription creation in Ireland through cross-border transmission and foreign dispensation, to the eDispensation response returned to the Irish National Contact Point for eHealth (NCPeH).


What This Section Covers

Page Description
Patient Profile & Scenarios Reference patient Seán Murphy, all 11 cross-border scenarios, eIDAS identifiers, workflow diagrams, drug code system mapping by country
Sample Payloads & Downloads All FHIR Bundle JSON, CDA XML, and IPS examples with descriptions, download links, and API testing commands

Scope

Outbound (Ireland → EU)

An Irish GP issues a prescription using IE MPD ePrescription profiles. The prescription is transmitted via the Irish NCPeH (HSE eHealth) through the MyHealth@EU Central Hub to the destination country's NCPeH, where a foreign pharmacy can retrieve and dispense it.

Nine destination countries are illustrated in this guide:

# Destination Drug Code System Medications
1 🇩🇪 Germany PZN (Pharmazentralnummer) Metformin + Lisinopril
2 🇪🇸 Spain CIMA (Agencia Española) Metformin + Lisinopril + Atorvastatin
3 🇫🇷 France CIP (ANSM) Metformin + Lisinopril
4 🇳🇱 Netherlands G-Standaard GNK Metformin + Lisinopril + Atorvastatin
5 🇱🇻 Latvia ZRA (Zāļu reģistrs) Metformin + Lisinopril
6 🇵🇹 Portugal INFARMED Sertraline + Omeprazole
7 🇩🇰 Denmark DKMA/VNR Warfarin 5mg
8 🇸🇪 Sweden LMV (Läkemedelsverket) Insulin Glargine + Insulin Aspart
9 🇦🇹 Austria BASG Atorvastatin 80mg + Ramipril 10mg

Inbound (EU → Ireland via NePS)

EU citizens visiting Ireland can have their foreign prescriptions dispensed at Irish pharmacies through the National ePrescription Service (NePS). Foreign drug codes are mapped to Irish NMPC codes, with SNOMED CT Irish Edition carried as secondary coding where available.

# Origin Patient Irish Pharmacy
10 🇫🇮 Finland Mikko Korhonen Hickey's Pharmacy, O'Connell Street, Dublin
11 🇧🇪 Belgium Lars Janssen McCauley's Pharmacy, Grafton Street, Dublin

Technical Infrastructure

The following sequence diagram shows the full cross-border ePrescription workflow from prescription creation in Ireland through dispensation in an EU member state and return of the eDispensation record.

sequenceDiagram
    autonumber
    participant GP as 🏥 Irish GP<br/>(HSE eHealth)
    participant NCPeH_IE as 🇮🇪 NCPeH Ireland<br/>(HSE)
    participant Hub as 🌐 MyHealth@EU<br/>Central Hub
    participant NCPeH_EU as 🇪�� EU NCPeH<br/>(Dispensing Country)
    participant Pharmacy as 🏪 EU Pharmacy
    participant Patient as 👤 Patient<br/>(EUDI Wallet)

    GP->>NCPeH_IE: Issue ePrescription<br/>(FHIR MedicationRequest Bundle)
    NCPeH_IE->>NCPeH_IE: Validate & sign<br/>(qualified e-signature, IHE ATNA audit)
    NCPeH_IE-->>Hub: Register prescription availability<br/>(XCA)

    Patient->>Pharmacy: Present with eIDAS digital ID<br/>(EUDI Wallet, LoA: High)
    Pharmacy->>NCPeH_EU: Request patient ePrescription<br/>(XCPD patient discovery)
    NCPeH_EU->>Hub: Forward request<br/>(cross-border PID: IE/CC/1234567T)
    Hub->>NCPeH_IE: Query prescription<br/>(XCA document retrieve, SOAP/HTTPS)
    NCPeH_IE-->>Hub: Return signed ePrescription Bundle
    Hub-->>NCPeH_EU: Deliver ePrescription<br/>(audit logged, consent verified)
    NCPeH_EU-->>Pharmacy: Provide ePrescription<br/>(translated to local format)

    Pharmacy->>Pharmacy: Verify prescription<br/>Check allergy alerts<br/>Apply generic substitution
    Pharmacy->>Patient: Dispense medication

    Pharmacy->>NCPeH_EU: Create eDispensation<br/>(FHIR MedicationDispense)
    NCPeH_EU->>Hub: Forward eDispensation
    Hub->>NCPeH_IE: Return eDispensation<br/>(prescription marked as used)

Cross-Border Routing Overview

The diagram below shows how Ireland routes outbound ePrescriptions to nine EU destination countries through the MyHealth@EU Central Hub, each using the destination country's national drug code system.

flowchart LR
    IE["🇮🇪 **Ireland**
NCPeH IE / HSE"]
    Hub(["🌐 MyHealth@EU
Central Hub"])

    IE --> Hub

    Hub --> DE["🇩🇪 **Germany**
PZN codes"]
    Hub --> ES["🇪🇸 **Spain**
CIMA codes"]
    Hub --> FR["🇫🇷 **France**
CIP codes"]
    Hub --> NL["🇳🇱 **Netherlands**
G-Standaard GNK"]
    Hub --> LV["🇱🇻 **Latvia**
ZRA codes"]
    Hub --> PT["🇵🇹 **Portugal**
INFARMED codes"]
    Hub --> DK["🇩🇰 **Denmark**
DKMA/VNR codes"]
    Hub --> SE["🇸🇪 **Sweden**
LMV codes"]
    Hub --> AT["🇦🇹 **Austria**
BASG codes"]

    style IE fill:#169b62,color:#fff,stroke:#169b62
    style Hub fill:#003399,color:#fff,stroke:#003399

XT-EHR 1.0.0 ePrescription Model Changes

The XT-EHR EHDSMedicationPrescription logical model was updated in v1.0.0 with the following additions. IE MPD ePrescription profiles have been updated to reflect these changes.

XT-EHR 1.0.0 Addition IE MPD Element Notes
prescriptionItem.offLabel MedicationRequest.extension[IEMpdOffLabelUse] Boolean + optional reason; prescriber has knowingly prescribed outside approved indications
prescriptionItem.statusReason MedicationRequest.statusReason Reason for current prescription status (e.g., why cancelled or on hold)
prescriptionItem.minimumDispenseInterval MedicationRequest.dispenseRequest.dispenseInterval Minimum interval between dispensations for repeating prescriptions
prescriptionItem.intendedUseType MedicationRequest.category Categorisation of prescription intent (prophylaxis, treatment, anaesthesia, etc.)

Off-label prescribing note: The IEMpdOffLabelUse extension is added at the MedicationRequest level. IE MPD profiles for ePrescription, eDispensation, and Medication are formally derived from the EU MPD IG (hl7.fhir.eu.mpd@1.0.0 STU, published Jun 2026). The extension contains two sub-extensions: isOffLabelUse (boolean, 1..1) and reason (CodeableConcept or string, 0..*).

R4/R5 note: The XT-EHR logical models are authored in FHIR R5. In FHIR R4, MedicationRequest.statusReason and dispenseRequest.dispenseInterval are both available and map directly to the XT-EHR elements.

IHE Profiles Used

IHE Profile Purpose Protocol
XCPD (Cross-Community Patient Discovery) Find patient in home country SOAP/HTTPS
XCA (Cross-Community Access) Retrieve ePrescription document SOAP/HTTPS
MHD (Mobile access to Health Documents) FHIR-based document exchange REST/HTTPS
ATNA (Audit Trail and Node Authentication) Security audit logging Syslog/TLS
IUA (Internet User Authorization) OAuth2/SMART on FHIR OAuth2
DSG (Document Digital Signature) Digital signing of prescription bundles XAdES / JAdES

FHIR Profiles Used

Scenario IE MPD Profile
Patient identity IE MPD Patient
GP / Prescriber IE MPD Practitioner
Allergy alert IE MPD AllergyIntolerance
ePrescription IE MPD MedicationRequest (ePrescription)
eDispensation IE MPD MedicationDispense (eDispensation)
Medication IE MPD Medication (ePrescription)
Patient Summary IE MPD Patient Summary

Cross-Border Security

This section describes the security requirements that apply specifically to cross-border ePrescription and eDispensation exchange via MyHealth@EU. For domestic security requirements, see the Security page.

eHDSI Security Framework

The eHealth Digital Service Infrastructure (eHDSI) Security Framework governs all cross-border healthcare data exchange. It is based on:

  • eHDSI Security and Privacy Architecture (eHDSI-S-EP v2.2+) — defines security zones, trust hierarchies, and access control policies for all MyHealth@EU services
  • eIDAS Regulation 2014/910/EU and eIDAS 2.0 (Regulation 2024/1183/EU) — electronic identification and qualified trust services
  • GDPR (2016/679/EU) — data protection requirements applying to all cross-border health data exchange
  • EHDS Regulation (2025/327) — data governance framework for primary and secondary use of health data

The eHDSI Security Framework defines three security domains:

Domain Description Participants
National Domain Each Member State's internal health infrastructure NCPeH, national health systems
Central Infrastructure Domain MyHealth@EU Central Hub services OpenNCP Central Connector, PMPOC
Service Provider Domain Healthcare providers accessing NCP services GPs, hospitals, pharmacies

Prescription Bundle Signing

Two different signatures are involved, and IE MPD only profiles the first:

  1. The prescriber's signature (HIQA EP 2.13, a legal requirement for cross-border prescriptions). IE MPD carries it as a Provenance record whose target covers every prescription item, inside an IE MPD cross-border ePG (invariant ie-bnd-xb-2; ADR-003). A Provenance signature survives storage in NePS and re-bundling, which Bundle.signature does not. The signature format and eIDAS assurance level are Requires Clarification (OI-009).
  2. A transport or organisational seal that a National Contact Point may apply before sending. It is outside the HIQA drafts. The flow below illustrates it as it was originally drafted for this IG.

The illustrative flow assumes that the Irish NCPeH applies a Qualified Electronic Seal to outbound bundles before transmission to the MyHealth@EU Central Hub.

Signing process:

sequenceDiagram
    autonumber
    participant GP as 🏥 Irish GP
    participant NePS as 🇮🇪 NePS/HSE System
    participant NCPeH_IE as 🇮🇪 NCPeH Ireland
    participant Hub as 🌐 MyHealth@EU Hub

    GP->>NePS: Create ePrescription (FHIR MedicationRequest Bundle)
    NePS->>NCPeH_IE: Submit for cross-border export
    NCPeH_IE->>NCPeH_IE: Validate FHIR bundle against IE MPD profiles
    NCPeH_IE->>NCPeH_IE: Apply QeSeal (JAdES enveloping signature)<br/>using HSE/NCPeH qualified certificate
    NCPeH_IE->>NCPeH_IE: Set Bundle.signature (sigFormat: application/jose)
    NCPeH_IE->>Hub: Transmit signed bundle via mTLS (XCA)
    Hub->>Hub: Verify QeSeal against Irish QTSP Trust List
    Hub-->>NCPeH_IE: Acknowledgement

Signature elements in FHIR Bundle:

Element Value Notes
Bundle.signature.type 1.2.840.10065.1.12.1.7 (Consent Signature) or 1.2.840.10065.1.12.1.5 (Verification Signature) HL7 Signature Type codes
Bundle.signature.when ISO 8601 datetime Signing time
Bundle.signature.who Reference to NCPeH organization or prescribing practitioner Signer identity
Bundle.signature.sigFormat application/jose (JAdES) or application/signature+xml (XAdES) Signature format
Bundle.signature.data Base64-encoded JAdES/XAdES signature bytes Actual signature

mTLS for NCP-to-NCP Communications

All NCP-to-Hub and Hub-to-NCP communications SHALL use mutual TLS (mTLS):

Parameter Requirement
Protocol TLS 1.3 (preferred) or TLS 1.2 (minimum)
Client certificate Qualified certificate for electronic seal (QCSeal) — eIDAS Article 38
Server certificate Qualified website authentication certificate (QWAC) — eIDAS Article 45
QTSP Certificate issuer must be listed on the EU Trust Service Status List (EUTSL)
Key length RSA 4096-bit or ECDSA P-384 minimum for QCSeal
Certificate pinning NCP certificate fingerprints SHOULD be pinned in the Central Hub configuration

Patient Identity Verification (eIDAS / EUDI Wallet)

When a patient presents at a foreign EU pharmacy to retrieve a cross-border prescription, the pharmacy SHALL verify the patient's identity using an eIDAS-compliant mechanism:

Identity Mechanism LoA Acceptance
EUDI Wallet (PID attestation) High SHALL be accepted from 2026
National eID (eIDAS notified scheme) High or Substantial Accepted if LoA ≥ Substantial
EUDI Wallet (provisional / non-notified) Substantial Accepted during EUDI transition period

The pharmacy system extracts the personal_identifier from the PID attestation (format: Origin/Destination/NationalID, e.g. IE/DE/1234567T) and submits this to the NCPeH for patient discovery (XCPD).

Before a foreign NCPeH returns a prescription to the dispensing country, consent SHALL be verified:

  1. Implicit consent — The patient presenting their EUDI Wallet / eIDAS identity at a pharmacy constitutes implicit consent for the pharmacy to retrieve their prescription, in accordance with the eHDSI consent model and EHDS Regulation 2025/327
  2. Explicit opt-out — Patients may register an opt-out with their home country NCPeH to prevent cross-border data sharing
  3. Consent logging — The consent decision (implicit/explicit, timestamp, patient identity, purpose of use) SHALL be logged as a FHIR AuditEvent at both the originating and receiving NCPs

Consent records SHOULD use the following AuditEvent structure:

{
  "resourceType": "AuditEvent",
  "type": { "system": "http://dicom.nema.org/resources/ontology/DCM", "code": "110106", "display": "Export" },
  "action": "R",
  "recorded": "2025-01-20T10:30:00Z",
  "outcome": "0",
  "purposeOfEvent": [{ "system": "http://terminology.hl7.org/CodeSystem/v3-ActReason", "code": "TREAT", "display": "Treatment" }],
  "agent": [
    { "type": { "coding": [{ "code": "110150", "display": "Application" }] }, "who": { "display": "NCPeH Ireland (HSE)" }, "requestor": false },
    { "type": { "coding": [{ "code": "110153", "display": "Source Role ID" }] }, "who": { "identifier": { "system": "urn:oid:1.3.6.1.4.1.12559.11.10.1.3.1.42.1", "value": "IE/DE/1234567T" } }, "requestor": true }
  ],
  "source": { "site": "NCPeH-IE", "observer": { "display": "HSE NCPeH Ireland" } },
  "entity": [{ "what": { "reference": "Bundle/ie-bundle-to-de-eprescription" }, "role": { "code": "4", "display": "Domain Resource" } }]
}

References

Standard URL
EHDS Regulation 2025/327 https://health.ec.europa.eu/ehds
xt-EHR Project https://xt-ehr.eu
MyHealth@EU https://health.ec.europa.eu/ehealth-digital-health-and-care/myhealtheu_en
IPS FHIR IG http://hl7.org/fhir/uv/ips/
EU MPD FHIR IG http://hl7.eu/fhir/mpd/
eHDSI Technical Specs https://ehealth.ec.europa.eu/wiki/display/EHOPERATIONS
eIDAS 2.0 (Regulation 2024/1183) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1183
EUDI ARF (Architecture & Reference Framework) https://digital-strategy.ec.europa.eu/en/policies/eudi-wallet-technical-specifications
IHE XCPD https://profiles.ihe.net/ITI/XCPD
IHE XCA https://profiles.ihe.net/ITI/TF/Volume1/ch-18.html
IHE DSG https://profiles.ihe.net/ITI/TF/Volume1/ch-37.html
ETSI eSignature (XAdES, JAdES, CAdES) https://www.etsi.org/technologies/electronic-signatures
EDQM Standard Terms https://standardterms.edqm.eu
ATC/DDD WHO https://www.whocc.no/atc_ddd_index/