Electronic dispensation in FHIR
Electronic dispensation is a priority category of the European Health Data Space (Article 14(1) point (c) of Regulation (EU) 2025/327). It applies from March 26, 2029. HL7 Europe covers it with mpd 1.0.0.
- Regulation
- Regulation (EU) 2025/327, Article 14(1)(c), Annex I
- Applies from
- March 26, 2029
- HL7 Europe guides
- hl7.fhir.eu.mpd 1.0.0, published
- Xt-EHR logical models
- EHDSMedicationDispense
- Validator
- Open the EHDS profile validator
What the Regulation says
Annex I of the Regulation describes the main characteristics of this category. The text is the English original.
Electronic dispensationsInformation on the supply of a medicinal product to a natural person by a pharmacy based on an electronic prescription.
FHIR profiles 3
Profiles defined by the guides above. The rules column counts the elements where the profile goes beyond base FHIR (required, forbidden or limited), which the validator checks; of the slices, only the required ones that a fixed value or the resource type identifies are checked.
| Profile | Resource | HL7 Europe guide | Rules checked | Slices checked / defined |
|---|---|---|---|---|
Medication: MPD http://hl7.eu/fhir/mpd/StructureDefinition/Medication-eu-mpd | Medication | mpd | 0 | 0 / 12 |
MedicationDispense: MPD http://hl7.eu/fhir/mpd/StructureDefinition/MedicationDispense-eu-mpd | MedicationDispense | mpd | 2 | 0 / 3 |
MedicationRequest: MPD http://hl7.eu/fhir/mpd/StructureDefinition/MedicationRequest-eu-mpd | MedicationRequest | mpd | 2 | 0 / 7 |
Terminology bindings 0
Value sets that the profiles of this category bind elements to with a required or extensible binding. A required binding only allows codes of the value set; an extensible one expects them unless none fits. Value sets that the HL7 Europe packages define are listed with their codes in the value set reference.
The profiles of this category state no required or extensible binding of their own. The profiles also state 0 preferred and 4 example bindings.
Extensions 1
HL7 Europe extensions that the profiles of this category carry, with the element that holds each one.
| Extension | Context | Value | Used in |
|---|---|---|---|
Medication: Package type http://hl7.eu/fhir/StructureDefinition/medication-package-type | Medication | CodeableConcept | MedicationEuMpd extension:packageType 0..1 |
Logical model EHDSMedicationDispense 17
Elements of the Xt-EHR logical model with their cardinality and obligations. Obligations tell producers and consumers of the data what a system SHALL or SHOULD do with each element.
Obligations by actor
How many elements of EHDSMedicationDispense carry each obligation for each actor.
| Obligation | Actor | Elements |
|---|---|---|
SHALL:able-to-populate | producer | 7 |
SHALL:process | consumer | 5 |
SHOULD:able-to-populate | producer | 1 |
SHOULD:process | consumer | 3 |
Elements 17
| Element | Card. | Obligations | Description |
|---|---|---|---|
header | 1..1 | Basic metadata for this information | |
subject | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | The person for whom the medication is prescribed. [Used for searching] |
identifier | 0..* | Business identifier(s) for the dispense record. [Used for searching] | |
author[x] | 1..* | SHALL:able-to-populate producerSystems shall support at least EHDSHealthProfessional data type for the element. SHOULD:process consumer | The actor who issued the dispense record. Responsibility for the dispense should be traceable from this information. |
date | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Date and time of issuing the dispense record. [Used for searching] |
status | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | The status of the dispense, e.g. completed, declined, entered-in-error. [Used for searching] |
source | 0..0 | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information. | |
language | 0..1 | Language in which the resource is written. Language is expressed by the IETF language tag. | |
dispenseLocation | 0..1 | Location of dispense | |
receiver[x] | 0..1 | Identification of the person who received the dispensed medication, especially when it was not the patient. When not present, it is assumed that the patient is the receiver. | |
relatedRequest | 0..* | SHALL:able-to-populate producerSHALL:process consumer | Identifier of the prescription item the dispense is related to. [Used for searching] |
medication | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | Exact dispensed product. If multiple medications are dispensed together, multiple dispense records should be created. |
dispensedQuantity | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | Number of dispensed packages if the package size is known, or number of smaller items/units, according to the medication dispensed. A unit is expected. |
timeOfDispensation | 0..1 | Date and time when medication was handed over. When not present, the time of dispensation is assumed to be the time of issuing dispense record. | |
substitutionOccurred | 0..1 | Whether substitution was made by the dispenser. Definition of substitution is specific to the jurisdiction. | |
dosageInstructions | 0..1 | SHOULD:able-to-populate producerSHOULD:process consumer | Dosage and administration instructions |
note | 0..1 | Additional information or comments |
Mapping of EHDSMedicationDispense to FHIR 0
The HL7 Europe guides do not publish an element mapping for this model.
CDA documents (eHDSI)
The same category is carried in CDA by these eHDSI document templates. Their structure, value sets and a validator for CDA documents are in the CDA guide.
Sources
Regulation (EU) 2025/327, Official Journal of the European Union; HL7 Europe FHIR implementation guides; Xt-EHR logical models (xtehr.eu.ehds.models). Ballot guides may still change. This guide is informational: it is not legal advice and not a certification of conformity.