EHDS Logical Information Models
0.1.0 - ci-build

EHDS Logical Information Models, published by Xt-EHR. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/Xt-EHR/xt-ehr-common/ and changes regularly. See the Directory of published versions

Logical Model: Medicinal product model

Official URL: https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSMedication Version: 0.1.0
Active as of 2025-03-31 Computable Name: EHDSMedication

Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. EHDSMedication 0..* Base Medicinal product model
Instances of this logical model can be the target of a Reference
... identifyingCode[x] 0..* Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.
.... identifyingCodeCodeableConcept CodeableConcept
.... identifyingCodeIdentifier Identifier
... classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Binding Description (No ValueSet): (preferred): WHO ATC


... productName 0..1 string Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.
.... organizationName 0..1 string Name of the organisation holding the authorisation for marketing/mahufacturing
.... organizationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location
... doseForm 0..1 CodeableConcept Dose form(s) on a product level. Dose form for a single package item is defined below.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

... packSize 0..* Quantity Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.


... item 0..* Base A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined
.... doseForm 0..1 CodeableConcept Dose form
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... ingredient 1..* Base Ingredients
..... isActive 0..1 boolean Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.
..... substance 1..1 CodeableConcept Substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

..... strengthInfo 0..1 Base Strength of the product - amount of substance per unit
...... strength 1..1 Ratio Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet
...... basisOfStrengthSubstance 0..1 CodeableConcept Substance that the strength refers to, in case it's different from the main substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

.... unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... containedQuantity 0..1 Ratio Manufactured item quantity for liquids (3ml / 1 vial)
.... amount 0..1 Quantity Number of such manufactured items in this product (5 vials)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.

.... packageType 0..1 CodeableConcept Type of package of the medication item
Binding Description (No ValueSet): (preferred): EDQM Standard Terms for packaging.

... device 0..* Base Administration device included in the product
.... deviceQuantity 1..1 Quantity Number of such devices
.... device[x] 1..1 Device coded
..... deviceCodeableConcept CodeableConcept
..... deviceReference Reference(Device model)
... characteristic 0..* Base Other features of the product
.... type 1..1 CodeableConcept A code expressing the type of characteristic
.... value[x] 0..1 Description of the characteristic
..... valueBoolean boolean
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueQuantity Quantity
..... valueDateTime dateTime
..... valueInteger integer
..... valueDecimal decimal
..... valueRatio Ratio
... batch 0..1 Base Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
.... lotNumber 0..1 string Batch identifier of the medicinal product
.... expirationDate 0..1 dateTime Batch expiration date of the medicinal product.

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
EHDSMedication.classificationpreferred
EHDSMedication.doseFormpreferred
EHDSMedication.packSizepreferred
EHDSMedication.item.doseFormpreferred
EHDSMedication.item.ingredient.substancepreferred
EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstancepreferred
EHDSMedication.item.unitOfPresentationpreferred
EHDSMedication.item.amountpreferred
EHDSMedication.item.packageTypepreferred

 

Other representations of profile: CSV, Excel