HL7 Europe Base and Core FHIR IG, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.2.0-ci-build built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/base-r5/ and changes regularly. See the Directory of published versions
This page explains how conceptual elements from the EHDS logical model are expressed in the corresponding FHIR MedicationEuCore and OrganizationEuCore profiles used by this Implementation Guide.
The model supports prescribed/dispensed medication and can represent both generic (virtual) products and branded (real) products.
| EHDSMedication (Logical Model) | Relationship | Medication | ||||
|---|---|---|---|---|---|---|
| Element | Description | Relation | Resource | Element | Description | Notes |
| identifyingCodeCodeableConcept | Identifier or code for the product (virtual/branded/package). | equivalent | Medication | code | Code that identifies this medication. | |
| identifyingCodeIdentifier | Identifier for the product (virtual/branded/package). | equivalent | Medication | identifier | Business identifiers for the medication entry. | Use multiple identifiers if needed; avoid conflicting meanings. |
| classification | Classification (e.g. ATC; narcotic/psychotropic; orphan drug). | equivalent | Medication | extension:classification | Classifications of the product, e.g ATC, narcotic/psychotropic, orphan drug, etc | |
| productName | Name of the product (full/invented/other). | equivalent | Medication | extension:productName | Text representation of the medication name. | Official name of branded medicinal product. |
| marketingAuthorisationHolder | Marketing authorisation holder / manufacturer. | equivalent | Medication | manufacturer 〔R4〕 | Manufacturer of the item. | Reference to Organization.
|
| marketingAuthorisationHolder | Marketing authorisation holder / manufacturer. | equivalent | Medication | marketingAuthorizationHolder 〔R5〕 | Organization that has authorization to market medication. | Reference to Organization.
|
| marketingAuthorisationHolder.organisationName | Name of the MAH/manufacturing organisation. | equivalent | Organization | name | Name used for the organization. | Populate the referenced Organization's name. |
| marketingAuthorisationHolder.organisationIdentifier | Identifier of the MAH/manufacturing organisation. | equivalent | Organization | identifier | Identifies this organization across multiple systems | |
| doseForm | Dose form(s) on a product level. | equivalent | Medication | form | Dose form of the medication. | |
| packSize | Overall amount of product in one package. | related-to | Medication | amount〔R4〕 | Amount of the medication in the package. | R4 amount is a Ratio; in R5 totalVolume. |
| packSize | Overall amount of product in one package. | related-to | Medication | totalVolume 〔R5〕 | When the specified product code does not infer a package size, this is the specific amount of drug in the product. | R4 amount is a Ratio; in R5 totalVolume |
| item | A medication item (components in a combination pack). | equivalent | Medication | ingredient.item | A particular constituent of interest in the product. | An item - included in a product - is represented by a Medication resource referenced by the ingredient.item (see the example at https://hl7.eu/fhir/mpd-r5/Medication-02A-ClotrimazoleCanifugCremolum.html). If the item is the product, the item is the Medication itself. |
| item.doseForm | Dose form of the manufactured item. | equivalent | Medication | doseForm | Dose Form | See note above about item |
| item.ingredient | Ingredients of the item. | equivalent | Medication | ingredient | Medication ingredients. | Replicate per-item ingredients into ingredient. See note above about item |
| item.ingredient.isActive | Marks if the ingredient is active. | equivalent | Medication | ingredient.isActive | Is this an active ingredient. | Replicate per-item ingredients intoingredient. See note above about item |
| item.ingredient.substance | Substance. | equivalent | Medication | ingredient.itemCodeableConcept | The substance of the ingredient. | Replicate per-item ingredients intoingredient. See note above about item |
| item.ingredient.strengthInfo.strength | Strength of the substance. | equivalent | Medication | ingredient.strengthRatio | Quantity of ingredient present. | Replicate per-item ingredients intoingredient. See note above about item |
| item.ingredient.strengthInfo.basisOfStrengthSubstance | Substance the strength refers to (if different). | equivalent | Medication | ingredient.strength[x].extension:basisOfStrengthSubstance | Substance the strength refers to (if different). | Replicate per-item ingredients intoingredient. See note above about item
|
| item.unitOfPresentation | Unit of presentation for the manufactured item. | equivalent | Medication | extension:unitOfPresentation | Unit of presentation | See note above about item |
| item.containedQuantity | Quantity for liquids (e.g., 3ml / 1 vial). | equivalent | Medication | extension:sizeOfItem | Size of one item (for example, in a pack of 5 vials, this would represent the size of 1 vial). | See note above about item |
| item.amount | Number of such manufactured items in this product. | equivalent | Medication | amount 〔R4〕 | Amount of the medication in the package. | See note above about item |
| item.amount | Number of such manufactured items in this product. | equivalent | Medication | totalVolume 〔R5〕 | When the specified product code does not infer a package size, this is the specific amount of drug in the product. | See note above about item |
| item.packageType | Type of package of the medication item. | equivalent | Medication | extension:packageType | Type of packaging. | See note above about item |
| device | Administration device included in the product. | equivalent | Medication | extension:device | Device | |
| device.deviceQuantity | Number of such devices. | equivalent | Medication | extension:device.extension:quantity | ||
| device.device[x] | Device coded (codeable concept or reference). | equivalent | Medication | extension:device.extension:device.value[x] | ||
| characteristic | Other features of the product. | equivalent | Medication | extension:characteristic | Characteristics of the medication. | |
| characteristic.type | Type of characteristic. | equivalent | Medication | extension:characteristic.extension:type | Type of characteristic. | |
| characteristic.value[x] | Value of the characteristic. | equivalent | Medication | extension:characteristic.extension:value | Value of the characteristic. | Supports boolean, CodeableConcept, string, Quantity, dateTime, integer, decimal, Ratio in R5 |
| batch.lotNumber | Batch identifier of the medicinal product. | equivalent | Medication | batch.lotNumber | Lot number of a particular batch. | Traceability / pharmacovigilance. |
| batch.expirationDate | Batch expiration date of the medicinal product. | equivalent | Medication | batch.expirationDate | When the batch expires. | |
Return to overview: EHDS Logical Models → FHIR Profiles