EHDS Logical Information Models
0.4.0 - draft

EHDS Logical Information Models, published by Xt-EHR. This guide is not an authorized publication; it is the continuous build for version 0.4.0 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: Immunisation obligations

Official URL: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSImmunisationObligations | Version: 0.4.0
Draft as of 2026-03-03 | Computable Name: EHDSImmunisationObligations

Obligations for the logical model for immunisation.

Usages:

- This Logical Model Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

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

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSImmunisation |  | 0..* | EHDSImmunisation | Immunisation model
header |  | 1..1 | Base | Basic metadata for this information
subject | O | 1..1 | EHDSPatient | Patient/subject information
Obligations | Actor
SHALL:able-to-populate | Producer
identifier | O | 0..* | Identifier | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Obligations | Actor
SHOULD:able-to-populate | Producer
author[x] |  | 0..* |  | The author of the immunisation statement.
authorEHDSHealthProfessional |  |  | EHDSHealthProfessional |
authorEHDSOrganisation |  |  | EHDSOrganisation |
authorEHDSDevice |  |  | EHDSDevice |
date |  | 0..1 | dateTime | Date and optionally time of authoring/issuing
status | O | 1..1 | CodeableConcept | Status of the immunisation event (completed, not-done).
Obligations | Actor
SHALL:able-to-populate | Producer
source |  | 0..1 | CodeableConcept | 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 | CodeableConcept | Language in which the resource is written. Language is expressed by the IETF language tag. Binding Description: (preferred): BCP 47
diseaseOrAgentTargeted |  | 0..* | CodeableConcept | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus). Binding Description: (preferred): ICD-10, SNOMED CT
vaccine | O | 1..1 | CodeableConcept | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product. Binding Description: (preferred): SNOMED CT, ATC
Obligations | Actor
SHALL:able-to-populate | Producer
administeredProduct | O | 0..1 | EHDSMedication | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm |  | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item |  | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
doseForm |  | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance |  | 1..1 | CodeableConcept | Substance Binding Description: (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 '100 mg/1 ml' or '500 mg per 1 tablet'
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (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: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (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: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch | O | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Obligations | Actor
SHOULD:able-to-populate | Producer
lotNumber | O | 0..1 | string | Batch identifier of the medicinal product.
Obligations | Actor
SHOULD:able-to-populate | Producer
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
administrationTime | O | 1..1 | dateTime | The date and optionally the exact time when the vaccination was administered.
Obligations | Actor
SHALL:able-to-populate | Producer
administeringCentre |  | 0..1 | EHDSOrganisation | Administering centre or a health authority responsible for the vaccination event
administrator |  | 0..1 | EHDSHealthProfessional | Health professional responsible for administering the immunisation product.
note |  | 0..1 | string | Any additional free-text information about the immunisation
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSImmunisation.header.​language | Base | preferred |  | Not State | Unknown
EHDSImmunisation.diseaseOrAgentTargeted | Base | preferred |  | Not State | Unknown
EHDSImmunisation.vaccine | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​classification | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.amount | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.packageType | Base | preferred |  | Not State | Unknown

This structure is derived from EHDSImmunisation

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSImmunisation |  | 0..* | EHDSImmunisation | Immunisation model
header |  |  |  |
subject | O | 1..1 | EHDSPatient | Patient/subject information
Obligations | Actor
SHALL:able-to-populate | Producer
identifier | O | 0..* | Identifier | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Obligations | Actor
SHOULD:able-to-populate | Producer
status | O | 1..1 | CodeableConcept | Status of the immunisation event (completed, not-done).
Obligations | Actor
SHALL:able-to-populate | Producer
vaccine | O | 1..1 | CodeableConcept | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.
Obligations | Actor
SHALL:able-to-populate | Producer
administeredProduct | O | 0..1 | EHDSMedication | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCode[x] | O | 0..* | CodeableConcept, Identifier | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHOULD:able-to-populate | Producer
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
batch | O | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Obligations | Actor
SHOULD:able-to-populate | Producer
lotNumber | O | 0..1 | string | Batch identifier of the medicinal product.
Obligations | Actor
SHOULD:able-to-populate | Producer
administrationTime | O | 1..1 | dateTime | The date and optionally the exact time when the vaccination was administered.
Obligations | Actor
SHALL:able-to-populate | Producer
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSImmunisation |  | 0..* | EHDSImmunisation | Immunisation model
header |  | 1..1 | Base | Basic metadata for this information
subject | O | 1..1 | EHDSPatient | Patient/subject information
Obligations | Actor
SHALL:able-to-populate | Producer
identifier | O | 0..* | Identifier | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Obligations | Actor
SHOULD:able-to-populate | Producer
author[x] |  | 0..* |  | The author of the immunisation statement.
authorEHDSHealthProfessional |  |  | EHDSHealthProfessional |
authorEHDSOrganisation |  |  | EHDSOrganisation |
authorEHDSDevice |  |  | EHDSDevice |
date |  | 0..1 | dateTime | Date and optionally time of authoring/issuing
status | O | 1..1 | CodeableConcept | Status of the immunisation event (completed, not-done).
Obligations | Actor
SHALL:able-to-populate | Producer
source |  | 0..1 | CodeableConcept | 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 | CodeableConcept | Language in which the resource is written. Language is expressed by the IETF language tag. Binding Description: (preferred): BCP 47
diseaseOrAgentTargeted |  | 0..* | CodeableConcept | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus). Binding Description: (preferred): ICD-10, SNOMED CT
vaccine | O | 1..1 | CodeableConcept | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product. Binding Description: (preferred): SNOMED CT, ATC
Obligations | Actor
SHALL:able-to-populate | Producer
administeredProduct | O | 0..1 | EHDSMedication | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm |  | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item |  | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
doseForm |  | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance |  | 1..1 | CodeableConcept | Substance Binding Description: (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 '100 mg/1 ml' or '500 mg per 1 tablet'
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (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: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (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: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch | O | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Obligations | Actor
SHOULD:able-to-populate | Producer
lotNumber | O | 0..1 | string | Batch identifier of the medicinal product.
Obligations | Actor
SHOULD:able-to-populate | Producer
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
administrationTime | O | 1..1 | dateTime | The date and optionally the exact time when the vaccination was administered.
Obligations | Actor
SHALL:able-to-populate | Producer
administeringCentre |  | 0..1 | EHDSOrganisation | Administering centre or a health authority responsible for the vaccination event
administrator |  | 0..1 | EHDSHealthProfessional | Health professional responsible for administering the immunisation product.
note |  | 0..1 | string | Any additional free-text information about the immunisation
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSImmunisation.header.​language | Base | preferred |  | Not State | Unknown
EHDSImmunisation.diseaseOrAgentTargeted | Base | preferred |  | Not State | Unknown
EHDSImmunisation.vaccine | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​classification | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.amount | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.packageType | Base | preferred |  | Not State | Unknown

This structure is derived from EHDSImmunisation

Summary

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSImmunisation |  | 0..* | EHDSImmunisation | Immunisation model
header |  | 1..1 | Base | Basic metadata for this information
subject | O | 1..1 | EHDSPatient | Patient/subject information
Obligations | Actor
SHALL:able-to-populate | Producer
identifier | O | 0..* | Identifier | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Obligations | Actor
SHOULD:able-to-populate | Producer
author[x] |  | 0..* |  | The author of the immunisation statement.
authorEHDSHealthProfessional |  |  | EHDSHealthProfessional |
authorEHDSOrganisation |  |  | EHDSOrganisation |
authorEHDSDevice |  |  | EHDSDevice |
date |  | 0..1 | dateTime | Date and optionally time of authoring/issuing
status | O | 1..1 | CodeableConcept | Status of the immunisation event (completed, not-done).
Obligations | Actor
SHALL:able-to-populate | Producer
source |  | 0..1 | CodeableConcept | 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 | CodeableConcept | Language in which the resource is written. Language is expressed by the IETF language tag. Binding Description: (preferred): BCP 47
diseaseOrAgentTargeted |  | 0..* | CodeableConcept | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus). Binding Description: (preferred): ICD-10, SNOMED CT
vaccine | O | 1..1 | CodeableConcept | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product. Binding Description: (preferred): SNOMED CT, ATC
Obligations | Actor
SHALL:able-to-populate | Producer
administeredProduct | O | 0..1 | EHDSMedication | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm |  | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item |  | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
doseForm |  | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance |  | 1..1 | CodeableConcept | Substance Binding Description: (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 '100 mg/1 ml' or '500 mg per 1 tablet'
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (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: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (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: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch | O | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Obligations | Actor
SHOULD:able-to-populate | Producer
lotNumber | O | 0..1 | string | Batch identifier of the medicinal product.
Obligations | Actor
SHOULD:able-to-populate | Producer
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
administrationTime | O | 1..1 | dateTime | The date and optionally the exact time when the vaccination was administered.
Obligations | Actor
SHALL:able-to-populate | Producer
administeringCentre |  | 0..1 | EHDSOrganisation | Administering centre or a health authority responsible for the vaccination event
administrator |  | 0..1 | EHDSHealthProfessional | Health professional responsible for administering the immunisation product.
note |  | 0..1 | string | Any additional free-text information about the immunisation
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSImmunisation.header.​language | Base | preferred |  | Not State | Unknown
EHDSImmunisation.diseaseOrAgentTargeted | Base | preferred |  | Not State | Unknown
EHDSImmunisation.vaccine | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​classification | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.amount | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.packageType | Base | preferred |  | Not State | Unknown

Differential View

This structure is derived from EHDSImmunisation

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSImmunisation |  | 0..* | EHDSImmunisation | Immunisation model
header |  |  |  |
subject | O | 1..1 | EHDSPatient | Patient/subject information
Obligations | Actor
SHALL:able-to-populate | Producer
identifier | O | 0..* | Identifier | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Obligations | Actor
SHOULD:able-to-populate | Producer
status | O | 1..1 | CodeableConcept | Status of the immunisation event (completed, not-done).
Obligations | Actor
SHALL:able-to-populate | Producer
vaccine | O | 1..1 | CodeableConcept | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.
Obligations | Actor
SHALL:able-to-populate | Producer
administeredProduct | O | 0..1 | EHDSMedication | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCode[x] | O | 0..* | CodeableConcept, Identifier | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHOULD:able-to-populate | Producer
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
batch | O | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Obligations | Actor
SHOULD:able-to-populate | Producer
lotNumber | O | 0..1 | string | Batch identifier of the medicinal product.
Obligations | Actor
SHOULD:able-to-populate | Producer
administrationTime | O | 1..1 | dateTime | The date and optionally the exact time when the vaccination was administered.
Obligations | Actor
SHALL:able-to-populate | Producer
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSImmunisation |  | 0..* | EHDSImmunisation | Immunisation model
header |  | 1..1 | Base | Basic metadata for this information
subject | O | 1..1 | EHDSPatient | Patient/subject information
Obligations | Actor
SHALL:able-to-populate | Producer
identifier | O | 0..* | Identifier | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Obligations | Actor
SHOULD:able-to-populate | Producer
author[x] |  | 0..* |  | The author of the immunisation statement.
authorEHDSHealthProfessional |  |  | EHDSHealthProfessional |
authorEHDSOrganisation |  |  | EHDSOrganisation |
authorEHDSDevice |  |  | EHDSDevice |
date |  | 0..1 | dateTime | Date and optionally time of authoring/issuing
status | O | 1..1 | CodeableConcept | Status of the immunisation event (completed, not-done).
Obligations | Actor
SHALL:able-to-populate | Producer
source |  | 0..1 | CodeableConcept | 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 | CodeableConcept | Language in which the resource is written. Language is expressed by the IETF language tag. Binding Description: (preferred): BCP 47
diseaseOrAgentTargeted |  | 0..* | CodeableConcept | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus). Binding Description: (preferred): ICD-10, SNOMED CT
vaccine | O | 1..1 | CodeableConcept | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product. Binding Description: (preferred): SNOMED CT, ATC
Obligations | Actor
SHALL:able-to-populate | Producer
administeredProduct | O | 0..1 | EHDSMedication | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHOULD:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm |  | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item |  | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
doseForm |  | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance |  | 1..1 | CodeableConcept | Substance Binding Description: (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 '100 mg/1 ml' or '500 mg per 1 tablet'
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (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: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (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: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch | O | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Obligations | Actor
SHOULD:able-to-populate | Producer
lotNumber | O | 0..1 | string | Batch identifier of the medicinal product.
Obligations | Actor
SHOULD:able-to-populate | Producer
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
administrationTime | O | 1..1 | dateTime | The date and optionally the exact time when the vaccination was administered.
Obligations | Actor
SHALL:able-to-populate | Producer
administeringCentre |  | 0..1 | EHDSOrganisation | Administering centre or a health authority responsible for the vaccination event
administrator |  | 0..1 | EHDSHealthProfessional | Health professional responsible for administering the immunisation product.
note |  | 0..1 | string | Any additional free-text information about the immunisation
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSImmunisation.header.​language | Base | preferred |  | Not State | Unknown
EHDSImmunisation.diseaseOrAgentTargeted | Base | preferred |  | Not State | Unknown
EHDSImmunisation.vaccine | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​classification | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.doseForm | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.amount | Base | preferred |  | Not State | Unknown
EHDSImmunisation.administeredProduct.​item.packageType | Base | preferred |  | Not State | Unknown

This structure is derived from EHDSImmunisation

Summary

Other representations of profile: CSV, Excel