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 2026-02-22 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.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. EHDSImmunisation 0..* EHDSImmunisation Immunisation model
... header 1..1 Base Basic metadata for this information
.... subject O 1..1 EHDSPatient Patient/subject information
ObligationsActor
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).
ObligationsActor
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).
ObligationsActor
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
ObligationsActor
SHALL: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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
SHOULD:able-to-populate Producer
..... lotNumber O 0..1 string Batch identifier of the medicinal product.
ObligationsActor
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.
ObligationsActor
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

doco 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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. EHDSImmunisation 0..* EHDSImmunisation Immunisation model
... header
.... subject O 1..1 EHDSPatient Patient/subject information
ObligationsActor
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).
ObligationsActor
SHOULD:able-to-populate Producer
.... status O 1..1 CodeableConcept Status of the immunisation event (completed, not-done).
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
SHOULD:able-to-populate Producer
..... lotNumber O 0..1 string Batch identifier of the medicinal product.
ObligationsActor
SHOULD:able-to-populate Producer

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. EHDSImmunisation 0..* EHDSImmunisation Immunisation model
... header 1..1 Base Basic metadata for this information
.... subject O 1..1 EHDSPatient Patient/subject information
ObligationsActor
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).
ObligationsActor
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).
ObligationsActor
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
ObligationsActor
SHALL: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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
SHOULD:able-to-populate Producer
..... lotNumber O 0..1 string Batch identifier of the medicinal product.
ObligationsActor
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.
ObligationsActor
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

doco 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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. EHDSImmunisation 0..* EHDSImmunisation Immunisation model
... header 1..1 Base Basic metadata for this information
.... subject O 1..1 EHDSPatient Patient/subject information
ObligationsActor
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).
ObligationsActor
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).
ObligationsActor
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
ObligationsActor
SHALL: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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
SHOULD:able-to-populate Producer
..... lotNumber O 0..1 string Batch identifier of the medicinal product.
ObligationsActor
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.
ObligationsActor
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

doco 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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. EHDSImmunisation 0..* EHDSImmunisation Immunisation model
... header
.... subject O 1..1 EHDSPatient Patient/subject information
ObligationsActor
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).
ObligationsActor
SHOULD:able-to-populate Producer
.... status O 1..1 CodeableConcept Status of the immunisation event (completed, not-done).
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
SHOULD:able-to-populate Producer
..... lotNumber O 0..1 string Batch identifier of the medicinal product.
ObligationsActor
SHOULD:able-to-populate Producer

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. EHDSImmunisation 0..* EHDSImmunisation Immunisation model
... header 1..1 Base Basic metadata for this information
.... subject O 1..1 EHDSPatient Patient/subject information
ObligationsActor
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).
ObligationsActor
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).
ObligationsActor
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
ObligationsActor
SHALL: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.
ObligationsActor
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.
ObligationsActor
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.
ObligationsActor
SHOULD:able-to-populate Producer
..... lotNumber O 0..1 string Batch identifier of the medicinal product.
ObligationsActor
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.
ObligationsActor
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

doco 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