Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi | Version: 1.1.0 | |||
Standards status: Trial-use | Maturity Level: 2 | Computable Name: ClinicalUseDefinitionIndicationUvEpi |
ClinicalUseDefinition Indication (ePI)
Usages:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure Constraints: cud-1 |
![]() ![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() ![]() |
0..* | Resource | Contained, inline Resources | |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() ![]() |
Σ | 0..* | Identifier | Business identifier for this clinical use. |
![]() ![]() ![]() |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication |
![]() ![]() ![]() |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication |
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
![]() ![]() ![]() |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication |
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) |
![]() |
Path | Conformance | ValueSet / Code | URI |
ClinicalUseDefinition.type | required | Pattern Value: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0 From the FHIR Standard | |
ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra(a valid code from http://terminology.hl7.org/CodeSystem/mdr )http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra From this IG |
Id | Grade | Path(s) | Details | Requirements |
cud-1 | error | ClinicalUseDefinition | Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance : (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2 | |
dom-2 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ClinicalUseDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ClinicalUseDefinition
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
ClinicalUseDefinition | |||
![]() ![]() ![]() |
0..* | Identifier | Business identifier for this clinical use. | |
![]() ![]() ![]() |
1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Required Pattern: indication | |
![]() ![]() ![]() |
1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | |
![]() ![]() ![]() |
0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired | |
![]() ![]() ![]() |
0..0 | |||
![]() ![]() ![]() |
1..1 | BackboneElement | Specifics for when this is an indication | |
![]() ![]() ![]() ![]() |
0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | |
![]() ![]() ![]() |
0..0 | |||
![]() ![]() ![]() |
0..0 | |||
![]() ![]() ![]() |
0..0 | |||
![]() |
Path | Conformance | ValueSet | URI |
ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra(a valid code from http://terminology.hl7.org/CodeSystem/mdr )http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra From this IG |
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
---|---|---|---|---|---|---|---|---|
![]() ![]() |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure Constraints: cud-1 | ||||
![]() ![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() ![]() |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
![]() ![]() ![]() |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
![]() ![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() ![]() |
Σ | 0..* | Identifier | Business identifier for this clinical use. | ||||
![]() ![]() ![]() |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication | ||||
![]() ![]() ![]() |
Σ | 0..* | CodeableConcept | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ClinicalUseDefinitionCategory (preferred): A categorisation for a clinical use information item. | ||||
![]() ![]() ![]() |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | ||||
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
![]() ![]() ![]() |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The status of the disease or symptom for the indication Binding: DiseaseStatus (example): The status of a disease or symptom. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..* | CodeableReference(ObservationDefinition) | A comorbidity or coinfection as part of the indication Binding: DiseaseSymptomProcedure (example): A symptom, disease or procedure. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The intended effect, aim or strategy to be achieved Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Timing or duration information | |||||
![]() ![]() ![]() ![]() ![]() |
Range | |||||||
![]() ![]() ![]() ![]() ![]() |
string | |||||||
![]() ![]() ![]() ![]() |
Σ | 0..* | Reference(ClinicalUseDefinition) | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication | ||||
![]() ![]() ![]() ![]() |
0..1 | Expression | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements | |||||
![]() ![]() ![]() ![]() |
Σ | 0..* | See otherTherapy (ClinicalUseDefinition) | The use of the medicinal product in relation to other therapies described as part of the indication | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
![]() ![]() ![]() |
Σ | 0..* | canonical(Library) | Logic used by the clinical use definition | ||||
![]() |
Path | Conformance | ValueSet / Code | URI |
ClinicalUseDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
ClinicalUseDefinition.type | required | Pattern Value: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0 From the FHIR Standard | |
ClinicalUseDefinition.category | preferred | ClinicalUseDefinitionCategoryhttp://hl7.org/fhir/ValueSet/clinical-use-definition-category From the FHIR Standard | |
ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedure From the FHIR Standard | |
ClinicalUseDefinition.contraindication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-status From the FHIR Standard | |
ClinicalUseDefinition.contraindication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedure From the FHIR Standard | |
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | preferred | TherapyRelationshipTypehttp://hl7.org/fhir/ValueSet/therapy-relationship-type From the FHIR Standard | |
ClinicalUseDefinition.contraindication.otherTherapy.treatment | example | Therapyhttp://hl7.org/fhir/ValueSet/therapy From the FHIR Standard | |
ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra(a valid code from http://terminology.hl7.org/CodeSystem/mdr )http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra From this IG | |
ClinicalUseDefinition.indication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-status From the FHIR Standard | |
ClinicalUseDefinition.indication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedure From the FHIR Standard | |
ClinicalUseDefinition.indication.intendedEffect | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-use From the FHIR Standard | |
ClinicalUseDefinition.interaction.interactant.item[x] | example | Interactanthttp://hl7.org/fhir/ValueSet/interactant From the FHIR Standard | |
ClinicalUseDefinition.interaction.type | example | InteractionTypehttp://hl7.org/fhir/ValueSet/interaction-type From the FHIR Standard | |
ClinicalUseDefinition.interaction.effect | example | InteractionEffecthttp://hl7.org/fhir/ValueSet/interaction-effect From the FHIR Standard | |
ClinicalUseDefinition.interaction.incidence | example | InteractionIncidencehttp://hl7.org/fhir/ValueSet/interaction-incidence From the FHIR Standard | |
ClinicalUseDefinition.interaction.management | example | InteractionManagementhttp://hl7.org/fhir/ValueSet/interaction-management From the FHIR Standard | |
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptomhttp://hl7.org/fhir/ValueSet/undesirable-effect-symptom From the FHIR Standard | |
ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassificationhttp://hl7.org/fhir/ValueSet/undesirable-effect-classification From the FHIR Standard | |
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequencyhttp://hl7.org/fhir/ValueSet/undesirable-effect-frequency From the FHIR Standard | |
ClinicalUseDefinition.warning.code | example | WarningTypehttp://hl7.org/fhir/ValueSet/warning-type From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cud-1 | error | ClinicalUseDefinition | Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance : (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2 | |
dom-2 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ClinicalUseDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ClinicalUseDefinition
Summary
Mandatory: 2 elements
Prohibited: 4 elements
Structures
This structure refers to these other structures:
Maturity: 2
Key Elements View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure Constraints: cud-1 |
![]() ![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() ![]() |
0..* | Resource | Contained, inline Resources | |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() ![]() |
Σ | 0..* | Identifier | Business identifier for this clinical use. |
![]() ![]() ![]() |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication |
![]() ![]() ![]() |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication |
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
![]() ![]() ![]() |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication |
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) |
![]() |
Path | Conformance | ValueSet / Code | URI |
ClinicalUseDefinition.type | required | Pattern Value: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0 From the FHIR Standard | |
ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra(a valid code from http://terminology.hl7.org/CodeSystem/mdr )http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra From this IG |
Id | Grade | Path(s) | Details | Requirements |
cud-1 | error | ClinicalUseDefinition | Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance : (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2 | |
dom-2 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ClinicalUseDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Differential View
This structure is derived from ClinicalUseDefinition
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
ClinicalUseDefinition | |||
![]() ![]() ![]() |
0..* | Identifier | Business identifier for this clinical use. | |
![]() ![]() ![]() |
1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Required Pattern: indication | |
![]() ![]() ![]() |
1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | |
![]() ![]() ![]() |
0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired | |
![]() ![]() ![]() |
0..0 | |||
![]() ![]() ![]() |
1..1 | BackboneElement | Specifics for when this is an indication | |
![]() ![]() ![]() ![]() |
0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | |
![]() ![]() ![]() |
0..0 | |||
![]() ![]() ![]() |
0..0 | |||
![]() ![]() ![]() |
0..0 | |||
![]() |
Path | Conformance | ValueSet | URI |
ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra(a valid code from http://terminology.hl7.org/CodeSystem/mdr )http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra From this IG |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
---|---|---|---|---|---|---|---|---|
![]() ![]() |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure Constraints: cud-1 | ||||
![]() ![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() ![]() |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
![]() ![]() ![]() |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
![]() ![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() ![]() |
Σ | 0..* | Identifier | Business identifier for this clinical use. | ||||
![]() ![]() ![]() |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication | ||||
![]() ![]() ![]() |
Σ | 0..* | CodeableConcept | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ClinicalUseDefinitionCategory (preferred): A categorisation for a clinical use information item. | ||||
![]() ![]() ![]() |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | ||||
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
![]() ![]() ![]() |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The status of the disease or symptom for the indication Binding: DiseaseStatus (example): The status of a disease or symptom. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..* | CodeableReference(ObservationDefinition) | A comorbidity or coinfection as part of the indication Binding: DiseaseSymptomProcedure (example): A symptom, disease or procedure. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The intended effect, aim or strategy to be achieved Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Timing or duration information | |||||
![]() ![]() ![]() ![]() ![]() |
Range | |||||||
![]() ![]() ![]() ![]() ![]() |
string | |||||||
![]() ![]() ![]() ![]() |
Σ | 0..* | Reference(ClinicalUseDefinition) | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication | ||||
![]() ![]() ![]() ![]() |
0..1 | Expression | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements | |||||
![]() ![]() ![]() ![]() |
Σ | 0..* | See otherTherapy (ClinicalUseDefinition) | The use of the medicinal product in relation to other therapies described as part of the indication | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
![]() ![]() ![]() |
Σ | 0..* | canonical(Library) | Logic used by the clinical use definition | ||||
![]() |
Path | Conformance | ValueSet / Code | URI |
ClinicalUseDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
ClinicalUseDefinition.type | required | Pattern Value: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0 From the FHIR Standard | |
ClinicalUseDefinition.category | preferred | ClinicalUseDefinitionCategoryhttp://hl7.org/fhir/ValueSet/clinical-use-definition-category From the FHIR Standard | |
ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedure From the FHIR Standard | |
ClinicalUseDefinition.contraindication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-status From the FHIR Standard | |
ClinicalUseDefinition.contraindication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedure From the FHIR Standard | |
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | preferred | TherapyRelationshipTypehttp://hl7.org/fhir/ValueSet/therapy-relationship-type From the FHIR Standard | |
ClinicalUseDefinition.contraindication.otherTherapy.treatment | example | Therapyhttp://hl7.org/fhir/ValueSet/therapy From the FHIR Standard | |
ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra(a valid code from http://terminology.hl7.org/CodeSystem/mdr )http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra From this IG | |
ClinicalUseDefinition.indication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-status From the FHIR Standard | |
ClinicalUseDefinition.indication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedure From the FHIR Standard | |
ClinicalUseDefinition.indication.intendedEffect | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-use From the FHIR Standard | |
ClinicalUseDefinition.interaction.interactant.item[x] | example | Interactanthttp://hl7.org/fhir/ValueSet/interactant From the FHIR Standard | |
ClinicalUseDefinition.interaction.type | example | InteractionTypehttp://hl7.org/fhir/ValueSet/interaction-type From the FHIR Standard | |
ClinicalUseDefinition.interaction.effect | example | InteractionEffecthttp://hl7.org/fhir/ValueSet/interaction-effect From the FHIR Standard | |
ClinicalUseDefinition.interaction.incidence | example | InteractionIncidencehttp://hl7.org/fhir/ValueSet/interaction-incidence From the FHIR Standard | |
ClinicalUseDefinition.interaction.management | example | InteractionManagementhttp://hl7.org/fhir/ValueSet/interaction-management From the FHIR Standard | |
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptomhttp://hl7.org/fhir/ValueSet/undesirable-effect-symptom From the FHIR Standard | |
ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassificationhttp://hl7.org/fhir/ValueSet/undesirable-effect-classification From the FHIR Standard | |
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequencyhttp://hl7.org/fhir/ValueSet/undesirable-effect-frequency From the FHIR Standard | |
ClinicalUseDefinition.warning.code | example | WarningTypehttp://hl7.org/fhir/ValueSet/warning-type From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cud-1 | error | ClinicalUseDefinition | Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance : (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2 | |
dom-2 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ClinicalUseDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ClinicalUseDefinition
Summary
Mandatory: 2 elements
Prohibited: 4 elements
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron