Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 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: 1.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: ClinicalUseDefinitionIndicationUvEpi | ||
ClinicalUseDefinition Indication (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ClinicalUseDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ClinicalUseDefinition |
ClinicalUseDefinition | |||
  identifier |
0..* | Identifier | Business identifier for this clinical use. | |
| type |
1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Required Pattern: indication | |
 subject |
1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | |
| status |
0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired | |
| contraindication |
0..0 | |||
 indication |
1..1 | BackboneElement | Specifics for when this is an indication | |
  diseaseSymptomProcedure |
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) | |
| interaction |
0..0 | |||
| undesirableEffect |
0..0 | |||
| warning |
0..0 | |||
| Documentation for this format | ||||
| 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/meddrafrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ClinicalUseDefinition |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure cud-1: Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 identifier |
Σ | 0..* | Identifier | Business identifier for this clinical use. |
| type |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication |
| subject |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication |
| status |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
 indication |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| diseaseSymptomProcedure |
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) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ClinicalUseDefinition.type | required | Pattern: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0from the FHIR Standard | |
| ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom 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/meddrafrom 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() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ClinicalUseDefinition |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure cud-1: Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business identifier for this clinical use. | ||||
| type |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication | ||||
| category |
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. | ||||
| subject |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | ||||
| status |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| indication |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| diseaseSymptomProcedure |
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) | ||||
| diseaseStatus |
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. | ||||
| comorbidity |
Σ | 0..* | CodeableReference(ObservationDefinition) | A comorbidity or coinfection as part of the indication Binding: DiseaseSymptomProcedure (example): A symptom, disease or procedure. | ||||
| intendedEffect |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The intended effect, aim or strategy to be achieved Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
 duration[x] |
Σ | 0..1 | Timing or duration information | |||||
| durationRange |
Range | |||||||
| durationString |
string | |||||||
| undesirableEffect |
Σ | 0..* | Reference(ClinicalUseDefinition) | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication | ||||
| applicability |
0..1 | Expression | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements | |||||
| otherTherapy |
Σ | 0..* | See otherTherapy (ClinicalUseDefinition) | The use of the medicinal product in relation to other therapies described as part of the indication | ||||
| population |
Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
| library |
Σ | 0..* | canonical(Library) | Logic used by the clinical use definition | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| ClinicalUseDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| ClinicalUseDefinition.type | required | Pattern: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0from the FHIR Standard | |
| ClinicalUseDefinition.category | preferred | ClinicalUseDefinitionCategoryhttp://hl7.org/fhir/ValueSet/clinical-use-definition-categoryfrom the FHIR Standard | |
| ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedurefrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-statusfrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedurefrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | preferred | TherapyRelationshipTypehttp://hl7.org/fhir/ValueSet/therapy-relationship-typefrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.otherTherapy.treatment | example | Therapyhttp://hl7.org/fhir/ValueSet/therapyfrom 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/meddrafrom this IG | |
| ClinicalUseDefinition.indication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-statusfrom the FHIR Standard | |
| ClinicalUseDefinition.indication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedurefrom the FHIR Standard | |
| ClinicalUseDefinition.indication.intendedEffect | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-usefrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.interactant.item[x] | example | Interactanthttp://hl7.org/fhir/ValueSet/interactantfrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.type | example | InteractionTypehttp://hl7.org/fhir/ValueSet/interaction-typefrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.effect | example | InteractionEffecthttp://hl7.org/fhir/ValueSet/interaction-effectfrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.incidence | example | InteractionIncidencehttp://hl7.org/fhir/ValueSet/interaction-incidencefrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.management | example | InteractionManagementhttp://hl7.org/fhir/ValueSet/interaction-managementfrom the FHIR Standard | |
| ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptomhttp://hl7.org/fhir/ValueSet/undesirable-effect-symptomfrom the FHIR Standard | |
| ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassificationhttp://hl7.org/fhir/ValueSet/undesirable-effect-classificationfrom the FHIR Standard | |
| ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequencyhttp://hl7.org/fhir/ValueSet/undesirable-effect-frequencyfrom the FHIR Standard | |
| ClinicalUseDefinition.warning.code | example | WarningTypehttp://hl7.org/fhir/ValueSet/warning-typefrom 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
Differential View
This structure is derived from ClinicalUseDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ClinicalUseDefinition |
ClinicalUseDefinition | |||
| identifier |
0..* | Identifier | Business identifier for this clinical use. | |
| type |
1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Required Pattern: indication | |
| subject |
1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | |
| status |
0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired | |
| contraindication |
0..0 | |||
| indication |
1..1 | BackboneElement | Specifics for when this is an indication | |
| diseaseSymptomProcedure |
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) | |
| interaction |
0..0 | |||
| undesirableEffect |
0..0 | |||
| warning |
0..0 | |||
| Documentation for this format | ||||
| 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/meddrafrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ClinicalUseDefinition |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure cud-1: Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier |
Σ | 0..* | Identifier | Business identifier for this clinical use. |
| type |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication |
| subject |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication |
| status |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| indication |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| diseaseSymptomProcedure |
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) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ClinicalUseDefinition.type | required | Pattern: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0from the FHIR Standard | |
| ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom 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/meddrafrom 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ClinicalUseDefinition |
C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure cud-1: Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business identifier for this clinical use. | ||||
| type |
Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication | ||||
| category |
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. | ||||
| subject |
Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. for which this is an indication | ||||
| status |
Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| indication |
ΣC | 1..1 | BackboneElement | Specifics for when this is an indication | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| diseaseSymptomProcedure |
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) | ||||
| diseaseStatus |
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. | ||||
| comorbidity |
Σ | 0..* | CodeableReference(ObservationDefinition) | A comorbidity or coinfection as part of the indication Binding: DiseaseSymptomProcedure (example): A symptom, disease or procedure. | ||||
| intendedEffect |
Σ | 0..1 | CodeableReference(ObservationDefinition) | The intended effect, aim or strategy to be achieved Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
| duration[x] |
Σ | 0..1 | Timing or duration information | |||||
| durationRange |
Range | |||||||
| durationString |
string | |||||||
| undesirableEffect |
Σ | 0..* | Reference(ClinicalUseDefinition) | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication | ||||
| applicability |
0..1 | Expression | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements | |||||
| otherTherapy |
Σ | 0..* | See otherTherapy (ClinicalUseDefinition) | The use of the medicinal product in relation to other therapies described as part of the indication | ||||
| population |
Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
| library |
Σ | 0..* | canonical(Library) | Logic used by the clinical use definition | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| ClinicalUseDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| ClinicalUseDefinition.type | required | Pattern: indicationhttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0from the FHIR Standard | |
| ClinicalUseDefinition.category | preferred | ClinicalUseDefinitionCategoryhttp://hl7.org/fhir/ValueSet/clinical-use-definition-categoryfrom the FHIR Standard | |
| ClinicalUseDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedurefrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-statusfrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedurefrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | preferred | TherapyRelationshipTypehttp://hl7.org/fhir/ValueSet/therapy-relationship-typefrom the FHIR Standard | |
| ClinicalUseDefinition.contraindication.otherTherapy.treatment | example | Therapyhttp://hl7.org/fhir/ValueSet/therapyfrom 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/meddrafrom this IG | |
| ClinicalUseDefinition.indication.diseaseStatus | example | DiseaseStatushttp://hl7.org/fhir/ValueSet/disease-statusfrom the FHIR Standard | |
| ClinicalUseDefinition.indication.comorbidity | example | DiseaseSymptomProcedurehttp://hl7.org/fhir/ValueSet/disease-symptom-procedurefrom the FHIR Standard | |
| ClinicalUseDefinition.indication.intendedEffect | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-usefrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.interactant.item[x] | example | Interactanthttp://hl7.org/fhir/ValueSet/interactantfrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.type | example | InteractionTypehttp://hl7.org/fhir/ValueSet/interaction-typefrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.effect | example | InteractionEffecthttp://hl7.org/fhir/ValueSet/interaction-effectfrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.incidence | example | InteractionIncidencehttp://hl7.org/fhir/ValueSet/interaction-incidencefrom the FHIR Standard | |
| ClinicalUseDefinition.interaction.management | example | InteractionManagementhttp://hl7.org/fhir/ValueSet/interaction-managementfrom the FHIR Standard | |
| ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptomhttp://hl7.org/fhir/ValueSet/undesirable-effect-symptomfrom the FHIR Standard | |
| ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassificationhttp://hl7.org/fhir/ValueSet/undesirable-effect-classificationfrom the FHIR Standard | |
| ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequencyhttp://hl7.org/fhir/ValueSet/undesirable-effect-frequencyfrom the FHIR Standard | |
| ClinicalUseDefinition.warning.code | example | WarningTypehttp://hl7.org/fhir/ValueSet/warning-typefrom 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
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2024-04-08
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