Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

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

Resource Profile: ClinicalUseDefinitionIndicationUvEpi - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the ClinicalUseDefinition-indication-uv-epi resource profile.

Guidance on how to interpret the contents of this table can be found here

0. ClinicalUseDefinition
2. ClinicalUseDefinition.identifier
ShortBusiness identifier for this clinical use.
NoteThis is a business identifier, not a resource identifier (see discussion)
4. ClinicalUseDefinition.type
Pattern Valueindication
6. ClinicalUseDefinition.subject
Control1..?
TypeReference(MedicinalProductDefinition (ePI))
8. ClinicalUseDefinition.status
ShortDefines whether this clinical use is draft, active or retired
10. ClinicalUseDefinition.contraindication
Control0..0
12. ClinicalUseDefinition.indication
Control1..?
14. ClinicalUseDefinition.indication.diseaseSymptomProcedure
BindingThe codes SHOULD be taken from MedDRA Terms for clinical diseases and symptoms
(preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra)
16. ClinicalUseDefinition.interaction
Control0..0
18. ClinicalUseDefinition.undesirableEffect
Control0..0
20. ClinicalUseDefinition.warning
Control0..0

Guidance on how to interpret the contents of this table can be found here

0. ClinicalUseDefinition
Definition

A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.

ShortA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantscud-1: 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: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ClinicalUseDefinition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ClinicalUseDefinition.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. ClinicalUseDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. ClinicalUseDefinition.identifier
Definition

Business identifier for this issue.

ShortBusiness identifier for this clinical use.Business identifier for this issue
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ClinicalUseDefinition.type
Definition

indication | contraindication | interaction | undesirable-effect | warning.

Shortindication | contraindication | interaction | undesirable-effect | warning
Control1..1
BindingThe codes SHALL be taken from ClinicalUseDefinitionTypehttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0
(required to http://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0)

Overall defining type of this clinical use definition.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Pattern Valueindication
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. ClinicalUseDefinition.subject
Definition

The medication, product, substance, device, procedure etc. for which this is an indication.

ShortThe medication, product, substance, device, procedure etc. for which this is an indication
Control10..*
TypeReference(MedicinalProductDefinition (ePI), MedicinalProductDefinition, Medication, ActivityDefinition, PlanDefinition, Device, DeviceDefinition, Substance, NutritionProduct, BiologicallyDerivedProduct)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. ClinicalUseDefinition.status
Definition

Whether this is a current issue or one that has been retired etc.

ShortDefines whether this clinical use is draft, active or retiredWhether this is a current issue or one that has been retired etc
Control0..1
BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status
(preferred to http://hl7.org/fhir/ValueSet/publication-status)

The lifecycle status of an artifact.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. ClinicalUseDefinition.contraindication
Definition

Specifics for when this is a contraindication.

ShortSpecifics for when this is a contraindication
Control0..01
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
19. ClinicalUseDefinition.indication
Definition

Specifics for when this is an indication.

ShortSpecifics for when this is an indication
Control10..1
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
21. ClinicalUseDefinition.indication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
23. ClinicalUseDefinition.indication.diseaseSymptomProcedure
Definition

The situation that is being documented as an indicaton for this item.

ShortThe situation that is being documented as an indicaton for this item
Control0..1
BindingThe codes SHOULD be taken from For example codes, see MedDRA Terms for clinical diseases and symptomshttp://hl7.org/fhir/ValueSet/disease-symptom-procedure
(preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra)
TypeCodeableReference(ObservationDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
25. ClinicalUseDefinition.interaction
Definition

Specifics for when this is an interaction.

ShortSpecifics for when this is an interaction
Control0..01
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ClinicalUseDefinition.undesirableEffect
Definition

Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.

ShortA possible negative outcome from the use of this treatment
Control0..01
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
31. ClinicalUseDefinition.warning
Definition

A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.

ShortCritical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
Control0..01
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. ClinicalUseDefinition
Definition

A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.

ShortA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantscud-1: 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: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ClinicalUseDefinition.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

Control0..1
Typeid
Is Modifierfalse
Must Supportfalse
Summarytrue
4. ClinicalUseDefinition.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. ClinicalUseDefinition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. ClinicalUseDefinition.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

IETF language tag for a human language

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ClinicalUseDefinition.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. ClinicalUseDefinition.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. ClinicalUseDefinition.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. ClinicalUseDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. ClinicalUseDefinition.identifier
Definition

Business identifier for this issue.

ShortBusiness identifier for this clinical use.
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. ClinicalUseDefinition.type
Definition

indication | contraindication | interaction | undesirable-effect | warning.

Shortindication | contraindication | interaction | undesirable-effect | warning
Control1..1
BindingThe codes SHALL be taken from ClinicalUseDefinitionType
(required to http://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0)

Overall defining type of this clinical use definition.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Pattern Valueindication
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. ClinicalUseDefinition.category
Definition

A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines".

ShortA categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
Control0..*
BindingThe codes SHOULD be taken from ClinicalUseDefinitionCategory
(preferred to http://hl7.org/fhir/ValueSet/clinical-use-definition-category)

A categorisation for a clinical use information item.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. ClinicalUseDefinition.subject
Definition

The medication, product, substance, device, procedure etc. for which this is an indication.

ShortThe medication, product, substance, device, procedure etc. for which this is an indication
Control1..*
TypeReference(MedicinalProductDefinition (ePI))
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. ClinicalUseDefinition.status
Definition

Whether this is a current issue or one that has been retired etc.

ShortDefines whether this clinical use is draft, active or retired
Control0..1
BindingThe codes SHOULD be taken from PublicationStatus
(preferred to http://hl7.org/fhir/ValueSet/publication-status)

The lifecycle status of an artifact.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ClinicalUseDefinition.contraindication
Definition

Specifics for when this is a contraindication.

ShortSpecifics for when this is a contraindication
Control0..0
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. ClinicalUseDefinition.indication
Definition

Specifics for when this is an indication.

ShortSpecifics for when this is an indication
Control1..1
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. ClinicalUseDefinition.indication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
48. ClinicalUseDefinition.indication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
50. ClinicalUseDefinition.indication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
52. ClinicalUseDefinition.indication.diseaseSymptomProcedure
Definition

The situation that is being documented as an indicaton for this item.

ShortThe situation that is being documented as an indicaton for this item
Control0..1
BindingThe codes SHOULD be taken from MedDRA Terms for clinical diseases and symptoms
(preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra)
TypeCodeableReference(ObservationDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. ClinicalUseDefinition.indication.diseaseStatus
Definition

The status of the disease or symptom for the indication, for example "chronic" or "metastatic".

ShortThe status of the disease or symptom for the indication
Control0..1
BindingFor example codes, see DiseaseStatus
(example to http://hl7.org/fhir/ValueSet/disease-status)

The status of a disease or symptom.

TypeCodeableReference(ObservationDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. ClinicalUseDefinition.indication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection as part of the indication.

ShortA comorbidity or coinfection as part of the indication
Control0..*
BindingFor example codes, see DiseaseSymptomProcedure
(example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure)

A symptom, disease or procedure.

TypeCodeableReference(ObservationDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ClinicalUseDefinition.indication.intendedEffect
Definition

The intended effect, aim or strategy to be achieved.

ShortThe intended effect, aim or strategy to be achieved
Control0..1
BindingThe codes SHOULD be taken from ProductIntendedUse
(preferred to http://hl7.org/fhir/ValueSet/product-intended-use)

The overall intended use of a product.

TypeCodeableReference(ObservationDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. ClinicalUseDefinition.indication.duration[x]
Definition

Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months).

ShortTiming or duration information
Control0..1
TypeChoice of: Range, string
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. ClinicalUseDefinition.indication.undesirableEffect
Definition

An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication.

ShortAn unwanted side effect or negative outcome of the subject of this resource when being used for this indication
Control0..*
TypeReference(ClinicalUseDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. ClinicalUseDefinition.indication.applicability
Definition

An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.

ShortAn expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
Comments

The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.

Control0..1
TypeExpression
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. ClinicalUseDefinition.indication.otherTherapy
Definition

Information about the use of the medicinal product in relation to other therapies described as part of the indication.

ShortThe use of the medicinal product in relation to other therapies described as part of the indication
Control0..*
TypeSeettp://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition#ClinicalUseDefinition.contraindication.otherTherapy
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. ClinicalUseDefinition.interaction
Definition

Specifics for when this is an interaction.

ShortSpecifics for when this is an interaction
Control0..0
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. ClinicalUseDefinition.population
Definition

The population group to which this applies.

ShortThe population group to which this applies
Control0..*
TypeReference(Group)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. ClinicalUseDefinition.library
Definition

Logic used by the clinical use definition.

ShortLogic used by the clinical use definition
Control0..*
Typecanonical(Library)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. ClinicalUseDefinition.undesirableEffect
Definition

Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.

ShortA possible negative outcome from the use of this treatment
Control0..0
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. ClinicalUseDefinition.warning
Definition

A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.

ShortCritical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
Control0..0
This element is affected by the following invariants: cud-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))