Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

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

Resource Profile: ClinicalUseDefinition Undesirable Effect (ePI) - Detailed Descriptions

Active as of 2026-01-02

Definitions for the clinical-use-definition-undesirable-effect-uv-epi resource profile

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

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.

Control10..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
Control10..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.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.


A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control10..*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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()))
10. 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
12. 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())
14. ClinicalUseDefinition.identifier
Definition

Business identifier for this issue.

ShortBusiness identifier for this issue
NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. ClinicalUseDefinition.identifier.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. ClinicalUseDefinition.identifier.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

ExampleGeneral: http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. ClinicalUseDefinition.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control10..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
ExampleGeneral: 123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. 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
Fixed Valueundesirable-effect
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. 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"
Control10..*
BindingThe codes SHOULD be taken from ClinicalUseDefinitionCategoryhttp://hl7.org/fhir/ValueSet/clinical-use-definition-category|5.0.0
(preferred to http://hl7.org/fhir/ValueSet/clinical-use-definition-category|5.0.0)

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()))
26. 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()))
28. ClinicalUseDefinition.status
Definition

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

ShortWhether this is a current issue or one that has been retired etc
Control10..1
BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0
(preferred to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)

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()))
30. ClinicalUseDefinition.population
Definition

The population group to which this applies.

ShortThe population group to which this applies
Control10..*
TypeReference(Group)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. 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
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()))
34. ClinicalUseDefinition.undesirableEffect.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())
36. ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
Definition

The situation in which the undesirable effect may manifest.

ShortThe situation in which the undesirable effect may manifest
Control0..1
BindingFor example codes, see UndesirableEffectSymptomhttp://hl7.org/fhir/ValueSet/undesirable-effect-symptom|5.0.0
(example to http://hl7.org/fhir/ValueSet/undesirable-effect-symptom|5.0.0)

An undesirable effect of clinical use.

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

High level classification of the effect.

ShortHigh level classification of the effect
Control0..1
BindingFor example codes, see UndesirableEffectClassificationhttp://hl7.org/fhir/ValueSet/undesirable-effect-classification|5.0.0
(example to http://hl7.org/fhir/ValueSet/undesirable-effect-classification|5.0.0)

A categorisation for an undesirable effect.

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

How often the effect is seen.

ShortHow often the effect is seen
Control0..1
BindingFor example codes, see UndesirablEffectFrequencyhttp://hl7.org/fhir/ValueSet/undesirable-effect-frequency|5.0.0
(example to http://hl7.org/fhir/ValueSet/undesirable-effect-frequency|5.0.0)

A categorisation for a frequency of occurence of an undesirable effect.

TypeCodeableConcept
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 foundhere

0. ClinicalUseDefinition
2. ClinicalUseDefinition.id
Control1..?
4. ClinicalUseDefinition.meta
Control1..?
6. ClinicalUseDefinition.meta.profile
Control1..?
8. ClinicalUseDefinition.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..?
10. ClinicalUseDefinition.identifier.system
Control1..?
12. ClinicalUseDefinition.identifier.value
Control1..?
14. ClinicalUseDefinition.type
Control1..?
Fixed Valueundesirable-effect
16. ClinicalUseDefinition.category
Control1..?
18. ClinicalUseDefinition.subject
Control1..?
TypeReference(MedicinalProductDefinition (ePI))
20. ClinicalUseDefinition.status
Control1..?
22. ClinicalUseDefinition.population
Control1..?
24. ClinicalUseDefinition.undesirableEffect
Control1..?
26. ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
28. ClinicalUseDefinition.undesirableEffect.classification
30. ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence

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

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.

Control1..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
Control1..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.meta.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
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
8. ClinicalUseDefinition.meta.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())
SlicingThis element introduces a set of slices on ClinicalUseDefinition.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 10. ClinicalUseDefinition.meta.versionId
    Definition

    The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

    ShortVersion specific identifier
    Comments

    The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

    Control0..1
    Typeid
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. ClinicalUseDefinition.meta.lastUpdated
    Definition

    When the resource last changed - e.g. when the version changed.

    ShortWhen the resource version last changed
    Comments

    This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

    Control0..1
    Typeinstant
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. ClinicalUseDefinition.meta.source
    Definition

    A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

    ShortIdentifies where the resource comes from
    Comments

    The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

    This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

    Control0..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. ClinicalUseDefinition.meta.profile
    Definition

    A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

    ShortProfiles this resource claims to conform to
    Comments

    It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

    Control1..*
    Typecanonical(StructureDefinition)
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. ClinicalUseDefinition.meta.security
    Definition

    Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

    ShortSecurity Labels applied to this resource
    Comments

    The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

    Control0..*
    BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
    (extensible to http://hl7.org/fhir/ValueSet/security-labels|5.0.0)

    Security Labels from the Healthcare Privacy and Security Classification System.

    TypeCoding
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. ClinicalUseDefinition.meta.tag
    Definition

    Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

    ShortTags applied to this resource
    Comments

    The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

    Control0..*
    BindingFor example codes, see CommonTags
    (example to http://hl7.org/fhir/ValueSet/common-tags|5.0.0)

    Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

    TypeCoding
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. 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()))
    24. 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()))
    26. 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()))
    28. 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
    30. 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())
    32. 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())
    34. ClinicalUseDefinition.identifier
    Definition

    Business identifier for this issue.

    ShortBusiness identifier for this issue
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control1..*
    TypeIdentifier
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. ClinicalUseDefinition.identifier.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
    Typeid
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    38. ClinicalUseDefinition.identifier.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())
    SlicingThis element introduces a set of slices on ClinicalUseDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 40. ClinicalUseDefinition.identifier.use
      Definition

      The purpose of this identifier.

      Shortusual | official | temp | secondary | old (If known)
      Comments

      Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

      Control0..1
      BindingThe codes SHALL be taken from IdentifierUse
      (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

      Identifies the purpose for this identifier, if known .

      Typecode
      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. ClinicalUseDefinition.identifier.type
      Definition

      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

      ShortDescription of identifier
      Comments

      This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
      (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)

      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

      TypeCodeableConcept
      Is Modifierfalse
      Summarytrue
      Requirements

      Allows users to make use of identifiers when the identifier system is not known.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. ClinicalUseDefinition.identifier.system
      Definition

      Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

      ShortThe namespace for the identifier value
      Comments

      Identifier.system is always case sensitive.

      Control1..1
      Typeuri
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

      ExampleGeneral: http://www.acme.com/identifiers/patient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. ClinicalUseDefinition.identifier.value
      Definition

      The portion of the identifier typically relevant to the user and which is unique within the context of the system.

      ShortThe value that is unique
      Comments

      If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

      Control1..1
      This element is affected by the following invariants: ident-1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      ExampleGeneral: 123456
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. ClinicalUseDefinition.identifier.period
      Definition

      Time period during which identifier is/was valid for use.

      ShortTime period when id is/was valid for use
      Control0..1
      TypePeriod
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      50. ClinicalUseDefinition.identifier.assigner
      Definition

      Organization that issued/manages the identifier.

      ShortOrganization that issued id (may be just text)
      Comments

      The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

      Control0..1
      TypeReference(Organization)
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      52. 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
      Fixed Valueundesirable-effect
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      54. 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"
      Control1..*
      BindingThe codes SHOULD be taken from ClinicalUseDefinitionCategory
      (preferred to http://hl7.org/fhir/ValueSet/clinical-use-definition-category|5.0.0)

      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()))
      56. 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()))
      58. ClinicalUseDefinition.status
      Definition

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

      ShortWhether this is a current issue or one that has been retired etc
      Control1..1
      BindingThe codes SHOULD be taken from PublicationStatus
      (preferred to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)

      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()))
      60. ClinicalUseDefinition.contraindication
      Definition

      Specifics for when this is a contraindication.

      ShortSpecifics for when this is a contraindication
      Control0..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()))
      62. ClinicalUseDefinition.contraindication.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
      64. ClinicalUseDefinition.contraindication.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())
      66. ClinicalUseDefinition.contraindication.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())
      68. ClinicalUseDefinition.contraindication.diseaseSymptomProcedure
      Definition

      The situation that is being documented as contraindicating against this item.

      ShortThe situation that is being documented as contraindicating against this item
      Control0..1
      BindingFor example codes, see DiseaseSymptomProcedure
      (example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure|5.0.0)

      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()))
      70. ClinicalUseDefinition.contraindication.diseaseStatus
      Definition

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

      ShortThe status of the disease or symptom for the contraindication
      Control0..1
      BindingFor example codes, see DiseaseStatus
      (example to http://hl7.org/fhir/ValueSet/disease-status|5.0.0)

      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()))
      72. ClinicalUseDefinition.contraindication.comorbidity
      Definition

      A comorbidity (concurrent condition) or coinfection.

      ShortA comorbidity (concurrent condition) or coinfection
      Control0..*
      BindingFor example codes, see DiseaseSymptomProcedure
      (example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure|5.0.0)

      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()))
      74. ClinicalUseDefinition.contraindication.indication
      Definition

      The indication which this is a contraidication for.

      ShortThe indication which this is a contraidication for
      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()))
      76. ClinicalUseDefinition.contraindication.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()))
      78. ClinicalUseDefinition.contraindication.otherTherapy
      Definition

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

      ShortInformation about use of the product in relation to other therapies described as part of the contraindication
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      80. ClinicalUseDefinition.contraindication.otherTherapy.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
      82. ClinicalUseDefinition.contraindication.otherTherapy.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())
      84. ClinicalUseDefinition.contraindication.otherTherapy.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())
      86. ClinicalUseDefinition.contraindication.otherTherapy.relationshipType
      Definition

      The type of relationship between the medicinal product indication or contraindication and another therapy.

      ShortThe type of relationship between the product indication/contraindication and another therapy
      Control1..1
      BindingThe codes SHOULD be taken from TherapyRelationshipType
      (preferred to http://hl7.org/fhir/ValueSet/therapy-relationship-type|5.0.0)

      Classification of relationship between a therapy and a contraindication or an indication.

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

      Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication.

      ShortReference to a specific medication, substance etc. as part of an indication or contraindication
      Control1..1
      BindingFor example codes, see Therapy
      (example to http://hl7.org/fhir/ValueSet/therapy|5.0.0)

      A therapy.

      TypeCodeableReference(MedicinalProductDefinition, Medication, Substance, SubstanceDefinition, NutritionProduct, BiologicallyDerivedProduct, ActivityDefinition)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      90. ClinicalUseDefinition.indication
      Definition

      Specifics for when this is an indication.

      ShortSpecifics for when this is an indication
      Control0..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()))
      92. 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
      94. 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())
      96. 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())
      98. 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
      BindingFor example codes, see DiseaseSymptomProcedure
      (example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure|5.0.0)

      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()))
      100. 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|5.0.0)

      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()))
      102. 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|5.0.0)

      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()))
      104. 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|5.0.0)

      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()))
      106. 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()))
      108. 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()))
      110. 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()))
      112. 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()))
      114. ClinicalUseDefinition.interaction
      Definition

      Specifics for when this is an interaction.

      ShortSpecifics for when this is an interaction
      Control0..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()))
      116. ClinicalUseDefinition.interaction.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
      118. ClinicalUseDefinition.interaction.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())
      120. ClinicalUseDefinition.interaction.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())
      122. ClinicalUseDefinition.interaction.interactant
      Definition

      The specific medication, product, food, substance etc. or laboratory test that interacts.

      ShortThe specific medication, product, food etc. or laboratory test that interacts
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      124. ClinicalUseDefinition.interaction.interactant.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
      126. ClinicalUseDefinition.interaction.interactant.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())
      128. ClinicalUseDefinition.interaction.interactant.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())
      130. ClinicalUseDefinition.interaction.interactant.item[x]
      Definition

      The specific medication, product, food, substance etc. or laboratory test that interacts.

      ShortThe specific medication, product, food etc. or laboratory test that interacts
      Control1..1
      BindingFor example codes, see Interactant
      (example to http://hl7.org/fhir/ValueSet/interactant|5.0.0)

      An interactant - a substance that may have a clinically significant effect on another.

      TypeChoice of: Reference(MedicinalProductDefinition, Medication, Substance, NutritionProduct, BiologicallyDerivedProduct, ObservationDefinition), CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      132. ClinicalUseDefinition.interaction.type
      Definition

      The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.

      ShortThe type of the interaction e.g. drug-drug interaction, drug-lab test interaction
      Control0..1
      BindingFor example codes, see InteractionType
      (example to http://hl7.org/fhir/ValueSet/interaction-type|5.0.0)

      A categorisation for an interaction between two substances.

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

      The effect of the interaction, for example "reduced gastric absorption of primary medication".

      ShortThe effect of the interaction, for example "reduced gastric absorption of primary medication"
      Control0..1
      BindingFor example codes, see InteractionEffect
      (example to http://hl7.org/fhir/ValueSet/interaction-effect|5.0.0)

      A interaction effect of clinical use of a medication or other substance.

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

      The incidence of the interaction, e.g. theoretical, observed.

      ShortThe incidence of the interaction, e.g. theoretical, observed
      Control0..1
      BindingFor example codes, see InteractionIncidence
      (example to http://hl7.org/fhir/ValueSet/interaction-incidence|5.0.0)

      A categorisation for incidence of occurence of an interaction.

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

      Actions for managing the interaction.

      ShortActions for managing the interaction
      Control0..*
      BindingFor example codes, see InteractionManagement
      (example to http://hl7.org/fhir/ValueSet/interaction-management|5.0.0)

      A type of management for an interaction of a medication or other substance.

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

      The population group to which this applies.

      ShortThe population group to which this applies
      Control1..*
      TypeReference(Group)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      142. 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()))
      144. 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
      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()))
      146. ClinicalUseDefinition.undesirableEffect.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
      148. ClinicalUseDefinition.undesirableEffect.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())
      150. ClinicalUseDefinition.undesirableEffect.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())
      152. ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
      Definition

      The situation in which the undesirable effect may manifest.

      ShortThe situation in which the undesirable effect may manifest
      Control0..1
      BindingFor example codes, see UndesirableEffectSymptom
      (example to http://hl7.org/fhir/ValueSet/undesirable-effect-symptom|5.0.0)

      An undesirable effect of clinical use.

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

      High level classification of the effect.

      ShortHigh level classification of the effect
      Control0..1
      BindingFor example codes, see UndesirableEffectClassification
      (example to http://hl7.org/fhir/ValueSet/undesirable-effect-classification|5.0.0)

      A categorisation for an undesirable effect.

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

      How often the effect is seen.

      ShortHow often the effect is seen
      Control0..1
      BindingFor example codes, see UndesirablEffectFrequency
      (example to http://hl7.org/fhir/ValueSet/undesirable-effect-frequency|5.0.0)

      A categorisation for a frequency of occurence of an undesirable effect.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      158. 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..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()))
      160. ClinicalUseDefinition.warning.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
      162. ClinicalUseDefinition.warning.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())
      164. ClinicalUseDefinition.warning.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())
      166. ClinicalUseDefinition.warning.description
      Definition

      A textual definition of this warning, with formatting.

      ShortA textual definition of this warning, with formatting
      Control0..1
      Typemarkdown
      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()))
      168. ClinicalUseDefinition.warning.code
      Definition

      A coded or unformatted textual definition of this warning.

      ShortA coded or unformatted textual definition of this warning
      Control0..1
      BindingFor example codes, see WarningType
      (example to http://hl7.org/fhir/ValueSet/warning-type|5.0.0)

      Classification of warning type.

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