Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition		0..*	ClinicalUseDefinition	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
identifier		0..*	Identifier	Business identifier for this clinical use.
type		1..1	code	indication | contraindication | interaction | undesirable-effect | warning Required Pattern: interaction
subject		1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication
status		0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired
contraindication		0..0
indication		0..0
interaction
interactant
Slices for item[x]		1..1	Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition), CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Slice: Unordered, Open by type:$this
item[x]:itemCodeableConcept		0..1	CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Binding: Interactant (example): The specific substance that interacts. see additional bindings in JSON OR XML
type		0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab.
undesirableEffect		0..0
warning		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ClinicalUseDefinition.interaction.interactant.item[x]:itemCodeableConcept	example	Interactant

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition	C	0..*	ClinicalUseDefinition	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for this clinical use.
type	Σ	1..1	code	indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: interaction
subject	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication
status	Σ	0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.type	required	Pattern: interaction
ClinicalUseDefinition.status	preferred	PublicationStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
cud-1	error	ClinicalUseDefinition	Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance : (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2
dom-2	error	ClinicalUseDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ClinicalUseDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ClinicalUseDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ClinicalUseDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ClinicalUseDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition	C	0..*	ClinicalUseDefinition	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for this clinical use.
type	Σ	1..1	code	indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: interaction
category	Σ	0..*	CodeableConcept	A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ClinicalUseDefinitionCategory (preferred): A categorisation for a clinical use information item.
subject	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication
status	Σ	0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
interaction	ΣC	0..1	BackboneElement	Specifics for when this is an interaction
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
interactant	Σ	0..*	BackboneElement	The specific medication, product, food etc. or laboratory test that interacts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for item[x]	Σ	1..1		The specific medication, product, food etc. or laboratory test that interacts Slice: Unordered, Open by type:$this Binding: Interactant (example): An interactant - a substance that may have a clinically significant effect on another.
itemReference			Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition)
itemCodeableConcept			CodeableConcept
item[x]:itemCodeableConcept	Σ	0..1	CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Binding: Interactant (example): The specific substance that interacts. see additional bindings in JSON OR XML
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab. Binding: InteractionType (example): A categorisation for an interaction between two substances.
effect	Σ	0..1	CodeableReference(ObservationDefinition)	The effect of the interaction, for example "reduced gastric absorption of primary medication" Binding: InteractionEffect (example): A interaction effect of clinical use of a medication or other substance.
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed Binding: InteractionIncidence (example): A categorisation for incidence of occurence of an interaction.
management	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: InteractionManagement (example): A type of management for an interaction of a medication or other substance.
population	Σ	0..*	Reference(Group)	The population group to which this applies
library	Σ	0..*	canonical(Library)	Logic used by the clinical use definition
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.language	required	AllLanguages
ClinicalUseDefinition.type	required	Pattern: interaction
ClinicalUseDefinition.category	preferred	ClinicalUseDefinitionCategory
ClinicalUseDefinition.status	preferred	PublicationStatus
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure	example	DiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.diseaseStatus	example	DiseaseStatus
ClinicalUseDefinition.contraindication.comorbidity	example	DiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType	preferred	TherapyRelationshipType
ClinicalUseDefinition.contraindication.otherTherapy.treatment	example	Therapy
ClinicalUseDefinition.indication.diseaseSymptomProcedure	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.diseaseStatus	example	DiseaseStatus
ClinicalUseDefinition.indication.comorbidity	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.intendedEffect	preferred	ProductIntendedUse
ClinicalUseDefinition.interaction.interactant.item[x]	example	Interactant
ClinicalUseDefinition.interaction.interactant.item[x]:itemCodeableConcept	example	Interactant
ClinicalUseDefinition.interaction.type	example	InteractionType
ClinicalUseDefinition.interaction.effect	example	InteractionEffect
ClinicalUseDefinition.interaction.incidence	example	InteractionIncidence
ClinicalUseDefinition.interaction.management	example	InteractionManagement
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect	example	UndesirableEffectSymptom
ClinicalUseDefinition.undesirableEffect.classification	example	UndesirableEffectClassification
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence	example	UndesirablEffectFrequency
ClinicalUseDefinition.warning.code	example	WarningType

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Summary

Mandatory: 1 element
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)

Slices

This structure defines the following Slices:

• The element ClinicalUseDefinition.interaction.interactant.item[x] is sliced based on the value of type:$this

Maturity: 2

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition		0..*	ClinicalUseDefinition	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
identifier		0..*	Identifier	Business identifier for this clinical use.
type		1..1	code	indication | contraindication | interaction | undesirable-effect | warning Required Pattern: interaction
subject		1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication
status		0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired
contraindication		0..0
indication		0..0
interaction
interactant
Slices for item[x]		1..1	Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition), CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Slice: Unordered, Open by type:$this
item[x]:itemCodeableConcept		0..1	CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Binding: Interactant (example): The specific substance that interacts. see additional bindings in JSON OR XML
type		0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab.
undesirableEffect		0..0
warning		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ClinicalUseDefinition.interaction.interactant.item[x]:itemCodeableConcept	example	Interactant

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition	C	0..*	ClinicalUseDefinition	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for this clinical use.
type	Σ	1..1	code	indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: interaction
subject	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication
status	Σ	0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.type	required	Pattern: interaction
ClinicalUseDefinition.status	preferred	PublicationStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
cud-1	error	ClinicalUseDefinition	Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance : (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2
dom-2	error	ClinicalUseDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ClinicalUseDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ClinicalUseDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ClinicalUseDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ClinicalUseDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition	C	0..*	ClinicalUseDefinition	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for this clinical use.
type	Σ	1..1	code	indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: interaction
category	Σ	0..*	CodeableConcept	A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ClinicalUseDefinitionCategory (preferred): A categorisation for a clinical use information item.
subject	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication
status	Σ	0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
interaction	ΣC	0..1	BackboneElement	Specifics for when this is an interaction
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
interactant	Σ	0..*	BackboneElement	The specific medication, product, food etc. or laboratory test that interacts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for item[x]	Σ	1..1		The specific medication, product, food etc. or laboratory test that interacts Slice: Unordered, Open by type:$this Binding: Interactant (example): An interactant - a substance that may have a clinically significant effect on another.
itemReference			Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition)
itemCodeableConcept			CodeableConcept
item[x]:itemCodeableConcept	Σ	0..1	CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Binding: Interactant (example): The specific substance that interacts. see additional bindings in JSON OR XML
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab. Binding: InteractionType (example): A categorisation for an interaction between two substances.
effect	Σ	0..1	CodeableReference(ObservationDefinition)	The effect of the interaction, for example "reduced gastric absorption of primary medication" Binding: InteractionEffect (example): A interaction effect of clinical use of a medication or other substance.
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed Binding: InteractionIncidence (example): A categorisation for incidence of occurence of an interaction.
management	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: InteractionManagement (example): A type of management for an interaction of a medication or other substance.
population	Σ	0..*	Reference(Group)	The population group to which this applies
library	Σ	0..*	canonical(Library)	Logic used by the clinical use definition
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.language	required	AllLanguages
ClinicalUseDefinition.type	required	Pattern: interaction
ClinicalUseDefinition.category	preferred	ClinicalUseDefinitionCategory
ClinicalUseDefinition.status	preferred	PublicationStatus
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure	example	DiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.diseaseStatus	example	DiseaseStatus
ClinicalUseDefinition.contraindication.comorbidity	example	DiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType	preferred	TherapyRelationshipType
ClinicalUseDefinition.contraindication.otherTherapy.treatment	example	Therapy
ClinicalUseDefinition.indication.diseaseSymptomProcedure	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.diseaseStatus	example	DiseaseStatus
ClinicalUseDefinition.indication.comorbidity	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.intendedEffect	preferred	ProductIntendedUse
ClinicalUseDefinition.interaction.interactant.item[x]	example	Interactant
ClinicalUseDefinition.interaction.interactant.item[x]:itemCodeableConcept	example	Interactant
ClinicalUseDefinition.interaction.type	example	InteractionType
ClinicalUseDefinition.interaction.effect	example	InteractionEffect
ClinicalUseDefinition.interaction.incidence	example	InteractionIncidence
ClinicalUseDefinition.interaction.management	example	InteractionManagement
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect	example	UndesirableEffectSymptom
ClinicalUseDefinition.undesirableEffect.classification	example	UndesirableEffectClassification
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence	example	UndesirablEffectFrequency
ClinicalUseDefinition.warning.code	example	WarningType

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Summary

Mandatory: 1 element
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)

Slices

This structure defines the following Slices:

• The element ClinicalUseDefinition.interaction.interactant.item[x] is sliced based on the value of type:$this

Maturity: 2