Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	Σ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu)	Subject impacted by event
Slices for extension				Content/Rules for all slices
extension:subjectReseachSubject		0..1	Reference(ResearchSubject)	Imaging Adverse Event Subject Research Subject URL: http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance	Σ	1..1	Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)	Refers to the specific entity that caused the adverse event
suspectEntity:procedure	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance	Σ	1..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
Slices for subjectMedicalHistory	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory Slice: Unordered, Open by profile:$this
subjectMedicalHistory:allergy	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AdverseEvent	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	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	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AdverseEvent	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    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
subject		1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu)	Subject impacted by event
Slices for extension				Content/Rules for all slices
extension:subjectReseachSubject		0..1	Reference(ResearchSubject)	Imaging Adverse Event Subject Research Subject URL: http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject
Slices for suspectEntity		0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:procedure		0..*	BackboneElement	The suspected agent causing the adverse event
instance		1..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
Slices for subjectMedicalHistory		0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory Slice: Unordered, Open by profile:$this
subjectMedicalHistory:allergy		0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	Σ	0..*	CodeableConcept	product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject	Σ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu)	Subject impacted by event
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:subjectReseachSubject		0..1	Reference(ResearchSubject)	Imaging Adverse Event Subject Research Subject URL: http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	Σ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingCondition	Σ	0..*	Reference(Condition)	Effect on the subject due to this event
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	Σ	0..1	CodeableConcept	mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
outcome	Σ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Who was involved in the adverse event or the potential adverse event
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
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
instance	Σ	1..1	Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)	Refers to the specific entity that caused the adverse event
causality	Σ	0..*	BackboneElement	Information on the possible cause of the event
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
assessment	Σ	0..1	CodeableConcept	Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness	Σ	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
author	Σ	0..1	Reference(Practitioner | PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
method	Σ	0..1	CodeableConcept	ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
suspectEntity:procedure	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
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
instance	Σ	1..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
causality	Σ	0..*	BackboneElement	Information on the possible cause of the event
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
assessment	Σ	0..1	CodeableConcept	Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness	Σ	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
author	Σ	0..1	Reference(Practitioner | PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
method	Σ	0..1	CodeableConcept	ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
Slices for subjectMedicalHistory	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory Slice: Unordered, Open by profile:$this
subjectMedicalHistory:allergy	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory
referenceDocument	Σ	0..*	Reference(DocumentReference)	AdverseEvent.referenceDocument
study	Σ	0..*	Reference(ResearchStudy)	AdverseEvent.study
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages From the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard
AdverseEvent.category	extensible	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category From the FHIR Standard
AdverseEvent.event	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/adverse-event-type From the FHIR Standard
AdverseEvent.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types From the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness From the FHIR Standard
AdverseEvent.severity	required	AdverseEventSeverity http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 From the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 From the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess From the FHIR Standard
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method From the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess From the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AdverseEvent	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	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	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AdverseEvent	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()

Summary

Structures

This structure refers to these other structures:

• IM Imaging Patient (http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImPatient)
• Practitioner (EU base) (http://hl7.eu/fhir/base/StructureDefinition/practitioner-eu)
• RelatedPerson Eu (http://hl7.eu/fhir/imaging-r4/StructureDefinition/RelatedPersonEu)
• IM Imaging Procedure (http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImProcedure)
• EU AllergyIntolerance (http://hl7.eu/fhir/imaging-r4/StructureDefinition/AllergyIntoleranceEu)

Extensions

This structure refers to these extensions:

• http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of AdverseEvent.suspectEntity
• The element 1 is sliced based on the value of AdverseEvent.subjectMedicalHistory

Maturity: 1

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	Σ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu)	Subject impacted by event
Slices for extension				Content/Rules for all slices
extension:subjectReseachSubject		0..1	Reference(ResearchSubject)	Imaging Adverse Event Subject Research Subject URL: http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance	Σ	1..1	Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)	Refers to the specific entity that caused the adverse event
suspectEntity:procedure	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance	Σ	1..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
Slices for subjectMedicalHistory	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory Slice: Unordered, Open by profile:$this
subjectMedicalHistory:allergy	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AdverseEvent	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	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	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AdverseEvent	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    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
subject		1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu)	Subject impacted by event
Slices for extension				Content/Rules for all slices
extension:subjectReseachSubject		0..1	Reference(ResearchSubject)	Imaging Adverse Event Subject Research Subject URL: http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject
Slices for suspectEntity		0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:procedure		0..*	BackboneElement	The suspected agent causing the adverse event
instance		1..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
Slices for subjectMedicalHistory		0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory Slice: Unordered, Open by profile:$this
subjectMedicalHistory:allergy		0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	Σ	0..*	CodeableConcept	product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject	Σ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu)	Subject impacted by event
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:subjectReseachSubject		0..1	Reference(ResearchSubject)	Imaging Adverse Event Subject Research Subject URL: http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	Σ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingCondition	Σ	0..*	Reference(Condition)	Effect on the subject due to this event
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	Σ	0..1	CodeableConcept	mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
outcome	Σ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Who was involved in the adverse event or the potential adverse event
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
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
instance	Σ	1..1	Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)	Refers to the specific entity that caused the adverse event
causality	Σ	0..*	BackboneElement	Information on the possible cause of the event
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
assessment	Σ	0..1	CodeableConcept	Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness	Σ	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
author	Σ	0..1	Reference(Practitioner | PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
method	Σ	0..1	CodeableConcept	ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
suspectEntity:procedure	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
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
instance	Σ	1..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
causality	Σ	0..*	BackboneElement	Information on the possible cause of the event
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
assessment	Σ	0..1	CodeableConcept	Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness	Σ	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
author	Σ	0..1	Reference(Practitioner | PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
method	Σ	0..1	CodeableConcept	ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
Slices for subjectMedicalHistory	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory Slice: Unordered, Open by profile:$this
subjectMedicalHistory:allergy	Σ	0..*	Reference(EU AllergyIntolerance)	AdverseEvent.subjectMedicalHistory
referenceDocument	Σ	0..*	Reference(DocumentReference)	AdverseEvent.referenceDocument
study	Σ	0..*	Reference(ResearchStudy)	AdverseEvent.study
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages From the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard
AdverseEvent.category	extensible	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category From the FHIR Standard
AdverseEvent.event	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/adverse-event-type From the FHIR Standard
AdverseEvent.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types From the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness From the FHIR Standard
AdverseEvent.severity	required	AdverseEventSeverity http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 From the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 From the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess From the FHIR Standard
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method From the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess From the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AdverseEvent	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	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	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AdverseEvent	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()

Summary

Structures

This structure refers to these other structures:

• IM Imaging Patient (http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImPatient)
• Practitioner (EU base) (http://hl7.eu/fhir/base/StructureDefinition/practitioner-eu)
• RelatedPerson Eu (http://hl7.eu/fhir/imaging-r4/StructureDefinition/RelatedPersonEu)
• IM Imaging Procedure (http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImProcedure)
• EU AllergyIntolerance (http://hl7.eu/fhir/imaging-r4/StructureDefinition/AllergyIntoleranceEu)

Extensions

This structure refers to these extensions:

• http://hl7.eu/fhir/imaging-r4/StructureDefinition/ImAdverseEventSubjectReseachSubject

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of AdverseEvent.suspectEntity
• The element 1 is sliced based on the value of AdverseEvent.subjectMedicalHistory

Maturity: 1