This page is part of the HL7 Europe Imaging Study Report (v0.1.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

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Resource Profile: Report obligations for ImAdverseEvent

Report obligations for ImAdverseEvent

Usage:

• This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
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Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	ImAdverseEvent	An event that may be related to unintended effects on a patient or research participant dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	?!OΣ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. ele-1: All FHIR elements must have a @value or children
code	OΣ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
subject	OΣ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu | ResearchSubject)	Subject impacted by event ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance ele-1: All FHIR elements must have a @value or children
suspectEntity:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
suspectEntity:procedure	OΣ	0..*	BackboneElement	The suspected agent causing the adverse event ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
Slices for instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this ele-1: All FHIR elements must have a @value or children
contributingFactor:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. ele-1: All FHIR elements must have a @value or children
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	OΣ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
Slices for item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. ele-1: All FHIR elements must have a @value or children
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(EU AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.code	example	AdverseEventType http://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.contributingFactor:allergy.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor 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().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	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()

This structure is derived from ImAdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	ImAdverseEvent	An event that may be related to unintended effects on a patient or research participant
status	O	1..1	code	in-progress | completed | entered-in-error | unknown Obligations Actor SHALL:populate-if-known Imaging study report provider
code	O	0..1	CodeableConcept	Event or incident that occurred or was averted Obligations Actor SHALL:populate-if-known Imaging study report provider
subject	O	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu | ResearchSubject)	Subject impacted by event Obligations Actor SHALL:populate-if-known Imaging study report provider
Slices for suspectEntity				Content/Rules for all slices
suspectEntity:procedure	O	0..*	BackboneElement	The suspected agent causing the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
Slices for contributingFactor				Content/Rules for all slices
contributingFactor:allergy	O	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	ImAdverseEvent	An event that may be related to unintended effects on a patient or research participant
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 Additional Bindings Purpose CommonLanguages Starter
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 the event
status	?!OΣ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. Obligations Actor SHALL:populate-if-known Imaging study report provider
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	wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.
code	OΣ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. Obligations Actor SHALL:populate-if-known Imaging study report provider
subject	OΣ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu | ResearchSubject)	Subject impacted by event Obligations Actor SHALL:populate-if-known Imaging study report provider
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	Σ	0..1		When the event occurred
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingEffect	Σ	0..*	Reference(Condition | Observation)	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 or gravity of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: AdverseEventOutcome (example): Codes describing the type of outcome from the adverse event.
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
participant	Σ	0..*	BackboneElement	Who was involved in the adverse event or the potential adverse event and what they did
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
function	Σ	0..1	CodeableConcept	Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)	Who was involved in the adverse event or the potential adverse event
study	Σ	0..*	Reference(ResearchStudy)	Research study that the subject is enrolled in
expectedInResearchStudy		0..1	boolean	Considered likely or probable or anticipated in the research study
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[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
causality	Σ	0..1	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
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
suspectEntity:procedure	OΣ	0..*	BackboneElement	The suspected agent causing the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
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 instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
causality	Σ	0..1	BackboneElement	Information on the possible cause of the event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor: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
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	OΣ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
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		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(EU AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
preventiveAction	Σ	0..*	BackboneElement	Preventive actions that contributed to avoiding 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
item[x]	Σ	1..1		Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event.
itemReference			Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
mitigatingAction	Σ	0..*	BackboneElement	Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
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
item[x]	Σ	1..1		Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.
itemReference			Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to 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
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.category	example	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.code	example	AdverseEventType http://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard
AdverseEvent.outcome	example	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome from the FHIR Standard
AdverseEvent.participant.function	example	AdverseEventParticipantFunction http://hl7.org/fhir/ValueSet/adverse-event-participant-function from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.entityRelatedness	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.contributingFactor:allergy.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation http://hl7.org/fhir/ValueSet/adverse-event-supporting-info 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().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	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()

This structure is derived from ImAdverseEvent

Summary

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	ImAdverseEvent	An event that may be related to unintended effects on a patient or research participant dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	?!OΣ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. ele-1: All FHIR elements must have a @value or children
code	OΣ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
subject	OΣ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu | ResearchSubject)	Subject impacted by event ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance ele-1: All FHIR elements must have a @value or children
suspectEntity:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
suspectEntity:procedure	OΣ	0..*	BackboneElement	The suspected agent causing the adverse event ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
Slices for instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this ele-1: All FHIR elements must have a @value or children
contributingFactor:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. ele-1: All FHIR elements must have a @value or children
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	OΣ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event ele-1: All FHIR elements must have a @value or children Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
Slices for item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. ele-1: All FHIR elements must have a @value or children
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(EU AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.code	example	AdverseEventType http://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.contributingFactor:allergy.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor 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().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	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()

Differential View

This structure is derived from ImAdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	ImAdverseEvent	An event that may be related to unintended effects on a patient or research participant
status	O	1..1	code	in-progress | completed | entered-in-error | unknown Obligations Actor SHALL:populate-if-known Imaging study report provider
code	O	0..1	CodeableConcept	Event or incident that occurred or was averted Obligations Actor SHALL:populate-if-known Imaging study report provider
subject	O	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu | ResearchSubject)	Subject impacted by event Obligations Actor SHALL:populate-if-known Imaging study report provider
Slices for suspectEntity				Content/Rules for all slices
suspectEntity:procedure	O	0..*	BackboneElement	The suspected agent causing the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
Slices for contributingFactor				Content/Rules for all slices
contributingFactor:allergy	O	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	ImAdverseEvent	An event that may be related to unintended effects on a patient or research participant
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 Additional Bindings Purpose CommonLanguages Starter
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 the event
status	?!OΣ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. Obligations Actor SHALL:populate-if-known Imaging study report provider
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	wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.
code	OΣ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. Obligations Actor SHALL:populate-if-known Imaging study report provider
subject	OΣ	1..1	Reference(IM Imaging Patient | Group | Practitioner (EU base) | RelatedPerson Eu | ResearchSubject)	Subject impacted by event Obligations Actor SHALL:populate-if-known Imaging study report provider
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	Σ	0..1		When the event occurred
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingEffect	Σ	0..*	Reference(Condition | Observation)	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 or gravity of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: AdverseEventOutcome (example): Codes describing the type of outcome from the adverse event.
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
participant	Σ	0..*	BackboneElement	Who was involved in the adverse event or the potential adverse event and what they did
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
function	Σ	0..1	CodeableConcept	Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)	Who was involved in the adverse event or the potential adverse event
study	Σ	0..*	Reference(ResearchStudy)	Research study that the subject is enrolled in
expectedInResearchStudy		0..1	boolean	Considered likely or probable or anticipated in the research study
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[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
causality	Σ	0..1	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
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
suspectEntity:procedure	OΣ	0..*	BackboneElement	The suspected agent causing the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
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 instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(IM Imaging Procedure)	Refers to the specific entity that caused the adverse event
causality	Σ	0..1	BackboneElement	Information on the possible cause of the event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor: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
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	OΣ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Obligations Actor SHALL:populate-if-known Imaging study report provider
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		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(EU AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
preventiveAction	Σ	0..*	BackboneElement	Preventive actions that contributed to avoiding 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
item[x]	Σ	1..1		Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event.
itemReference			Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
mitigatingAction	Σ	0..*	BackboneElement	Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
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
item[x]	Σ	1..1		Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.
itemReference			Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to 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
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.category	example	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.code	example	AdverseEventType http://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard
AdverseEvent.outcome	example	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome from the FHIR Standard
AdverseEvent.participant.function	example	AdverseEventParticipantFunction http://hl7.org/fhir/ValueSet/adverse-event-participant-function from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity:procedure.causality.entityRelatedness	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.contributingFactor:allergy.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation http://hl7.org/fhir/ValueSet/adverse-event-supporting-info 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().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	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()

This structure is derived from ImAdverseEvent

Summary

Other representations of profile: CSV, Excel, Schematron