HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento, published by HL7 Portugal. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-pt/adr-ig/ and changes regularly. See the Directory of published versions

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Resource Profile: Perfil para notificação de RAM

Perfil para notificação de RAM

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.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
identifier	S	1..*	Identifier	Business identifier for the event
subject	S	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
recorder	S	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
suspectEntity	S	1..1	BackboneElement	The suspected agent causing the adverse event
instance[x]	S	1..1	CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)	Refers to the specific entity that caused the adverse event
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
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	SΣ	1..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
suspectEntity	SΣ	1..1	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	SΣ	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)
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

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()

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	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 Set
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	SΣ	1..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an 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	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	Σ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event.
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
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	SΣ	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
suspectEntity	SΣ	1..1	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[x]	SΣ	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
contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of 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		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
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.contributingFactor.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 AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 5 elements

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
identifier	S	1..*	Identifier	Business identifier for the event
subject	S	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
recorder	S	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
suspectEntity	S	1..1	BackboneElement	The suspected agent causing the adverse event
instance[x]	S	1..1	CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)	Refers to the specific entity that caused the adverse event
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
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	SΣ	1..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
suspectEntity	SΣ	1..1	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	SΣ	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)
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

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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	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 Set
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	SΣ	1..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an 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	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	Σ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event.
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
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	SΣ	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
suspectEntity	SΣ	1..1	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[x]	SΣ	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
contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of 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		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
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.contributingFactor.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 AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 5 elements

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