Standard Health Record FHIR Implementation Guide

SHR AdverseEvent Profile

 

The official URL for this profile is:

http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-AdverseEvent

Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): back pain, headache, pulmonary embolism, death. The AdverseEvent may also document a causal relationship to an intervention is at least a reasonable possibility i.e., the relationship cannot be ruled out.

This profile builds on AdverseEvent.

This profile was published on Wed Dec 20 00:00:00 EST 2017 as a draft by The MITRE Corporation: Standard Health Record Collaborative.

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

Summary

Mandatory: 0 element (3 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

SHR Mapping Source

This structure represents the following SHR mapping definition:

shr.adverse.AdverseEvent maps to AdverseEvent:
  CodeableConcept maps to type 
  Details maps to description
  Subject maps to subject
  OccurrenceTime maps to date
  SeriousAdverseEvent maps to seriousness
  Outcome maps to outcome
  Author maps to recorder 
  AdverseEventAttribution maps to suspectEntity.instance
  AdverseEventAttribution.Certainty maps to suspectEntity.causalityAssessment	
  AssociatedStudy maps to study

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent SHR AdverseEvent Profile
... type 1..1Binding: SHR MedDRAVS ValueSet (required)
... subject Reference(SHR Patient Profile), Reference(SHR Device Profile)
... seriousness Binding: SHR YesNoUnknownVS ValueSet (required)
... recorder Reference(SHR Patient Profile), Reference(SHR RelatedPerson Profile)
... suspectEntity
.... instance Reference(SHR Substance Profile)
.... causalityAssessment Binding: SHR QualitativeValueScaleVS ValueSet (required)
... study 0..1Reference(SHR Study Profile)
... shr-base-RelatedEncounter-extension 0..1Reference(SHR EncounterPerformed Profile)SHR RelatedEncounter Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-RelatedEncounter-extension
... shr-base-Informant-extension 0..1(Complex)SHR Informant Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Informant-extension
... shr-finding-FocalSubject-extension 0..1CodeableConceptSHR FocalSubject Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubject-extension
... shr-finding-FocalSubjectReference-extension 0..1(Complex)SHR FocalSubjectReference Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubjectReference-extension
... shr-finding-FindingMethod-extension 0..1CodeableConceptSHR FindingMethod Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingMethod-extension
... shr-finding-FindingStatus-extension 0..1CodeableConceptSHR FindingStatus Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingStatus-extension
Binding: ObservationStatus (required)
... shr-finding-Evidence-extension 0..*(Complex)SHR Evidence Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-Evidence-extension
... shr-adverse-AdverseEventGrade-extension 1..1CodeableConceptSHR AdverseEventGrade Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-AdverseEventGrade-extension
Binding: SHR AdverseEventGradeVS ValueSet (required)
... shr-adverse-CauseCategory-extension 1..1CodeableConceptSHR CauseCategory Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-CauseCategory-extension
Binding: SHR AttributionCategoryVS ValueSet (required)
... shr-adverse-ActionTaken-extension 0..*(Complex)SHR ActionTaken Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-ActionTaken-extension

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent I0..*SHR AdverseEvent Profile
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (extensible)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... shr-base-RelatedEncounter-extension 0..1Reference(SHR EncounterPerformed Profile)SHR RelatedEncounter Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-RelatedEncounter-extension
... shr-base-Informant-extension 0..1(Complex)SHR Informant Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Informant-extension
... shr-finding-FocalSubject-extension 0..1CodeableConceptSHR FocalSubject Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubject-extension
... shr-finding-FocalSubjectReference-extension 0..1(Complex)SHR FocalSubjectReference Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubjectReference-extension
... shr-finding-FindingMethod-extension 0..1CodeableConceptSHR FindingMethod Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingMethod-extension
... shr-finding-FindingStatus-extension 0..1CodeableConceptSHR FindingStatus Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingStatus-extension
Binding: ObservationStatus (required)
... shr-finding-Evidence-extension 0..*(Complex)SHR Evidence Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-Evidence-extension
... shr-adverse-AdverseEventGrade-extension 1..1CodeableConceptSHR AdverseEventGrade Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-AdverseEventGrade-extension
Binding: SHR AdverseEventGradeVS ValueSet (required)
... shr-adverse-CauseCategory-extension 1..1CodeableConceptSHR CauseCategory Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-CauseCategory-extension
Binding: SHR AttributionCategoryVS ValueSet (required)
... shr-adverse-ActionTaken-extension 0..*(Complex)SHR ActionTaken Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-ActionTaken-extension
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... category Σ0..1codeAE | PAE An adverse event is an event that caused harm to a patient, an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
Binding: AdverseEventCategory (required)
... type Σ1..1CodeableConceptactual | potential
Binding: SHR MedDRAVS ValueSet (required)
... subject Σ0..1Reference(SHR Patient Profile), Reference(SHR Device Profile)Subject or group impacted by event
... date Σ0..1dateTimeWhen the event occurred
... reaction Σ0..*Reference(Condition)Adverse Reaction Events linked to exposure to substance
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptMild | Moderate | Severe
Binding: SHR YesNoUnknownVS ValueSet (required)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
... recorder Σ0..1Reference(SHR Patient Profile), Reference(SHR RelatedPerson Profile)Who recorded the adverse event
... eventParticipant Σ0..1Reference(Practitioner), Reference(Device)Who was involved in the adverse event or the potential adverse event
... description Σ0..1stringDescription of the adverse event
... suspectEntity ΣI0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... instance Σ1..1Reference(SHR Substance Profile)Refers to the specific entity that caused the adverse event
.... causality Σ0..1codecausality1 | causality2
Binding: AdverseEventCausality (required)
.... causalityAssessment Σ0..1CodeableConceptassess1 | assess2
Binding: SHR QualitativeValueScaleVS ValueSet (required)
.... causalityProductRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
.... causalityMethod Σ0..1CodeableConceptmethod1 | method2
Binding: AdverseEventCausalityMethod (example)
.... causalityAuthor Σ0..1Reference(Practitioner), Reference(PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
.... causalityResult Σ0..1CodeableConceptresult1 | result2
Binding: AdverseEventCausalityResult (example)
... subjectMedicalHistory Σ0..*Reference(Condition), Reference(Observation), Reference(AllergyIntolerance), Reference(FamilyMemberHistory), Reference(Immunization), Reference(Procedure)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..1Reference(SHR Study Profile)AdverseEvent.study

doco Documentation for this format

Summary

Mandatory: 0 element (3 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

SHR Mapping Source

This structure represents the following SHR mapping definition:

shr.adverse.AdverseEvent maps to AdverseEvent:
  CodeableConcept maps to type 
  Details maps to description
  Subject maps to subject
  OccurrenceTime maps to date
  SeriousAdverseEvent maps to seriousness
  Outcome maps to outcome
  Author maps to recorder 
  AdverseEventAttribution maps to suspectEntity.instance
  AdverseEventAttribution.Certainty maps to suspectEntity.causalityAssessment	
  AssociatedStudy maps to study

Differential View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent SHR AdverseEvent Profile
... type 1..1Binding: SHR MedDRAVS ValueSet (required)
... subject Reference(SHR Patient Profile), Reference(SHR Device Profile)
... seriousness Binding: SHR YesNoUnknownVS ValueSet (required)
... recorder Reference(SHR Patient Profile), Reference(SHR RelatedPerson Profile)
... suspectEntity
.... instance Reference(SHR Substance Profile)
.... causalityAssessment Binding: SHR QualitativeValueScaleVS ValueSet (required)
... study 0..1Reference(SHR Study Profile)
... shr-base-RelatedEncounter-extension 0..1Reference(SHR EncounterPerformed Profile)SHR RelatedEncounter Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-RelatedEncounter-extension
... shr-base-Informant-extension 0..1(Complex)SHR Informant Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Informant-extension
... shr-finding-FocalSubject-extension 0..1CodeableConceptSHR FocalSubject Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubject-extension
... shr-finding-FocalSubjectReference-extension 0..1(Complex)SHR FocalSubjectReference Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubjectReference-extension
... shr-finding-FindingMethod-extension 0..1CodeableConceptSHR FindingMethod Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingMethod-extension
... shr-finding-FindingStatus-extension 0..1CodeableConceptSHR FindingStatus Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingStatus-extension
Binding: ObservationStatus (required)
... shr-finding-Evidence-extension 0..*(Complex)SHR Evidence Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-Evidence-extension
... shr-adverse-AdverseEventGrade-extension 1..1CodeableConceptSHR AdverseEventGrade Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-AdverseEventGrade-extension
Binding: SHR AdverseEventGradeVS ValueSet (required)
... shr-adverse-CauseCategory-extension 1..1CodeableConceptSHR CauseCategory Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-CauseCategory-extension
Binding: SHR AttributionCategoryVS ValueSet (required)
... shr-adverse-ActionTaken-extension 0..*(Complex)SHR ActionTaken Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-ActionTaken-extension

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent I0..*SHR AdverseEvent Profile
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (extensible)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... shr-base-RelatedEncounter-extension 0..1Reference(SHR EncounterPerformed Profile)SHR RelatedEncounter Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-RelatedEncounter-extension
... shr-base-Informant-extension 0..1(Complex)SHR Informant Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Informant-extension
... shr-finding-FocalSubject-extension 0..1CodeableConceptSHR FocalSubject Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubject-extension
... shr-finding-FocalSubjectReference-extension 0..1(Complex)SHR FocalSubjectReference Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FocalSubjectReference-extension
... shr-finding-FindingMethod-extension 0..1CodeableConceptSHR FindingMethod Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingMethod-extension
... shr-finding-FindingStatus-extension 0..1CodeableConceptSHR FindingStatus Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-FindingStatus-extension
Binding: ObservationStatus (required)
... shr-finding-Evidence-extension 0..*(Complex)SHR Evidence Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-finding-Evidence-extension
... shr-adverse-AdverseEventGrade-extension 1..1CodeableConceptSHR AdverseEventGrade Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-AdverseEventGrade-extension
Binding: SHR AdverseEventGradeVS ValueSet (required)
... shr-adverse-CauseCategory-extension 1..1CodeableConceptSHR CauseCategory Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-CauseCategory-extension
Binding: SHR AttributionCategoryVS ValueSet (required)
... shr-adverse-ActionTaken-extension 0..*(Complex)SHR ActionTaken Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-adverse-ActionTaken-extension
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... category Σ0..1codeAE | PAE An adverse event is an event that caused harm to a patient, an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
Binding: AdverseEventCategory (required)
... type Σ1..1CodeableConceptactual | potential
Binding: SHR MedDRAVS ValueSet (required)
... subject Σ0..1Reference(SHR Patient Profile), Reference(SHR Device Profile)Subject or group impacted by event
... date Σ0..1dateTimeWhen the event occurred
... reaction Σ0..*Reference(Condition)Adverse Reaction Events linked to exposure to substance
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptMild | Moderate | Severe
Binding: SHR YesNoUnknownVS ValueSet (required)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
... recorder Σ0..1Reference(SHR Patient Profile), Reference(SHR RelatedPerson Profile)Who recorded the adverse event
... eventParticipant Σ0..1Reference(Practitioner), Reference(Device)Who was involved in the adverse event or the potential adverse event
... description Σ0..1stringDescription of the adverse event
... suspectEntity ΣI0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... instance Σ1..1Reference(SHR Substance Profile)Refers to the specific entity that caused the adverse event
.... causality Σ0..1codecausality1 | causality2
Binding: AdverseEventCausality (required)
.... causalityAssessment Σ0..1CodeableConceptassess1 | assess2
Binding: SHR QualitativeValueScaleVS ValueSet (required)
.... causalityProductRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
.... causalityMethod Σ0..1CodeableConceptmethod1 | method2
Binding: AdverseEventCausalityMethod (example)
.... causalityAuthor Σ0..1Reference(Practitioner), Reference(PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
.... causalityResult Σ0..1CodeableConceptresult1 | result2
Binding: AdverseEventCausalityResult (example)
... subjectMedicalHistory Σ0..*Reference(Condition), Reference(Observation), Reference(AllergyIntolerance), Reference(FamilyMemberHistory), Reference(Immunization), Reference(Procedure)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..1Reference(SHR Study Profile)AdverseEvent.study

doco Documentation for this format

Downloads: StructureDefinition: (XML, JSON, TTL), Schema: XML Schematron

 

Terminology Bindings

PathNameConformanceValueSet
AdverseEvent.languageCommon LanguagesextensibleCommon Languages
AdverseEvent.categoryAdverseEventCategoryrequiredAdverseEventCategory
AdverseEvent.typeSHR MedDRAVS ValueSetrequiredSHR MedDRAVS ValueSet
AdverseEvent.seriousnessSHR YesNoUnknownVS ValueSetrequiredSHR YesNoUnknownVS ValueSet
AdverseEvent.outcomeAdverseEventOutcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causalityAdverseEventCausalityrequiredAdverseEventCausality
AdverseEvent.suspectEntity.causalityAssessmentSHR QualitativeValueScaleVS ValueSetrequiredSHR QualitativeValueScaleVS ValueSet
AdverseEvent.suspectEntity.causalityMethodAdverseEventCausalityMethodexampleAdverseEventCausalityMethod
AdverseEvent.suspectEntity.causalityResultAdverseEventCausalityResultexampleAdverseEventCausalityResult

 

Constraints

IdPathDetailsRequirements
dom-2AdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-1AdverseEventIf the resource is contained in another resource, it SHALL NOT contain any narrative
: contained.text.empty()
dom-4AdverseEventIf 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-3AdverseEventIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
: contained.where(('#'+id in %resource.descendants().reference).not()).empty()
ele-1AdverseEvent.suspectEntityAll FHIR elements must have a @value or children
: hasValue() | (children().count() > id.count())