IDEA4RC FHIR Implementation Guide
0.1.0 - CI Build 150

IDEA4RC FHIR Implementation Guide, published by IDEA4RC Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/idea4rc/ and changes regularly. See the Directory of published versions

Resource Profile: AdverseEvent: IDEA4RC

Official URL: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/adverseEvent-eu-i4rc Version: 0.1.0
Draft as of 2024-11-12 Computable Name: AdverseEventI4rc

This profile defines how to represent the Adverse vent model in FHIR for the purpose of the IDEA4RC project.

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.

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... event 1..1 CodeableConcept ADD VOC BINDING
... suspectEntity
.... instance 1..1 Reference(MedicationAdministration: Chemotherapy | Procedure) Refers to the specific entity that caused the adverse event

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... subject Σ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Subject impacted by event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... 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 ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event Σ 1..1 CodeableConcept ADD VOC BINDING
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject Σ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Subject impacted by event
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance Σ 1..1 Reference(MedicationAdministration: Chemotherapy | Procedure) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

This structure is derived from AdverseEvent

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... event 1..1 CodeableConcept ADD VOC BINDING
... suspectEntity
.... instance 1..1 Reference(MedicationAdministration: Chemotherapy | Procedure) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... subject Σ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Subject impacted by event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... 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 ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event Σ 1..1 CodeableConcept ADD VOC BINDING
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject Σ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Subject impacted by event
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance Σ 1..1 Reference(MedicationAdministration: Chemotherapy | Procedure) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

This structure is derived from AdverseEvent

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron