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
Official URL: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/adverseEvent-eu-i4rc | Version: 0.1.0 | |||
Draft as of 2025-01-13 | Computable Name: AdverseEventI4rc |
This profile defines how to represent the Adverse vent model in FHIR for the purpose of the IDEA4RC project.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
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0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury 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 | |
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?!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 |
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?! | 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 |
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?!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 |
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Σ | 1..1 | CodeableConcept | ADD VOC BINDING Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event ele-1: All FHIR elements must have a @value or children |
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Path | Conformance | ValueSet | URI |
AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard | |
AdverseEvent.event | example | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard |
This structure is derived from AdverseEvent
Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
![]() ![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
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1..1 | CodeableConcept | ADD VOC BINDING | |
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||||
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1..1 | Reference(MedicationAdministration: Chemotherapy | Procedure) | Refers to the specific entity that caused the adverse event | |
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Name | Flags | Card. | Type | Description & Constraints![]() | ||||
---|---|---|---|---|---|---|---|---|
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0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?! | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 0..1 | Identifier | Business identifier for the event | ||||
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?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
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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. | ||||
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Σ | 1..1 | CodeableConcept | ADD VOC BINDING Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. | ||||
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Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
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Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
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Σ | 0..1 | dateTime | When the event occurred | ||||
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Σ | 0..1 | dateTime | When the event was detected | ||||
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Σ | 0..1 | dateTime | When the event was recorded | ||||
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Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | ||||
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Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
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Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
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Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
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Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
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Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event | ||||
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Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | ||||
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Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | Reference(MedicationAdministration: Chemotherapy | Procedure) | Refers to the specific entity that caused the adverse event | ||||
![]() ![]() ![]() ![]() |
Σ | 0..* | BackboneElement | Information on the possible cause of the event | ||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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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. | ||||
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Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
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Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
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Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
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Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
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Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
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Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
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Path | Conformance | ValueSet | URI | |||
AdverseEvent.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages from the FHIR Standard
| ||||
AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard | ||||
AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard | ||||
AdverseEvent.event | example | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard | ||||
AdverseEvent.seriousness | example | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard | ||||
AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 from the FHIR Standard | ||||
AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 from the FHIR Standard | ||||
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard | ||||
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard |
This structure is derived from AdverseEvent
Key Elements View
Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
![]() ![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury 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 | |
![]() ![]() ![]() |
?!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 |
![]() ![]() ![]() |
?! | 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 |
![]() ![]() ![]() |
?!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 |
![]() ![]() ![]() |
Σ | 1..1 | CodeableConcept | ADD VOC BINDING Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. ele-1: All FHIR elements must have a @value or children |
![]() ![]() ![]() |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event ele-1: All FHIR elements must have a @value or children |
![]() |
Path | Conformance | ValueSet | URI |
AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard | |
AdverseEvent.event | example | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard |
Differential View
This structure is derived from AdverseEvent
Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
![]() ![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
![]() ![]() ![]() |
1..1 | CodeableConcept | ADD VOC BINDING | |
![]() ![]() ![]() |
||||
![]() ![]() ![]() ![]() |
1..1 | Reference(MedicationAdministration: Chemotherapy | Procedure) | Refers to the specific entity that caused the adverse event | |
![]() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints![]() | ||||
---|---|---|---|---|---|---|---|---|
![]() ![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |||||
![]() ![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
![]() ![]() ![]() |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
![]() ![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() ![]() |
Σ | 0..1 | Identifier | Business identifier for the event | ||||
![]() ![]() ![]() |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
![]() ![]() ![]() |
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. | ||||
![]() ![]() ![]() |
Σ | 1..1 | CodeableConcept | ADD VOC BINDING Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. | ||||
![]() ![]() ![]() |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
![]() ![]() ![]() |
Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
![]() ![]() ![]() |
Σ | 0..1 | dateTime | When the event occurred | ||||
![]() ![]() ![]() |
Σ | 0..1 | dateTime | When the event was detected | ||||
![]() ![]() ![]() |
Σ | 0..1 | dateTime | When the event was recorded | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | ||||
![]() ![]() ![]() |
Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
![]() ![]() ![]() |
Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | ||||
![]() ![]() ![]() |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() ![]() |
Σ | 1..1 | Reference(MedicationAdministration: Chemotherapy | Procedure) | Refers to the specific entity that caused the adverse event | ||||
![]() ![]() ![]() ![]() |
Σ | 0..* | BackboneElement | Information on the possible cause of the event | ||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() ![]() ![]() |
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. | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
![]() |
Path | Conformance | ValueSet | URI | |||
AdverseEvent.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages from the FHIR Standard
| ||||
AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard | ||||
AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard | ||||
AdverseEvent.event | example | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard | ||||
AdverseEvent.seriousness | example | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard | ||||
AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 from the FHIR Standard | ||||
AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 from the FHIR Standard | ||||
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard | ||||
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard |
This structure is derived from AdverseEvent
Other representations of profile: CSV, Excel, Schematron