FR Document Core (FHIR)
0.1.0 - ci-build

FR Document Core (FHIR), publié par Agence du Numérique en Santé (ANS) - 2-10 Rue d'Oradour-sur-Glane, 75015 Paris. Ce guide n'est pas une publication autorisée ; C'est la version en intégration continue pour la version 0.1.0 construite par le CI Build FHIR (HL7® FHIR® Standard). Cette version est basée sur le contenu actuel de https://github.com/ansforge/interop-IG-fhir-document-core/ et change régulièrement. Voir le répertoire des versions publiées

## Profil de ressource: AdverseEvent - FR adverse event Document

URL officielle: https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-adverse-event-document | Version: 0.1.0 | Surligner les changements ?
Draft à partir de 2026-08-07 | Nom computable: FRAdverseEventDocument

FRAdverseEventDocument permet de décrire un effet indésirable prévisible lié à un médicament

Utilisations:

- Ce Profil n'est utilisé par aucun autre profil dans ce guide d'implémentation

Vous pouvez également vérifier les usages dans le FHIR IG Statistics

### Vues formelles du contenu du profil

Description des profils, des différentiels, des instantanés et de leurs représentations.

- Tableau des éléments clés
- Tableau différentiel (differential)
- Tableau récapitulatif (snapshot)
- Statistiques/Références
- Tous

Nom | Drapeaux | Card. | Type | Description et contraintes Filter: Bindings Contraintes Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent(4.0.1) | 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 Constraints: ext-1
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | S Σ | 1..1 | CodeableConcept | Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
date | S Σ | 1..1 | dateTime | Date de début de l'effet indésirable
detected | S Σ | 1..1 | dateTime | Date de détection de l'effet indésirable
resultingCondition | S Σ | 0..* | Reference(Condition - FR Condition Document(0.1.0)) | Réaction observée
severity | S Σ | 1..1 | CodeableConcept | Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome | S Σ | 0..1 | CodeableConcept | Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity | S Σ | 1..* | BackboneElement | Agent soupçonné d’être à l’origine de l’événement indésirable
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance | S Σ | 1..1 | Reference(MedicationAdministration - FR Medication Administration Document(0.1.0)) | Médicament, substance incriminée, posologie
causality | S Σ | 0..1 | BackboneElement | Imputabilité
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment | S Σ | 1..1 | CodeableConcept | Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
Documentation pour ce format

#### Bindings terminologiques

Chemin | Statut | Usage | Jeu de valeurs (ValueSet) | Version | Source
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | Std. FHIR
AdverseEvent.category | Base | required | JDV Origine Effet Indesirable CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.severity | Base | required | JDV Gravite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.outcome | Base | required | JDV Evolution CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment | Base | required | JDV Imputabilite CISIS | 📍20260619134042 | Terminologies de Santé v1.11

#### Contraintes

Id | Grade | Chemin(s) | Description | Expression
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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 | bonne pratique | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | AdverseEvent.implicitRules, AdverseEvent.modifierExtension, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.subject, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.resultingCondition, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.modifierExtension | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

Cette structure est dérivée de AdverseEvent

Nom | Drapeaux | Card. | Type | Description et contraintes Filter: Bindings Contraintes Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent(4.0.1) | Medical care, research study or other healthcare event causing physical injury
category | S | 1..1 | CodeableConcept | Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
date | S | 1..1 | dateTime | Date de début de l'effet indésirable
detected | S | 1..1 | dateTime | Date de détection de l'effet indésirable
resultingCondition | S | 0..* | Reference(Condition - FR Condition Document(0.1.0)) | Réaction observée
severity | S | 1..1 | CodeableConcept | Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome | S | 0..1 | CodeableConcept | Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity | S | 1..* | BackboneElement | Agent soupçonné d’être à l’origine de l’événement indésirable
instance | S | 1..1 | Reference(MedicationAdministration - FR Medication Administration Document(0.1.0)) | Médicament, substance incriminée, posologie
causality | S | 0..1 | BackboneElement | Imputabilité
assessment | S | 1..1 | CodeableConcept | Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
Documentation pour ce format

#### Bindings terminologiques (différentiel)

Chemin | Statut | Usage | Jeu de valeurs (ValueSet) | Version | Source
AdverseEvent.category | Base | required | JDV Origine Effet Indesirable CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.severity | Base | required | JDV Gravite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.outcome | Base | required | JDV Evolution CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment | Base | required | JDV Imputabilite CISIS | 📍20260619134042 | Terminologies de Santé v1.11

Nom | Drapeaux | Card. | Type | Description et contraintes Filter: Bindings Contraintes Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent(4.0.1) | 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.
Bindings Additionnels | But
AllLanguages | Binding Max
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations Constraints: ext-1
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1
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 | S Σ | 1..1 | CodeableConcept | Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject 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 | S Σ | 1..1 | dateTime | Date de début de l'effet indésirable
detected | S Σ | 1..1 | dateTime | Date de détection de l'effet indésirable
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
resultingCondition | S Σ | 0..* | Reference(Condition - FR Condition Document(0.1.0)) | Réaction observée
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 | S Σ | 1..1 | CodeableConcept | Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome | S Σ | 0..1 | CodeableConcept | Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (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 | S Σ | 1..* | BackboneElement | Agent soupçonné d’être à l’origine de l’événement indésirable
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Constraints: ext-1
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance | S Σ | 1..1 | Reference(MedicationAdministration - FR Medication Administration Document(0.1.0)) | Médicament, substance incriminée, posologie
causality | S Σ | 0..1 | BackboneElement | Imputabilité
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Constraints: ext-1
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment | S Σ | 1..1 | CodeableConcept | Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
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
Documentation pour ce format

#### Bindings terminologiques

Chemin | Statut | Usage | Jeu de valeurs (ValueSet) | Version | Source
AdverseEvent.language | Base | preferred | Common Languages | 📍4.0.1 | Std. FHIR
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | Std. FHIR
AdverseEvent.category | Base | required | JDV Origine Effet Indesirable CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.event | Base | example | SNOMED CT Clinical Findings | 📍4.0.1 | Std. FHIR
AdverseEvent.seriousness | Base | example | AdverseEventSeriousness | 📍4.0.1 | Std. FHIR
AdverseEvent.severity | Base | required | JDV Gravite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.outcome | Base | required | JDV Evolution CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment | Base | required | JDV Imputabilite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.method | Base | example | AdverseEventCausalityMethod | 📍4.0.1 | Std. FHIR

#### Contraintes

Id | Grade | Chemin(s) | Description | Expression
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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 | bonne pratique | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | AdverseEvent.meta, AdverseEvent.implicitRules, AdverseEvent.language, AdverseEvent.text, AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.identifier, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment, AdverseEvent.suspectEntity.causality.productRelatedness, AdverseEvent.suspectEntity.causality.author, AdverseEvent.suspectEntity.causality.method, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

Cette structure est dérivée de AdverseEvent

Résumé

Obligatoire : 5 éléments(1 élément obligatoire(s) imbriqué(s))
Must-Support : 10 éléments

Structures

Cette structure fait référence à ces autres structures:

- Condition - FR Condition Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-condition-document|0.1.0)
- MedicationAdministration - FR Medication Administration Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-medication-administration-document|0.1.0)

Vue des éléments clés

Nom | Drapeaux | Card. | Type | Description et contraintes Filter: Bindings Contraintes Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent(4.0.1) | 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 Constraints: ext-1
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | S Σ | 1..1 | CodeableConcept | Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
date | S Σ | 1..1 | dateTime | Date de début de l'effet indésirable
detected | S Σ | 1..1 | dateTime | Date de détection de l'effet indésirable
resultingCondition | S Σ | 0..* | Reference(Condition - FR Condition Document(0.1.0)) | Réaction observée
severity | S Σ | 1..1 | CodeableConcept | Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome | S Σ | 0..1 | CodeableConcept | Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity | S Σ | 1..* | BackboneElement | Agent soupçonné d’être à l’origine de l’événement indésirable
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance | S Σ | 1..1 | Reference(MedicationAdministration - FR Medication Administration Document(0.1.0)) | Médicament, substance incriminée, posologie
causality | S Σ | 0..1 | BackboneElement | Imputabilité
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment | S Σ | 1..1 | CodeableConcept | Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
Documentation pour ce format

#### Bindings terminologiques

Chemin | Statut | Usage | Jeu de valeurs (ValueSet) | Version | Source
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | Std. FHIR
AdverseEvent.category | Base | required | JDV Origine Effet Indesirable CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.severity | Base | required | JDV Gravite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.outcome | Base | required | JDV Evolution CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment | Base | required | JDV Imputabilite CISIS | 📍20260619134042 | Terminologies de Santé v1.11

#### Contraintes

Id | Grade | Chemin(s) | Description | Expression
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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 | bonne pratique | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | AdverseEvent.implicitRules, AdverseEvent.modifierExtension, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.subject, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.resultingCondition, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.modifierExtension | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

Vue différentielle

Cette structure est dérivée de AdverseEvent

Nom | Drapeaux | Card. | Type | Description et contraintes Filter: Bindings Contraintes Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent(4.0.1) | Medical care, research study or other healthcare event causing physical injury
category | S | 1..1 | CodeableConcept | Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
date | S | 1..1 | dateTime | Date de début de l'effet indésirable
detected | S | 1..1 | dateTime | Date de détection de l'effet indésirable
resultingCondition | S | 0..* | Reference(Condition - FR Condition Document(0.1.0)) | Réaction observée
severity | S | 1..1 | CodeableConcept | Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome | S | 0..1 | CodeableConcept | Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity | S | 1..* | BackboneElement | Agent soupçonné d’être à l’origine de l’événement indésirable
instance | S | 1..1 | Reference(MedicationAdministration - FR Medication Administration Document(0.1.0)) | Médicament, substance incriminée, posologie
causality | S | 0..1 | BackboneElement | Imputabilité
assessment | S | 1..1 | CodeableConcept | Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
Documentation pour ce format

#### Bindings terminologiques (différentiel)

Chemin | Statut | Usage | Jeu de valeurs (ValueSet) | Version | Source
AdverseEvent.category | Base | required | JDV Origine Effet Indesirable CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.severity | Base | required | JDV Gravite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.outcome | Base | required | JDV Evolution CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment | Base | required | JDV Imputabilite CISIS | 📍20260619134042 | Terminologies de Santé v1.11

Vue d'ensembleView

Nom | Drapeaux | Card. | Type | Description et contraintes Filter: Bindings Contraintes Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent(4.0.1) | 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.
Bindings Additionnels | But
AllLanguages | Binding Max
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations Constraints: ext-1
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1
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 | S Σ | 1..1 | CodeableConcept | Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject 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 | S Σ | 1..1 | dateTime | Date de début de l'effet indésirable
detected | S Σ | 1..1 | dateTime | Date de détection de l'effet indésirable
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
resultingCondition | S Σ | 0..* | Reference(Condition - FR Condition Document(0.1.0)) | Réaction observée
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 | S Σ | 1..1 | CodeableConcept | Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome | S Σ | 0..1 | CodeableConcept | Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (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 | S Σ | 1..* | BackboneElement | Agent soupçonné d’être à l’origine de l’événement indésirable
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Constraints: ext-1
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance | S Σ | 1..1 | Reference(MedicationAdministration - FR Medication Administration Document(0.1.0)) | Médicament, substance incriminée, posologie
causality | S Σ | 0..1 | BackboneElement | Imputabilité
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Constraints: ext-1
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment | S Σ | 1..1 | CodeableConcept | Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
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
Documentation pour ce format

#### Bindings terminologiques

Chemin | Statut | Usage | Jeu de valeurs (ValueSet) | Version | Source
AdverseEvent.language | Base | preferred | Common Languages | 📍4.0.1 | Std. FHIR
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | Std. FHIR
AdverseEvent.category | Base | required | JDV Origine Effet Indesirable CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.event | Base | example | SNOMED CT Clinical Findings | 📍4.0.1 | Std. FHIR
AdverseEvent.seriousness | Base | example | AdverseEventSeriousness | 📍4.0.1 | Std. FHIR
AdverseEvent.severity | Base | required | JDV Gravite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.outcome | Base | required | JDV Evolution CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment | Base | required | JDV Imputabilite CISIS | 📍20260619134042 | Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.method | Base | example | AdverseEventCausalityMethod | 📍4.0.1 | Std. FHIR

#### Contraintes

Id | Grade | Chemin(s) | Description | Expression
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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 | bonne pratique | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | AdverseEvent.meta, AdverseEvent.implicitRules, AdverseEvent.language, AdverseEvent.text, AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.identifier, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment, AdverseEvent.suspectEntity.causality.productRelatedness, AdverseEvent.suspectEntity.causality.author, AdverseEvent.suspectEntity.causality.method, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

Cette structure est dérivée de AdverseEvent

Résumé

Obligatoire : 5 éléments(1 élément obligatoire(s) imbriqué(s))
Must-Support : 10 éléments

Structures

Cette structure fait référence à ces autres structures:

- Condition - FR Condition Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-condition-document|0.1.0)
- MedicationAdministration - FR Medication Administration Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-medication-administration-document|0.1.0)

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