ANS IG document core
0.1.0 - ci-build

ANS IG document core - version de développement local (v0.1.0) construite par les outils de publication FHIR (HL7® FHIR® Standard). Voir le répertoire des versions publiées

## Resource Profile: FRAdverseEventDocument - Detailed Descriptions

Draft as of 2025-12-15

Definitions for the fr-adverse-event-document resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Des conseils sur linterprétation du contenu de ce tableau peuvent être trouvésici

0. AdverseEvent
Définition | Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.
Court | Medical care, research study or other healthcare event causing physical injury
Contrôle | 0..*
Est modificateur | false
Résumé | false
Noms alternatifs | AE
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) 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 (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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AdverseEvent.implicitRules
Définition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Court | A set of rules under which this content was created
Commentaires | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Contrôle | 0..1
Type | uri
Est modificateur | true parce que This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. AdverseEvent.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Court | Extensions that cannot be ignored
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | true parce que Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résumé | false
Exigences | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Noms alternatifs | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. AdverseEvent.actuality
Définition | Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.
Court | actual | potential
Contrôle | 1..1
Binding | Les codes DOIVENT (SHALL) être pris de AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 (required to `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` ) Overall nature of the adverse event, e.g. real or potential.
Type | code
Est modificateur | true parce que This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. AdverseEvent.category
Définition | The overall type of event, intended for search and filtering purposes.
Court | Type d'effet indésirableproduct-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
Contrôle | 10..1*
Binding | Les codes DOIVENT (SHALL) être pris de Sauf si inapproprié, ces codes DOIVENT (SHALL) être pris de JDV Origine Effet Indesirable CISIS http://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1 (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-origine-effet-indesirable-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. AdverseEvent.subject
Définition | This subject or group impacted by the event.
Court | Subject impacted by event
Commentaires | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Contrôle | 1..1
Type | Reference(Patient, Group, Practitioner, RelatedPerson)
Est modificateur | false
Résumé | true
Exigences | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Noms alternatifs | patient
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. AdverseEvent.date
Définition | The date (and perhaps time) when the adverse event occurred.
Court | Date de débutWhen the event occurred
Contrôle | 10..1
Type | dateTime
Est modificateur | false
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. AdverseEvent.detected
Définition | Estimated or actual date the AdverseEvent began, in the opinion of the reporter.
Court | Date de finWhen the event was detected
Contrôle | 10..1
Type | dateTime
Est modificateur | false
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. AdverseEvent.resultingCondition
Définition | Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).
Court | Réaction observéeEffect on the subject due to this event
Contrôle | 0..*
Type | Reference(Condition - FR Condition Document, Condition)
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. AdverseEvent.seriousness
Définition | Assessment whether this event was of real importance.
Court | Gravité de l'effet indésirableSeriousness of the event
Contrôle | 10..1
Binding | Les codes DOIVENT (SHALL) être pris de Pour des exemples de codes, voir JDV Gravite CISIS http://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1 (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-gravite-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. AdverseEvent.outcome
Définition | Describes the type of outcome from the adverse event.
Court | Évolution de l'effet indésirableresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Contrôle | 0..1
Binding | Les codes DOIVENT (SHALL) être pris de JDV Evolution CISIS http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-evolution-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. AdverseEvent.suspectEntity
Définition | Describes the entity that is suspected to have caused the adverse event.
Court | Agent soupçonné d’être à l’origine de l’événement indésirableThe suspected agent causing the adverse event
Contrôle | 10..*
Type | BackboneElement
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. AdverseEvent.suspectEntity.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Court | Extensions that cannot be ignored even if unrecognized
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | true parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumé | true
Exigences | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Noms alternatifs | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
26. AdverseEvent.suspectEntity.instance
Définition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.
Court | Médicament, substance incriminée, posologieRefers to the specific entity that caused the adverse event
Contrôle | 1..1
Type | Reference(MedicationAdministration - FR Medication Administration Document, Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Noms alternatifs | Substance or Medication or Device
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. AdverseEvent.suspectEntity.causality
Définition | Information on the possible cause of the event.
Court | ImputabilitéInformation on the possible cause of the event
Contrôle | 0..1*
Type | BackboneElement
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. AdverseEvent.suspectEntity.causality.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Court | Extensions that cannot be ignored even if unrecognized
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | true parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumé | true
Exigences | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Noms alternatifs | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
32. AdverseEvent.suspectEntity.causality.assessment
Définition | Assessment of if the entity caused the event.
Court | Niveau d'imputabilitéAssessment of if the entity caused the event
Contrôle | 10..1
Binding | Les codes DOIVENT (SHALL) être pris de Pour des exemples de codes, voir JDV Imputabilite CISIS http://hl7.org/fhir/ValueSet/adverse-event-causality-assess|4.0.1 (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-imputabilite-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Des conseils sur linterprétation du contenu de ce tableau peuvent être trouvésici

0. AdverseEvent
2. AdverseEvent.category
Court | Type d'effet indésirable
Contrôle | 1..1
Binding | Les codes DOIVENT (SHALL) être pris de JDV Origine Effet Indesirable CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-origine-effet-indesirable-cisis` )
Doit être pris en charge (Must Support) | true
4. AdverseEvent.date
Court | Date de début
Contrôle | 1..?
Doit être pris en charge (Must Support) | true
6. AdverseEvent.detected
Court | Date de fin
Contrôle | 1..?
Doit être pris en charge (Must Support) | true
8. AdverseEvent.resultingCondition
Court | Réaction observée
Type | Reference(Condition - FR Condition Document)
Doit être pris en charge (Must Support) | true
10. AdverseEvent.seriousness
Court | Gravité de l'effet indésirable
Contrôle | 1..?
Binding | Les codes DOIVENT (SHALL) être pris de JDV Gravite CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-gravite-cisis` )
Doit être pris en charge (Must Support) | true
12. AdverseEvent.outcome
Court | Évolution de l'effet indésirable
Binding | Les codes DOIVENT (SHALL) être pris de JDV Evolution CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-evolution-cisis` )
Doit être pris en charge (Must Support) | true
14. AdverseEvent.suspectEntity
Court | Agent soupçonné d’être à l’origine de l’événement indésirable
Contrôle | 1..?
Doit être pris en charge (Must Support) | true
16. AdverseEvent.suspectEntity.instance
Court | Médicament, substance incriminée, posologie
Type | Reference(MedicationAdministration - FR Medication Administration Document)
Doit être pris en charge (Must Support) | true
18. AdverseEvent.suspectEntity.causality
Court | Imputabilité
Contrôle | 0..1
Doit être pris en charge (Must Support) | true
20. AdverseEvent.suspectEntity.causality.assessment
Court | Niveau d'imputabilité
Contrôle | 1..?
Binding | Les codes DOIVENT (SHALL) être pris de JDV Imputabilite CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-imputabilite-cisis` )
Doit être pris en charge (Must Support) | true

Des conseils sur linterprétation du contenu de ce tableau peuvent être trouvésici

0. AdverseEvent
Définition | Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.
Court | Medical care, research study or other healthcare event causing physical injury
Contrôle | 0..*
Est modificateur | false
Résumé | false
Noms alternatifs | AE
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) 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 (`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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) dom-6: A resource should have narrative for robust management (`text.`div`.exists()`)
2. AdverseEvent.id
Définition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Court | Logical id of this artifact
Commentaires | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Contrôle | 0..1
Type | id
Est modificateur | false
Résumé | true
4. AdverseEvent.meta
Définition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Court | Metadata about the resource
Contrôle | 0..1
Type | Meta
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. AdverseEvent.implicitRules
Définition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Court | A set of rules under which this content was created
Commentaires | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Contrôle | 0..1
Type | uri
Est modificateur | true parce que This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. AdverseEvent.language
Définition | The base language in which the resource is written.
Court | Language of the resource content
Commentaires | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Contrôle | 0..1
Binding | Les codes DEVRAIENT (SHOULD) être pris de CommonLanguages (preferred to `http://hl7.org/fhir/ValueSet/languages|4.0.1` ) A human language.
Bindings Additionnels | But
AllLanguages | Binding Max
Type | code
Est modificateur | false
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. AdverseEvent.text
Définition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Court | Text summary of the resource, for human interpretation
Commentaires | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Contrôle | 0..1
Type | Narrative
Est modificateur | false
Résumé | false
Noms alternatifs | narrative, html, xhtml, display
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
12. AdverseEvent.contained
Définition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Court | Contained, inline Resources
Commentaires | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Contrôle | 0..*
Type | Resource
Est modificateur | false
Résumé | false
Noms alternatifs | inline resources, anonymous resources, contained resources
14. AdverseEvent.extension
Définition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Court | Additional content defined by implementations
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | false
Résumé | false
Noms alternatifs | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
16. AdverseEvent.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Court | Extensions that cannot be ignored
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | true parce que Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résumé | false
Exigences | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Noms alternatifs | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. AdverseEvent.identifier
Définition | Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.
Court | Business identifier for the event
Commentaires | This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.
Note | Ceci est un identifiant métier, pas un identifiant de ressource (voir discussion)
Contrôle | 0..1
Type | Identifier
Est modificateur | false
Résumé | true
Exigences | Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. AdverseEvent.actuality
Définition | Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.
Court | actual | potential
Contrôle | 1..1
Binding | Les codes DOIVENT (SHALL) être pris de AdverseEventActuality (required to `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` ) Overall nature of the adverse event, e.g. real or potential.
Type | code
Est modificateur | true parce que This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. AdverseEvent.category
Définition | The overall type of event, intended for search and filtering purposes.
Court | Type d'effet indésirable
Contrôle | 1..1
Binding | Les codes DOIVENT (SHALL) être pris de JDV Origine Effet Indesirable CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-origine-effet-indesirable-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. AdverseEvent.event
Définition | This element defines the specific type of event that occurred or that was prevented from occurring.
Court | Type of the event itself in relation to the subject
Contrôle | 0..1
Binding | Pour des exemples de codes, voir SNOMEDCTClinicalFindings (example to `http://hl7.org/fhir/ValueSet/adverse-event-type|4.0.1` ) Detailed type of event.
Type | CodeableConcept
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. AdverseEvent.subject
Définition | This subject or group impacted by the event.
Court | Subject impacted by event
Commentaires | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Contrôle | 1..1
Type | Reference(Patient, Group, Practitioner, RelatedPerson)
Est modificateur | false
Résumé | true
Exigences | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Noms alternatifs | patient
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. AdverseEvent.encounter
Définition | The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.
Court | Encounter created as part of
Commentaires | This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.
Contrôle | 0..1
Type | Reference(Encounter)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. AdverseEvent.date
Définition | The date (and perhaps time) when the adverse event occurred.
Court | Date de début
Contrôle | 1..1
Type | dateTime
Est modificateur | false
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. AdverseEvent.detected
Définition | Estimated or actual date the AdverseEvent began, in the opinion of the reporter.
Court | Date de fin
Contrôle | 1..1
Type | dateTime
Est modificateur | false
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. AdverseEvent.recordedDate
Définition | The date on which the existence of the AdverseEvent was first recorded.
Court | When the event was recorded
Commentaires | The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.
Contrôle | 0..1
Type | dateTime
Est modificateur | false
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. AdverseEvent.resultingCondition
Définition | Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).
Court | Réaction observée
Contrôle | 0..*
Type | Reference(Condition - FR Condition Document)
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. AdverseEvent.location
Définition | The information about where the adverse event occurred.
Court | Location where adverse event occurred
Contrôle | 0..1
Type | Reference(Location)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. AdverseEvent.seriousness
Définition | Assessment whether this event was of real importance.
Court | Gravité de l'effet indésirable
Contrôle | 1..1
Binding | Les codes DOIVENT (SHALL) être pris de JDV Gravite CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-gravite-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. AdverseEvent.severity
Définition | Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.
Court | mild | moderate | severe
Contrôle | 0..1
Binding | Les codes DOIVENT (SHALL) être pris de AdverseEventSeverity (required to `http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1` ) The severity of the adverse event itself, in direct relation to the subject.
Type | CodeableConcept
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. AdverseEvent.outcome
Définition | Describes the type of outcome from the adverse event.
Court | Évolution de l'effet indésirable
Contrôle | 0..1
Binding | Les codes DOIVENT (SHALL) être pris de JDV Evolution CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-evolution-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. AdverseEvent.recorder
Définition | Information on who recorded the adverse event. May be the patient or a practitioner.
Court | Who recorded the adverse event
Contrôle | 0..1
Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
48. AdverseEvent.contributor
Définition | Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).
Court | Who was involved in the adverse event or the potential adverse event
Contrôle | 0..*
Type | Reference(Practitioner, PractitionerRole, Device)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
50. AdverseEvent.suspectEntity
Définition | Describes the entity that is suspected to have caused the adverse event.
Court | Agent soupçonné d’être à l’origine de l’événement indésirable
Contrôle | 1..*
Type | BackboneElement
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
52. AdverseEvent.suspectEntity.id
Définition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Court | Unique id for inter-element referencing
Contrôle | 0..1
Type | string
Est modificateur | false
Format XML | Dans le format XML, cette propriété est représentée comme attribut.
Résumé | false
54. AdverseEvent.suspectEntity.extension
Définition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Court | Additional content defined by implementations
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | false
Résumé | false
Noms alternatifs | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
56. AdverseEvent.suspectEntity.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Court | Extensions that cannot be ignored even if unrecognized
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | true parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumé | true
Exigences | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Noms alternatifs | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
58. AdverseEvent.suspectEntity.instance
Définition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.
Court | Médicament, substance incriminée, posologie
Contrôle | 1..1
Type | Reference(MedicationAdministration - FR Medication Administration Document)
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Noms alternatifs | Substance or Medication or Device
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
60. AdverseEvent.suspectEntity.causality
Définition | Information on the possible cause of the event.
Court | Imputabilité
Contrôle | 0..1
Type | BackboneElement
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
62. AdverseEvent.suspectEntity.causality.id
Définition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Court | Unique id for inter-element referencing
Contrôle | 0..1
Type | string
Est modificateur | false
Format XML | Dans le format XML, cette propriété est représentée comme attribut.
Résumé | false
64. AdverseEvent.suspectEntity.causality.extension
Définition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Court | Additional content defined by implementations
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | false
Résumé | false
Noms alternatifs | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
66. AdverseEvent.suspectEntity.causality.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Court | Extensions that cannot be ignored even if unrecognized
Commentaires | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Contrôle | 0..*
Type | Extension
Est modificateur | true parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumé | true
Exigences | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Noms alternatifs | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
68. AdverseEvent.suspectEntity.causality.assessment
Définition | Assessment of if the entity caused the event.
Court | Niveau d'imputabilité
Contrôle | 1..1
Binding | Les codes DOIVENT (SHALL) être pris de JDV Imputabilite CISIS (required to `https://smt.esante.gouv.fr/fhir/ValueSet/jdv-imputabilite-cisis` )
Type | CodeableConcept
Est modificateur | false
Doit être pris en charge (Must Support) | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
70. AdverseEvent.suspectEntity.causality.productRelatedness
Définition | AdverseEvent.suspectEntity.causalityProductRelatedness.
Court | AdverseEvent.suspectEntity.causalityProductRelatedness
Contrôle | 0..1
Type | string
Est modificateur | false
Valeur primitive | Cet élément primitif peut être présent, absent ou remplacé par une extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
72. AdverseEvent.suspectEntity.causality.author
Définition | AdverseEvent.suspectEntity.causalityAuthor.
Court | AdverseEvent.suspectEntity.causalityAuthor
Contrôle | 0..1
Type | Reference(Practitioner, PractitionerRole)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. AdverseEvent.suspectEntity.causality.method
Définition | ProbabilityScale | Bayesian | Checklist.
Court | ProbabilityScale | Bayesian | Checklist
Contrôle | 0..1
Binding | Pour des exemples de codes, voir AdverseEventCausalityMethod (example to `http://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1` ) TODO.
Type | CodeableConcept
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. AdverseEvent.subjectMedicalHistory
Définition | AdverseEvent.subjectMedicalHistory.
Court | AdverseEvent.subjectMedicalHistory
Contrôle | 0..*
Type | Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. AdverseEvent.referenceDocument
Définition | AdverseEvent.referenceDocument.
Court | AdverseEvent.referenceDocument
Contrôle | 0..*
Type | Reference(DocumentReference)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
80. AdverseEvent.study
Définition | AdverseEvent.study.
Court | AdverseEvent.study
Contrôle | 0..*
Type | Reference(ResearchStudy)
Est modificateur | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)