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Resource Profile: FRAdverseEventDocument - Detailed Descriptions

Draft as of 2025-12-05

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

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.

CourtMedical care, research study or other healthcare event causing physical injury
Contrôle0..*
Est modificateurfalse
Résuméfalse
Noms alternatifsAE
Invariantsdom-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.

CourtA 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.

Contrôle0..1
Typeuri
Est modificateurtrue 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 primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-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).

CourtExtensions 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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résuméfalse
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 alternatifsextensions, user content
Invariantsele-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.

Courtactual | potential
Contrôle1..1
BindingLes codes DOIVENT (SHALL) être pris de AdverseEventActualityhttp://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.

Typecode
Est modificateurtrue 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 primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-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.

CourtType 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
Contrôle10..1*
BindingLes codes DOIVENT (SHALL) être pris de Sauf si inapproprié, ces codes DOIVENT (SHALL) être pris de JDV Origine Effet Indesirable CISIShttp://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-origine-effet-indesirable-cisis)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtSubject impacted by event
Commentaires

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Contrôle1..1
TypeReference(Patient, Group, Practitioner, RelatedPerson)
Est modificateurfalse
Résumétrue
Exigences

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

Noms alternatifspatient
Invariantsele-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.

CourtDate de débutWhen the event occurred
Contrôle10..1
TypedateTime
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtDate de finWhen the event was detected
Contrôle10..1
TypedateTime
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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).

CourtRéaction observéeEffect on the subject due to this event
Contrôle0..*
TypeReference(Condition - FR Condition Document, Condition)
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtGravité de l'effet indésirableSeriousness of the event
Contrôle10..1
BindingLes codes DOIVENT (SHALL) être pris de Pour des exemples de codes, voir JDV Gravite CISIShttp://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-gravite-cisis)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtÉvolution de l'effet indésirableresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Contrôle0..1
BindingLes codes DOIVENT (SHALL) être pris de JDV Evolution CISIShttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-evolution-cisis)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtAgent soupçonné d’être à l’origine de l’événement indésirableThe suspected agent causing the adverse event
Contrôle10..*
TypeBackboneElement
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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).

CourtExtensions 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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
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 alternatifsextensions, user content, modifiers
Invariantsele-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.

CourtMédicament, substance incriminée, posologieRefers to the specific entity that caused the adverse event
Contrôle1..1
TypeReference(MedicationAdministration - FR Medication Administration Document, Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Noms alternatifsSubstance or Medication or Device
Invariantsele-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.

CourtImputabilitéInformation on the possible cause of the event
Contrôle0..1*
TypeBackboneElement
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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).

CourtExtensions 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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
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 alternatifsextensions, user content, modifiers
Invariantsele-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.

CourtNiveau d'imputabilitéAssessment of if the entity caused the event
Contrôle10..1
BindingLes codes DOIVENT (SHALL) être pris de Pour des exemples de codes, voir JDV Imputabilite CISIShttp://hl7.org/fhir/ValueSet/adverse-event-causality-assess|4.0.1
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-imputabilite-cisis)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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
CourtType d'effet indésirable
Contrôle1..1
BindingLes 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
CourtDate de début
Contrôle1..?
Doit être pris en charge (Must Support)true
6. AdverseEvent.detected
CourtDate de fin
Contrôle1..?
Doit être pris en charge (Must Support)true
8. AdverseEvent.resultingCondition
CourtRéaction observée
TypeReference(Condition - FR Condition Document)
Doit être pris en charge (Must Support)true
10. AdverseEvent.seriousness
CourtGravité de l'effet indésirable
Contrôle1..?
BindingLes 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
CourtÉvolution de l'effet indésirable
BindingLes 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
CourtAgent soupçonné d’être à l’origine de l’événement indésirable
Contrôle1..?
Doit être pris en charge (Must Support)true
16. AdverseEvent.suspectEntity.instance
CourtMédicament, substance incriminée, posologie
TypeReference(MedicationAdministration - FR Medication Administration Document)
Doit être pris en charge (Must Support)true
18. AdverseEvent.suspectEntity.causality
CourtImputabilité
Contrôle0..1
Doit être pris en charge (Must Support)true
20. AdverseEvent.suspectEntity.causality.assessment
CourtNiveau d'imputabilité
Contrôle1..?
BindingLes 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.

CourtMedical care, research study or other healthcare event causing physical injury
Contrôle0..*
Est modificateurfalse
Résuméfalse
Noms alternatifsAE
Invariantsdom-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.

CourtLogical 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.

Contrôle0..1
Typeid
Est modificateurfalse
Résumétrue
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.

CourtMetadata about the resource
Contrôle0..1
TypeMeta
Est modificateurfalse
Résumétrue
Invariantsele-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.

CourtA 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.

Contrôle0..1
Typeuri
Est modificateurtrue 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 primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-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.

CourtLanguage 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).

Contrôle0..1
BindingLes codes DEVRAIENT (SHOULD) être pris de CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

A human language.

Bindings AdditionnelsBut
AllLanguagesBinding Max
Typecode
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-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.

CourtText 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.

Contrôle0..1
TypeNarrative
Est modificateurfalse
Résuméfalse
Noms alternatifsnarrative, html, xhtml, display
Invariantsele-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.

CourtContained, 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.

Contrôle0..*
TypeResource
Est modificateurfalse
Résuméfalse
Noms alternatifsinline 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.

CourtAdditional 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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-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).

CourtExtensions 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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résuméfalse
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 alternatifsextensions, user content
Invariantsele-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.

CourtBusiness 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.

NoteCeci est un identifiant métier, pas un identifiant de ressource (voir discussion)
Contrôle0..1
TypeIdentifier
Est modificateurfalse
Résumétrue
Exigences

Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-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.

Courtactual | potential
Contrôle1..1
BindingLes 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.

Typecode
Est modificateurtrue 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 primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-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.

CourtType d'effet indésirable
Contrôle1..1
BindingLes 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)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtType of the event itself in relation to the subject
Contrôle0..1
BindingPour des exemples de codes, voir SNOMEDCTClinicalFindings
(example to http://hl7.org/fhir/ValueSet/adverse-event-type|4.0.1)

Detailed type of event.

TypeCodeableConcept
Est modificateurfalse
Résumétrue
Invariantsele-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.

CourtSubject impacted by event
Commentaires

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Contrôle1..1
TypeReference(Patient, Group, Practitioner, RelatedPerson)
Est modificateurfalse
Résumétrue
Exigences

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

Noms alternatifspatient
Invariantsele-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.

CourtEncounter 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.

Contrôle0..1
TypeReference(Encounter)
Est modificateurfalse
Résumétrue
Invariantsele-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.

CourtDate de début
Contrôle1..1
TypedateTime
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtDate de fin
Contrôle1..1
TypedateTime
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtWhen 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.

Contrôle0..1
TypedateTime
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-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).

CourtRéaction observée
Contrôle0..*
TypeReference(Condition - FR Condition Document)
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtLocation where adverse event occurred
Contrôle0..1
TypeReference(Location)
Est modificateurfalse
Résumétrue
Invariantsele-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.

CourtGravité de l'effet indésirable
Contrôle1..1
BindingLes codes DOIVENT (SHALL) être pris de JDV Gravite CISIS
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-gravite-cisis)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

Courtmild | moderate | severe
Contrôle0..1
BindingLes 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.

TypeCodeableConcept
Est modificateurfalse
Résumétrue
Invariantsele-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.

CourtÉvolution de l'effet indésirable
Contrôle0..1
BindingLes codes DOIVENT (SHALL) être pris de JDV Evolution CISIS
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-evolution-cisis)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtWho recorded the adverse event
Contrôle0..1
TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
Est modificateurfalse
Résumétrue
Invariantsele-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).

CourtWho was involved in the adverse event or the potential adverse event
Contrôle0..*
TypeReference(Practitioner, PractitionerRole, Device)
Est modificateurfalse
Résumétrue
Invariantsele-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.

CourtAgent soupçonné d’être à l’origine de l’événement indésirable
Contrôle1..*
TypeBackboneElement
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtUnique id for inter-element referencing
Contrôle0..1
Typestring
Est modificateurfalse
Format XMLDans le format XML, cette propriété est représentée comme attribut.
Résuméfalse
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.

CourtAdditional 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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-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).

CourtExtensions 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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
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 alternatifsextensions, user content, modifiers
Invariantsele-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.

CourtMédicament, substance incriminée, posologie
Contrôle1..1
TypeReference(MedicationAdministration - FR Medication Administration Document)
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Noms alternatifsSubstance or Medication or Device
Invariantsele-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.

CourtImputabilité
Contrôle0..1
TypeBackboneElement
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtUnique id for inter-element referencing
Contrôle0..1
Typestring
Est modificateurfalse
Format XMLDans le format XML, cette propriété est représentée comme attribut.
Résuméfalse
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.

CourtAdditional 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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-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).

CourtExtensions 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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
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 alternatifsextensions, user content, modifiers
Invariantsele-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.

CourtNiveau d'imputabilité
Contrôle1..1
BindingLes codes DOIVENT (SHALL) être pris de JDV Imputabilite CISIS
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-imputabilite-cisis)
TypeCodeableConcept
Est modificateurfalse
Doit être pris en charge (Must Support)true
Résumétrue
Invariantsele-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.

CourtAdverseEvent.suspectEntity.causalityProductRelatedness
Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-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.

CourtAdverseEvent.suspectEntity.causalityAuthor
Contrôle0..1
TypeReference(Practitioner, PractitionerRole)
Est modificateurfalse
Résumétrue
Invariantsele-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.

CourtProbabilityScale | Bayesian | Checklist
Contrôle0..1
BindingPour des exemples de codes, voir AdverseEventCausalityMethod
(example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1)

TODO.

TypeCodeableConcept
Est modificateurfalse
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. AdverseEvent.subjectMedicalHistory
Définition

AdverseEvent.subjectMedicalHistory.

CourtAdverseEvent.subjectMedicalHistory
Contrôle0..*
TypeReference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
Est modificateurfalse
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. AdverseEvent.referenceDocument
Définition

AdverseEvent.referenceDocument.

CourtAdverseEvent.referenceDocument
Contrôle0..*
TypeReference(DocumentReference)
Est modificateurfalse
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. AdverseEvent.study
Définition

AdverseEvent.study.

CourtAdverseEvent.study
Contrôle0..*
TypeReference(ResearchStudy)
Est modificateurfalse
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))