HL7 Europe Imaging Study Report
0.1.0-ballot - ci-build 150

HL7 Europe Imaging Study Report, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.1.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/oijauregui/ehdsimaging/tree/master and changes regularly. See the Directory of published versions

Resource Profile: Report_ImAdverseEvent - Detailed Descriptions

Draft as of 2025-07-02

Definitions for the Report-ImAdverseEvent resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. AdverseEvent
Definition

An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

ShortAn event that may be related to unintended effects on a patient or research participant
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesAE
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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
Definition

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.

ShortA set of rules under which this content was created
Comments

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 its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. AdverseEvent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

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.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. AdverseEvent.modifierExtension
Definition

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 managable, 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).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

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.

Alternate Namesextensions, 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())
8. AdverseEvent.status
Definition

The current state of the adverse event or potential adverse event.

Shortin-progress | completed | entered-in-error | unknown
Comments

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Control1..1
BindingThe codes SHALL be taken from AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0
(required to http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0)

Codes identifying the lifecycle stage of an event.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Obligations
    ObligationsActorDocumentation
    SHALL:populate-if-knownImaging study report provider

    EHDSImagingReportBody.examinationReport.adverseReaction

    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. AdverseEvent.actuality
    Definition

    Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

    Shortactual | potential
    Comments

    AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.

    Control1..1
    BindingThe codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0
    (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0)

    Overall nature of the adverse event, e.g. real or potential.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. AdverseEvent.code
    Definition

    Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

    ShortEvent or incident that occurred or was averted
    Control0..1
    BindingFor example codes, see AdverseEventTypehttp://hl7.org/fhir/ValueSet/adverse-event-type
    (example to http://hl7.org/fhir/ValueSet/adverse-event-type)

    Detailed type of event.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Obligations
      ObligationsActorDocumentation
      SHALL:populate-if-knownImaging study report provider

      EHDSImagingReportBody.examinationReport.adverseReaction

      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      14. AdverseEvent.subject
      Definition

      This subject or group impacted by the event.

      ShortSubject impacted by event
      Comments

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

      Control1..1
      TypeReference(IM Imaging Patient, Group, Practitioner (EU base), RelatedPerson Eu, ResearchSubject, Patient, Practitioner, RelatedPerson)
      Is Modifierfalse
      Must Supportfalse
      Obligations
        ObligationsActorDocumentation
        SHALL:populate-if-knownImaging study report provider

        EHDSImagingReportBody.examinationReport.adverseReaction

        Summarytrue
        Requirements

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

        Alternate Namespatient
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. AdverseEvent.suspectEntity
        Definition

        Describes the entity that is suspected to have caused the adverse event.

        ShortThe suspected agent causing the adverse event
        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on AdverseEvent.suspectEntity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • profile @ instance
        • 18. AdverseEvent.suspectEntity.modifierExtension
          Definition

          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 managable, 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).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          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.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          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.

          Alternate Namesextensions, 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())
          20. AdverseEvent.suspectEntity.instance[x]
          Definition

          Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

          ShortRefers to the specific entity that caused the adverse event
          Control1..1
          TypeChoice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Alternate NamesSubstance or Medication or Device
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. AdverseEvent.suspectEntity:procedure
          Slice Nameprocedure
          Definition

          Describes the entity that is suspected to have caused the adverse event.

          ShortThe suspected agent causing the adverse event
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Obligations
            ObligationsActorDocumentation
            SHALL:populate-if-knownImaging study report provider

            EHDSImagingReportBody.examinationReport.adverseReaction

            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            24. AdverseEvent.suspectEntity:procedure.modifierExtension
            Definition

            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 managable, 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).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            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.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            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.

            Alternate Namesextensions, 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:procedure.instance[x]
            Definition

            Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

            ShortRefers to the specific entity that caused the adverse event
            Control1..1
            TypeChoice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy)
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Alternate NamesSubstance or Medication or Device
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on AdverseEvent.suspectEntity.instance[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 28. AdverseEvent.suspectEntity:procedure.instance[x]:instanceReference
              Slice NameinstanceReference
              Definition

              Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

              ShortRefers to the specific entity that caused the adverse event
              Control01..1
              TypeReference(IM Imaging Procedure, Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy), CodeableConcept
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Alternate NamesSubstance or Medication or Device
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              30. AdverseEvent.contributingFactor
              Definition

              The contributing factors suspected to have increased the probability or severity of the adverse event.

              ShortContributing factors suspected to have increased the probability or severity of the adverse event
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on AdverseEvent.contributingFactor. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • profile @ $this
              • 32. AdverseEvent.contributingFactor.modifierExtension
                Definition

                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 managable, 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).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                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.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                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.

                Alternate Namesextensions, 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())
                34. AdverseEvent.contributingFactor.item[x]
                Definition

                The item that is suspected to have increased the probability or severity of the adverse event.

                ShortItem suspected to have increased the probability or severity of the adverse event
                Control1..1
                BindingFor example codes, see AdverseEventContributingFactorhttp://hl7.org/fhir/ValueSet/adverse-event-contributing-factor
                (example to http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor)

                Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

                TypeChoice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Device, DeviceUsage, DocumentReference, MedicationAdministration, MedicationStatement), CodeableConcept
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                36. AdverseEvent.contributingFactor:allergy
                Slice Nameallergy
                Definition

                The contributing factors suspected to have increased the probability or severity of the adverse event.

                ShortContributing factors suspected to have increased the probability or severity of the adverse event
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Obligations
                  ObligationsActorDocumentation
                  SHALL:populate-if-knownImaging study report provider

                  EHDSImagingReportBody.examinationReport.adverseReaction

                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  38. AdverseEvent.contributingFactor:allergy.modifierExtension
                  Definition

                  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 managable, 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).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  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.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  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.

                  Alternate Namesextensions, 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())
                  40. AdverseEvent.contributingFactor:allergy.item[x]
                  Definition

                  The item that is suspected to have increased the probability or severity of the adverse event.

                  ShortItem suspected to have increased the probability or severity of the adverse event
                  Control1..1
                  BindingFor example codes, see AdverseEventContributingFactorhttp://hl7.org/fhir/ValueSet/adverse-event-contributing-factor
                  (example to http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor)

                  Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

                  TypeChoice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Device, DeviceUsage, DocumentReference, MedicationAdministration, MedicationStatement), CodeableConcept
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  SlicingThis element introduces a set of slices on AdverseEvent.contributingFactor.item[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • type @ $this
                  • 42. AdverseEvent.contributingFactor:allergy.item[x]:itemReference
                    Slice NameitemReference
                    Definition

                    The item that is suspected to have increased the probability or severity of the adverse event.

                    ShortItem suspected to have increased the probability or severity of the adverse event
                    Control01..1
                    TypeReference(EU AllergyIntolerance, Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Device, DeviceUsage, DocumentReference, MedicationAdministration, MedicationStatement), CodeableConcept
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

                    Guidance on how to interpret the contents of this table can be foundhere

                    0. AdverseEvent
                    2. AdverseEvent.status
                    Obligations
                      ObligationsActorDocumentation
                      SHALL:populate-if-knownImaging study report provider

                      EHDSImagingReportBody.examinationReport.adverseReaction

                      4. AdverseEvent.code
                      Obligations
                        ObligationsActorDocumentation
                        SHALL:populate-if-knownImaging study report provider

                        EHDSImagingReportBody.examinationReport.adverseReaction

                        6. AdverseEvent.subject
                        Obligations
                          ObligationsActorDocumentation
                          SHALL:populate-if-knownImaging study report provider

                          EHDSImagingReportBody.examinationReport.adverseReaction

                          8. AdverseEvent.suspectEntity:procedure
                          Slice Nameprocedure
                          Obligations
                            ObligationsActorDocumentation
                            SHALL:populate-if-knownImaging study report provider

                            EHDSImagingReportBody.examinationReport.adverseReaction

                            10. AdverseEvent.contributingFactor:allergy
                            Slice Nameallergy
                            Obligations
                              ObligationsActorDocumentation
                              SHALL:populate-if-knownImaging study report provider

                              EHDSImagingReportBody.examinationReport.adverseReaction

                              Guidance on how to interpret the contents of this table can be foundhere

                              0. AdverseEvent
                              Definition

                              An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

                              ShortAn event that may be related to unintended effects on a patient or research participant
                              Control0..*
                              Is Modifierfalse
                              Must Supportfalse
                              Summaryfalse
                              Alternate NamesAE
                              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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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
                              Definition

                              The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                              ShortLogical id of this artifact
                              Comments

                              Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

                              Control0..1
                              Typeid
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              4. AdverseEvent.meta
                              Definition

                              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.

                              ShortMetadata about the resource
                              Control0..1
                              TypeMeta
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              6. AdverseEvent.implicitRules
                              Definition

                              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.

                              ShortA set of rules under which this content was created
                              Comments

                              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 its narrative along with other profiles, value sets, etc.

                              Control0..1
                              Typeuri
                              Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              8. AdverseEvent.language
                              Definition

                              The base language in which the resource is written.

                              ShortLanguage of the resource content
                              Comments

                              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).

                              Control0..1
                              BindingThe codes SHALL be taken from AllLanguages
                              (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                              IETF language tag for a human language

                              Typecode
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              10. AdverseEvent.text
                              Definition

                              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.

                              ShortText summary of the resource, for human interpretation
                              Comments

                              Contained resources do not have a 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.

                              Control0..1
                              This element is affected by the following invariants: dom-6
                              TypeNarrative
                              Is Modifierfalse
                              Must Supportfalse
                              Summaryfalse
                              Alternate Namesnarrative, html, xhtml, display
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              12. AdverseEvent.contained
                              Definition

                              These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

                              ShortContained, inline Resources
                              Comments

                              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.

                              Control0..*
                              This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                              TypeResource
                              Is Modifierfalse
                              Must Supportfalse
                              Summaryfalse
                              Alternate Namesinline resources, anonymous resources, contained resources
                              14. AdverseEvent.extension
                              Definition

                              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 managable, 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.

                              ShortAdditional content defined by implementations
                              Comments

                              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.

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Must Supportfalse
                              Summaryfalse
                              Alternate Namesextensions, 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
                              Definition

                              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 managable, 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).

                              ShortExtensions that cannot be ignored
                              Comments

                              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.

                              Control0..*
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                              Must Supportfalse
                              Summarytrue
                              Requirements

                              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.

                              Alternate Namesextensions, 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
                              Definition

                              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.

                              ShortBusiness identifier for the event
                              Comments

                              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.

                              NoteThis is a business identifier, not a resource identifier (see discussion)
                              Control0..*
                              TypeIdentifier
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Requirements

                              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.status
                              Definition

                              The current state of the adverse event or potential adverse event.

                              Shortin-progress | completed | entered-in-error | unknown
                              Comments

                              This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

                              Control1..1
                              BindingThe codes SHALL be taken from AdverseEventStatus
                              (required to http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0)

                              Codes identifying the lifecycle stage of an event.

                              Typecode
                              Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Obligations
                                ObligationsActorDocumentation
                                SHALL:populate-if-knownImaging study report provider

                                EHDSImagingReportBody.examinationReport.adverseReaction

                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                22. AdverseEvent.actuality
                                Definition

                                Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

                                Shortactual | potential
                                Comments

                                AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.

                                Control1..1
                                BindingThe codes SHALL be taken from AdverseEventActuality
                                (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0)

                                Overall nature of the adverse event, e.g. real or potential.

                                Typecode
                                Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                24. AdverseEvent.category
                                Definition

                                The overall type of event, intended for search and filtering purposes.

                                Shortwrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
                                Control0..*
                                BindingFor example codes, see AdverseEventCategory
                                (example to http://hl7.org/fhir/ValueSet/adverse-event-category)

                                Overall categorization of the event, e.g. product-related or situational.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                26. AdverseEvent.code
                                Definition

                                Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

                                ShortEvent or incident that occurred or was averted
                                Control0..1
                                BindingFor example codes, see AdverseEventType
                                (example to http://hl7.org/fhir/ValueSet/adverse-event-type)

                                Detailed type of event.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Obligations
                                  ObligationsActorDocumentation
                                  SHALL:populate-if-knownImaging study report provider

                                  EHDSImagingReportBody.examinationReport.adverseReaction

                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  28. AdverseEvent.subject
                                  Definition

                                  This subject or group impacted by the event.

                                  ShortSubject impacted by event
                                  Comments

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

                                  Control1..1
                                  TypeReference(IM Imaging Patient, Group, Practitioner (EU base), RelatedPerson Eu, ResearchSubject)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Obligations
                                    ObligationsActorDocumentation
                                    SHALL:populate-if-knownImaging study report provider

                                    EHDSImagingReportBody.examinationReport.adverseReaction

                                    Summarytrue
                                    Requirements

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

                                    Alternate Namespatient
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    30. AdverseEvent.encounter
                                    Definition

                                    The Encounter associated with the start of the AdverseEvent.

                                    ShortThe Encounter associated with the start of the AdverseEvent
                                    Comments

                                    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 associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter.

                                    Control0..1
                                    TypeReference(Encounter)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    32. AdverseEvent.occurrence[x]
                                    Definition

                                    The date (and perhaps time) when the adverse event occurred.

                                    ShortWhen the event occurred
                                    Control0..1
                                    TypeChoice of: dateTime, Period, Timing
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supportfalse
                                    Summarytrue
                                    Alternate Namestiming
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    34. AdverseEvent.detected
                                    Definition

                                    Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

                                    ShortWhen the event was detected
                                    Control0..1
                                    TypedateTime
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    36. AdverseEvent.recordedDate
                                    Definition

                                    The date on which the existence of the AdverseEvent was first recorded.

                                    ShortWhen the event was recorded
                                    Comments

                                    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.

                                    Control0..1
                                    TypedateTime
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    38. AdverseEvent.resultingEffect
                                    Definition

                                    Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall.

                                    ShortEffect on the subject due to this event
                                    Control0..*
                                    TypeReference(Condition, Observation)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    40. AdverseEvent.location
                                    Definition

                                    The information about where the adverse event occurred.

                                    ShortLocation where adverse event occurred
                                    Control0..1
                                    TypeReference(Location)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    42. AdverseEvent.seriousness
                                    Definition

                                    Assessment whether this event, or averted event, was of clinical importance.

                                    ShortSeriousness or gravity of the event
                                    Comments

                                    Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.

                                    Control0..1
                                    BindingFor example codes, see AdverseEventSeriousness
                                    (example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness)

                                    Overall seriousness of this event for the patient.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    44. AdverseEvent.outcome
                                    Definition

                                    Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.

                                    ShortType of outcome from the adverse event
                                    Control0..*
                                    BindingFor example codes, see AdverseEventOutcome
                                    (example to http://hl7.org/fhir/ValueSet/adverse-event-outcome)

                                    Codes describing the type of outcome from the adverse event.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    46. AdverseEvent.recorder
                                    Definition

                                    Information on who recorded the adverse event. May be the patient or a practitioner.

                                    ShortWho recorded the adverse event
                                    Control0..1
                                    TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson, ResearchSubject)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    48. AdverseEvent.participant
                                    Definition

                                    Indicates who or what participated in the adverse event and how they were involved.

                                    ShortWho was involved in the adverse event or the potential adverse event and what they did
                                    Control0..*
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    50. AdverseEvent.participant.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typestring
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    52. AdverseEvent.participant.extension
                                    Definition

                                    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 managable, 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.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    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.

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, 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())
                                    54. AdverseEvent.participant.modifierExtension
                                    Definition

                                    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 managable, 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).

                                    ShortExtensions that cannot be ignored even if unrecognized
                                    Comments

                                    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.

                                    Control0..*
                                    TypeExtension
                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                    Summarytrue
                                    Requirements

                                    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.

                                    Alternate Namesextensions, 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())
                                    56. AdverseEvent.participant.function
                                    Definition

                                    Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant.

                                    ShortType of involvement
                                    Control0..1
                                    BindingFor example codes, see AdverseEventParticipantFunction
                                    (example to http://hl7.org/fhir/ValueSet/adverse-event-participant-function)

                                    Codes describing the type of involvement of the actor in the adverse event.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    58. AdverseEvent.participant.actor
                                    Definition

                                    Indicates who or what participated in the event.

                                    ShortWho was involved in the adverse event or the potential adverse event
                                    Comments

                                    For example, the physician prescribing a drug, a nurse administering the drug, a device that administered the drug, a witness to the event, or an informant of clinical history.

                                    Control1..1
                                    TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson, ResearchSubject)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    60. AdverseEvent.study
                                    Definition

                                    The research study that the subject is enrolled in.

                                    ShortResearch study that the subject is enrolled in
                                    Control0..*
                                    TypeReference(ResearchStudy)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    62. AdverseEvent.expectedInResearchStudy
                                    Definition

                                    Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

                                    ShortConsidered likely or probable or anticipated in the research study
                                    Control0..1
                                    Typeboolean
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supportfalse
                                    Summaryfalse
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    64. AdverseEvent.suspectEntity
                                    Definition

                                    Describes the entity that is suspected to have caused the adverse event.

                                    ShortThe suspected agent causing the adverse event
                                    Control0..*
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    SlicingThis element introduces a set of slices on AdverseEvent.suspectEntity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • profile @ instance
                                    • 66. AdverseEvent.suspectEntity.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typestring
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      68. AdverseEvent.suspectEntity.extension
                                      Definition

                                      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 managable, 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.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      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.

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, 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())
                                      70. AdverseEvent.suspectEntity.modifierExtension
                                      Definition

                                      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 managable, 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).

                                      ShortExtensions that cannot be ignored even if unrecognized
                                      Comments

                                      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.

                                      Control0..*
                                      TypeExtension
                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                      Summarytrue
                                      Requirements

                                      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.

                                      Alternate Namesextensions, 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())
                                      72. AdverseEvent.suspectEntity.instance[x]
                                      Definition

                                      Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

                                      ShortRefers to the specific entity that caused the adverse event
                                      Control1..1
                                      TypeChoice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy)
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Alternate NamesSubstance or Medication or Device
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      74. AdverseEvent.suspectEntity.causality
                                      Definition

                                      Information on the possible cause of the event.

                                      ShortInformation on the possible cause of the event
                                      Control0..1
                                      TypeBackboneElement
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      76. AdverseEvent.suspectEntity.causality.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typestring
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      78. AdverseEvent.suspectEntity.causality.extension
                                      Definition

                                      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 managable, 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.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      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.

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, 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())
                                      80. AdverseEvent.suspectEntity.causality.modifierExtension
                                      Definition

                                      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 managable, 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).

                                      ShortExtensions that cannot be ignored even if unrecognized
                                      Comments

                                      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.

                                      Control0..*
                                      TypeExtension
                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                      Summarytrue
                                      Requirements

                                      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.

                                      Alternate Namesextensions, 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())
                                      82. AdverseEvent.suspectEntity.causality.assessmentMethod
                                      Definition

                                      The method of evaluating the relatedness of the suspected entity to the event.

                                      ShortMethod of evaluating the relatedness of the suspected entity to the event
                                      Control0..1
                                      BindingFor example codes, see AdverseEventCausalityMethod
                                      (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)

                                      TODO.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      84. AdverseEvent.suspectEntity.causality.entityRelatedness
                                      Definition

                                      The result of the assessment regarding the relatedness of the suspected entity to the event.

                                      ShortResult of the assessment regarding the relatedness of the suspected entity to the event
                                      Control0..1
                                      BindingFor example codes, see AdverseEventCausalityAssessment
                                      (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-assess)

                                      Codes for the assessment of whether the entity caused the event.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      86. AdverseEvent.suspectEntity.causality.author
                                      Definition

                                      The author of the information on the possible cause of the event.

                                      ShortAuthor of the information on the possible cause of the event
                                      Control0..1
                                      TypeReference(Practitioner, PractitionerRole, Patient, RelatedPerson, ResearchSubject)
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      88. AdverseEvent.suspectEntity:procedure
                                      Slice Nameprocedure
                                      Definition

                                      Describes the entity that is suspected to have caused the adverse event.

                                      ShortThe suspected agent causing the adverse event
                                      Control0..*
                                      TypeBackboneElement
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Obligations
                                        ObligationsActorDocumentation
                                        SHALL:populate-if-knownImaging study report provider

                                        EHDSImagingReportBody.examinationReport.adverseReaction

                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        90. AdverseEvent.suspectEntity:procedure.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typestring
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        92. AdverseEvent.suspectEntity:procedure.extension
                                        Definition

                                        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 managable, 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.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        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.

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, 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())
                                        94. AdverseEvent.suspectEntity:procedure.modifierExtension
                                        Definition

                                        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 managable, 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).

                                        ShortExtensions that cannot be ignored even if unrecognized
                                        Comments

                                        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.

                                        Control0..*
                                        TypeExtension
                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                        Summarytrue
                                        Requirements

                                        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.

                                        Alternate Namesextensions, 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())
                                        96. AdverseEvent.suspectEntity:procedure.instance[x]
                                        Definition

                                        Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

                                        ShortRefers to the specific entity that caused the adverse event
                                        Control1..1
                                        TypeChoice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy)
                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Alternate NamesSubstance or Medication or Device
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        SlicingThis element introduces a set of slices on AdverseEvent.suspectEntity.instance[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • type @ $this
                                        • 98. AdverseEvent.suspectEntity:procedure.instance[x]:instanceReference
                                          Slice NameinstanceReference
                                          Definition

                                          Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

                                          ShortRefers to the specific entity that caused the adverse event
                                          Control0..1
                                          TypeReference(IM Imaging Procedure)
                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Alternate NamesSubstance or Medication or Device
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          100. AdverseEvent.suspectEntity:procedure.causality
                                          Definition

                                          Information on the possible cause of the event.

                                          ShortInformation on the possible cause of the event
                                          Control0..1
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          102. AdverseEvent.suspectEntity:procedure.causality.id
                                          Definition

                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                          ShortUnique id for inter-element referencing
                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typestring
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          104. AdverseEvent.suspectEntity:procedure.causality.extension
                                          Definition

                                          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 managable, 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.

                                          ShortAdditional content defined by implementations
                                          Comments

                                          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.

                                          Control0..*
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Alternate Namesextensions, 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())
                                          106. AdverseEvent.suspectEntity:procedure.causality.modifierExtension
                                          Definition

                                          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 managable, 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).

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

                                          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.

                                          Control0..*
                                          TypeExtension
                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                          Summarytrue
                                          Requirements

                                          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.

                                          Alternate Namesextensions, 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())
                                          108. AdverseEvent.suspectEntity:procedure.causality.assessmentMethod
                                          Definition

                                          The method of evaluating the relatedness of the suspected entity to the event.

                                          ShortMethod of evaluating the relatedness of the suspected entity to the event
                                          Control0..1
                                          BindingFor example codes, see AdverseEventCausalityMethod
                                          (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)

                                          TODO.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          110. AdverseEvent.suspectEntity:procedure.causality.entityRelatedness
                                          Definition

                                          The result of the assessment regarding the relatedness of the suspected entity to the event.

                                          ShortResult of the assessment regarding the relatedness of the suspected entity to the event
                                          Control0..1
                                          BindingFor example codes, see AdverseEventCausalityAssessment
                                          (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-assess)

                                          Codes for the assessment of whether the entity caused the event.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          112. AdverseEvent.suspectEntity:procedure.causality.author
                                          Definition

                                          The author of the information on the possible cause of the event.

                                          ShortAuthor of the information on the possible cause of the event
                                          Control0..1
                                          TypeReference(Practitioner, PractitionerRole, Patient, RelatedPerson, ResearchSubject)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          114. AdverseEvent.contributingFactor
                                          Definition

                                          The contributing factors suspected to have increased the probability or severity of the adverse event.

                                          ShortContributing factors suspected to have increased the probability or severity of the adverse event
                                          Control0..*
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          SlicingThis element introduces a set of slices on AdverseEvent.contributingFactor. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • profile @ $this
                                          • 116. AdverseEvent.contributingFactor.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typestring
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            118. AdverseEvent.contributingFactor.extension
                                            Definition

                                            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 managable, 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.

                                            ShortAdditional content defined by implementations
                                            Comments

                                            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.

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, 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())
                                            120. AdverseEvent.contributingFactor.modifierExtension
                                            Definition

                                            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 managable, 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).

                                            ShortExtensions that cannot be ignored even if unrecognized
                                            Comments

                                            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.

                                            Control0..*
                                            TypeExtension
                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                            Summarytrue
                                            Requirements

                                            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.

                                            Alternate Namesextensions, 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())
                                            122. AdverseEvent.contributingFactor.item[x]
                                            Definition

                                            The item that is suspected to have increased the probability or severity of the adverse event.

                                            ShortItem suspected to have increased the probability or severity of the adverse event
                                            Control1..1
                                            BindingFor example codes, see AdverseEventContributingFactor
                                            (example to http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor)

                                            Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

                                            TypeChoice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Device, DeviceUsage, DocumentReference, MedicationAdministration, MedicationStatement), CodeableConcept
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            124. AdverseEvent.contributingFactor:allergy
                                            Slice Nameallergy
                                            Definition

                                            The contributing factors suspected to have increased the probability or severity of the adverse event.

                                            ShortContributing factors suspected to have increased the probability or severity of the adverse event
                                            Control0..*
                                            TypeBackboneElement
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Obligations
                                              ObligationsActorDocumentation
                                              SHALL:populate-if-knownImaging study report provider

                                              EHDSImagingReportBody.examinationReport.adverseReaction

                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              126. AdverseEvent.contributingFactor:allergy.id
                                              Definition

                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                              ShortUnique id for inter-element referencing
                                              Control0..1
                                              This element is affected by the following invariants: ele-1
                                              Typestring
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              128. AdverseEvent.contributingFactor:allergy.extension
                                              Definition

                                              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 managable, 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.

                                              ShortAdditional content defined by implementations
                                              Comments

                                              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.

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, 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())
                                              130. AdverseEvent.contributingFactor:allergy.modifierExtension
                                              Definition

                                              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 managable, 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).

                                              ShortExtensions that cannot be ignored even if unrecognized
                                              Comments

                                              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.

                                              Control0..*
                                              TypeExtension
                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                              Summarytrue
                                              Requirements

                                              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.

                                              Alternate Namesextensions, 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())
                                              132. AdverseEvent.contributingFactor:allergy.item[x]
                                              Definition

                                              The item that is suspected to have increased the probability or severity of the adverse event.

                                              ShortItem suspected to have increased the probability or severity of the adverse event
                                              Control1..1
                                              BindingFor example codes, see AdverseEventContributingFactor
                                              (example to http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor)

                                              Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

                                              TypeChoice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Device, DeviceUsage, DocumentReference, MedicationAdministration, MedicationStatement), CodeableConcept
                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              SlicingThis element introduces a set of slices on AdverseEvent.contributingFactor.item[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                              • type @ $this
                                              • 134. AdverseEvent.contributingFactor:allergy.item[x]:itemReference
                                                Slice NameitemReference
                                                Definition

                                                The item that is suspected to have increased the probability or severity of the adverse event.

                                                ShortItem suspected to have increased the probability or severity of the adverse event
                                                Control0..1
                                                TypeReference(EU AllergyIntolerance)
                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                136. AdverseEvent.preventiveAction
                                                Definition

                                                Preventive actions that contributed to avoiding the adverse event.

                                                ShortPreventive actions that contributed to avoiding the adverse event
                                                Control0..*
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                138. AdverseEvent.preventiveAction.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typestring
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                140. AdverseEvent.preventiveAction.extension
                                                Definition

                                                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 managable, 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.

                                                ShortAdditional content defined by implementations
                                                Comments

                                                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.

                                                Control0..*
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Alternate Namesextensions, 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())
                                                142. AdverseEvent.preventiveAction.modifierExtension
                                                Definition

                                                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 managable, 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).

                                                ShortExtensions that cannot be ignored even if unrecognized
                                                Comments

                                                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.

                                                Control0..*
                                                TypeExtension
                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                Summarytrue
                                                Requirements

                                                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.

                                                Alternate Namesextensions, 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())
                                                144. AdverseEvent.preventiveAction.item[x]
                                                Definition

                                                The action that contributed to avoiding the adverse event.

                                                ShortAction that contributed to avoiding the adverse event
                                                Control1..1
                                                BindingFor example codes, see AdverseEventPreventiveAction
                                                (example to http://hl7.org/fhir/ValueSet/adverse-event-preventive-action)

                                                Codes describing the preventive actions that contributed to avoiding the adverse event.

                                                TypeChoice of: Reference(Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationRequest), CodeableConcept
                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                146. AdverseEvent.mitigatingAction
                                                Definition

                                                The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.

                                                ShortAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm
                                                Control0..*
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                148. AdverseEvent.mitigatingAction.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typestring
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                150. AdverseEvent.mitigatingAction.extension
                                                Definition

                                                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 managable, 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.

                                                ShortAdditional content defined by implementations
                                                Comments

                                                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.

                                                Control0..*
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Alternate Namesextensions, 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())
                                                152. AdverseEvent.mitigatingAction.modifierExtension
                                                Definition

                                                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 managable, 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).

                                                ShortExtensions that cannot be ignored even if unrecognized
                                                Comments

                                                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.

                                                Control0..*
                                                TypeExtension
                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                Summarytrue
                                                Requirements

                                                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.

                                                Alternate Namesextensions, 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())
                                                154. AdverseEvent.mitigatingAction.item[x]
                                                Definition

                                                The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.

                                                ShortAmeliorating action taken after the adverse event occured in order to reduce the extent of harm
                                                Control1..1
                                                BindingFor example codes, see AdverseEventMitigatingAction
                                                (example to http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action)

                                                Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.

                                                TypeChoice of: Reference(Procedure, DocumentReference, MedicationAdministration, MedicationRequest), CodeableConcept
                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                156. AdverseEvent.supportingInfo
                                                Definition

                                                Supporting information relevant to the event.

                                                ShortSupporting information relevant to the event
                                                Control0..*
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                158. AdverseEvent.supportingInfo.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typestring
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                160. AdverseEvent.supportingInfo.extension
                                                Definition

                                                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 managable, 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.

                                                ShortAdditional content defined by implementations
                                                Comments

                                                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.

                                                Control0..*
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Alternate Namesextensions, 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())
                                                162. AdverseEvent.supportingInfo.modifierExtension
                                                Definition

                                                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 managable, 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).

                                                ShortExtensions that cannot be ignored even if unrecognized
                                                Comments

                                                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.

                                                Control0..*
                                                TypeExtension
                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                Summarytrue
                                                Requirements

                                                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.

                                                Alternate Namesextensions, 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())
                                                164. AdverseEvent.supportingInfo.item[x]
                                                Definition

                                                Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

                                                ShortSubject medical history or document relevant to this adverse event
                                                Control1..1
                                                BindingFor example codes, see AdverseEventSupportingInforation
                                                (example to http://hl7.org/fhir/ValueSet/adverse-event-supporting-info)

                                                Codes describing the supporting information relevant to the event.

                                                TypeChoice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationStatement, QuestionnaireResponse), CodeableConcept
                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                166. AdverseEvent.note
                                                Definition

                                                Comments made about the adverse event by the performer, subject or other participants.

                                                ShortComment on adverse event
                                                Control0..*
                                                TypeAnnotation
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))