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: ImAdverseEvent - Detailed Descriptions

Page standards status: Draft Maturity Level: 1

Definitions for the ImAdverseEvent resource profile.

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

0. AdverseEvent
Definition

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

ShortMedical care, research study or other healthcare event causing physical injury
Control0..*
Is Modifierfalse
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AdverseEvent.implicitRules
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 it's 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 it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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
Summaryfalse
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())
6. AdverseEvent.actuality
Definition

Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

Shortactual | potential
Control1..1
BindingThe codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
(required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

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

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

This subject or group impacted by the event.

ShortSubject impacted by event
Comments

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

Control1..1
TypeReference(IM Imaging Patient, Group, Practitioner (EU base), RelatedPerson Eu, Patient, Practitioner, RelatedPerson)
Is Modifierfalse
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()))
10. AdverseEvent.subject.extension:subjectReseachSubject
Slice NamesubjectReseachSubject
Definition

Extension to capture the relationship of the subject to the ReseachSubject.

ShortImaging Adverse Event Subject Research Subject
Control0..1
TypeExtension(Imaging Adverse Event Subject Research Subject) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta)
Is Modifierfalse
Summaryfalse
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())
12. 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
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
  • 14. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    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())
    16. AdverseEvent.suspectEntity.instance
    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
    TypeReference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
    Is Modifierfalse
    Summarytrue
    Alternate NamesSubstance or Medication or Device
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. 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
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    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())
    22. AdverseEvent.suspectEntity:procedure.instance
    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
    TypeReference(IM Imaging Procedure, Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
    Is Modifierfalse
    Summarytrue
    Alternate NamesSubstance or Medication or Device
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. AdverseEvent.subjectMedicalHistory
    Definition

    AdverseEvent.subjectMedicalHistory.

    ShortAdverseEvent.subjectMedicalHistory
    Control0..*
    TypeReference(EU AllergyIntolerance, Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
    Is Modifierfalse
    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.subjectMedicalHistory. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • profile @ $this
    • 26. AdverseEvent.subjectMedicalHistory:allergy
      Slice Nameallergy
      Definition

      AdverseEvent.subjectMedicalHistory.

      ShortAdverseEvent.subjectMedicalHistory
      Control0..*
      TypeReference(EU AllergyIntolerance, Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
      Is Modifierfalse
      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.subject
      TypeReference(IM Imaging Patient, Group, Practitioner (EU base), RelatedPerson Eu)
      4. AdverseEvent.subject.extension:subjectReseachSubject
      Slice NamesubjectReseachSubject
      Control0..1
      TypeExtension(Imaging Adverse Event Subject Research Subject) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta)
      6. AdverseEvent.suspectEntity
      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
      • 8. AdverseEvent.suspectEntity:procedure
        Slice Nameprocedure
        Control0..*
        10. AdverseEvent.suspectEntity:procedure.instance
        TypeReference(IM Imaging Procedure)
        12. AdverseEvent.subjectMedicalHistory
        TypeReference(EU AllergyIntolerance)
        SlicingThis element introduces a set of slices on AdverseEvent.subjectMedicalHistory. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • profile @ $this
        • 14. AdverseEvent.subjectMedicalHistory:allergy
          Slice Nameallergy
          Control0..*
          TypeReference(EU AllergyIntolerance)

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

          0. AdverseEvent
          Definition

          Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

          ShortMedical care, research study or other healthcare event causing physical injury
          Control0..*
          Is Modifierfalse
          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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
          dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
          dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          2. AdverseEvent.id
          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

          The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

          Control0..1
          Typeid
          Is Modifierfalse
          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
          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 it's 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 it's meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          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 SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages)

          A human language.

          Additional BindingsPurpose
          AllLanguagesMax Binding
          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          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 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
          TypeNarrative
          Is Modifierfalse
          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, and nor can they have their own independent transaction scope.

          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..*
          TypeResource
          Is Modifierfalse
          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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          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())
          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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          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
          Summaryfalse
          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..1
          TypeIdentifier
          Is Modifierfalse
          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.actuality
          Definition

          Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

          Shortactual | potential
          Control1..1
          BindingThe codes SHALL be taken from AdverseEventActuality
          (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

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

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

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

          Shortproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
          Control0..*
          BindingUnless not suitable, these codes SHALL be taken from AdverseEventCategory
          (extensible to http://hl7.org/fhir/ValueSet/adverse-event-category)

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

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

          This element defines the specific type of event that occurred or that was prevented from occurring.

          ShortType of the event itself in relation to the subject
          Control0..1
          BindingFor example codes, see SNOMEDCTClinicalFindings
          (example to http://hl7.org/fhir/ValueSet/adverse-event-type)

          Detailed type of event.

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

          This subject or group impacted by the event.

          ShortSubject impacted by event
          Comments

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

          Control1..1
          TypeReference(IM Imaging Patient, Group, Practitioner (EU base), RelatedPerson Eu)
          Is Modifierfalse
          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()))
          28. AdverseEvent.subject.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
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          30. AdverseEvent.subject.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          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())
          SlicingThis element introduces a set of slices on AdverseEvent.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 32. AdverseEvent.subject.extension:subjectReseachSubject
            Slice NamesubjectReseachSubject
            Definition

            Extension to capture the relationship of the subject to the ReseachSubject.

            ShortImaging Adverse Event Subject Research Subject
            Control0..1
            TypeExtension(Imaging Adverse Event Subject Research Subject) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta)
            Is Modifierfalse
            Summaryfalse
            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.subject.reference
            Definition

            A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

            ShortLiteral reference, Relative, internal or absolute URL
            Comments

            Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

            Control0..1
            This element is affected by the following invariants: ref-1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            36. AdverseEvent.subject.type
            Definition

            The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

            The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

            ShortType the reference refers to (e.g. "Patient")
            Comments

            This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

            Control0..1
            BindingUnless not suitable, these codes SHALL be taken from ResourceType
            (extensible to http://hl7.org/fhir/ValueSet/resource-types)

            Aa resource (or, for logical models, the URI of the logical model).

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

            An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

            ShortLogical reference, when literal reference is not known
            Comments

            When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

            When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

            Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

            Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control0..1
            TypeIdentifier
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            40. AdverseEvent.subject.display
            Definition

            Plain text narrative that identifies the resource in addition to the resource reference.

            ShortText alternative for the resource
            Comments

            This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

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

            The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

            ShortEncounter created as part of
            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 context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.

            Control0..1
            TypeReference(Encounter)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            44. AdverseEvent.date
            Definition

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

            ShortWhen the event occurred
            Control0..1
            TypedateTime
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            46. 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
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            48. 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
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            50. AdverseEvent.resultingCondition
            Definition

            Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

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

            The information about where the adverse event occurred.

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

            Assessment whether this event was of real importance.

            ShortSeriousness of the event
            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
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. AdverseEvent.severity
            Definition

            Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.

            Shortmild | moderate | severe
            Control0..1
            BindingThe codes SHALL be taken from AdverseEventSeverity
            (required to http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1)

            The severity of the adverse event itself, in direct relation to the subject.

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

            Describes the type of outcome from the adverse event.

            Shortresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
            Control0..1
            BindingThe codes SHALL be taken from AdverseEventOutcome
            (required to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1)

            TODO (and should this be required?).

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            60. 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)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            62. AdverseEvent.contributor
            Definition

            Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).

            ShortWho was involved in the adverse event or the potential adverse event
            Control0..*
            TypeReference(Practitioner, PractitionerRole, Device)
            Is Modifierfalse
            Summarytrue
            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
            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
              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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              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
              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
              TypeReference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
              Is Modifierfalse
              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..*
              TypeBackboneElement
              Is Modifierfalse
              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
              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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              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.assessment
              Definition

              Assessment of if the entity caused the event.

              ShortAssessment of if the entity caused 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
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              84. AdverseEvent.suspectEntity.causality.productRelatedness
              Definition

              AdverseEvent.suspectEntity.causalityProductRelatedness.

              ShortAdverseEvent.suspectEntity.causalityProductRelatedness
              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              86. AdverseEvent.suspectEntity.causality.author
              Definition

              AdverseEvent.suspectEntity.causalityAuthor.

              ShortAdverseEvent.suspectEntity.causalityAuthor
              Control0..1
              TypeReference(Practitioner, PractitionerRole)
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              88. AdverseEvent.suspectEntity.causality.method
              Definition

              ProbabilityScale | Bayesian | Checklist.

              ShortProbabilityScale | Bayesian | Checklist
              Control0..1
              BindingFor example codes, see AdverseEventCausalityMethod
              (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)

              TODO.

              TypeCodeableConcept
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              90. 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
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              92. 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
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              94. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              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())
              96. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              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())
              98. AdverseEvent.suspectEntity:procedure.instance
              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
              TypeReference(IM Imaging Procedure)
              Is Modifierfalse
              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..*
              TypeBackboneElement
              Is Modifierfalse
              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
              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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              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.assessment
              Definition

              Assessment of if the entity caused the event.

              ShortAssessment of if the entity caused 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
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              110. AdverseEvent.suspectEntity:procedure.causality.productRelatedness
              Definition

              AdverseEvent.suspectEntity.causalityProductRelatedness.

              ShortAdverseEvent.suspectEntity.causalityProductRelatedness
              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              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

              AdverseEvent.suspectEntity.causalityAuthor.

              ShortAdverseEvent.suspectEntity.causalityAuthor
              Control0..1
              TypeReference(Practitioner, PractitionerRole)
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              114. AdverseEvent.suspectEntity:procedure.causality.method
              Definition

              ProbabilityScale | Bayesian | Checklist.

              ShortProbabilityScale | Bayesian | Checklist
              Control0..1
              BindingFor example codes, see AdverseEventCausalityMethod
              (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)

              TODO.

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

              AdverseEvent.subjectMedicalHistory.

              ShortAdverseEvent.subjectMedicalHistory
              Control0..*
              TypeReference(EU AllergyIntolerance)
              Is Modifierfalse
              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.subjectMedicalHistory. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • profile @ $this
              • 118. AdverseEvent.subjectMedicalHistory:allergy
                Slice Nameallergy
                Definition

                AdverseEvent.subjectMedicalHistory.

                ShortAdverseEvent.subjectMedicalHistory
                Control0..*
                TypeReference(EU AllergyIntolerance)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                120. AdverseEvent.referenceDocument
                Definition

                AdverseEvent.referenceDocument.

                ShortAdverseEvent.referenceDocument
                Control0..*
                TypeReference(DocumentReference)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                122. AdverseEvent.study
                Definition

                AdverseEvent.study.

                ShortAdverseEvent.study
                Control0..*
                TypeReference(ResearchStudy)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))