Fujitsu Healthy Living Implementation Guide
1.1.28 - release

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Extension: Fujitsu Suspect Entity

Official URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity Version: 1.1.28
Active as of 2025-07-09 Computable Name: FujitsuSuspectEntity

Describes the entity that is suspected to have caused the adverse event.
有害事象を引き起こしたと疑われる因子を記述する。

Context of Use

This extension may be used on the following element(s):

  • Element ID AdverseEvent

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Complex Extension: Describes the entity that is suspected to have caused the adverse event.
有害事象を引き起こしたと疑われる因子を記述する。

  • instance: Reference: An Extension
  • assessmentMethod: CodeableConcept: An Extension
  • entityRelatedness: CodeableConcept: An Extension
  • author: Reference: An Extension

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Suspect Entity (有害事象を引き起こしたと疑われる因子)
... extension 2..* Extension Extension
... extension:instance 1..1 Extension Refers to the specific entity that is suspected of causing the adverse event (有害事象を引き起こしたと疑われる因子)
.... extension 0..0
.... url 1..1 uri "instance"
.... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Open by type:$this
..... value[x]:valueReference 0..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) Value of extension
... extension:causality 1..1 Extension Causality - information on the possible cause of the event (因果関係)
.... extension:assessmentMethod 0..1 Extension Method of evaluating the relatedness of the suspected entity to the event. (関連性の評価方法)
..... extension 0..0
..... url 1..1 uri "assessmentMethod"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.

.... extension:entityRelatedness 0..1 Extension Result of the assessment regarding the relatedness of the suspected entity to the event (関連性の評価結果)
..... extension 0..0
..... url 1..1 uri "entityRelatedness"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
.... extension:author 0..1 Extension Author of the information on the possible cause of the event (情報の著者)
..... extension 0..0
..... url 1..1 uri "author"
..... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueReference 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Value of extension
.... url 1..1 uri "causality"
.... value[x] 0..0
... value[x] 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Suspect Entity (有害事象を引き起こしたと疑われる因子)
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
... extension:instance 1..1 Extension Refers to the specific entity that is suspected of causing the adverse event (有害事象を引き起こしたと疑われる因子)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "instance"
.... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Closed by type:$this
..... value[x]:valueReference 0..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) Value of extension
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:assessmentMethod 0..1 Extension Method of evaluating the relatedness of the suspected entity to the event. (関連性の評価方法)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "assessmentMethod"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.

.... extension:entityRelatedness 0..1 Extension Result of the assessment regarding the relatedness of the suspected entity to the event (関連性の評価結果)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "entityRelatedness"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
.... extension:author 0..1 Extension Author of the information on the possible cause of the event (情報の著者)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "author"
..... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueReference 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Value of extension
.... url 1..1 uri "causality"
... url 1..1 uri "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Describes the entity that is suspected to have caused the adverse event.
有害事象を引き起こしたと疑われる因子を記述する。

  • instance: Reference: An Extension
  • assessmentMethod: CodeableConcept: An Extension
  • entityRelatedness: CodeableConcept: An Extension
  • author: Reference: An Extension

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Suspect Entity (有害事象を引き起こしたと疑われる因子)
... extension 2..* Extension Extension
... extension:instance 1..1 Extension Refers to the specific entity that is suspected of causing the adverse event (有害事象を引き起こしたと疑われる因子)
.... extension 0..0
.... url 1..1 uri "instance"
.... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Open by type:$this
..... value[x]:valueReference 0..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) Value of extension
... extension:causality 1..1 Extension Causality - information on the possible cause of the event (因果関係)
.... extension:assessmentMethod 0..1 Extension Method of evaluating the relatedness of the suspected entity to the event. (関連性の評価方法)
..... extension 0..0
..... url 1..1 uri "assessmentMethod"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.

.... extension:entityRelatedness 0..1 Extension Result of the assessment regarding the relatedness of the suspected entity to the event (関連性の評価結果)
..... extension 0..0
..... url 1..1 uri "entityRelatedness"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
.... extension:author 0..1 Extension Author of the information on the possible cause of the event (情報の著者)
..... extension 0..0
..... url 1..1 uri "author"
..... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueReference 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Value of extension
.... url 1..1 uri "causality"
.... value[x] 0..0
... value[x] 0..0

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Suspect Entity (有害事象を引き起こしたと疑われる因子)
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
... extension:instance 1..1 Extension Refers to the specific entity that is suspected of causing the adverse event (有害事象を引き起こしたと疑われる因子)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "instance"
.... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Closed by type:$this
..... value[x]:valueReference 0..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) Value of extension
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:assessmentMethod 0..1 Extension Method of evaluating the relatedness of the suspected entity to the event. (関連性の評価方法)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "assessmentMethod"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.

.... extension:entityRelatedness 0..1 Extension Result of the assessment regarding the relatedness of the suspected entity to the event (関連性の評価結果)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "entityRelatedness"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
.... extension:author 0..1 Extension Author of the information on the possible cause of the event (情報の著者)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "author"
..... Slices for value[x] 0..1 Reference() Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueReference 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Value of extension
.... url 1..1 uri "causality"
... url 1..1 uri "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConceptpreferredAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard
Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConceptpreferredAdverseEventClinicalResearchCausalityRelatedness
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()