Package | hl7.fhir.uv.ae-research-backport-ig |
Type | StructureDefinition |
Id | suspect-entity |
FHIR Version | R4 |
Source | http://hl7.org/fhir/uv/ae-research-backport-ig/https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig/StructureDefinition-suspect-entity.html |
URL | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity |
Version | 1.0.1 |
Status | active |
Date | 2024-04-30T20:04:27+00:00 |
Name | SuspectEntity |
Title | Suspect Entity |
Realm | uv |
Authority | hl7 |
Description | Describes the entity that is suspected to have caused the adverse event. |
Type | Extension |
Kind | complex-type |
StructureDefinition | |
AdverseEvent-clinical-research | Adverse Event Clinical Research |
ValueSet | |
adverse-event-clinical-research-causality-relatedness | Adverse Event Clinical Research Causality Relatedness |
adverse-event-clinical-research-causality-relatedness | Adverse Event Clinical Research Causality Relatedness |
Note: links and images are rebased to the (stated) source
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
![]() ![]() | 0..* | Extension | Suspect Entity | |
![]() ![]() ![]() | 2..* | Extension | Extension | |
![]() ![]() ![]() | 1..1 | Extension | Refers to the specific entity that is suspected of causing the adverse event | |
![]() ![]() ![]() ![]() | 0..0 | |||
![]() ![]() ![]() ![]() | 1..1 | uri | "instance" | |
![]() ![]() ![]() ![]() | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this | |
![]() ![]() ![]() ![]() ![]() | 0..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | Value of extension | |
![]() ![]() ![]() | 1..1 | Extension | Causality - information on the possible cause of the event | |
![]() ![]() ![]() ![]() | 0..1 | Extension | Method of evaluating the relatedness of the suspected entity to the event. | |
![]() ![]() ![]() ![]() ![]() | 0..0 | |||
![]() ![]() ![]() ![]() ![]() | 1..1 | uri | "assessmentMethod" | |
![]() ![]() ![]() ![]() ![]() | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this | |
![]() ![]() ![]() ![]() ![]() ![]() | 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. | |
![]() ![]() ![]() ![]() | 0..1 | Extension | Result of the assessment regarding the relatedness of the suspected entity to the event | |
![]() ![]() ![]() ![]() ![]() | 0..0 | |||
![]() ![]() ![]() ![]() ![]() | 1..1 | uri | "entityRelatedness" | |
![]() ![]() ![]() ![]() ![]() | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this | |
![]() ![]() ![]() ![]() ![]() ![]() | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Causality Relatedness (preferred) | |
![]() ![]() ![]() ![]() | 0..1 | Extension | Author of the information on the possible cause of the event | |
![]() ![]() ![]() ![]() ![]() | 0..0 | |||
![]() ![]() ![]() ![]() ![]() | 1..1 | uri | "author" | |
![]() ![]() ![]() ![]() ![]() | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this | |
![]() ![]() ![]() ![]() ![]() ![]() | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Value of extension | |
![]() ![]() ![]() ![]() | 1..1 | uri | "causality" | |
![]() ![]() ![]() ![]() | 0..0 | |||
![]() ![]() ![]() | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity" | |
![]() ![]() ![]() | 0..0 | |||
{ "resourceType": "StructureDefinition", "id": "suspect-entity", "text": { "status": "extensions", "div": "<!-- snip (see above) -->" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 2, "_valueInteger": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom", "valueCanonical": "http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use", "_valueCode": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom", "valueCanonical": "http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig" } ] } } ], "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity", "version": "1.0.1", "name": "SuspectEntity", "title": "Suspect Entity", "status": "active", "date": "2024-04-30T20:04:27+00:00", "publisher": "HL7 International / Biomedical Research and Regulation", "contact": [ { "name": "Biomedical Research and Regulation WG", "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/rcrim" } ] } ], "description": "Describes the entity that is suspected to have caused the adverse event.", "jurisdiction": [ { "coding": [ { "system": "http://unstats.un.org/unsd/methods/m49/m49.htm", "code": "001" } ] } ], "fhirVersion": "4.0.1", "mapping": [ { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" } ], "kind": "complex-type", "abstract": false, "context": [ { "type": "element", "expression": "AdverseEvent" } ], "type": "Extension", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension", "derivation": "constraint", "snapshot": { "element": [ { "id": "Extension", "path": "Extension", "short": "Suspect Entity", "definition": "Describes the entity that is suspected to have caused the adverse event.", "min": 0, "max": "*", "base": { "path": "Extension", "min": 0, "max": "*" }, "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false }, { "id": "Extension.id", "path": "Extension.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "Extension.extension", "path": "Extension.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Extension", "definition": "An Extension", "min": 2, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:instance", "path": "Extension.extension", "sliceName": "instance", "short": "Refers to the specific entity that is suspected of causing the adverse event", "definition": "An Extension", "min": 1, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:instance.id", "path": "Extension.extension.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "Extension.extension:instance.extension", "path": "Extension.extension.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Extension", "definition": "An Extension", "min": 0, "max": "0", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:instance.url", "path": "Extension.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "min": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "fixedUri": "instance", "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:instance.value[x]", "path": "Extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "closed" }, "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "Reference" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:instance.value[x]:valueReference", "path": "Extension.extension.value[x]", "sliceName": "valueReference", "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Immunization", "http://hl7.org/fhir/StructureDefinition/Procedure", "http://hl7.org/fhir/StructureDefinition/Substance", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/MedicationAdministration", "http://hl7.org/fhir/StructureDefinition/MedicationStatement", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct", "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality", "path": "Extension.extension", "sliceName": "causality", "short": "Causality - information on the possible cause of the event", "definition": "An Extension", "min": 1, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:causality.id", "path": "Extension.extension.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "Extension.extension:causality.extension", "path": "Extension.extension.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "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.", "comment": "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.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "Extension.extension:causality.extension:assessmentMethod", "path": "Extension.extension.extension", "sliceName": "assessmentMethod", "short": "Method of evaluating the relatedness of the suspected entity to the event.", "definition": "An Extension", "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:causality.extension:assessmentMethod.id", "path": "Extension.extension.extension.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "Extension.extension:causality.extension:assessmentMethod.extension", "path": "Extension.extension.extension.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Extension", "definition": "An Extension", "min": 0, "max": "0", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:causality.extension:assessmentMethod.url", "path": "Extension.extension.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "min": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "fixedUri": "assessmentMethod", "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:assessmentMethod.value[x]", "path": "Extension.extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "closed" }, "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConcept", "path": "Extension.extension.extension.value[x]", "sliceName": "valueCodeableConcept", "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventCausalityMethod" } ], "strength": "preferred", "description": "Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-causality-method" }, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:entityRelatedness", "path": "Extension.extension.extension", "sliceName": "entityRelatedness", "short": "Result of the assessment regarding the relatedness of the suspected entity to the event", "definition": "An Extension", "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:causality.extension:entityRelatedness.id", "path": "Extension.extension.extension.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "Extension.extension:causality.extension:entityRelatedness.extension", "path": "Extension.extension.extension.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Extension", "definition": "An Extension", "min": 0, "max": "0", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:causality.extension:entityRelatedness.url", "path": "Extension.extension.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "min": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "fixedUri": "entityRelatedness", "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:entityRelatedness.value[x]", "path": "Extension.extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "closed" }, "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConcept", "path": "Extension.extension.extension.value[x]", "sliceName": "valueCodeableConcept", "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "binding": { "strength": "preferred", "valueSet": "http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness" }, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:author", "path": "Extension.extension.extension", "sliceName": "author", "short": "Author of the information on the possible cause of the event", "definition": "An Extension", "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:causality.extension:author.id", "path": "Extension.extension.extension.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "Extension.extension:causality.extension:author.extension", "path": "Extension.extension.extension.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Extension", "definition": "An Extension", "min": 0, "max": "0", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "isSummary": false }, { "id": "Extension.extension:causality.extension:author.url", "path": "Extension.extension.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "min": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "fixedUri": "author", "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:author.value[x]", "path": "Extension.extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "closed" }, "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "Reference" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.extension:author.value[x]:valueReference", "path": "Extension.extension.extension.value[x]", "sliceName": "valueReference", "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/ResearchSubject" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.url", "path": "Extension.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "min": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "fixedUri": "causality", "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.extension:causality.value[x]", "path": "Extension.extension.value[x]", "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "0", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "canonical" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "url" }, { "code": "uuid" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "ContactDetail" }, { "code": "Contributor" }, { "code": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Dosage" }, { "code": "Meta" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.url", "path": "Extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "min": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "fixedUri": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity", "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "id": "Extension.value[x]", "path": "Extension.value[x]", "short": "Value of extension", "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).", "min": 0, "max": "0", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "canonical" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "url" }, { "code": "uuid" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "ContactDetail" }, { "code": "Contributor" }, { "code": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Dosage" }, { "code": "Meta" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "N/A" } ] } ] }, "differential": { "element": [ { "id": "Extension", "path": "Extension", "short": "Suspect Entity", "definition": "Describes the entity that is suspected to have caused the adverse event." }, { "id": "Extension.extension", "path": "Extension.extension", "min": 2 }, { "id": "Extension.extension:instance", "path": "Extension.extension", "sliceName": "instance", "short": "Refers to the specific entity that is suspected of causing the adverse event", "min": 1, "max": "1" }, { "id": "Extension.extension:instance.extension", "path": "Extension.extension.extension", "max": "0" }, { "id": "Extension.extension:instance.url", "path": "Extension.extension.url", "fixedUri": "instance" }, { "id": "Extension.extension:instance.value[x]", "path": "Extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "open" } }, { "id": "Extension.extension:instance.value[x]:valueReference", "path": "Extension.extension.value[x]", "sliceName": "valueReference", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Immunization", "http://hl7.org/fhir/StructureDefinition/Procedure", "http://hl7.org/fhir/StructureDefinition/Substance", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/MedicationAdministration", "http://hl7.org/fhir/StructureDefinition/MedicationStatement", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct", "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ] }, { "id": "Extension.extension:causality", "path": "Extension.extension", "sliceName": "causality", "short": "Causality - information on the possible cause of the event", "min": 1, "max": "1" }, { "id": "Extension.extension:causality.extension:assessmentMethod", "path": "Extension.extension.extension", "sliceName": "assessmentMethod", "short": "Method of evaluating the relatedness of the suspected entity to the event.", "min": 0, "max": "1" }, { "id": "Extension.extension:causality.extension:assessmentMethod.extension", "path": "Extension.extension.extension.extension", "max": "0" }, { "id": "Extension.extension:causality.extension:assessmentMethod.url", "path": "Extension.extension.extension.url", "fixedUri": "assessmentMethod" }, { "id": "Extension.extension:causality.extension:assessmentMethod.value[x]", "path": "Extension.extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "open" } }, { "id": "Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConcept", "path": "Extension.extension.extension.value[x]", "sliceName": "valueCodeableConcept", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventCausalityMethod" } ], "strength": "preferred", "description": "Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-causality-method" } }, { "id": "Extension.extension:causality.extension:entityRelatedness", "path": "Extension.extension.extension", "sliceName": "entityRelatedness", "short": "Result of the assessment regarding the relatedness of the suspected entity to the event", "min": 0, "max": "1" }, { "id": "Extension.extension:causality.extension:entityRelatedness.extension", "path": "Extension.extension.extension.extension", "max": "0" }, { "id": "Extension.extension:causality.extension:entityRelatedness.url", "path": "Extension.extension.extension.url", "fixedUri": "entityRelatedness" }, { "id": "Extension.extension:causality.extension:entityRelatedness.value[x]", "path": "Extension.extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "open" } }, { "id": "Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConcept", "path": "Extension.extension.extension.value[x]", "sliceName": "valueCodeableConcept", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "preferred", "valueSet": "http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness" } }, { "id": "Extension.extension:causality.extension:author", "path": "Extension.extension.extension", "sliceName": "author", "short": "Author of the information on the possible cause of the event", "min": 0, "max": "1" }, { "id": "Extension.extension:causality.extension:author.extension", "path": "Extension.extension.extension.extension", "max": "0" }, { "id": "Extension.extension:causality.extension:author.url", "path": "Extension.extension.extension.url", "fixedUri": "author" }, { "id": "Extension.extension:causality.extension:author.value[x]", "path": "Extension.extension.extension.value[x]", "slicing": { "discriminator": [ { "type": "type", "path": "$this" } ], "ordered": false, "rules": "open" } }, { "id": "Extension.extension:causality.extension:author.value[x]:valueReference", "path": "Extension.extension.extension.value[x]", "sliceName": "valueReference", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/ResearchSubject" ] } ] }, { "id": "Extension.extension:causality.url", "path": "Extension.extension.url", "fixedUri": "causality" }, { "id": "Extension.extension:causality.value[x]", "path": "Extension.extension.value[x]", "max": "0" }, { "id": "Extension.url", "path": "Extension.url", "fixedUri": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity" }, { "id": "Extension.value[x]", "path": "Extension.value[x]", "max": "0" } ] } }