{ "resourceType": "StructureDefinition", "id": "Group-uv-epi", "text": { "status": "extensions", "div": "

Generated Narrative: StructureDefinition Group-uv-epi

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NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" Group 0..*GroupGroup of multiple entities
\".\"\".\"\".\" type 1..1codeperson | animal | practitioner | device | careteam | healthcareservice | location | organization | relatedperson | specimen
Required Pattern: person
\".\"\".\"\".\" membership 1..1codedefinitional - the group is defined by the characteristics below, not by an enumerated member list
Required Pattern: definitional
\".\"\".\"\".\" Slices for characteristic 1..*BackboneElementOne population axis. Combine multiple characteristics with AND. Open: add further axes as needed.
Slice: Unordered, Open by pattern:code
\".\"\".\"\".\"\".\" characteristic:sex 0..1BackboneElementInclude / Exclude group members by Trait
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: sex
\".\"\".\"\".\"\".\"\".\" value[x] 1..1CodeableConceptValue held by characteristic
Binding: Group Sex Value (ePI) (extensible)
\".\"\".\"\".\"\".\" characteristic:age 0..1BackboneElementAge range. Use UCUM 'a' (years) or 'd' (days) so neonatal/paediatric bands can be expressed.
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: age
\".\"\".\"\".\"\".\"\".\" value[x] 1..1RangeValue held by characteristic
\".\"\".\"\".\"\".\" characteristic:bodyWeight 0..1BackboneElementBody weight as a population selector (e.g., ≥ 40 kg). Distinct from mg/kg dose rates, which are expressed in Dosage.doseAndRate.
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: body-weight
\".\"\".\"\".\"\".\"\".\" value[x] 1..1RangeValue held by characteristic
\".\"\".\"\".\"\".\" characteristic:race 0..*BackboneElementInclude / Exclude group members by Trait
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: race
\".\"\".\"\".\"\".\"\".\" value[x] 1..1CodeableConceptValue held by characteristic
Binding: Group Race Value (ePI) (extensible)
\".\"\".\"\".\"\".\" characteristic:lifestyle 0..*BackboneElementInclude / Exclude group members by Trait
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: lifestyle
\".\"\".\"\".\"\".\"\".\" value[x] 1..1CodeableConceptValue held by characteristic
Binding: Group Lifestyle Value (ePI) (extensible)
\".\"\".\"\".\"\".\" characteristic:renalFunction 0..1BackboneElementRenal function, typically a creatinine-clearance range in mL/min.
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: renal-function
\".\"\".\"\".\"\".\"\".\" value[x] 1..1RangeValue held by characteristic
\".\"\".\"\".\"\".\" characteristic:hepaticFunction 0..1BackboneElementInclude / Exclude group members by Trait
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: hepatic-function
\".\"\".\"\".\"\".\"\".\" value[x] 1..1CodeableConceptValue held by characteristic
Binding: Group Hepatic Function Value (ePI) (extensible)
\".\"\".\"\".\"\".\" characteristic:immuneStatus 0..*BackboneElementInclude / Exclude group members by Trait
\".\"\".\"\".\"\".\"\".\" code 1..1CodeableConceptKind of characteristic
Required Pattern: At least the following
\".\"\".\"\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (Complex)
\".\"\".\"\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type
\".\"\".\"\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: immune-status
\".\"\".\"\".\"\".\"\".\" value[x] 1..1CodeableConceptValue held by characteristic
Binding: Group Immune Status Value (ePI) (extensible)

\"doco\" Documentation for this format
" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "informative", "_valueCode": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom", "valueCanonical": "http://hl7.org/fhir/uv/emedicinal-product-info/ImplementationGuide/hl7.fhir.uv.emedicinal-product-info" } ] } } ], "url": "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Group-uv-epi", "version": "1.1.0", "name": "GroupUvEpi", "title": "Group (ePI)", "status": "active", "experimental": true, "date": "2026-07-01T13:09:50+00:00", "publisher": "HL7 International / Biomedical Research and Regulation", "contact": [ { "name": "HL7 International / Biomedical Research and Regulation", "telecom": [ { "system": "url", "value": "http://hl7.org/Special/committees/rcrim" } ] } ], "description": "Group (ePI) - a definitional population used to stratify clinical use and dosing.\n\nA Group is the single, canonical representation of a population in an ePI. It is referenced from:\n* ClinicalUseDefinition.population - the population an indication / contraindication / interaction / undesirable effect / warning applies to, and\n* (conceptually) the population a structured dose is intended for.\n\nEach population axis (sex, age, weight, race, lifestyle, renal/hepatic function, immune status) is one `characteristic`. Multiple characteristics are combined with AND. The slicing is **open**: real product information regularly stratifies on axes not enumerated here, and authors may add further characteristics.", "jurisdiction": [ { "coding": [ { "system": "http://unstats.un.org/unsd/methods/m49/m49.htm", "code": "001", "display": "World" } ] } ], "fhirVersion": "5.0.0", "mapping": [ { "identity": "w5", "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping" }, { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" }, { "identity": "interface", "uri": "http://hl7.org/fhir/interface", "name": "Interface Pattern" } ], "kind": "resource", "abstract": false, "type": "Group", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Group", "derivation": "constraint", "snapshot": { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version", "valueString": "5.0.0" } ] }, "differential": { "element": [ { "id": "Group", "path": "Group" }, { "id": "Group.type", "path": "Group.type", "patternCode": "person" }, { "id": "Group.membership", "path": "Group.membership", "short": "definitional - the group is defined by the characteristics below, not by an enumerated member list", "patternCode": "definitional" }, { "id": "Group.characteristic", "path": "Group.characteristic", "slicing": { "discriminator": [ { "type": "pattern", "path": "code" } ], "rules": "open" }, "short": "One population axis. Combine multiple characteristics with AND. Open: add further axes as needed.", "min": 1 }, { "id": "Group.characteristic:sex", "path": "Group.characteristic", "sliceName": "sex", "min": 0, "max": "1" }, { "id": "Group.characteristic:sex.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "sex" } ] } }, { "id": "Group.characteristic:sex.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "extensible", "valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-sex-value" } }, { "id": "Group.characteristic:age", "path": "Group.characteristic", "sliceName": "age", "short": "Age range. Use UCUM 'a' (years) or 'd' (days) so neonatal/paediatric bands can be expressed.", "min": 0, "max": "1" }, { "id": "Group.characteristic:age.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "age" } ] } }, { "id": "Group.characteristic:age.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "Range" } ] }, { "id": "Group.characteristic:bodyWeight", "path": "Group.characteristic", "sliceName": "bodyWeight", "short": "Body weight as a population selector (e.g., ≥ 40 kg). Distinct from mg/kg dose rates, which are expressed in Dosage.doseAndRate.", "min": 0, "max": "1" }, { "id": "Group.characteristic:bodyWeight.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "body-weight" } ] } }, { "id": "Group.characteristic:bodyWeight.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "Range" } ] }, { "id": "Group.characteristic:race", "path": "Group.characteristic", "sliceName": "race", "min": 0, "max": "*" }, { "id": "Group.characteristic:race.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "race" } ] } }, { "id": "Group.characteristic:race.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "extensible", "valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-race-value" } }, { "id": "Group.characteristic:lifestyle", "path": "Group.characteristic", "sliceName": "lifestyle", "min": 0, "max": "*" }, { "id": "Group.characteristic:lifestyle.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "lifestyle" } ] } }, { "id": "Group.characteristic:lifestyle.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "extensible", "valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-lifestyle-value" } }, { "id": "Group.characteristic:renalFunction", "path": "Group.characteristic", "sliceName": "renalFunction", "short": "Renal function, typically a creatinine-clearance range in mL/min.", "min": 0, "max": "1" }, { "id": "Group.characteristic:renalFunction.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "renal-function" } ] } }, { "id": "Group.characteristic:renalFunction.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "Range" } ] }, { "id": "Group.characteristic:hepaticFunction", "path": "Group.characteristic", "sliceName": "hepaticFunction", "min": 0, "max": "1" }, { "id": "Group.characteristic:hepaticFunction.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "hepatic-function" } ] } }, { "id": "Group.characteristic:hepaticFunction.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "extensible", "valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-hepatic-function-value" } }, { "id": "Group.characteristic:immuneStatus", "path": "Group.characteristic", "sliceName": "immuneStatus", "min": 0, "max": "*" }, { "id": "Group.characteristic:immuneStatus.code", "path": "Group.characteristic.code", "patternCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type", "code": "immune-status" } ] } }, { "id": "Group.characteristic:immuneStatus.value[x]", "path": "Group.characteristic.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "extensible", "valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/group-immune-status-value" } } ] } }