emaGmoCodeableConcept
type: StructureDefinition
node role: treeRoot
id:
  v: emaGmoCodeableConcept
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition emaGmoCodeableConcept Name Flags Card. Type Description & Constraints CodeableConcept 0..* EmaRefTermCodeableConceptRestrictions Concept - reference to a terminology or just text coding 1..1 Coding Code defined by a terminology system Binding: Genetically Modified Organism (required) extension 0..1 boolean The Complies with directive Extension URL: http://ema.europa.eu/fhir/extension/compliesWithDirective system 1..1 uri Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/gmo display 0..0 Documentation for this format
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics
  value: code
    v: can-bind
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics
  value: code
    v: do-translations
url:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaGmoCodeableConcept
version:
  v: 1.2.0
name:
  v: EmaGmoCodeableConcept
title:
  v: EMA Genetically Modified Organisms CodeableConcept
status:
  v: draft
date:
  v: 2025-10-21T12:20:05+01:00
publisher:
  v: EMA
contact:
  name:
    v: EMA
  telecom:
    system:
      v: url
    value:
      v: https://support.ema.europa.eu/esc
description:
  v: EMA Genetically Modified Organisms CodeableConcept
fhir version:
  v: 5.0.0
mapping:
  identity:
    v: v2
  uri:
    v: http://hl7.org/v2
  name:
    v: HL7 V2 Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
mapping:
  identity:
    v: orim
  uri:
    v: http://hl7.org/orim
  name:
    v: Ontological RIM Mapping
kind:
  v: complex-type
abstract:
  v: false
type:
  v: CodeableConcept
base definition:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConceptRestrictions
  link: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConceptRestrictions
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
    value: string
      v: 1.2.0
  element:
    id:
      v: CodeableConcept
    path:
      v: CodeableConcept
    short:
      v: Concept - reference to a terminology or just text
    definition:
      v: A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.
    comment:
      v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: CodeableConcept
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: ele-1
      severity:
        v: error
      human:
        v: All FHIR elements must have a @value or children
      expression:
        v: hasValue() or (children().count() > id.count())
      source:
        v: http://hl7.org/fhir/StructureDefinition/Element
        link: http://hl7.org/fhir/StructureDefinition/Element
    is modifier:
      v: false
    mapping:
      identity:
        v: rim
      map:
        v: n/a,CD
    mapping:
      identity:
        v: v2
      map:
        v: CE/CNE/CWE
    mapping:
      identity:
        v: orim
      map:
        v: fhir:CodeableConcept rdfs:subClassOf dt:CD
  element:
    id:
      v: CodeableConcept.id
    path:
      v: CodeableConcept.id
    representation:
      v: xmlAttr
    short:
      v: Unique id for inter-element referencing
    definition:
      v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
    min:
      v: 0
    max:
      v: 1
    base:
      path:
        v: Element.id
      min:
        v: 0
      max:
        v: 1
    type:
      extension:
        value: url
      code:
        v: http://hl7.org/fhirpath/System.String
    condition:
      v: ele-1
    is modifier:
      v: false
    is summary:
      v: false
    mapping:
      identity:
        v: rim
      map:
        v: n/a
  element:
    id:
      v: CodeableConcept.extension
    path:
      v: CodeableConcept.extension
    slicing:
      description:
        v: Extensions are always sliced by (at least) url
      rules:
        v: open
    short:
      v: Extension
    definition:
      v: An Extension
    min:
      v: 0
    max:
      v: 0
    base:
      path:
        v: Element.extension
      min:
        v: 0
      max:
        v: *
    type:
      code:
        v: Extension
    constraint:
      key:
        v: ele-1
      severity:
        v: error

url
v: id

v: value

v: url

v: All FHIR elements must have a @value or children

v: hasValue() or (children().count() > id.count())

key:
  v: ext-1
severity:
  v: error
human:
  v: Must have either extensions or value[x], not both
expression:
  v: extension.exists() != value.exists()
source:
  v: http://hl7.org/fhir/StructureDefinition/Extension
  link: http://hl7.org/fhir/StructureDefinition/Extension

v: false

v: false

id:
  v: CodeableConcept.coding
path:
  v: CodeableConcept.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/geneticallyModifiedOrganism
    link: http://ema.europa.eu/fhir/vs/geneticallyModifiedOrganism
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: CodeableConcept.coding.id
path:
  v: CodeableConcept.coding.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: CodeableConcept.coding.extension
path:
  v: CodeableConcept.coding.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: The Complies with directive Extension
definition:
  v: The Complies with directive Extension
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
  profile:
    v: http://ema.europa.eu/fhir/extension/compliesWithDirective
    link: http://ema.europa.eu/fhir/extension/compliesWithDirective
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: CodeableConcept.coding.system
path:
  v: CodeableConcept.coding.system
short:
  v: Identity of the terminology system
definition:
  v: The identification of the code system that defines the meaning of the symbol in the code.
comment:
  v: The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
requirements:
  v: Need to be unambiguous about the source of the definition of the symbol.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Coding.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
pattern: uri
  v: http://ema.europa.eu/fhir/gmo
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.3
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystem
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem

id:
  v: CodeableConcept.coding.version
path:
  v: CodeableConcept.coding.version
short:
  v: Version of the system - if relevant
definition:
  v: The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
comment:
  v: Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.version
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.7
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystemVersion
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion

id:
  v: CodeableConcept.coding.code
path:
  v: CodeableConcept.coding.code
short:
  v: Symbol in syntax defined by the system
definition:
  v: A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
requirements:
  v: Need to refer to a particular code in the system.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1
mapping:
  identity:
    v: rim
  map:
    v: ./code
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code

id:
  v: CodeableConcept.coding.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: CodeableConcept.coding.display
short:
  v: Representation defined by the system
definition:
  v: A representation of the meaning of the code in the system, following the rules of the system.
requirements:
  v: Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Coding.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.2 - but note this is not well followed
mapping:
  identity:
    v: rim
  map:
    v: CV.displayName
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName

id:
  v: CodeableConcept.coding.userSelected
path:
  v: CodeableConcept.coding.userSelected
short:
  v: If this coding was chosen directly by the user
definition:
  v: Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
comment:
  v: Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
requirements:
  v: This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.userSelected
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: boolean
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: Sometimes implied by being first
mapping:
  identity:
    v: rim
  map:
    v: CD.codingRationale
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]

id:
  v: CodeableConcept.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: CodeableConcept.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

element:
  id:
    v: CodeableConcept
  path:
    v: CodeableConcept
element:
  id:
    v: CodeableConcept.coding
  path:
    v: CodeableConcept.coding
  min:
    v: 1
  max:
    v: 1
  binding:
    strength:
      v: required
    value set:
      v: http://ema.europa.eu/fhir/vs/geneticallyModifiedOrganism
      link: http://ema.europa.eu/fhir/vs/geneticallyModifiedOrganism
element:
  id:
    v: CodeableConcept.coding.extension
  path:
    v: CodeableConcept.coding.extension
  max:
    v: 1
  type:
    code:
      v: Extension
    profile:
      v: http://ema.europa.eu/fhir/extension/compliesWithDirective
      link: http://ema.europa.eu/fhir/extension/compliesWithDirective
element:
  id:
    v: CodeableConcept.coding.system
  path:
    v: CodeableConcept.coding.system
  min:
    v: 1
  pattern: uri
    v: http://ema.europa.eu/fhir/gmo
element:
  id:
    v: CodeableConcept.coding.display
  path:
    v: CodeableConcept.coding.display
  max:
    v: 0