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| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
ShEx statement for clinicalusedefinition
PREFIX fhir: <http://hl7.org/fhir/>
PREFIX fhirvs: <http://hl7.org/fhir/ValueSet/>
PREFIX xsd: <http://www.w3.org/2001/XMLSchema#>
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#>
IMPORT <code.shex>
IMPORT <Range.shex>
IMPORT <Group.shex>
IMPORT <string.shex>
IMPORT <markdown.shex>
IMPORT <canonical.shex>
IMPORT <Reference.shex>
IMPORT <Identifier.shex>
IMPORT <Medication.shex>
IMPORT <Expression.shex>
IMPORT <DomainResource.shex>
IMPORT <CodeableConcept.shex>
IMPORT <BackboneElement.shex>
IMPORT <NutritionProduct.shex>
IMPORT <CodeableReference.shex>
IMPORT <SubstanceDefinition.shex>
IMPORT <ObservationDefinition.shex>
IMPORT <MedicinalProductDefinition.shex>
IMPORT <BiologicallyDerivedProduct.shex>
start=@<ClinicalUseDefinition> AND {fhir:nodeRole [fhir:treeRoot]}
# A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
<ClinicalUseDefinition> EXTENDS @<DomainResource> CLOSED {
a [fhir:ClinicalUseDefinition]?;fhir:nodeRole [fhir:treeRoot]?;
fhir:identifier @<OneOrMore_Identifier>?; # Business identifier for this issue
fhir:type @<code> AND
{fhir:v @fhirvs:clinical-use-definition-type}; # indication | contraindication |
# interaction | undesirable-effect |
# warning
fhir:category @<OneOrMore_CodeableConcept>?; # A categorisation of the issue,
# primarily for dividing warnings
# into subject heading areas such as
# "Pregnancy", "Overdose"
fhir:subject @<OneOrMore_CodeableReference>?; # The medication, product,
# substance, device, procedure etc.
# for which this is an indication,
# contraindication, interaction,
# undesirable effect, or warning
fhir:status @<CodeableConcept>?; # Whether this is a current issue or
# one that has been retired etc
fhir:contraindication @<ClinicalUseDefinition.contraindication>?; # Specifics for when this is a
# contraindication
fhir:indication @<ClinicalUseDefinition.indication>?; # Specifics for when this is an
# indication
fhir:interaction @<ClinicalUseDefinition.interaction>?; # Specifics for when this is an
# interaction
fhir:population @<OneOrMore_Reference_Group>?; # The population group to which this
# applies
fhir:library @<OneOrMore_canonical>?; # Logic used by the clinical use
# definition
fhir:undesirableEffect @<ClinicalUseDefinition.undesirableEffect>?; # A possible negative outcome from
# the use of this treatment
fhir:warning @<ClinicalUseDefinition.warning>?; # Critical environmental, health or
# physical risks or hazards. For
# example 'Do not operate heavy
# machinery', 'May cause drowsiness'
}
# Specifics for when this is an interaction
<ClinicalUseDefinition.interaction> EXTENDS @<BackboneElement> CLOSED {
fhir:interactant @<OneOrMore_ClinicalUseDefinition.interaction.interactant>?; # The specific medication, product,
# food etc. or laboratory test that
# interacts
fhir:type @<CodeableConcept>?; # The type of the interaction e.g.
# drug-drug interaction, drug-lab
# test interaction
fhir:effect @<CodeableReference>?; # The effect of the interaction, for
# example "reduced gastric
# absorption of primary medication"
fhir:incidence @<CodeableConcept>?; # The incidence of the interaction,
# e.g. theoretical, observed
fhir:management @<OneOrMore_CodeableConcept>?; # Actions for managing the
# interaction
}
# The specific medication, product, food etc. or laboratory test that interacts
<ClinicalUseDefinition.interaction.interactant> EXTENDS @<BackboneElement> CLOSED {
fhir:item (@<Reference> AND {fhir:link @<MedicinalProductDefinition> OR
@<Medication> OR
@<SubstanceDefinition> OR
@<NutritionProduct> OR
@<BiologicallyDerivedProduct> OR
@<ObservationDefinition> }) OR
@<CodeableConcept> ; # The specific medication, product,
# food etc. or laboratory test that
# interacts
}
# Specifics for when this is an indication
<ClinicalUseDefinition.indication> EXTENDS @<BackboneElement> CLOSED {
fhir:diseaseSymptomProcedure @<CodeableReference>?; # The situation that is being
# documented as an indication for
# this item
fhir:diseaseStatus @<CodeableReference>?; # The status of the disease or
# symptom for the indication
fhir:comorbidity @<OneOrMore_CodeableReference>?; # A comorbidity or coinfection as
# part of the indication
fhir:intendedEffect @<OneOrMore_CodeableReference>?; # The intended effect, aim or
# strategy to be achieved
fhir:duration @<Range> OR
@<string> ?; # Timing or duration information
fhir:undesirableEffect @<OneOrMore_Reference_ClinicalUseDefinition>?; # An unwanted side effect or
# negative outcome of the subject of
# this resource when being used for
# this indication
fhir:applicability @<Expression>?; # An expression that returns true or
# false, indicating whether the
# indication is applicable or not,
# after having applied its other
# elements
fhir:otherTherapy @<OneOrMore_ClinicalUseDefinition.contraindication.otherTherapy>?; # The use of the medicinal product
# in relation to other therapies
# described as part of the
# indication
}
# Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
<ClinicalUseDefinition.warning> EXTENDS @<BackboneElement> CLOSED {
fhir:description @<markdown>?; # A textual definition of this
# warning, with formatting
fhir:code @<CodeableConcept>?; # A coded or unformatted textual
# definition of this warning
}
# Specifics for when this is a contraindication
<ClinicalUseDefinition.contraindication> EXTENDS @<BackboneElement> CLOSED {
fhir:diseaseSymptomProcedure @<CodeableReference>?; # The situation that is being
# documented as contraindicating
# against this item
fhir:diseaseStatus @<CodeableReference>?; # The status of the disease or
# symptom for the contraindication
fhir:comorbidity @<OneOrMore_CodeableReference>?; # A comorbidity (concurrent
# condition) or coinfection
fhir:indication @<OneOrMore_Reference_ClinicalUseDefinition>?; # The indication which this is a
# contraindication for
fhir:applicability @<Expression>?; # An expression that returns true or
# false, indicating whether the
# indication is applicable or not,
# after having applied its other
# elements
fhir:otherTherapy @<OneOrMore_ClinicalUseDefinition.contraindication.otherTherapy>?; # Information about use of the
# product in relation to other
# therapies described as part of the
# contraindication
}
# Information about use of the product in relation to other therapies described as part of the contraindication
<ClinicalUseDefinition.contraindication.otherTherapy> EXTENDS @<BackboneElement> CLOSED {
fhir:relationshipType @<CodeableConcept>; # The type of relationship between
# the product
# indication/contraindication and
# another therapy
fhir:treatment @<CodeableReference>; # Reference to a specific
# medication, substance etc. as part
# of an indication or
# contraindication
}
# A possible negative outcome from the use of this treatment
<ClinicalUseDefinition.undesirableEffect> EXTENDS @<BackboneElement> CLOSED {
fhir:symptomConditionEffect @<CodeableReference>?; # The situation in which the
# undesirable effect may manifest
fhir:classification @<CodeableConcept>?; # High level classification of the
# effect
fhir:frequencyOfOccurrence @<CodeableConcept>?; # How often the effect is seen
}
#---------------------- Cardinality Types (OneOrMore) -------------------
<OneOrMore_Identifier> CLOSED {
rdf:first @<Identifier> ;
rdf:rest [rdf:nil] OR @<OneOrMore_Identifier>
}
<OneOrMore_CodeableConcept> CLOSED {
rdf:first @<CodeableConcept> ;
rdf:rest [rdf:nil] OR @<OneOrMore_CodeableConcept>
}
<OneOrMore_CodeableReference> CLOSED {
rdf:first @<CodeableReference> ;
rdf:rest [rdf:nil] OR @<OneOrMore_CodeableReference>
}
<OneOrMore_Reference_Group> CLOSED {
rdf:first @<Reference> AND {fhir:link
@<Group> } ;
rdf:rest [rdf:nil] OR @<OneOrMore_Reference_Group>
}
<OneOrMore_canonical> CLOSED {
rdf:first @<canonical> ;
rdf:rest [rdf:nil] OR @<OneOrMore_canonical>
}
<OneOrMore_ClinicalUseDefinition.interaction.interactant> CLOSED {
rdf:first @<ClinicalUseDefinition.interaction.interactant> ;
rdf:rest [rdf:nil] OR @<OneOrMore_ClinicalUseDefinition.interaction.interactant>
}
<OneOrMore_Reference_ClinicalUseDefinition> CLOSED {
rdf:first @<Reference> AND {fhir:link
@<ClinicalUseDefinition> } ;
rdf:rest [rdf:nil] OR @<OneOrMore_Reference_ClinicalUseDefinition>
}
<OneOrMore_ClinicalUseDefinition.contraindication.otherTherapy> CLOSED {
rdf:first @<ClinicalUseDefinition.contraindication.otherTherapy> ;
rdf:rest [rdf:nil] OR @<OneOrMore_ClinicalUseDefinition.contraindication.otherTherapy>
}
#---------------------- Value Sets ------------------------
# Overall defining type of this clinical use definition.
fhirvs:clinical-use-definition-type ["indication" "contraindication" "interaction" "undesirable-effect" "warning"]
Usage note: every effort has been made to ensure that the ShEx files are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot3 generated on Sat, Oct 25, 2025 06:26+0000.
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