Regulatedauthorization.shex

ShEx statement for regulatedauthorization

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 <Period.shex>
IMPORT <markdown.shex>
IMPORT <dateTime.shex>
IMPORT <Location.shex>
IMPORT <Reference.shex>
IMPORT <Identifier.shex>
IMPORT <Ingredient.shex>
IMPORT <Organization.shex>
IMPORT <Practitioner.shex>
IMPORT <ResearchStudy.shex>
IMPORT <DomainResource.shex>
IMPORT <PlanDefinition.shex>
IMPORT <CodeableConcept.shex>
IMPORT <BackboneElement.shex>
IMPORT <DeviceDefinition.shex>
IMPORT <NutritionProduct.shex>
IMPORT <CodeableReference.shex>
IMPORT <DocumentReference.shex>
IMPORT <ActivityDefinition.shex>
IMPORT <SubstanceDefinition.shex>
IMPORT <ObservationDefinition.shex>
IMPORT <PackagedProductDefinition.shex>
IMPORT <BiologicallyDerivedProduct.shex>
IMPORT <ManufacturedItemDefinition.shex>
IMPORT <MedicinalProductDefinition.shex>

start=@<RegulatedAuthorization> AND {fhir:nodeRole [fhir:treeRoot]}

# Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
<RegulatedAuthorization> EXTENDS @<DomainResource> CLOSED {   
    a [fhir:RegulatedAuthorization]?;fhir:nodeRole [fhir:treeRoot]?;

    fhir:identifier @<OneOrMore_Identifier>?;  # Business identifier for the 
                                            # authorization, typically assigned 
                                            # by the authorizing body 
    fhir:subject @<OneOrMore_Reference_ActivityDefinition_OR_BiologicallyDerivedProduct_OR_DeviceDefinition_OR_Ingredient_OR_Location_OR_ManufacturedItemDefinition_OR_MedicinalProductDefinition_OR_NutritionProduct_OR_ObservationDefinition_OR_Organization_OR_PackagedProductDefinition_OR_PlanDefinition_OR_Practitioner_OR_ResearchStudy_OR_SubstanceDefinition>?;  # The product type, treatment, 
                                            # facility or activity that is being 
                                            # authorized 
    fhir:type @<CodeableConcept>?;          # Overall type of this 
                                            # authorization, for example drug 
                                            # marketing approval, orphan drug 
                                            # designation 
    fhir:description @<markdown>?;          # General textual supporting 
                                            # information 
    fhir:region @<OneOrMore_CodeableConcept>?;  # The territory in which the 
                                            # authorization has been granted 
    fhir:status @<CodeableConcept>?;        # The status that is authorised e.g. 
                                            # approved. Intermediate states can 
                                            # be tracked with cases and 
                                            # applications 
    fhir:statusDate @<dateTime>?;           # The date at which the current 
                                            # status was assigned 
    fhir:validityPeriod @<Period>?;         # The time period in which the 
                                            # regulatory approval etc. is in 
                                            # effect, e.g. a Marketing 
                                            # Authorization includes the date of 
                                            # authorization and/or expiration 
                                            # date 
    fhir:indication @<OneOrMore_CodeableReference>?;  # Condition for which the use of the 
                                            # regulated product applies 
    fhir:intendedUse @<CodeableConcept>?;   # The intended use of the product, 
                                            # e.g. prevention, treatment 
    fhir:basis @<OneOrMore_CodeableConcept>?;  # The legal/regulatory framework or 
                                            # reasons under which this 
                                            # authorization is granted 
    fhir:holder @<Reference> AND {fhir:link 
    			@<Organization> ? }?;  # The organization that has been 
                                            # granted this authorization, by the 
                                            # regulator 
    fhir:regulator @<Reference> AND {fhir:link 
    			@<Organization> ? }?;  # The regulatory authority or 
                                            # authorizing body granting the 
                                            # authorization 
    fhir:attachedDocument @<OneOrMore_Reference_DocumentReference>?;  # Additional information or 
                                            # supporting documentation about the 
                                            # authorization 
    fhir:case @<RegulatedAuthorization.case>?;  # The case or regulatory procedure 
                                            # for granting or amending a 
                                            # regulated authorization. Note: 
                                            # This area is subject to ongoing 
                                            # review and the workgroup is 
                                            # seeking implementer feedback on 
                                            # its use (see link at bottom of 
                                            # page) 
}  

# Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
<RegulatedAuthorization.case.applicationnull> CLOSED {   
}  

# The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
<RegulatedAuthorization.case> EXTENDS @<BackboneElement> CLOSED {   
    fhir:identifier @<Identifier>?;         # Identifier by which this case can 
                                            # be referenced 
    fhir:type @<CodeableConcept>?;          # The defining type of case
    fhir:status @<CodeableConcept>?;        # The status associated with the case
    fhir:date @<Period>  OR 
    			@<dateTime>  ?;  # Relevant date for this case
    fhir:application @<OneOrMore_RegulatedAuthorization.case>?;  # Applications submitted to obtain a 
                                            # regulated authorization. Steps 
                                            # within the longer running case or 
                                            # procedure 
}  

#---------------------- Cardinality Types (OneOrMore) -------------------
<OneOrMore_Identifier> CLOSED {
    rdf:first @<Identifier>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Identifier> 
}
<OneOrMore_Reference_ActivityDefinition_OR_BiologicallyDerivedProduct_OR_DeviceDefinition_OR_Ingredient_OR_Location_OR_ManufacturedItemDefinition_OR_MedicinalProductDefinition_OR_NutritionProduct_OR_ObservationDefinition_OR_Organization_OR_PackagedProductDefinition_OR_PlanDefinition_OR_Practitioner_OR_ResearchStudy_OR_SubstanceDefinition> CLOSED {
    rdf:first @<Reference> AND {fhir:link 
			@<ActivityDefinition> OR 
			@<BiologicallyDerivedProduct> OR 
			@<DeviceDefinition> OR 
			@<Ingredient> OR 
			@<Location> OR 
			@<ManufacturedItemDefinition> OR 
			@<MedicinalProductDefinition> OR 
			@<NutritionProduct> OR 
			@<ObservationDefinition> OR 
			@<Organization> OR 
			@<PackagedProductDefinition> OR 
			@<PlanDefinition> OR 
			@<Practitioner> OR 
			@<ResearchStudy> OR 
			@<SubstanceDefinition> } ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Reference_ActivityDefinition_OR_BiologicallyDerivedProduct_OR_DeviceDefinition_OR_Ingredient_OR_Location_OR_ManufacturedItemDefinition_OR_MedicinalProductDefinition_OR_NutritionProduct_OR_ObservationDefinition_OR_Organization_OR_PackagedProductDefinition_OR_PlanDefinition_OR_Practitioner_OR_ResearchStudy_OR_SubstanceDefinition> 
}
<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_DocumentReference> CLOSED {
    rdf:first @<Reference> AND {fhir:link 
			@<DocumentReference> } ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Reference_DocumentReference> 
}
<OneOrMore_RegulatedAuthorization.case> CLOSED {
    rdf:first @<RegulatedAuthorization.case>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_RegulatedAuthorization.case> 
}