Data Model Libraries
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    Class RegulatedAuthorization

    RegulatedAuthorization Class

    Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.

    FHIR Specification

    • Short: Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
    • Definition: Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.
    • FHIR Version: 4.3.0

    FHIR RegulatedAuthorization

    Hierarchy (View Summary)

    Implements

    Index

    Constructors

    constructor

    Properties

    identifier? subject? type_? description? region? status? statusDate? validityPeriod? indication? intendedUse? basis? holder? regulator? case_?

    Methods

    parse getIdentifier setIdentifier addIdentifier hasIdentifier getSubject setSubject addSubject hasSubject getType setType hasType getDescriptionElement setDescriptionElement hasDescriptionElement getDescription setDescription hasDescription getRegion setRegion addRegion hasRegion getStatus setStatus hasStatus getStatusDateElement setStatusDateElement hasStatusDateElement getStatusDate setStatusDate hasStatusDate getValidityPeriod setValidityPeriod hasValidityPeriod getIndication setIndication hasIndication getIntendedUse setIntendedUse hasIntendedUse getBasis setBasis addBasis hasBasis getHolder setHolder hasHolder getRegulator setRegulator hasRegulator getCase setCase hasCase fhirType isEmpty copy toJSON getText setText hasText getContained setContained addContained hasContained getExtension setExtension hasExtension getExtensionByUrl addExtension removeExtension getModifierExtension setModifierExtension hasModifierExtension getModifierExtensionByUrl addModifierExtension removeModifierExtension resourceType getIdElement setIdElement hasIdElement getId setId hasId getMeta setMeta hasMeta getImplicitRulesElement setImplicitRulesElement hasImplicitRulesElement getImplicitRules setImplicitRules hasImplicitRules getLanguageElement setLanguageElement hasLanguageElement getLanguage setLanguage hasLanguage isResource isRequiredFieldsEmpty isDataType isComplexDataType isPrimitive isBooleanPrimitive isStringPrimitive isNumberPrimitive isBigIntPrimitive isDateTimePrimitive copyValues initIdentifier initSubject initRegion initBasis

    Constructors

    Properties

    identifier?: Identifier[]

    RegulatedAuthorization.identifier Element

    FHIR Specification

    • Short: Business identifier for the authorization, typically assigned by the authorizing body
    • Definition: Business identifier for the authorization, typically assigned by the authorizing body.
    • FHIR Type: Identifier
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    subject?: Reference[]

    RegulatedAuthorization.subject Element

    FHIR Specification

    Private Optionaltype_

    type_?: CodeableConcept

    RegulatedAuthorization.type Element

    FHIR Specification

    • Short: Overall type of this authorization, for example drug marketing approval, orphan drug designation
    • Definition: Overall type of this authorization, for example drug marketing approval, orphan drug designation.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    description?: MarkdownType

    RegulatedAuthorization.description Element

    FHIR Specification

    • Short: General textual supporting information
    • Definition: General textual supporting information.
    • FHIR Type: markdown
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    region?: CodeableConcept[]

    RegulatedAuthorization.region Element

    FHIR Specification

    • Short: The territory in which the authorization has been granted
    • Definition: The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    status?: CodeableConcept

    RegulatedAuthorization.status Element

    FHIR Specification

    • Short: The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
    • Definition: The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    statusDate?: DateTimeType

    RegulatedAuthorization.statusDate Element

    FHIR Specification

    • Short: The date at which the current status was assigned
    • Definition: The date at which the current status was assigned.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    validityPeriod?: Period

    RegulatedAuthorization.validityPeriod Element

    FHIR Specification

    • Short: 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
    • Definition: The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.
    • FHIR Type: Period
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    indication?: CodeableReference

    RegulatedAuthorization.indication Element

    FHIR Specification

    • Short: Condition for which the use of the regulated product applies
    • Definition: Condition for which the use of the regulated product applies.
    • FHIR Type: CodeableReference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    intendedUse?: CodeableConcept

    RegulatedAuthorization.intendedUse Element

    FHIR Specification

    • Short: The intended use of the product, e.g. prevention, treatment
    • Definition: The intended use of the product, e.g. prevention, treatment, diagnosis.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    basis?: CodeableConcept[]

    RegulatedAuthorization.basis Element

    FHIR Specification

    • Short: The legal/regulatory framework or reasons under which this authorization is granted
    • Definition: The legal or regulatory framework against which this authorization is granted, or other reasons for it.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    holder?: Reference

    RegulatedAuthorization.holder Element

    FHIR Specification

    • Short: The organization that has been granted this authorization, by the regulator
    • Definition: The organization that has been granted this authorization, by some authoritative body (the 'regulator').
    • FHIR Type: Reference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    regulator?: Reference

    RegulatedAuthorization.regulator Element

    FHIR Specification

    • Short: The regulatory authority or authorizing body granting the authorization
    • Definition: The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.
    • FHIR Type: Reference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true

    Private Optionalcase_

    case_?: RegulatedAuthorizationCaseComponent

    RegulatedAuthorization.case Element

    FHIR Specification

    • Short: 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)
    • Definition: The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).
    • FHIR Type: BackboneElement
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true

    Methods

    • Parse the provided RegulatedAuthorization JSON to instantiate the RegulatedAuthorization data model.

      Parameters

      • sourceJson: Value

        JSON representing FHIR RegulatedAuthorization

      • OptionaloptSourceField: string

        Optional data source field (e.g. <complexTypeName>.<complexTypeFieldName>); defaults to RegulatedAuthorization

      Returns undefined | RegulatedAuthorization

      RegulatedAuthorization data model or undefined for RegulatedAuthorization

      JsonError if the provided JSON is not a valid JSON object

    • Assigns the provided Reference array value to the subject property.

      Parameters

      • value: undefined | Reference[]

        the subject array value

      Returns this

      this

      @ReferenceTargets('RegulatedAuthorization.subject', ['MedicinalProductDefinition','BiologicallyDerivedProduct','NutritionProduct','PackagedProductDefinition','SubstanceDefinition','DeviceDefinition','ResearchStudy','ActivityDefinition','PlanDefinition','ObservationDefinition','Practitioner','Organization','Location',])

      InvalidTypeError for invalid data type or reference value

    • Add the provided Reference value to the subject array property.

      Parameters

      • value: undefined | Reference

        the subject value

      Returns this

      this

      @ReferenceTargets('RegulatedAuthorization.subject', ['MedicinalProductDefinition','BiologicallyDerivedProduct','NutritionProduct','PackagedProductDefinition','SubstanceDefinition','DeviceDefinition','ResearchStudy','ActivityDefinition','PlanDefinition','ObservationDefinition','Practitioner','Organization','Location',])

      InvalidTypeError for invalid data type or reference value

    • Assigns the provided value to the text property.

      Parameters

      Returns this

      this

    • Returns boolean

      true if the text property exists and has a value; false otherwise

    • Assigns the provided Resource array value to the contained property.

      Parameters

      • value: undefined | IResource[]

        the contained array value

      Returns this

      this

    • Returns boolean

      true if the contained property exists and has a value; false otherwise

    • Assigns the provided array of Extension values to the extension property.

      Parameters

      • extension: undefined | IExtension[]

        array of Extensions

      Returns this

      this

    • Determines if the extension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url; false otherwise

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the extension property exists and has any values.

      AssertionError for invalid url

    • Adds the provided Extension to the extension property array.

      Parameters

      • extension: undefined | IExtension

        the Extension value to add to the extension property array

      Returns this

      this

    • Removes the Extension having the provided url from the extension property array.

      Parameters

      • url: string

        the url that identifies a specific Extension to remove

      Returns void

      AssertionError for invalid url

    • Determines if the modifierExtension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the modifierExtension property exists and has any values.

      AssertionError for invalid url

    • Assigns the provided PrimitiveType value to the id property.

      Parameters

      • element: undefined | IdType

        the id value

      Returns this

      this

    • Returns undefined | string

      the id property value as a primitive value

    • Assigns the provided primitive value to the id property.

      Parameters

      • value: undefined | string

        the id value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the id property exists and has a value; false otherwise

    • Assigns the provided value to the meta property.

      Parameters

      • value: undefined | Meta

        the meta value

      Returns this

      this

    • Returns boolean

      true if the meta property exists and has a value; false otherwise

    • Assigns the provided primitive value to the implicitRules property.

      Parameters

      • value: undefined | string

        the implicitRules value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns undefined | string

      the language property value as a primitive value

    • Assigns the provided primitive value to the language property.

      Parameters

      • value: undefined | string

        the language value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the language property exists and has a value; false otherwise

    • Returns boolean

      true if and only if the data model has required fields (min cardinality > 0) and at least one of those required fields in the instance is empty; false otherwise

    • Returns boolean

      true if the instance is a FHIR complex or primitive datatype; false otherwise

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