description: Regulatory approval, clearance or licensing 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.
package_name: hl7.fhir.r6.examples
derivation: specialization
name: RegulatedAuthorization
type: RegulatedAuthorization
elements:
  description: {isModifier: false, short: General textual supporting information, type: markdown, mustSupport: false, isSummary: true, index: 3}
  indication: {isModifier: false, short: Condition for which the use of the regulated product applies, type: CodeableReference, mustSupport: false, array: true, isSummary: true, index: 8}
  basis:
    isModifier: false
    short: The legal/regulatory framework or reasons under which this authorization is granted
    type: CodeableConcept
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/regulated-authorization-basis'}
    isSummary: true
    index: 10
  type:
    isModifier: false
    short: Overall type of this authorization, for example drug marketing approval, orphan drug designation
    type: CodeableConcept
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/regulated-authorization-type'}
    isSummary: true
    index: 2
  validityPeriod: {isModifier: false, 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', type: Period, mustSupport: false, isSummary: true, index: 7}
  region:
    isModifier: false
    short: The territory in which the authorization has been granted
    type: CodeableConcept
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://terminology.hl7.org/ValueSet/jurisdiction'}
    isSummary: true
    index: 4
  intendedUse:
    isModifier: false
    short: The intended use of the product, e.g. prevention, treatment
    type: CodeableConcept
    mustSupport: false
    binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/product-intended-use'}
    isSummary: true
    index: 9
  regulator:
    isModifier: false
    short: The regulatory authority or authorizing body granting the authorization
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    mustSupport: false
    isSummary: true
    index: 12
  status:
    isModifier: true
    short: The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
    type: CodeableConcept
    mustSupport: false
    binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/publication-status'}
    isModifierReason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
    isSummary: true
    index: 5
  case:
    isModifier: false
    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)'
    type: BackboneElement
    mustSupport: false
    isSummary: true
    index: 14
    elements:
      identifier: {isModifier: false, short: Identifier by which this case can be referenced, type: Identifier, mustSupport: false, isSummary: true, index: 15}
      type:
        isModifier: false
        short: The defining type of case
        type: CodeableConcept
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/regulated-authorization-case-type'}
        isSummary: true
        index: 16
      status:
        isModifier: false
        short: The status associated with the case
        type: CodeableConcept
        mustSupport: false
        binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/publication-status'}
        isSummary: true
        index: 17
      date:
        isModifier: false
        short: Relevant date for this case
        mustSupport: false
        choices: [datePeriod, dateDateTime]
        isSummary: true
        index: 19
      datePeriod: {isModifier: false, short: Relevant date for this case, type: Period, mustSupport: false, choiceOf: date, isSummary: true, index: 20}
      dateDateTime: {isModifier: false, short: Relevant date for this case, type: dateTime, mustSupport: false, choiceOf: date, isSummary: true, index: 21}
      application:
        elementReference: ['http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization', elements, case]
        isModifier: false
        short: Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
        mustSupport: false
        array: true
        isSummary: true
        index: 22
  identifier: {isModifier: false, short: 'Business identifier for the authorization, typically assigned by the authorizing body', type: Identifier, mustSupport: false, array: true, isSummary: true, index: 0}
  statusDate: {isModifier: false, short: The date at which the current status was assigned, type: dateTime, mustSupport: false, isSummary: true, index: 6}
  holder:
    isModifier: false
    short: The organization that has been granted this authorization, by the regulator
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    mustSupport: false
    isSummary: true
    index: 11
  attachedDocument:
    isModifier: false
    short: Additional information or supporting documentation about the authorization
    refers: ['http://hl7.org/fhir/StructureDefinition/DocumentReference']
    type: Reference
    mustSupport: false
    array: true
    isSummary: true
    index: 13
  subject:
    isModifier: false
    short: The product type, treatment, facility or activity that is being authorized
    refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition', 'http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct', 'http://hl7.org/fhir/StructureDefinition/DeviceDefinition', 'http://hl7.org/fhir/StructureDefinition/Ingredient', 'http://hl7.org/fhir/StructureDefinition/Location', 'http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition', 'http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition', 'http://hl7.org/fhir/StructureDefinition/NutritionProduct', 'http://hl7.org/fhir/StructureDefinition/ObservationDefinition', 'http://hl7.org/fhir/StructureDefinition/Organization', 'http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition', 'http://hl7.org/fhir/StructureDefinition/PlanDefinition', 'http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/ResearchStudy', 'http://hl7.org/fhir/StructureDefinition/SubstanceDefinition']
    type: Reference
    mustSupport: false
    array: true
    isSummary: true
    index: 1
package_version: 6.0.0-ballot4
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 6.0.0-ballot4