http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|5.0.0

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.
Structure JSON Dependencies FHIRSchema Other Versions Dependant (0)Elements Summary
description: 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.
derivation: specialization
name: RegulatedAuthorization
type: RegulatedAuthorization
elements:
  description: {isModifier: false, short: General textual supporting information, mustSupport: false, isSummary: true, index: 3}
  indication: {isModifier: false, short: Condition for which the use of the regulated product applies, mustSupport: false, array: true, isSummary: true, index: 8}
  basis:
    isModifier: false
    short: The legal/regulatory framework or reasons under which this authorization is granted
    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
    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', mustSupport: false, isSummary: true, index: 7}
  region:
    isModifier: false
    short: The territory in which the authorization has been granted
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/jurisdiction'}
    isSummary: true
    index: 4
  intendedUse:
    isModifier: false
    short: The intended use of the product, e.g. prevention, treatment
    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, mustSupport: false, isSummary: true, index: 12}
  status:
    isModifier: false
    short: The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
    mustSupport: false
    binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/publication-status'}
    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)'
    mustSupport: false
    isSummary: true
    index: 14
    elements:
      identifier: {isModifier: false, short: Identifier by which this case can be referenced, mustSupport: false, isSummary: true, index: 15}
      type:
        isModifier: false
        short: The defining type of case
        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
        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: []
        isSummary: true
        index: 19
      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: 20
  identifier: {isModifier: false, short: 'Business identifier for the authorization, typically assigned by the authorizing body', mustSupport: false, array: true, isSummary: true, index: 0}
  statusDate: {isModifier: false, short: The date at which the current status was assigned, mustSupport: false, isSummary: true, index: 6}
  holder: {isModifier: false, short: 'The organization that has been granted this authorization, by the regulator', mustSupport: false, isSummary: true, index: 11}
  attachedDocument: {isModifier: false, short: Additional information or supporting documentation about the authorization, mustSupport: false, array: true, isSummary: true, index: 13}
  subject: {isModifier: false, short: 'The product type, treatment, facility or activity that is being authorized', mustSupport: false, array: true, isSummary: true, index: 1}
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 5.0.0