RegulatedAuthorization constructor

const RegulatedAuthorization({ @Default(R5ResourceType.RegulatedAuthorization) @JsonKey(unknownEnumValue: R5ResourceType.RegulatedAuthorization) R5ResourceType resourceType, @JsonKey(includeFromJson: true, includeToJson: false) int? dbId, @JsonKey(name: 'id') FhirId? fhirId, FhirMeta? meta, FhirUri? implicitRules, @JsonKey(name: '_implicitRules') Element? implicitRulesElement, FhirCode? language, @JsonKey(name: '_language') Element? languageElement, Narrative? text, List<Resource>? contained, @JsonKey(name: 'extension') List<FhirExtension>? extension_, List<FhirExtension>? modifierExtension, List<Identifier>? identifier, List<Reference>? subject, CodeableConcept? type, FhirMarkdown? description, @JsonKey(name: '_description') Element? descriptionElement, List<CodeableConcept>? region, CodeableConcept? status, FhirDateTime? statusDate, @JsonKey(name: '_statusDate') Element? statusDateElement, Period? validityPeriod, List<CodeableReference>? indication, CodeableConcept? intendedUse, List<CodeableConcept>? basis, Reference? holder, Reference? regulator, List<Reference>? attachedDocument, @JsonKey(name: 'case') RegulatedAuthorizationCase? case_, })

RegulatedAuthorization 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.

resourceType This is a RegulatedAuthorization resource

id The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

meta The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

implicitRules A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

implicitRulesElement ("_implicitRules") Extensions for implicitRules

language The base language in which the resource is written.

languageElement ("_language") Extensions for language

text A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

contained These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

extension_ ("extension") May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

modifierExtension May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

identifier Business identifier for the authorization, typically assigned by the authorizing body.

subject The product type, treatment, facility or activity that is being authorized.

type Overall type of this authorization, for example drug marketing approval, orphan drug designation.

description General textual supporting information.

descriptionElement ("_description") Extensions for description

region The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.

status The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.

statusDate The date at which the current status was assigned.

statusDateElement ("_statusDate") Extensions for statusDate

validityPeriod 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.

indication Condition for which the use of the regulated product applies.

intendedUse The intended use of the product, e.g. prevention, treatment, diagnosis.

basis The legal or regulatory framework against which this authorization is granted, or other reasons for it.

holder The organization that has been granted this authorization, by some authoritative body (the 'regulator').

regulator The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.

attachedDocument Additional information or supporting documentation about the authorization.

case_ ("case") 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).

Implementation

const factory RegulatedAuthorization({
  /// [resourceType] This is a RegulatedAuthorization resource
  @Default(R5ResourceType.RegulatedAuthorization)
  @JsonKey(unknownEnumValue: R5ResourceType.RegulatedAuthorization)
  R5ResourceType resourceType,
  @JsonKey(includeFromJson: true, includeToJson: false) int? dbId,

  /// [id] The logical id of the resource, as used in the URL for the
  ///  resource. Once assigned, this value never changes.
  @JsonKey(name: 'id') FhirId? fhirId,

  /// [meta] The metadata about the resource. This is content that is
  ///  maintained by the infrastructure. Changes to the content might not
  ///  always be associated with version changes to the resource.
  FhirMeta? meta,

  /// [implicitRules] A reference to a set of rules that were followed when
  ///  the resource was constructed, and which must be understood when
  ///  processing the content. Often, this is a reference to an
  ///  implementation guide that defines the special rules along with other
  ///  profiles etc.
  FhirUri? implicitRules,

  /// [implicitRulesElement] ("_implicitRules") Extensions for implicitRules
  @JsonKey(name: '_implicitRules') Element? implicitRulesElement,

  /// [language] The base language in which the resource is written.
  FhirCode? language,

  /// [languageElement] ("_language") Extensions for language
  @JsonKey(name: '_language') Element? languageElement,

  /// [text] A human-readable narrative that contains a summary of the
  ///  resource and can be used to represent the content of the resource to a
  ///  human. The narrative need not encode all the structured data, but is
  ///  required to contain sufficient detail to make it "clinically safe" for
  ///  a human to just read the narrative. Resource definitions may define
  ///  what content should be represented in the narrative to ensure clinical
  ///  safety.
  Narrative? text,

  /// [contained] These resources do not have an independent existence apart
  ///  from the resource that contains them - they cannot be identified
  ///  independently, nor can they have their own independent transaction
  ///  scope. This is allowed to be a Parameters resource if and only if it
  ///  is referenced by a resource that provides context/meaning.
  List<Resource>? contained,

  /// [extension_] ("extension") May be used to represent additional
  ///  information that is not part of the basic definition of the resource.
  ///  To make the use of extensions safe and managable, there is a strict
  ///  set of governance applied to the definition and use of extensions.
  ///  Though any implementer can define an extension, there is a set of
  ///  requirements that SHALL be met as part of the definition of the
  ///  extension.
  @JsonKey(name: 'extension') List<FhirExtension>? extension_,

  /// [modifierExtension] May be used to represent additional information
  ///  that is not part of the basic definition of the resource and that
  ///  modifies the understanding of the element that contains it and/or the
  ///  understanding of the containing element's descendants. Usually
  ///  modifier elements provide negation or qualification. To make the use
  ///  of extensions safe and managable, there is a strict set of governance
  ///  applied to the definition and use of extensions. Though any
  ///  implementer is allowed to define an extension, there is a set of
  ///  requirements that SHALL be met as part of the definition of the
  ///  extension. Applications processing a resource are required to check
  ///  for modifier extensions.Modifier extensions SHALL NOT change the
  ///  meaning of any elements on Resource or DomainResource (including
  ///  cannot change the meaning of modifierExtension itself).
  List<FhirExtension>? modifierExtension,

  /// [identifier] Business identifier for the authorization, typically
  ///  assigned by the authorizing body.
  List<Identifier>? identifier,

  /// [subject] The product type, treatment, facility or activity that is
  ///  being authorized.
  List<Reference>? subject,

  /// [type] Overall type of this authorization, for example drug marketing
  ///  approval, orphan drug designation.
  CodeableConcept? type,

  /// [description] General textual supporting information.
  FhirMarkdown? description,

  /// [descriptionElement] ("_description") Extensions for description
  @JsonKey(name: '_description') Element? descriptionElement,

  /// [region] The territory (e.g., country, jurisdiction etc.) in which the
  ///  authorization has been granted.
  List<CodeableConcept>? region,

  /// [status] The status that is authorised e.g. approved. Intermediate
  ///  states and actions can be tracked with cases and applications.
  CodeableConcept? status,

  /// [statusDate] The date at which the current status was assigned.
  FhirDateTime? statusDate,

  /// [statusDateElement] ("_statusDate") Extensions for statusDate
  @JsonKey(name: '_statusDate') Element? statusDateElement,

  /// [validityPeriod] 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.
  Period? validityPeriod,

  /// [indication] Condition for which the use of the regulated product
  ///  applies.
  List<CodeableReference>? indication,

  /// [intendedUse] The intended use of the product, e.g. prevention,
  ///  treatment, diagnosis.
  CodeableConcept? intendedUse,

  /// [basis] The legal or regulatory framework against which this
  ///  authorization is granted, or other reasons for it.
  List<CodeableConcept>? basis,

  /// [holder] The organization that has been granted this authorization, by
  ///  some authoritative body (the 'regulator').
  Reference? holder,

  /// [regulator] The regulatory authority or authorizing body granting the
  ///  authorization. For example, European Medicines Agency (EMA), Food and
  ///  Drug Administration (FDA), Health Canada (HC), etc.
  Reference? regulator,

  /// [attachedDocument] Additional information or supporting documentation
  ///  about the authorization.
  List<Reference>? attachedDocument,

  /// [case_] ("case") 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).
  @JsonKey(name: 'case') RegulatedAuthorizationCase? case_,
}) = _RegulatedAuthorization;