FQL is a query language that allows you to retrieve, filter and project data from any data source containing FHIR Resources. It brings the power of three existing languages together: SQL, JSON and FhirPath. It allows you to create tables and is useful for gaining insight and perform quality control.
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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.
- type Profile on RegulatedAuthorization
- FHIR R4
- status Draft
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version4.3.0
The canonical from this resource does not match any claim in this context and conflicts with a claim from another scope.
http://hl7.org/fhir
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RegulatedAuthorization | I | DomainResource | Element idRegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product DefinitionRegulatory 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.
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id | Σ | 0..1 | id | There are no (further) constraints on this element Element idRegulatedAuthorization.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. |
meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idRegulatedAuthorization.meta Metadata about the resource DefinitionThe 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.
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idRegulatedAuthorization.implicitRules A set of rules under which this content was created DefinitionA 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. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
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language | 0..1 | codeBinding | There are no (further) constraints on this element Element idRegulatedAuthorization.language Language of the resource content DefinitionThe base language in which the resource is written. Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). IETF language tag
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text | 0..1 | Narrative | There are no (further) constraints on this element Element idRegulatedAuthorization.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA 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 resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
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contained | I | 0..* | Resource | There are no (further) constraints on this element Element idRegulatedAuthorization.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idRegulatedAuthorization.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idRegulatedAuthorization.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay 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 manageable, 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). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | Σ | 0..* | Identifier | Element idRegulatedAuthorization.identifier Business identifier for the authorization, typically assigned by the authorizing body DefinitionBusiness identifier for the authorization, typically assigned by the authorizing body.
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subject | Σ I | 0..* | Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) | Element idRegulatedAuthorization.subject The product type, treatment, facility or activity that is being authorized DefinitionThe product type, treatment, facility or activity that is being authorized. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) Constraints
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type | Σ | 0..1 | CodeableConcept | Element idRegulatedAuthorization.type Overall type of this authorization, for example drug marketing approval, orphan drug designation DefinitionOverall type of this authorization, for example drug marketing approval, orphan drug designation. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Overall type of this authorization.
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description | Σ | 0..1 | markdown | Element idRegulatedAuthorization.description General textual supporting information DefinitionGeneral textual supporting information. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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region | Σ | 0..* | CodeableConcept | Element idRegulatedAuthorization.region The territory in which the authorization has been granted DefinitionThe territory (e.g., country, jurisdiction etc.) in which the authorization has been granted. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Jurisdiction codes
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status | Σ | 0..1 | CodeableConceptBinding | Element idRegulatedAuthorization.status The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications DefinitionThe status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The lifecycle status of an artifact.
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statusDate | Σ | 0..1 | dateTime | Element idRegulatedAuthorization.statusDate The date at which the current status was assigned DefinitionThe date at which the current status was assigned.
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validityPeriod | Σ I | 0..1 | Period | Element idRegulatedAuthorization.validityPeriod 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 DefinitionThe 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. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration.
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indication | Σ | 0..1 | CodeableReference | Element idRegulatedAuthorization.indication Condition for which the use of the regulated product applies DefinitionCondition for which the use of the regulated product applies.
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intendedUse | Σ | 0..1 | CodeableConceptBinding | Element idRegulatedAuthorization.intendedUse The intended use of the product, e.g. prevention, treatment DefinitionThe intended use of the product, e.g. prevention, treatment, diagnosis. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The overall intended use of a product.
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basis | Σ | 0..* | CodeableConcept | Element idRegulatedAuthorization.basis The legal/regulatory framework or reasons under which this authorization is granted DefinitionThe legal or regulatory framework against which this authorization is granted, or other reasons for it. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. A legal or regulatory framework against which an authorization is granted, or other reasons for it.
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holder | Σ I | 0..1 | Reference(Organization) | Element idRegulatedAuthorization.holder The organization that has been granted this authorization, by the regulator DefinitionThe organization that has been granted this authorization, by some authoritative body (the 'regulator'). References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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regulator | Σ I | 0..1 | Reference(Organization) | Element idRegulatedAuthorization.regulator The regulatory authority or authorizing body granting the authorization DefinitionThe regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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case | Σ | 0..1 | BackboneElement | Element idRegulatedAuthorization.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) DefinitionThe 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).
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id | 0..1 | id | There are no (further) constraints on this element Element idRegulatedAuthorization.case.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idRegulatedAuthorization.case.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, 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. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idRegulatedAuthorization.case.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 manageable, 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. 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). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
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identifier | Σ | 0..1 | Identifier | Element idRegulatedAuthorization.case.identifier Identifier by which this case can be referenced DefinitionIdentifier by which this case can be referenced.
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type | Σ | 0..1 | CodeableConcept | Element idRegulatedAuthorization.case.type The defining type of case DefinitionThe defining type of case. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The type of a case involved in an application.
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status | Σ | 0..1 | CodeableConceptBinding | Element idRegulatedAuthorization.case.status The status associated with the case DefinitionThe status associated with the case. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The lifecycle status of an artifact.
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date[x] | Σ | 0..1 | Element idRegulatedAuthorization.case.date[x] Relevant date for this case DefinitionRelevant date for this case.
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datePeriod | Period | Data type | ||
dateDateTime | dateTime | Data type | ||
application | Σ | 0..* | see (case) | There are no (further) constraints on this element Element idRegulatedAuthorization.case.application Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure DefinitionA regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.
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