SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
Page standards status: Trial-use | Maturity Level: 1 |
Definitions for the SubmittedMedicinalProductMarketing resource profile.
Guidance on how to interpret the contents of this table can be found here
0. RegulatedAuthorization | |
2. RegulatedAuthorization.identifier | |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..? |
Must Support | true |
4. RegulatedAuthorization.subject | |
Control | 1..1 |
Type | Reference(SubmittedMedicinalProduct) |
Must Support | true |
6. RegulatedAuthorization.type | |
Must Support | true |
8. RegulatedAuthorization.region | |
Must Support | true |
10. RegulatedAuthorization.statusDate | |
Must Support | true |
Guidance on how to interpret the contents of this table can be found here
0. RegulatedAuthorization | |
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. |
Short | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) |
2. RegulatedAuthorization.implicitRules | |
Definition | 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. |
Short | A set of rules under which this content was created |
Comments | 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. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
4. RegulatedAuthorization.modifierExtension | |
Definition | 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 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). |
Short | Extensions that cannot be ignored |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | false |
Requirements | 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. |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
6. RegulatedAuthorization.identifier | |
Definition | Business identifier for the authorization, typically assigned by the authorizing body. |
Short | Business identifier for the authorization, typically assigned by the authorizing body |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 10..* |
Type | Identifier |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
8. RegulatedAuthorization.subject | |
Definition | The product type, treatment, facility or activity that is being authorized. |
Short | The product type, treatment, facility or activity that is being authorized |
Control | 10..1* |
Type | Reference(SubmittedMedicinalProduct, MedicinalProductDefinition, BiologicallyDerivedProduct, NutritionProduct, PackagedProductDefinition, SubstanceDefinition, DeviceDefinition, ResearchStudy, ActivityDefinition, PlanDefinition, ObservationDefinition, Practitioner, Organization, Location) |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
10. RegulatedAuthorization.type | |
Definition | Overall type of this authorization, for example drug marketing approval, orphan drug designation. |
Short | Overall type of this authorization, for example drug marketing approval, orphan drug designation |
Control | 0..1 |
Binding | For example codes, see RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-type (example to http://hl7.org/fhir/ValueSet/regulated-authorization-type )Overall type of this authorization. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. RegulatedAuthorization.region | |
Definition | The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted. |
Short | The territory in which the authorization has been granted |
Control | 0..* |
Binding | For example codes, see Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction (example to http://hl7.org/fhir/ValueSet/jurisdiction )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
14. RegulatedAuthorization.statusDate | |
Definition | The date at which the current status was assigned. |
Short | The date at which the current status was assigned |
Control | 0..1 |
Type | dateTime |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
0. RegulatedAuthorization | |||||
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. | ||||
Short | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | ||||
Control | 0..* | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | false | ||||
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty() )dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource ( contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() )dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() )dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty() )dom-6: A resource should have narrative for robust management ( text.`div`.exists() ) | ||||
2. RegulatedAuthorization.id | |||||
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. | ||||
Short | Logical id of this artifact | ||||
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||||
Control | 0..1 | ||||
Type | id | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
4. RegulatedAuthorization.meta | |||||
Definition | 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. | ||||
Short | Metadata about the resource | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
6. RegulatedAuthorization.implicitRules | |||||
Definition | 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. | ||||
Short | A set of rules under which this content was created | ||||
Comments | 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. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
8. RegulatedAuthorization.language | |||||
Definition | The base language in which the resource is written. | ||||
Short | Language of the resource content | ||||
Comments | 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). | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from CommonLanguages (preferred to http://hl7.org/fhir/ValueSet/languages )IETF language tag
| ||||
Type | code | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | false | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
10. RegulatedAuthorization.text | |||||
Definition | 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. | ||||
Short | Text summary of the resource, for human interpretation | ||||
Comments | 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. | ||||
Control | 0..1 | ||||
Type | Narrative | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | false | ||||
Alternate Names | narrative, html, xhtml, display | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
12. RegulatedAuthorization.contained | |||||
Definition | These 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. | ||||
Short | Contained, inline Resources | ||||
Comments | 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. | ||||
Control | 0..* | ||||
Type | Resource | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | false | ||||
Alternate Names | inline resources, anonymous resources, contained resources | ||||
Invariants | dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems (($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) ) | ||||
14. RegulatedAuthorization.extension | |||||
Definition | 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 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. | ||||
Short | Additional content defined by implementations | ||||
Comments | 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
16. RegulatedAuthorization.modifierExtension | |||||
Definition | 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 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). | ||||
Short | Extensions that cannot be ignored | ||||
Comments | 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them | ||||
Must Support | false | ||||
Summary | false | ||||
Requirements | 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. | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
18. RegulatedAuthorization.identifier | |||||
Definition | Business identifier for the authorization, typically assigned by the authorizing body. | ||||
Short | Business identifier for the authorization, typically assigned by the authorizing body | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 1..* | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
20. RegulatedAuthorization.subject | |||||
Definition | The product type, treatment, facility or activity that is being authorized. | ||||
Short | The product type, treatment, facility or activity that is being authorized | ||||
Control | 1..1 | ||||
Type | Reference(SubmittedMedicinalProduct) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
22. RegulatedAuthorization.type | |||||
Definition | Overall type of this authorization, for example drug marketing approval, orphan drug designation. | ||||
Short | Overall type of this authorization, for example drug marketing approval, orphan drug designation | ||||
Control | 0..1 | ||||
Binding | For example codes, see RegulatedAuthorizationType (example to http://hl7.org/fhir/ValueSet/regulated-authorization-type )Overall type of this authorization. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
24. RegulatedAuthorization.description | |||||
Definition | General textual supporting information. | ||||
Short | General textual supporting information | ||||
Control | 0..1 | ||||
Type | markdown | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
26. RegulatedAuthorization.region | |||||
Definition | The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted. | ||||
Short | The territory in which the authorization has been granted | ||||
Control | 0..* | ||||
Binding | For example codes, see Jurisdiction ValueSet (example to http://hl7.org/fhir/ValueSet/jurisdiction )Jurisdiction codes | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
28. RegulatedAuthorization.status | |||||
Definition | The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications. | ||||
Short | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from PublicationStatus (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
30. RegulatedAuthorization.statusDate | |||||
Definition | The date at which the current status was assigned. | ||||
Short | The date at which the current status was assigned | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
32. RegulatedAuthorization.validityPeriod | |||||
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. | ||||
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 | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
34. RegulatedAuthorization.indication | |||||
Definition | Condition for which the use of the regulated product applies. | ||||
Short | Condition for which the use of the regulated product applies | ||||
Control | 0..1 | ||||
Type | CodeableReference(ClinicalUseDefinition) | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
36. RegulatedAuthorization.intendedUse | |||||
Definition | The intended use of the product, e.g. prevention, treatment, diagnosis. | ||||
Short | The intended use of the product, e.g. prevention, treatment | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from ProductIntendedUse (preferred to http://hl7.org/fhir/ValueSet/product-intended-use )The overall intended use of a product. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
38. RegulatedAuthorization.basis | |||||
Definition | The legal or regulatory framework against which this authorization is granted, or other reasons for it. | ||||
Short | The legal/regulatory framework or reasons under which this authorization is granted | ||||
Control | 0..* | ||||
Binding | For example codes, see RegulatedAuthorizationBasis (example to http://hl7.org/fhir/ValueSet/regulated-authorization-basis )A legal or regulatory framework against which an authorization is granted, or other reasons for it. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
40. RegulatedAuthorization.holder | |||||
Definition | The organization that has been granted this authorization, by some authoritative body (the 'regulator'). | ||||
Short | The organization that has been granted this authorization, by the regulator | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
42. RegulatedAuthorization.regulator | |||||
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. | ||||
Short | The regulatory authority or authorizing body granting the authorization | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
44. RegulatedAuthorization.case | |||||
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). | ||||
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) | ||||
Control | 0..1 | ||||
Type | BackboneElement | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters ) | ||||
46. RegulatedAuthorization.case.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
48. RegulatedAuthorization.case.extension | |||||
Definition | May 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. | ||||
Short | Additional content defined by implementations | ||||
Comments | 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
50. RegulatedAuthorization.case.modifierExtension | |||||
Definition | May 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). | ||||
Short | Extensions that cannot be ignored even if unrecognized | ||||
Comments | 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them | ||||
Summary | true | ||||
Requirements | 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. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
52. RegulatedAuthorization.case.identifier | |||||
Definition | Identifier by which this case can be referenced. | ||||
Short | Identifier by which this case can be referenced | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
54. RegulatedAuthorization.case.type | |||||
Definition | The defining type of case. | ||||
Short | The defining type of case | ||||
Control | 0..1 | ||||
Binding | For example codes, see RegulatedAuthorizationCaseType (example to http://hl7.org/fhir/ValueSet/regulated-authorization-case-type )The type of a case involved in an application. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
56. RegulatedAuthorization.case.status | |||||
Definition | The status associated with the case. | ||||
Short | The status associated with the case | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from PublicationStatus (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
58. RegulatedAuthorization.case.date[x] | |||||
Definition | Relevant date for this case. | ||||
Short | Relevant date for this case | ||||
Control | 0..1 | ||||
Type | Choice of: Period, dateTime | ||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
60. RegulatedAuthorization.case.application | |||||
Definition | A 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. | ||||
Short | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | ||||
Control | 0..* | ||||
Type | See ttp://hl7.org/fhir/StructureDefinition/RegulatedAuthorization#RegulatedAuthorization.case | ||||
Is Modifier | false | ||||
Must Support | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |