Point-of-Care Device Implementation Guide
0.4.0 - CI Build International flag

Point-of-Care Device Implementation Guide, published by HL7 International / Devices. This guide is not an authorized publication; it is the continuous build for version 0.4.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-pocd/ and changes regularly. See the Directory of published versions

Extension: Approved Jurisdictions extension

Official URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions Version: 0.4.0
Standards status: Draft Maturity Level: 2 Computable Name: ApprovedJurisdictions

StructureDefinition that adds approved jurisdictions to a Device.

This extension is intended to declare countries or regions in which the device or device component is approved to be operated. Multiple instances can appear in a single Device resource instance. Missing Approved Jurisdictions extension shall be interpreted as unknown (i.e., defined elsewhere). This extension is different from Device.udiCarrier.jurisdiction, which identifies the authoritative source for UDI generation. The approved jurisdictions refer to the countries or regions where the device has regulatory approval, while UDI jurisdiction refers to the authoritative source for UDI generation.

Note that the FHIR Identifier Jurisdiction extension with URL http://hl7.org/fhir/StructureDefinition/identifier-jurisdiction could be used as well.

Context of Use

    This extension may be used on the following element(s)

Usage info

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..1 Extension Approved jurisdictions
Constraints: apj-1
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:approvedJurisdiction 0..* Extension Approved jurisdiction
..... url 1..1 uri "approvedJurisdiction"
..... valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region
.... extension:noApprovedJurisdictions 0..1 Extension No approved jurisdictions
..... url 1..1 uri "noApprovedJurisdictions"
..... valueBoolean 0..1 boolean Value of extension
Fixed Value: true
... url 1..1 uri "http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions"
... value[x] 0..0 Value of extension

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..1 Extension Approved jurisdictions
Constraints: apj-1
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:approvedJurisdiction 0..* Extension Approved jurisdiction
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "approvedJurisdiction"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region
.... extension:noApprovedJurisdictions 0..1 Extension No approved jurisdictions
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "noApprovedJurisdictions"
..... Slices for value[x] 0..1 boolean Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueBoolean 0..1 boolean Value of extension
Fixed Value: true
... url 1..1 uri "http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: StructureDefinition that adds approved jurisdictions to a Device.

  • approvedJurisdiction: CodeableConcept: National state, territory, or region where the device is approved to be operated. If the list does not contain any entries, then the device or component is not approved for any region.
  • noApprovedJurisdictions: boolean: Explicit indication that the device has no approved jurisdictions. A value of false signals that the device is not approved for any region, as opposed to the jurisdiction being unknown. When this extension is present, there are no approved jurisdictions (yet).

Maturity: 2

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..1 Extension Approved jurisdictions
Constraints: apj-1
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:approvedJurisdiction 0..* Extension Approved jurisdiction
..... url 1..1 uri "approvedJurisdiction"
..... valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region
.... extension:noApprovedJurisdictions 0..1 Extension No approved jurisdictions
..... url 1..1 uri "noApprovedJurisdictions"
..... valueBoolean 0..1 boolean Value of extension
Fixed Value: true
... url 1..1 uri "http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions"
... value[x] 0..0 Value of extension

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..1 Extension Approved jurisdictions
Constraints: apj-1
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:approvedJurisdiction 0..* Extension Approved jurisdiction
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "approvedJurisdiction"
..... Slices for value[x] 0..1 CodeableConcept Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region
.... extension:noApprovedJurisdictions 0..1 Extension No approved jurisdictions
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "noApprovedJurisdictions"
..... Slices for value[x] 0..1 boolean Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueBoolean 0..1 boolean Value of extension
Fixed Value: true
... url 1..1 uri "http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: StructureDefinition that adds approved jurisdictions to a Device.

  • approvedJurisdiction: CodeableConcept: National state, territory, or region where the device is approved to be operated. If the list does not contain any entries, then the device or component is not approved for any region.
  • noApprovedJurisdictions: boolean: Explicit indication that the device has no approved jurisdictions. A value of false signals that the device is not approved for any region, as opposed to the jurisdiction being unknown. When this extension is present, there are no approved jurisdictions (yet).

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:approvedJurisdiction.​value[x]:valueCodeableConcept Base extensible Jurisdiction 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
apj-1 error Extension When noApprovedJurisdictions is present, there shall be no approvedJurisdiction extensions. extension('noApprovedJurisdictions').exists() implies extension('approvedJurisdiction').empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()