Point-of-Care Device Implementation Guide
1.0.0 - STU 1

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 1.0.0 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: 1.0.0
Standards status: Trial-use | 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)

- Element ID: `Device`

Usage info

Usages:

- Use this Extension: MDS Device profile and VMD Device profile
- Examples for this Extension: Device/PhysioMonitorMdsDevice

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.

- Differential Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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"
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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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"
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()`