Approved Jurisdictions extension - Definitions - Point-of-Care Device Implementation Guide v0.4.0

Point-of-Care Device Implementation Guide
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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: ApprovedJurisdictions - Detailed Descriptions

Page standards status: Draft

Maturity Level: 2

Definitions for the approved-jurisdictions extension.

Key Elements Table
Differential Elements Table
Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

0. Extension
Definition	List of regions in which a device or device component is approved to be operated. This corresponds to the ApprovedJurisdictions element from IEEE 11073-10207. This extension is different to Device.udiCarrier.jurisdiction, which identifies the authoritative source for UDI generation. Optional Extension Element - found in all resources.
Short	Approved jurisdictionsOptional Extensions Element
Control	0..1* This element is affected by the following invariants: ele-1
Is Modifier	false
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()`) apj-1: When noApprovedJurisdictions is present, there shall be no approvedJurisdiction extensions. (`extension('noApprovedJurisdictions').exists() implies extension('approvedJurisdiction').empty()`) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2. Extension.extension
Definition	An Extension 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	ExtensionAdditional 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())
Slicing	This element introduces a set of slices on `Extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
4. Extension.extension:approvedJurisdiction
Slice Name	approvedJurisdiction
Definition	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.
Short	Approved jurisdictionAdditional content defined by implementations
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
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. Extension.extension:approvedJurisdiction.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`approvedJurisdiction`
8. Extension.extension:approvedJurisdiction.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.value[x]`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: type @ $this
10. Extension.extension:approvedJurisdiction.value[x]:valueCodeableConcept
Slice Name	valueCodeableConcept
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Binding	Unless not suitable, these codes SHALL be taken from For codes, see Jurisdiction ValueSet (extensible to `http://hl7.org/fhir/ValueSet/jurisdiction`) Codes for country, country subdivision and region
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Extension.extension:noApprovedJurisdictions
Slice Name	noApprovedJurisdictions
Definition	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).
Short	No approved jurisdictionsAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
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())
14. Extension.extension:noApprovedJurisdictions.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`noApprovedJurisdictions`
16. Extension.extension:noApprovedJurisdictions.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Type	boolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor 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
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.value[x]`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: type @ $this
18. Extension.extension:noApprovedJurisdictions.value[x]:valueBoolean
Slice Name	valueBoolean
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Type	boolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor 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
Summary	false
Fixed Value	`true`
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions`
22. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..01
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
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 foundhere

0. Extension
Definition	List of regions in which a device or device component is approved to be operated. This corresponds to the ApprovedJurisdictions element from IEEE 11073-10207. This extension is different to Device.udiCarrier.jurisdiction, which identifies the authoritative source for UDI generation.
Short	Approved jurisdictions
Control	0..1
Invariants	apj-1: When noApprovedJurisdictions is present, there shall be no approvedJurisdiction extensions. (`extension('noApprovedJurisdictions').exists() implies extension('approvedJurisdiction').empty()`)
2. Extension.extension
Slicing	This element introduces a set of slices on `Extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
4. Extension.extension:approvedJurisdiction
Slice Name	approvedJurisdiction
Definition	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.
Short	Approved jurisdiction
Control	0..*
6. Extension.extension:approvedJurisdiction.url
Fixed Value	`approvedJurisdiction`
8. Extension.extension:approvedJurisdiction.valueCodeableConcept
Binding	Unless not suitable, these codes SHALL be taken from Jurisdiction ValueSet (extensible to `http://hl7.org/fhir/ValueSet/jurisdiction`) Codes for country, country subdivision and region
Type	CodeableConcept
10. Extension.extension:noApprovedJurisdictions
Slice Name	noApprovedJurisdictions
Definition	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).
Short	No approved jurisdictions
Control	0..1
12. Extension.extension:noApprovedJurisdictions.url
Fixed Value	`noApprovedJurisdictions`
14. Extension.extension:noApprovedJurisdictions.valueBoolean
Type	boolean
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Fixed Value	`true`
16. Extension.url
Fixed Value	`http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions`
18. Extension.value[x]
Control	0..0

Guidance on how to interpret the contents of this table can be foundhere

0. Extension
Definition	List of regions in which a device or device component is approved to be operated. This corresponds to the ApprovedJurisdictions element from IEEE 11073-10207. This extension is different to Device.udiCarrier.jurisdiction, which identifies the authoritative source for UDI generation.
Short	Approved jurisdictions
Control	0..1 This element is affected by the following invariants: ele-1
Is Modifier	false
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()`) apj-1: When noApprovedJurisdictions is present, there shall be no approvedJurisdiction extensions. (`extension('noApprovedJurisdictions').exists() implies extension('approvedJurisdiction').empty()`)
2. Extension.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
4. Extension.extension
Definition	An Extension
Short	Extension
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
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()`)
Slicing	This element introduces a set of slices on `Extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
6. Extension.extension:approvedJurisdiction
Slice Name	approvedJurisdiction
Definition	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.
Short	Approved jurisdiction
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
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()`)
8. Extension.extension:approvedJurisdiction.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
10. Extension.extension:approvedJurisdiction.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()`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
12. Extension.extension:approvedJurisdiction.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`approvedJurisdiction`
14. Extension.extension:approvedJurisdiction.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.value[x]`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: type @ $this
16. Extension.extension:approvedJurisdiction.value[x]:valueCodeableConcept
Slice Name	valueCodeableConcept
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Binding	Unless not suitable, these codes SHALL be taken from Jurisdiction ValueSet (extensible to `http://hl7.org/fhir/ValueSet/jurisdiction`) Codes for country, country subdivision and region
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
18. Extension.extension:noApprovedJurisdictions
Slice Name	noApprovedJurisdictions
Definition	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).
Short	No approved jurisdictions
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
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()`)
20. Extension.extension:noApprovedJurisdictions.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
22. Extension.extension:noApprovedJurisdictions.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()`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
24. Extension.extension:noApprovedJurisdictions.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`noApprovedJurisdictions`
26. Extension.extension:noApprovedJurisdictions.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Type	boolean
[x] Note	SeeChoice of Data Typesfor 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
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.value[x]`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: type @ $this
28. Extension.extension:noApprovedJurisdictions.value[x]:valueBoolean
Slice Name	valueBoolean
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1
Type	boolean
[x] Note	SeeChoice of Data Typesfor 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
Summary	false
Fixed Value	`true`
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions`
32. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..0
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)

IG © 2017+ HL7 International / Devices. Package hl7.fhir.uv.pocd#0.4.0 based on FHIR 4.0.1. Generated 2026-03-19
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