Canadian Baseline
1.2.0 - CI Build
Canadian Baseline
1.2.0 - CI Build
Canadian Baseline, published by HL7 Canada - FHIR Implementation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7-Canada/ca-baseline/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-device-medical | Version: 1.2.0 | |||
| Draft as of 2024-08-09 | Computable Name: DeviceProfileMedical | |||
Proposed constraints on the Device resource for the minimal set of data to query and retrieve a medical or non-medical device.
This profile sets minimum expectations for the Device resource to record and search for medical and non-medical devices, wearable devices personal health devices, virtual devices such as computer programs and systems, etc., except patient's implantable device(s). It identifies which core elements SHALL be present in the resource when using this profile.
This profile defines core localization concepts for use in the Canadian context.
All elements or attributes within the FHIR specification have cardinality as part of their definition - a minimum number of required appearances and a maximum number of allowable appearances.
Most elements in the FHIR specification have a minimum cardinality of 0, so most elements are not required and subsequently they may be missing from a resource when it is exchanged between systems.
Required elements in the Device (Implantable) profile:
Some elements are marked as Must Support. This means that implementations generating, receiving, or otherwise using resources with Must Support elements SHALL provide support for those elements in some meaningful way (see Must Support definition).
The following elements are marked as Must Support in the Device (Medical and Non-medical) profile:
Must Support elements:
The following are example usage scenarios for the Medical and Non-medical Device profile:
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Device |
0..* | Device | Device Profile dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
  Slices for identifier |
S | 0..* | Identifier | Instance identifier Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children |
   identifier:All Slices |
Content/Rules for all slices | |||
  use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children |
 type |
SΣ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. ele-1: All FHIR elements must have a @value or children |
| system |
SΣ | 0..1 | uri | The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Example General: http://www.acme.com/identifiers/patient |
 value |
SΣ | 0..1 | string | The value that is unique within the system. ele-1: All FHIR elements must have a @value or children Example General: 123456 |
 identifier:EUI-64 |
0..1 | Identifier | IEEE 64-bit Extended Unique Identifier (EUI-64) ele-1: All FHIR elements must have a @value or children | |
 use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children |
| type |
SΣ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. ele-1: All FHIR elements must have a @value or children |
| system |
SΣ | 1..1 | uri | EUI-64 system identifier ele-1: All FHIR elements must have a @value or children Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680 |
 value |
SΣ | 1..1 | string | The value that is unique within the system. ele-1: All FHIR elements must have a @value or children Example General: 123456 |
 identifier:EUI-48 |
0..1 | Identifier | MAC Transport address identifier (EUI-48) ele-1: All FHIR elements must have a @value or children | |
 use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children |
| type |
SΣ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. ele-1: All FHIR elements must have a @value or children |
| system |
SΣ | 1..1 | uri | EUI-48 system identifier ele-1: All FHIR elements must have a @value or children Fixed Value: http://terminology.hl7.org/fhir/sid/eui-48 |
| value |
SΣ | 1..1 | string | The value that is unique within the system. ele-1: All FHIR elements must have a @value or children Example General: 123456 |
| udiCarrier |
SΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| deviceIdentifier |
SΣ | 0..1 | string | Mandatory fixed portion of UDI ele-1: All FHIR elements must have a @value or children |
| carrierAIDC |
SΣ | 0..1 | base64Binary | UDI Machine Readable Barcode String ele-1: All FHIR elements must have a @value or children |
 carrierHRF |
SΣ | 0..1 | string | UDI Human Readable Barcode String ele-1: All FHIR elements must have a @value or children |
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children |
| distinctIdentifier |
S | 0..1 | string | The distinct identification string ele-1: All FHIR elements must have a @value or children |
| manufacturer |
S | 0..1 | string | Name of device manufacturer ele-1: All FHIR elements must have a @value or children |
| manufactureDate |
S | 0..1 | dateTime | Date when the device was made ele-1: All FHIR elements must have a @value or children |
| expirationDate |
S | 0..1 | dateTime | Date and time of expiry of this device (if applicable) ele-1: All FHIR elements must have a @value or children |
| serialNumber |
S | 0..1 | string | Serial number assigned by the manufacturer ele-1: All FHIR elements must have a @value or children |
| deviceName |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| name |
1..1 | string | The name of the device ele-1: All FHIR elements must have a @value or children | |
| type |
1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. ele-1: All FHIR elements must have a @value or children | |
| type |
S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices ele-1: All FHIR elements must have a @value or children |
| version |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| value |
1..1 | string | The version text ele-1: All FHIR elements must have a @value or children | |
 patient |
S | 0..1 | Reference(Patient Profile) | Patient to whom Device is affixed ele-1: All FHIR elements must have a @value or children |
| parent |
0..1 | Reference(Device Profile (Medical and Non-medical)) | The parent device ele-1: All FHIR elements must have a @value or children | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1from the FHIR Standard | |
| Device.identifier.type | extensible | Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| Device.identifier:EUI-64.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1from the FHIR Standard | |
| Device.identifier:EUI-64.type | extensible | Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| Device.identifier:EUI-48.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1from the FHIR Standard | |
| Device.identifier:EUI-48.type | extensible | Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | |
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | |
| Device.type | extensible | FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kindfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | 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 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(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| 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() |
Other representations of profile: CSV, Excel, Schematron
The Device.identifier specifies a unique instance identifiers assigned to a device by manufacturer. This Device profile constrains the use of the Extended Unique Identifier (EUI) such as 64-bit Extended Unique Identifier (EUI-64) or 48-bit Extended Unique Identifier (EUI-48) by fixing the Identifier.system namespace for the identifier value.
