| Australian Digital Health Agency FHIR Implementation Guide 1.0.0

Australian Digital Health Agency FHIR Implementation Guide. This is the current published version. It is based on FHIR® version 4.0.1. See the Directory of published versions for a list of available versions.

### StructureDefinition: ADHA System Device [Active]

The purpose of this profile is to define a representation of a device as a system in the role of an author or exchange target or source for exchange usage scenarios to support the electronic exchange of health information between healthcare providers, and between healthcare providers and the My Health Record system infrastructure in Australia. In the context of an exchange of health information a system device is part of the context established for a set of healthcare-related information or it forms part of a target or source for the exchange.

This profile identifies the additional constraints, extensions, and value sets that build on and extend Device that are supported.

The Device resource, profiled as a system device, is used within the context of a referencing resource.

This profile is designed to set a Device standard for:

- Recording or updating a system device referenced by another resource
- Reading system devices referenced by another resource

#### Profile specific guidance

None.

#### Boundaries and relationships

This profile is referenced by ADHA Core DocumentReference and ADHA Core Flag.

#### Formal Views of Profile Content

The official URL for this profile is:

    http://ns.electronichealth.net.au/fhir/StructureDefinition/dh-device-system-1

The purpose of this profile is to define a representation of a device as a system in the role of an author or exchange target or source for exchange usage scenarios to support the electronic exchange of health information between individuals, healthcare providers, and the My Health Record system infrastructure in Australia.

This profile builds on Device.

This profile was published on 2023-04-14 04:02:01+0000 as a active by Australian Digital Health Agency.

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

- Differential Table
- Snapshot Table
- All

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
Slices for identifier | S | 1..* | Identifier | Instance identifier Slice: Unordered, Open by pattern:type
identifier:paid | S | 0..1 | AUPAIDIdentifier | My Health Record Assigned Identity - Device (PAI-D) Identifier
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
name | S | 1..1 | string | The name of the device
type | S | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
type | S | 0..1 | CodeableConcept | The kind or type of device Binding: https://healthterminologies.gov.au/fhir/ValueSet/information-system-device-type-1 (extensible)
owner | S C | 1..1 | Reference(ADHA Core Organization) | Organization responsible for device inv-dh-dev-01: At least reference, display, or a valid identifier shall be present
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | S | 1..* | Identifier | Instance identifier Slice: Unordered, Open by pattern:type
identifier:paid | S C | 0..1 | AUPAIDIdentifier | My Health Record Assigned Identity - Device (PAI-D) Identifier
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | Σ | 0..1 | string | Mandatory fixed portion of UDI
issuer |  | 0..1 | uri | UDI Issuing Organization
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | Σ | 0..1 | string | UDI Human Readable Barcode String
entryType |  | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason |  | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier |  | 0..1 | string | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate |  | 0..1 | dateTime | Date when the device was made
expirationDate |  | 0..1 | dateTime | Date and time of expiry of this device (if applicable)
lotNumber |  | 0..1 | string | Lot number of manufacture
serialNumber |  | 0..1 | string | Serial number assigned by the manufacturer
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 1..1 | string | The name of the device
type | S | 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.
modelNumber |  | 0..1 | string | The model number for the device
partNumber |  | 0..1 | string | The part number of the device
type | S | 0..1 | CodeableConcept | The kind or type of device Binding: https://healthterminologies.gov.au/fhir/ValueSet/information-system-device-type-1 (extensible)
specialization |  | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
systemType |  | 1..1 | CodeableConcept | The standard that is used to operate and communicate
version |  | 0..1 | string | The version of the standard that is used to operate and communicate
version |  | 0..* | BackboneElement | The actual design of the device or software version running on the device
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 0..1 | CodeableConcept | The type of the device version
component |  | 0..1 | Identifier | A single component of the device version
value |  | 1..1 | string | The version text
property |  | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity |  | 0..* | Quantity | Property value as a quantity
valueCode |  | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP)
patient |  | 0..1 | Reference(Patient) | Patient to whom Device is affixed
owner | S C | 1..1 | Reference(ADHA Core Organization) | Organization responsible for device inv-dh-dev-01: At least reference, display, or a valid identifier shall be present
contact |  | 0..* | ContactPoint | Details for human/organization for support
location |  | 0..1 | Reference(Location) | Where the device is found
url |  | 0..1 | uri | Network address to contact device
note |  | 0..* | Annotation | Device notes and comments
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device
parent |  | 0..1 | Reference(Device) | The parent device
Documentation for this format

Differential View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
Slices for identifier | S | 1..* | Identifier | Instance identifier Slice: Unordered, Open by pattern:type
identifier:paid | S | 0..1 | AUPAIDIdentifier | My Health Record Assigned Identity - Device (PAI-D) Identifier
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
name | S | 1..1 | string | The name of the device
type | S | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
type | S | 0..1 | CodeableConcept | The kind or type of device Binding: https://healthterminologies.gov.au/fhir/ValueSet/information-system-device-type-1 (extensible)
owner | S C | 1..1 | Reference(ADHA Core Organization) | Organization responsible for device inv-dh-dev-01: At least reference, display, or a valid identifier shall be present
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | S | 1..* | Identifier | Instance identifier Slice: Unordered, Open by pattern:type
identifier:paid | S C | 0..1 | AUPAIDIdentifier | My Health Record Assigned Identity - Device (PAI-D) Identifier
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | Σ | 0..1 | string | Mandatory fixed portion of UDI
issuer |  | 0..1 | uri | UDI Issuing Organization
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | Σ | 0..1 | string | UDI Human Readable Barcode String
entryType |  | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason |  | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier |  | 0..1 | string | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate |  | 0..1 | dateTime | Date when the device was made
expirationDate |  | 0..1 | dateTime | Date and time of expiry of this device (if applicable)
lotNumber |  | 0..1 | string | Lot number of manufacture
serialNumber |  | 0..1 | string | Serial number assigned by the manufacturer
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 1..1 | string | The name of the device
type | S | 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.
modelNumber |  | 0..1 | string | The model number for the device
partNumber |  | 0..1 | string | The part number of the device
type | S | 0..1 | CodeableConcept | The kind or type of device Binding: https://healthterminologies.gov.au/fhir/ValueSet/information-system-device-type-1 (extensible)
specialization |  | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
systemType |  | 1..1 | CodeableConcept | The standard that is used to operate and communicate
version |  | 0..1 | string | The version of the standard that is used to operate and communicate
version |  | 0..* | BackboneElement | The actual design of the device or software version running on the device
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 0..1 | CodeableConcept | The type of the device version
component |  | 0..1 | Identifier | A single component of the device version
value |  | 1..1 | string | The version text
property |  | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity |  | 0..* | Quantity | Property value as a quantity
valueCode |  | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP)
patient |  | 0..1 | Reference(Patient) | Patient to whom Device is affixed
owner | S C | 1..1 | Reference(ADHA Core Organization) | Organization responsible for device inv-dh-dev-01: At least reference, display, or a valid identifier shall be present
contact |  | 0..* | ContactPoint | Details for human/organization for support
location |  | 0..1 | Reference(Location) | Where the device is found
url |  | 0..1 | uri | Network address to contact device
note |  | 0..* | Annotation | Device notes and comments
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device
parent |  | 0..1 | Reference(Device) | The parent device
Documentation for this format

Downloads: StructureDefinition: (XML, JSON), Schema: XML Schematron

#### Terminology Bindings

Path | Conformance | ValueSet
Device.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
Device.udiCarrier.entryType | required | UDIEntryType
Device.status | required | FHIRDeviceStatus
Device.statusReason | extensible | FHIRDeviceStatusReason
Device.deviceName.type | required | DeviceNameType
Device.type | extensible | https://healthterminologies.gov.au/fhir/ValueSet/information-system-device-type-1

#### Search Parameters

None defined.