Australian Digital Health Agency FHIR Implementation Guide, published by Australian Digital Health Agency. This guide is not an authorized publication; it is the continuous build for version 1.2.0-ci-build built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/AuDigitalHealth/ci-fhir-r4/ and changes regularly. See the Directory of published versions

Resource Profile: ADHA Implantable Medical Device

Official URL: http://ns.electronichealth.net.au/fhir/StructureDefinition/dh-device-implantable-1 Version: 0.0.2
Draft as of 2024-12-19 Computable Name: ADHAImplantableMedicalDevice

Copyright/Legal: Copyright © 2023 Australian Digital Health Agency - All rights reserved. This content is licensed under a Creative Commons Attribution 4.0 International License. See https://creativecommons.org/licenses/by/4.0/.

The purpose of this profile is to define a representation of an implantable medical device for a patient 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 identifies the additional constraints, extensions, and value sets that build on and extend Device that are supported.

This profile is designed to set a Device standard for:

  • Query for a patient's implantable medical devices
  • Record or update an implantable medical device record for a patient

This profile may be referred to by APIs, which will be listed here when available.

Profile specific guidance

None.

Usage:

Formal Views of Profile Content

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

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... udiCarrier S 1..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
.... issuer S 0..1 uri UDI Issuing Organization
.... carrierAIDC S 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF S 0..1 string UDI Human Readable Barcode String
... manufactureDate S 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... type S 0..1 CodeableConcept The kind or type of device
... patient SC 1..1 Reference(ADHA Core Patient) Patient to whom Device is affixed
inv-dh-dev-01: At least reference or a valid identifier shall be present

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
inv-dh-dev-01errorDevice.patientAt least reference or a valid identifier shall be present
: reference.exists() or identifier.where(system.count() + value.count() >1).exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
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
... udiCarrier SΣ 1..* 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 1..1 string Mandatory fixed portion of UDI
ele-1: All FHIR elements must have a @value or children
.... issuer S 0..1 uri UDI Issuing Organization
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
... 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
... lotNumber S 0..1 string Lot number of manufacture
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
... type S 0..1 CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.


ele-1: All FHIR elements must have a @value or children
... patient SC 1..1 Reference(ADHA Core Patient) Patient to whom Device is affixed
ele-1: All FHIR elements must have a @value or children
inv-dh-dev-01: At least reference or a valid identifier shall be present

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
inv-dh-dev-01errorDevice.patientAt least reference or a valid identifier shall be present
: reference.exists() or identifier.where(system.count() + value.count() >1).exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 BindingsPurpose
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
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 1..* 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 SΣ 1..1 string Mandatory fixed portion of UDI
.... issuer S 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 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 S 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName 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 1..1 string The name of the device
.... 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.

... 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: DeviceType (example): Codes to identify medical devices.

... 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 SC 1..1 Reference(ADHA Core Patient) Patient to whom Device is affixed
inv-dh-dev-01: At least reference or a valid identifier shall be present
... owner 0..1 Reference(Organization) Organization responsible for device
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Additional Bindings Purpose
AllLanguages Max Binding
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
inv-dh-dev-01errorDevice.patientAt least reference or a valid identifier shall be present
: reference.exists() or identifier.where(system.count() + value.count() >1).exists()

This structure is derived from Device

Summary

Mandatory: 3 elements
Must-Support: 11 elements

Structures

This structure refers to these other structures:

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... udiCarrier S 1..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
.... issuer S 0..1 uri UDI Issuing Organization
.... carrierAIDC S 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF S 0..1 string UDI Human Readable Barcode String
... manufactureDate S 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... type S 0..1 CodeableConcept The kind or type of device
... patient SC 1..1 Reference(ADHA Core Patient) Patient to whom Device is affixed
inv-dh-dev-01: At least reference or a valid identifier shall be present

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
inv-dh-dev-01errorDevice.patientAt least reference or a valid identifier shall be present
: reference.exists() or identifier.where(system.count() + value.count() >1).exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
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
... udiCarrier SΣ 1..* 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 1..1 string Mandatory fixed portion of UDI
ele-1: All FHIR elements must have a @value or children
.... issuer S 0..1 uri UDI Issuing Organization
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
... 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
... lotNumber S 0..1 string Lot number of manufacture
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
... type S 0..1 CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.


ele-1: All FHIR elements must have a @value or children
... patient SC 1..1 Reference(ADHA Core Patient) Patient to whom Device is affixed
ele-1: All FHIR elements must have a @value or children
inv-dh-dev-01: At least reference or a valid identifier shall be present

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
inv-dh-dev-01errorDevice.patientAt least reference or a valid identifier shall be present
: reference.exists() or identifier.where(system.count() + value.count() >1).exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 BindingsPurpose
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
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 1..* 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 SΣ 1..1 string Mandatory fixed portion of UDI
.... issuer S 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 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 S 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName 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 1..1 string The name of the device
.... 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.

... 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: DeviceType (example): Codes to identify medical devices.

... 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 SC 1..1 Reference(ADHA Core Patient) Patient to whom Device is affixed
inv-dh-dev-01: At least reference or a valid identifier shall be present
... owner 0..1 Reference(Organization) Organization responsible for device
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Additional Bindings Purpose
AllLanguages Max Binding
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
inv-dh-dev-01errorDevice.patientAt least reference or a valid identifier shall be present
: reference.exists() or identifier.where(system.count() + value.count() >1).exists()

This structure is derived from Device

Summary

Mandatory: 3 elements
Must-Support: 11 elements

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron

Notes:

Below is an overview of the mandatory and optional search parameters. FHIR search operations and the syntax used to describe the interactions is described here.