Australian Digital Health Agency FHIR Implementation Guide
1.2.0-ci-build - draft
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
Official URL: http://ns.electronichealth.net.au/fhir/StructureDefinition/dh-device-implantable-1 | Version: 0.0.2 | |||
Draft as of 2024-09-12 | 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:
This profile may be referred to by APIs, which will be listed here when available.
None.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Device
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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) |
lotNumber | S | 0..1 | string | Lot number of manufacture |
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 |
Documentation for this format |
Id | Grade | Path(s) | Details | Requirements |
inv-dh-dev-01 | error | Device.patient | At least reference or a valid identifier shall be present : reference.exists() or identifier.where(system.count() + value.count() >1).exists() |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Device | 0..* | Device | Item used in healthcare | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
udiCarrier | SΣ | 1..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
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 |
carrierAIDC | SΣ | 0..1 | base64Binary | UDI Machine Readable Barcode String |
carrierHRF | SΣ | 0..1 | string | UDI Human Readable Barcode String |
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
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 |
type | S | 0..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. |
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 |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | |
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
inv-dh-dev-01 | error | Device.patient | At least reference or a valid identifier shall be present : reference.exists() or identifier.where(system.count() + value.count() >1).exists() |
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.
| |||||
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 | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
Device.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard | ||||
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | ||||
Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard | ||||
Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard | ||||
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
inv-dh-dev-01 | error | Device.patient | At 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
Differential View
This structure is derived from Device
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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) |
lotNumber | S | 0..1 | string | Lot number of manufacture |
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 |
Documentation for this format |
Id | Grade | Path(s) | Details | Requirements |
inv-dh-dev-01 | error | Device.patient | At least reference or a valid identifier shall be present : reference.exists() or identifier.where(system.count() + value.count() >1).exists() |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Device | 0..* | Device | Item used in healthcare | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
udiCarrier | SΣ | 1..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
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 |
carrierAIDC | SΣ | 0..1 | base64Binary | UDI Machine Readable Barcode String |
carrierHRF | SΣ | 0..1 | string | UDI Human Readable Barcode String |
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
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 |
type | S | 0..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. |
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 |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | |
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
inv-dh-dev-01 | error | Device.patient | At least reference or a valid identifier shall be present : reference.exists() or identifier.where(system.count() + value.count() >1).exists() |
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.
| |||||
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 | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
Device.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard | ||||
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | ||||
Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard | ||||
Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard | ||||
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
inv-dh-dev-01 | error | Device.patient | At 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
Other representations of profile: CSV, Excel, Schematron
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.