eHealth Infrastructure
3.3.0 - ci-build Denmark flag

eHealth Infrastructure, published by Den telemedicinske infrastruktur (eHealth Infrastructure). This guide is not an authorized publication; it is the continuous build for version 3.3.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/fut-infrastructure/implementation-guide/ and changes regularly. See the Directory of published versions

Resource Profile: ehealth-device

Official URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device Version: 3.3.0
Active as of 2024-11-07 Computable Name: ehealth-device

Introduction

This resource identifies a specific instance of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

Because the Device resource represents a specific instance of a Device, it must have at least one identifier, such as a serial no., which together with the manufacturer and model uniquely identifies the device instance.

Each Device can be related to a number of suppliers with different roles; such as e.g. the provisioner, and suppliers of user training, maintenance, or decommissioning of the device.

Scope and Usage

In eHealth Devices are registered as FHIR resources when they are actively used in a current CarePlan for a Patient. The relation between a CarePlan and a Device is represented by a DeviceUseStatement resource.

The main purpose of registering a specific Device to a Patient through a CarePlan is purely clinical; not logistical. If for example at some point it is determined that a specific device has yielded erroneous or biased measurements, it may be important to track which patients have used this device.

Device resources are created and updated automatically based on actions and information provided in the Service, Support & Logistics (SSL) domain of the eHealth Infrastructure. The use of Device therefore concerns reading and searching only.

Life cycle

The SSL services manage the lifecycle of Device resources. When the SSL services receive a message that a device has been delivered to a patient, then the SSL services create a Device resource and relate it to the Patient's CarePlan through a DeviceUseStatement.

Privately owned devices

Bring your own device (BYOD), where the patient provides the device him or herself, is indicated with the extension Device.privatelyOwned being set to true. In all other cases, it is set to null or false.

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 Device
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... privatelyOwned 0..1 boolean True if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
.... suppliers 0..* (Complex) Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... status 1..1 code active | inactive | entered-in-error | unknown
... type 0..1 CodeableConcept The kind or type of device
Binding: Device Types (required)
... owner 0..1 Reference(ehealth-organization) {r} Organization responsible for device
... note
.... Slices for author[x] 0..1 Reference(Practitioner | Patient | RelatedPerson | Organization), string Individual responsible for the annotation
Slice: Unordered, Open by type:$this
..... author[x]:authorReference 0..1 Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson) Individual responsible for the annotation
..... author[x]:authorString 0..1 string Individual responsible for the annotation

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typerequiredDeviceTypes
http://ehealth.sundhed.dk/vs/device-types
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... privatelyOwned 0..1 boolean True if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
.... suppliers 0..* (Complex) Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... type 0..1 CodeableConcept The kind or type of device
Binding: Device Types (required)
... owner 0..1 Reference(ehealth-organization) {r} Organization responsible for device

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.typerequiredDeviceTypes
http://ehealth.sundhed.dk/vs/device-types
from this IG
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
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... privatelyOwned 0..1 boolean True if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
.... suppliers 0..* (Complex) Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... 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 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 1..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 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 0..1 CodeableConcept The kind or type of device
Binding: Device Types (required)
... 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)
... owner 0..1 Reference(ehealth-organization) {r} 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for author[x] Σ 0..1 Individual responsible for the annotation
Slice: Unordered, Closed by type:$this
..... authorReference Reference(Practitioner | Patient | RelatedPerson | Organization)
..... authorString string
..... author[x]:authorReference Σ 0..1 Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson) Individual responsible for the annotation
..... author[x]:authorString Σ 0..1 string Individual responsible for the annotation
.... time Σ 0..1 dateTime When the annotation was made
.... text Σ 1..1 markdown The annotation - text content (as markdown)
... 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
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
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.typerequiredDeviceTypes
http://ehealth.sundhed.dk/vs/device-types
from this IG

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device Device
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... privatelyOwned 0..1 boolean True if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
.... suppliers 0..* (Complex) Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... status 1..1 code active | inactive | entered-in-error | unknown
... type 0..1 CodeableConcept The kind or type of device
Binding: Device Types (required)
... owner 0..1 Reference(ehealth-organization) {r} Organization responsible for device
... note
.... Slices for author[x] 0..1 Reference(Practitioner | Patient | RelatedPerson | Organization), string Individual responsible for the annotation
Slice: Unordered, Open by type:$this
..... author[x]:authorReference 0..1 Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson) Individual responsible for the annotation
..... author[x]:authorString 0..1 string Individual responsible for the annotation

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typerequiredDeviceTypes
http://ehealth.sundhed.dk/vs/device-types
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... privatelyOwned 0..1 boolean True if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
.... suppliers 0..* (Complex) Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... type 0..1 CodeableConcept The kind or type of device
Binding: Device Types (required)
... owner 0..1 Reference(ehealth-organization) {r} Organization responsible for device

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.typerequiredDeviceTypes
http://ehealth.sundhed.dk/vs/device-types
from this IG

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
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... privatelyOwned 0..1 boolean True if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
.... suppliers 0..* (Complex) Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... 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 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 1..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 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 0..1 CodeableConcept The kind or type of device
Binding: Device Types (required)
... 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)
... owner 0..1 Reference(ehealth-organization) {r} 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for author[x] Σ 0..1 Individual responsible for the annotation
Slice: Unordered, Closed by type:$this
..... authorReference Reference(Practitioner | Patient | RelatedPerson | Organization)
..... authorString string
..... author[x]:authorReference Σ 0..1 Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson) Individual responsible for the annotation
..... author[x]:authorString Σ 0..1 string Individual responsible for the annotation
.... time Σ 0..1 dateTime When the annotation was made
.... text Σ 1..1 markdown The annotation - text content (as markdown)
... 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
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
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.typerequiredDeviceTypes
http://ehealth.sundhed.dk/vs/device-types
from this IG

 

Other representations of profile: CSV, Excel, Schematron