eHealth Infrastructure
2022.2 - release

eHealth Infrastructure - Local Development build (v2022.2). See the Directory of published versions

Resource Profile: ehealth-device

Official URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device Version: 2022.2
Active as of 2022-06-20 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 life cycle of Device resources is normally managed by the SSL subsystem, when an SSL supplier or a practitioner signals that a device has been delivered to a patient. At this time the Device service is searched for an existing instance of this Device resource - if one is found it will be reused. Otherwise a new device resource is created and related 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:

  • Refer to this Resource Profile:

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..*DeviceItem used in healthcare
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ehealth-device-privatelyOwned 0..1booleanTrue if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
... ehealth-device-suppliers 0..*(Complex)Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... type 0..1CodeableConceptThe kind or type of device
Binding: Device Types (required)
... patient 0..0
... owner 0..1Reference(ehealth-organization) {r}Organization responsible for device
... note
.... authorReference 0..1Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson)Individual responsible for the annotation
.... authorString 0..1stringIndividual responsible for the annotation

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ehealth-device-privatelyOwned 0..1booleanTrue if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
... ehealth-device-suppliers 0..*(Complex)Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ1..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber 0..1stringSerial number assigned by the manufacturer
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-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..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 0..1CodeableConceptThe kind or type of device
Binding: Device Types (required)
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(ehealth-organization) {r}Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for author[x] Σ0..1Individual responsible for the annotation
Slice: Unordered, Closed by type:$this
..... authorReferenceReference(Any)
..... authorStringstring
..... author[x]:authorReference Σ0..1Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson)Individual responsible for the annotation
..... author[x]:authorString Σ0..1stringIndividual responsible for the annotation
.... time Σ0..1dateTimeWhen the annotation was made
.... text Σ1..1markdownThe annotation - text content (as markdown)
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ehealth-device-privatelyOwned 0..1booleanTrue if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
... ehealth-device-suppliers 0..*(Complex)Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... type 0..1CodeableConceptThe kind or type of device
Binding: Device Types (required)
... patient 0..0
... owner 0..1Reference(ehealth-organization) {r}Organization responsible for device
... note
.... authorReference 0..1Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson)Individual responsible for the annotation
.... authorString 0..1stringIndividual responsible for the annotation

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ehealth-device-privatelyOwned 0..1booleanTrue if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
... ehealth-device-suppliers 0..*(Complex)Different types of suppliers for a device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ1..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber 0..1stringSerial number assigned by the manufacturer
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-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..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 0..1CodeableConceptThe kind or type of device
Binding: Device Types (required)
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(ehealth-organization) {r}Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for author[x] Σ0..1Individual responsible for the annotation
Slice: Unordered, Closed by type:$this
..... authorReferenceReference(Any)
..... authorStringstring
..... author[x]:authorReference Σ0..1Reference(ehealth-practitioner | ehealth-patient | ehealth-relatedperson)Individual responsible for the annotation
..... author[x]:authorString Σ0..1stringIndividual responsible for the annotation
.... time Σ0..1dateTimeWhen the annotation was made
.... text Σ1..1markdownThe annotation - text content (as markdown)
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
Device.languagepreferredCommonLanguages
Max Binding: AllLanguages
Device.udiCarrier.entryTyperequiredUDIEntryType
Device.statusrequiredFHIRDeviceStatus
Device.statusReasonextensibleFHIRDeviceStatusReason
Device.deviceName.typerequiredDeviceNameType
Device.typerequiredDeviceTypes