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.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension: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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension:suppliers		0..*	(Complex)	Different types of suppliers for a device. URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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
status	?!Σ	1..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children
type		0..1	CodeableConcept	The kind or type of device Binding: Device Types (required) ele-1: All FHIR elements must have a @value or children
owner		0..1	Reference(ehealth-organization) {r}	Organization responsible for device ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.type	required	DeviceTypes http://ehealth.sundhed.dk/vs/device-types from this IG

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints
Device			Device
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension: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
extension: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)
patient		0..0
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Device.type	required	DeviceTypes http://ehealth.sundhed.dk/vs/device-types from this IG

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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension: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
extension: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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Device.udiCarrier.entryType	required	UDIEntryType http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.statusReason	extensible	FHIRDeviceStatusReason http://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard
Device.deviceName.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	required	DeviceTypes http://ehealth.sundhed.dk/vs/device-types from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension: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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension:suppliers		0..*	(Complex)	Different types of suppliers for a device. URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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
status	?!Σ	1..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children
type		0..1	CodeableConcept	The kind or type of device Binding: Device Types (required) ele-1: All FHIR elements must have a @value or children
owner		0..1	Reference(ehealth-organization) {r}	Organization responsible for device ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.type	required	DeviceTypes http://ehealth.sundhed.dk/vs/device-types from this IG

Differential View

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints
Device			Device
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension: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
extension: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)
patient		0..0
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Device.type	required	DeviceTypes http://ehealth.sundhed.dk/vs/device-types from this IG

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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension: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
extension: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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Device.udiCarrier.entryType	required	UDIEntryType http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.statusReason	extensible	FHIRDeviceStatusReason http://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard
Device.deviceName.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	required	DeviceTypes http://ehealth.sundhed.dk/vs/device-types from this IG

This structure is derived from Device

Summary

Mandatory: 1 element
Prohibited: 1 element

Structures

This structure refers to these other structures:

• ehealth-organization (http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-organization)
• ehealth-practitioner (http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-practitioner)
• ehealth-patient (http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-patient)
• ehealth-relatedperson (http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-relatedperson)

Extensions

This structure refers to these extensions:

• http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
• http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Device.note.author[x]