eHealth Infrastructure (v2020.2)

StructureDefinition: 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.

Formal Views of Profile Content

The official URL for this profile is: 

http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device

This profile builds on Device.

This profile was published on Tue Mar 31 08:26:16 UTC 2020 as a draft by ehealth.sundhed.dk.

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

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceAn instance or a type of a manufactured item that is used in the provision of healthcare.
... extension 0..*ExtensionSlice: 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 this device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... status 1..1code
... type 0..1CodeableConceptBinding: Device Types (required)
... patient 0..0
... owner 0..1Reference(eHealth Organization) {r}
... location 0..1Reference(Location) {r}
... note
.... author[x] 0..1
..... authorReferenceReference(eHealth Practitioner | eHealth Patient | eHealth RelatedPerson)
..... authorStringstring

doco Documentation for this format

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceAn instance or a type of a manufactured item that is used in the provision of healthcare.
... id Σ0..1idLogical 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: Common Languages (extensible)
Max Binding: All Languages
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ehealth-device-privatelyOwned I0..1booleanTrue if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
... ehealth-device-suppliers I0..*(Complex)Different types of suppliers for this device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... udi ΣI0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... name Σ0..1stringDevice Name as appears on UDI label
.... jurisdiction 0..1uriRegional UDI authority
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... issuer 0..1uriUDI Issuing Organization
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!Σ1..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... type 0..1CodeableConceptWhat kind of device this is
Binding: Device Types (required)
... lotNumber 0..1stringLot number of manufacture
... 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)
... model 0..1stringModel id assigned by the manufacturer
... version 0..1stringVersion number (i.e. software)
... owner 0..1Reference(eHealth Organization) {r}Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location) {r}Where the resource is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
.... author[x] Σ0..1Individual responsible for the annotation
..... authorReferenceReference(eHealth Practitioner | eHealth Patient | eHealth RelatedPerson)
..... authorStringstring
.... time Σ0..1dateTimeWhen the annotation was made
.... text 1..1stringThe annotation - text content
... safety Σ0..*CodeableConceptSafety Characteristics of Device
Binding: DeviceSafety (example)

doco Documentation for this format

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceAn instance or a type of a manufactured item that is used in the provision of healthcare.
... extension 0..*ExtensionSlice: 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 this device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... status 1..1code
... type 0..1CodeableConceptBinding: Device Types (required)
... patient 0..0
... owner 0..1Reference(eHealth Organization) {r}
... location 0..1Reference(Location) {r}
... note
.... author[x] 0..1
..... authorReferenceReference(eHealth Practitioner | eHealth Patient | eHealth RelatedPerson)
..... authorStringstring

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceAn instance or a type of a manufactured item that is used in the provision of healthcare.
... id Σ0..1idLogical 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: Common Languages (extensible)
Max Binding: All Languages
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ehealth-device-privatelyOwned I0..1booleanTrue if this device is owned or provided by the patient.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-privatelyOwned
... ehealth-device-suppliers I0..*(Complex)Different types of suppliers for this device.
URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-device-suppliers
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... udi ΣI0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... name Σ0..1stringDevice Name as appears on UDI label
.... jurisdiction 0..1uriRegional UDI authority
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... issuer 0..1uriUDI Issuing Organization
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!Σ1..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... type 0..1CodeableConceptWhat kind of device this is
Binding: Device Types (required)
... lotNumber 0..1stringLot number of manufacture
... 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)
... model 0..1stringModel id assigned by the manufacturer
... version 0..1stringVersion number (i.e. software)
... owner 0..1Reference(eHealth Organization) {r}Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location) {r}Where the resource is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
.... author[x] Σ0..1Individual responsible for the annotation
..... authorReferenceReference(eHealth Practitioner | eHealth Patient | eHealth RelatedPerson)
..... authorStringstring
.... time Σ0..1dateTimeWhen the annotation was made
.... text 1..1stringThe annotation - text content
... safety Σ0..*CodeableConceptSafety Characteristics of Device
Binding: DeviceSafety (example)

doco Documentation for this format

 

Terminology Bindings

PathConformanceValueSet
Device.languageextensibleCommon Languages
Max Binding: All Languages
Device.udi.entryTyperequiredUDIEntryType
Device.statusrequiredFHIRDeviceStatus
Device.typerequiredDeviceTypes
Device.safetyexampleDeviceSafety

Constraints

IdPathDetailsRequirements
dom-2DeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-1DeviceIf the resource is contained in another resource, it SHALL NOT contain any narrative
: contained.text.empty()
dom-4DeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-3DeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
: contained.where(('#'+id in %resource.descendants().reference).not()).empty()
ele-1Device.extension:privatelyOwnedAll FHIR elements must have a @value or children
: hasValue() | (children().count() > id.count())
ext-1Device.extension:privatelyOwnedMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.extension:suppliersAll FHIR elements must have a @value or children
: hasValue() | (children().count() > id.count())
ext-1Device.extension:suppliersMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.udiAll FHIR elements must have a @value or children
: hasValue() | (children().count() > id.count())
.