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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 Fri May 22 12:11:22 UTC 2020 as a draft by ehealth.sundhed.dk.

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

 

Terminology Bindings

Path	Conformance	ValueSet
Device.language	extensible	Common Languages Max Binding: All Languages
Device.udi.entryType	required	UDIEntryType
Device.status	required	FHIRDeviceStatus
Device.type	required	DeviceTypes
Device.safety	example	DeviceSafety

Constraints

Id	Path	Details	Requirements
dom-2	Device	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-1	Device	If the resource is contained in another resource, it SHALL NOT contain any narrative : contained.text.empty()
dom-4	Device	If 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-3	Device	If 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-1	Device.extension:privatelyOwned	All FHIR elements must have a @value or children : hasValue() | (children().count() > id.count())
ext-1	Device.extension:privatelyOwned	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	Device.extension:suppliers	All FHIR elements must have a @value or children : hasValue() | (children().count() > id.count())
ext-1	Device.extension:suppliers	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	Device.udi	All FHIR elements must have a @value or children : hasValue() | (children().count() > id.count())

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