Womens Health Technology Coordinated Registry Network Implementation Guide For Comment Ballot

This page is part of the Womens Health Technology Coordinated Registry Network FHIR IG (v0.1.0: STU 1 Draft) based on FHIR v3.5.0. . For a full list of available versions, see the Directory of published versions

Definitions for the StructureDefinition-devicedefinition-crn Profile.

DeviceDefinition
Definition

This is a CRN Device Profile.

Control0..*
Comments

For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.

InvariantsDefined on this element
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
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 (: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: 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-5: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (: text.div.exists())
DeviceDefinition.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

DeviceDefinition.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Control0..1
TypeMeta
DeviceDefinition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Control0..1
Typeuri
Is Modifiertrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

DeviceDefinition.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHOULD be taken from Common Languages
Typecode
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

DeviceDefinition.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Control0..1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

DeviceDefinition.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

DeviceDefinition.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.identifier
Definition

Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
DeviceDefinition.udiDeviceIdentifier
Definition

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

Control0..1
TypeBackboneElement
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
DeviceDefinition.udiDeviceIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
DeviceDefinition.udiDeviceIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.udiDeviceIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Definition

The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier.

Control1..1
Typestring
Must Supporttrue
DeviceDefinition.udiDeviceIdentifier.issuer
Definition

The organization that assigns the identifier algorithm.

Control1..1
Typeuri
Must Supporttrue
DeviceDefinition.udiDeviceIdentifier.jurisdiction
Definition

The jurisdiction to which the deviceIdentifier applies.

Control1..1
Typeuri
Must Supporttrue
DeviceDefinition.manufacturer[x]
Definition

A name of the manufacturer.

Control1..1
TypeChoice of: string, Reference(Organization)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
DeviceDefinition.deviceName
Definition

A name given to the device to identify it.

Control1..1
TypeBackboneElement
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
DeviceDefinition.deviceName.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
DeviceDefinition.deviceName.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.deviceName.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.deviceName.name
Definition

The name of the device.

Control1..1
Typestring
Must Supporttrue
Alternate NamesΣ
DeviceDefinition.deviceName.type
Definition

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Control1..1
BindingThe type of name the device is referred by.
The codes SHALL be taken from DeviceNameType
Typecode
Must Supporttrue
DeviceDefinition.modelNumber
Definition

The model number for the device.

Control0..1
Typestring
Must Supporttrue
DeviceDefinition.type
Definition

What kind of device or device system this is.

Control0..1
BindingType of device e.g. according to official classification.
For example codes, see FHIRDeviceTypes
TypeCodeableConcept
DeviceDefinition.specialization
Definition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
DeviceDefinition.specialization.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
DeviceDefinition.specialization.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.specialization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.specialization.systemType
Definition

The standard that is used to operate and communicate.

Control1..1
Typestring
Alternate NamesΣ
DeviceDefinition.specialization.version
Definition

The version of the standard that is used to operate and communicate.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
DeviceDefinition.version
Definition

The actual design of the device or software version running on the device.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..*
Typestring
DeviceDefinition.safety
Definition

Safety characteristics of the device.

Control0..*
TypeCodeableConcept
DeviceDefinition.shelfLifeStorage
Definition

Shelf Life and storage information.

Control0..*
TypeProductShelfLife
DeviceDefinition.physicalCharacteristics
Definition

Dimensions, color etc.

Control0..1
TypeProdCharacteristic
DeviceDefinition.languageCode
Definition

Language code for the human-readable text strings produced by the device (all supported).

Control0..*
TypeCodeableConcept
DeviceDefinition.capability
Definition

Device capabilities.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
DeviceDefinition.capability.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
DeviceDefinition.capability.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.capability.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.capability.type
Definition

Type of capability.

Control1..1
TypeCodeableConcept
DeviceDefinition.capability.description
Definition

Description of capability.

Control0..*
TypeCodeableConcept
DeviceDefinition.property
Definition

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
DeviceDefinition.property.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
DeviceDefinition.property.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.property.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.property.type
Definition

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Control1..1
TypeCodeableConcept
DeviceDefinition.property.valueQuanity
Definition

Property value as a quantity.

Control0..*
TypeQuantity
DeviceDefinition.property.valueCode
Definition

Property value as a code, e.g., NTP4 (synced to NTP).

Control0..*
TypeCodeableConcept
DeviceDefinition.owner
Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Control0..1
TypeReference(Organization)
DeviceDefinition.contact
Definition

Contact details for an organization or a particular human that is responsible for the device.

Control0..*
TypeContactPoint
Comments

used for troubleshooting etc.

DeviceDefinition.url
Definition

A network address on which the device may be contacted directly.

Control0..1
Typeuri
Comments

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

DeviceDefinition.onlineInformation
Definition

Access to on-line information about the device.

Control0..1
Typeuri
DeviceDefinition.note
Definition

Descriptive information, usage information or implantation information that is not captured in an existing element.

Control0..*
TypeAnnotation
DeviceDefinition.quantity
Definition

The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product).

Control0..1
TypeQuantity
DeviceDefinition.parentDevice
Definition

The parent device it can be part of.

Control0..1
TypeReference(DeviceDefinition)
DeviceDefinition.material
Definition

A substance used to create the material(s) of which the device is made.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
DeviceDefinition.material.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
DeviceDefinition.material.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.material.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

DeviceDefinition.material.substance
Definition

The substance.

Control1..1
TypeCodeableConcept
DeviceDefinition.material.alternate
Definition

Indicates an alternative material of the device.

Control0..1
Typeboolean
DeviceDefinition.material.allergenicIndicator
Definition

Whether the substance is a known or suspected allergen.

Control0..1
Typeboolean