Canonical Resource Management Infrastructure Implementation Guide
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Canonical Resource Management Infrastructure Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.1.0-cibuild built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/crmi-ig/ and changes regularly. See the Directory of published versions

Resource Profile: CRMISoftwareSystemDevice - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 3

Definitions for the crmi-softwaresystemdevice resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Device
Definition

A type 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.

ShortItem used in healthcare
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-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())
2. Device.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.

ShortA set of rules under which this content was created
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.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.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 and/or the understanding of the containing element's descendants. 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).

ShortExtensions that cannot be ignored
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Device.status
Definition

Status of the Device availability.

Shortactive | inactive | entered-in-error | unknown
Comments

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

Control0..1
BindingThe codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

The availability status of the device.

Typecode
Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Device.manufacturer
Definition

A name of the manufacturer.

ShortThe developers of the Software SystemName of device manufacturer
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.deviceName
Definition

This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

ShortThe name of the softwareThe name of the device as given by the manufacturer
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.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 and/or the understanding of the containing element's descendants. 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).

ShortExtensions that cannot be ignored even if unrecognized
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
14. Device.deviceName.name
Definition

The name of the device.

ShortThe name of the device
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Alternate NamesΣ
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Device.deviceName.type
Definition

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

Shortudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Control1..1
BindingThe codes SHALL be taken from DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1
(required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

The type of name the device is referred by.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Fixed Valuemanufacturer-name
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Device.type
Definition

The kind or type of device.

Shortauthoring | testing | tooling | evaluation | reporting | data-captureThe kind or type of device
Control0..1
BindingUnless not suitable, these codes SHALL be taken from For example codes, see Software System Typehttp://hl7.org/fhir/ValueSet/device-type
(extensible to http://terminology.hl7.org/ValueSet/software-system-type)

The software system type


Codes to identify medical devices.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Device.version
Definition

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

ShortThe actual design of the device or software version running on the device
NoteThis is a business version Id, not a resource version Id (see discussion)
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Device.version.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 and/or the understanding of the containing element's descendants. 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).

ShortExtensions that cannot be ignored even if unrecognized
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
24. Device.version.type
Definition

The type of the device version.

ShortThe type of the device version
Control0..01
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesΣ
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Device.version.component
Definition

A single component of the device version.

ShortA single component of the device version
Control0..01
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Device.version.value
Definition

The version text.

ShortThe version text
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Device.url
Definition

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

ShortNetwork address to contact device
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.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))