Details
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Change Request
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Resolution: Persuasive with Modification
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Medium
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FHIR Core (FHIR)
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R5
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Orders & Observations
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Device
DeviceDefinition -
Examples, valuesets and additional elements will be handled in new Jira tickets.
Motion to make the following changes:
Device
Device Element Card DataType Short Display Definition 
conformsTo0..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards. 
specification1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to
[Device SpecificationSpecialization SystemTypehttp://build.fhir.org/valueset-device-specialization-systemtype.html] (Example) 
version0..1 string Identifies the specific form or variant of the standard, specification, or formal guidance 
category0..1 Coding Describes the common type of the standard, specification, or formal guidance
communication | performance | measurement | risk class | electrical | material | exchange?
FHIRDeviceSpecializationCategory (Example)Add search parameters for 1) Device.specification; 2) Device.specification and Device.version (composite)
DeviceDefinition
Requires clarification for the DeviceDefinition.classification.type that previously included risk class. Risk class is now part of the conformsTo element.
Device Element Card Proposed DataType Proposed Description conformsTo0..* BackboneElement Identifies the the standards, specifications, or formal guidances for the capabilities supported by the device.
category0..1 Coding Describes the common type of the standard, specification or formal guidance
communication | performance | measurement | risk class | electrical | material | exchange?
FHIRDeviceSpecializationCategory (Example) specification1..1 CodeableConcept Identifies the standard, specification or formal guidance that the device adheres to
[Device -Specialization System Type-http://build.fhir.org/valueset-device-specialization-systemtype.html] (Example) version0..1 string Identifies the specific form or variant of the standard, specification or formal guidance source0..* RelatedArtifact Add search parameters for 1) DeviceDefinition.specification; 2) DeviceDefinition.specification and Device.version (composite)
Examples, valuesets and additional elements will be handled in new Jira tickets. Motion to make the following changes: Device Device Element Card DataType Short Display Definition conformsTo 0..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards. s pecification 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to [Device Specification Specialization System Type http://build.fhir.org/valueset-device-specialization-systemtype.html] ( Example ) version 0..1 string Identifies the specific form or variant of the standard, specification, or formal guidance category 0..1 Coding Describes the common type of the standard, specification, or formal guidance communication | performance | measurement | risk class | electrical | material | exchange? FHIRDeviceSpecializationCategory ( Example ) Add search parameters for 1) Device.specification; 2) Device.specification and Device.version (composite) DeviceDefinition Requires clarification for the DeviceDefinition.classification.type that previously included risk class. Risk class is now part of the conformsTo element. Device Element Card Proposed DataType Proposed Description conformsTo 0..* BackboneElement Identifies the the standards, specifications, or formal guidances for the capabilities supported by the device. category 0..1 Coding Describes the common type of the standard, specification or formal guidance communication | performance | measurement | risk class | electrical | material | exchange? FHIRDeviceSpecializationCategory ( Example ) s pecification 1..1 CodeableConcept Identifies the standard, specification or formal guidance that the device adheres to [Device - Specialization System Type - http://build.fhir.org/valueset-device-specialization-systemtype.html] ( Example ) version 0..1 string Identifies the specific form or variant of the standard, specification or formal guidance source 0..* RelatedArtifact Add search parameters for 1) DeviceDefinition.specification; 2) DeviceDefinition.specification and Device.version (composite) -
Elliot Silver / Yanick Gaudet : 13 - 0 - 0
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Enhancement
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Non-compatible
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R5
Description
There are other models of standards conformance (and compliance certification, and regulatory and legal compliance) than a specialization of IEEE 11073.
- Rename the Device.specialization element to conformsTo to support other approaches.
- Rename the systemType element to something that indicates that the code could be for a standard, rule, regulation, law, certification (or maybe "standard" is sufficient).
- Consider adding a "substandard," "option," or "clause" element (0..* CodeableConcept) to capture implemented options, DICOM SOP classes, IHE Actors and named Options, etc.; alternatively document how to claim conformance to such items.
- Ensure short, definition, and comment of specialization and sub-elements are updated to align. Ensure that the example Device Specialization value set includes non-IEEE 11073 examples, such as Bluetooth, DICOM (or a DICOM SOP class), IHE Profiles. Ensure the examples cover at least one law or regulation.
- Consider if DeviceDefinition.specialization should be updated to better align with Device.specialization (either current or with updates resulting from this ticket).
Please consider the issues raised in FHIR-38058 as included in this ticket by reference, and thus part of the R5 ballot.
