R4 Draft for Comment

This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Extension: din

Orders and Observations Work Group

Maturity Level: 1

Informative

Use Context: Any

URL for this extension:

http://hl7.org/fhir/StructureDefinition/device-din

Status: draft. Extension maintained by: Health Level Seven, Inc. - FHIR WG

The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional, variable portion of the production identifier (PI) of a Unique device Identifier (UDI). If the content is from an ICCBBA-encoded UDI, the URI to use for the system is: http://hl7.org/fhir/NamingSystem/iccbba-din. GS1 and HIBCC formatted UDIs do not currently convey the DIN element.

*Note to balloters: The Orders and Observations Workgroup has not yet determined whether the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.) and so the need for Donation Identification number is currently being met through this extension. If it is determined a separate resource is to be used for Devices of Human (or other) Origin (tissue, blood, etc.) then this extension may be deprecated in the future. Feedback on this issue is welcome.

Context of Use: Use on element: Device

usage info: insert a list of places where this extension is used

Summary

Name	Flags	Card.	Type	Description & Constraints
extension		0..1	Identifier	URL = http://hl7.org/fhir/StructureDefinition/device-din din: The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional, variable portion of the production identifier (PI) of a [Unique device Identifier (UDI)](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm). If the content is from an [ICCBBA](https://www.iccbba.org/)-encoded UDI, the URI to use for the system is: http://hl7.org/fhir/NamingSystem/iccbba-din. GS1 and HIBCC formatted UDIs do not currently convey the DIN element. *Note to balloters: The Orders and Observations Workgroup has not yet determined whether the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.) and so the need for Donation Identification number is currently being met through this extension. If it is determined a separate resource is to be used for Devices of Human (or other) Origin (tissue, blood, etc.) then this extension may be deprecated in the future. Feedback on this issue is welcome. Use on element: Device
Documentation for this format

Full Structure

Name	Card.	Type	Description & Constraints
extension	0..1	Extension	URL = http://hl7.org/fhir/StructureDefinition/device-din din: The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional, variable portion of the production identifier (PI) of a [Unique device Identifier (UDI)](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm). If the content is from an [ICCBBA](https://www.iccbba.org/)-encoded UDI, the URI to use for the system is: http://hl7.org/fhir/NamingSystem/iccbba-din. GS1 and HIBCC formatted UDIs do not currently convey the DIN element. *Note to balloters: The Orders and Observations Workgroup has not yet determined whether the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.) and so the need for Donation Identification number is currently being met through this extension. If it is determined a separate resource is to be used for Devices of Human (or other) Origin (tissue, blood, etc.) then this extension may be deprecated in the future. Feedback on this issue is welcome. Use on element: Device
url	1..1	uri	"http://hl7.org/fhir/StructureDefinition/device-din"
valueIdentifier	0..1	Identifier	Value of extension
Documentation for this format

XML Template

<!-- din -->

<extension xmlns="http://hl7.org/fhir"
     url="http://hl7.org/fhir/StructureDefinition/device-din" >
  <!-- from Element: extension -->
 <valueIdentifier><!-- 0..1 Identifier Value of extension --></valueIdentifier>
</extension>

JSON Template

{ // din
  // from Element: extension
    "extension" : [ //  sliced by value:url  in the specified order, Open ]
    "url" : "http://hl7.org/fhir/StructureDefinition/device-din", // R! 
    "valueIdentifier" : { Identifier } //Value of extension
  }

Summary

Name	Flags	Card.	Type	Description & Constraints
extension		0..1	Identifier	URL = http://hl7.org/fhir/StructureDefinition/device-din din: The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional, variable portion of the production identifier (PI) of a [Unique device Identifier (UDI)](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm). If the content is from an [ICCBBA](https://www.iccbba.org/)-encoded UDI, the URI to use for the system is: http://hl7.org/fhir/NamingSystem/iccbba-din. GS1 and HIBCC formatted UDIs do not currently convey the DIN element. *Note to balloters: The Orders and Observations Workgroup has not yet determined whether the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.) and so the need for Donation Identification number is currently being met through this extension. If it is determined a separate resource is to be used for Devices of Human (or other) Origin (tissue, blood, etc.) then this extension may be deprecated in the future. Feedback on this issue is welcome. Use on element: Device
Documentation for this format

Full Structure

Name	Card.	Type	Description & Constraints
extension	0..1	Extension	URL = http://hl7.org/fhir/StructureDefinition/device-din din: The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional, variable portion of the production identifier (PI) of a [Unique device Identifier (UDI)](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm). If the content is from an [ICCBBA](https://www.iccbba.org/)-encoded UDI, the URI to use for the system is: http://hl7.org/fhir/NamingSystem/iccbba-din. GS1 and HIBCC formatted UDIs do not currently convey the DIN element. *Note to balloters: The Orders and Observations Workgroup has not yet determined whether the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.) and so the need for Donation Identification number is currently being met through this extension. If it is determined a separate resource is to be used for Devices of Human (or other) Origin (tissue, blood, etc.) then this extension may be deprecated in the future. Feedback on this issue is welcome. Use on element: Device
url	1..1	uri	"http://hl7.org/fhir/StructureDefinition/device-din"
valueIdentifier	0..1	Identifier	Value of extension
Documentation for this format

XML Template

<!-- din -->

<extension xmlns="http://hl7.org/fhir"
     url="http://hl7.org/fhir/StructureDefinition/device-din" >
  <!-- from Element: extension -->
 <valueIdentifier><!-- 0..1 Identifier Value of extension --></valueIdentifier>
</extension>

JSON Template

{ // din
  // from Element: extension
    "extension" : [ //  sliced by value:url  in the specified order, Open ]
    "url" : "http://hl7.org/fhir/StructureDefinition/device-din", // R! 
    "valueIdentifier" : { Identifier } //Value of extension
  }

Constraints

ele-1: All FHIR elements must have a @value or children (xpath: @value|f:*|h:div)
ext-1: Must have either extensions or value[x], not both (xpath: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')]))