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Difference between revisions of "DeviceDefinition FHIR Resource Proposal"

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Current version: https://confluence.hl7.org/display/FHIR/DeviceDefinition+FHIR+Resource+Proposal<div style="float: left;">[[Image:OpenHotTopic.GIF|35px| ]]</div>
 
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This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
 
This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
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=PutProposedResourceNameHere=
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=DeviceDefinition=
  
 
<!-- Resource names should meet the following characteristics:
 
<!-- Resource names should meet the following characteristics:
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  -->
 
  -->
  
==Owning work group name==
+
==Owning Committee Name==
 
+
Orders & Observations
 
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
 
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
[[YourWorkGroupName]]
 
  
 
==Committee Approval Date:==
 
==Committee Approval Date:==
 
<i>Please enter the date that the committee approved this Resource proposal</i>
 
<i>Please enter the date that the committee approved this Resource proposal</i>
 +
 +
June 12, 2018 - http://confluence.hl7.org/display/OO/OO+Conf+Call+Minutes+-+Device+-+20180612
  
 
==Contributing or Reviewing Work Groups==
 
==Contributing or Reviewing Work Groups==
 +
Healthcare Devices
 +
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
  
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
+
*Work Group Name
* Work Group Name
+
*or link
* or link
+
*or "None"
* or "None"
 
  
 
==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
 
+
PI 952
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
  
 
==Scope of coverage==
 
==Scope of coverage==
 +
This is a specialized resource that defines the characteristics and capabilities of a device.  Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment and research for healthcare and public health, as well as devices such as an x-ray machine, lab analyzer, cellphone, computer, software/application, etc. A device may also be a simpler entity such as a syringe or applicator, provided with a medicinal product. 
 +
 +
The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn
 +
 +
The DeviceDefinition is typically used in catalogs, publications, or other use cases where the reference to a device is generically to a type of device, not a specific instance of a device.  For example, a catalog of orderable devices, or the mapping of device specific test codes and result values to industry standards. 
  
 
<!-- Define the full scope of coverage for the resource.  The scope must be clearly delineated such that it does not overlap with any other existing or expected resource.  The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"
 
<!-- Define the full scope of coverage for the resource.  The scope must be clearly delineated such that it does not overlap with any other existing or expected resource.  The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"
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==RIM scope==
 
==RIM scope==
 +
There does not appear to be a DeviceDefinition concept in the RIM, rather only the Device instance is referenced  The Common Product Model touches on elements, but not all.
  
 
<!-- Identify the formal RIM mapping for the root concept of the resource.  The expectation is that the RIM mapping will be sufficiently precise so as to not overlap with any other resource definition. -->
 
<!-- Identify the formal RIM mapping for the root concept of the resource.  The expectation is that the RIM mapping will be sufficiently precise so as to not overlap with any other resource definition. -->
  
 
==Resource appropriateness==
 
==Resource appropriateness==
 +
The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the manufacturer or a regulatory entity and allows defining valid hierarchical device configurations (devices as part of other devices).
 +
 +
Device vs DeviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location and operational status, which the DeviceDefinition resource does not have.
 +
 +
Separating the DeviceDefinition from Device enables clearer distinction, considering that a number of use cases primarily focus on Device, while others focus on DeviceDefinition. There will be many more Device instances than there will be DeviceDefinition instances.  The DeviceDefinition would be used in catalogs and would have a different update lifecycle to the Device resource instances.
  
 
<!-- Does the resource meet the following characteristics?
 
<!-- Does the resource meet the following characteristics?
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==Expected implementations==
 
==Expected implementations==
 +
Implementations of catalogs, e.g., LIVD as well as implementations needing to reference device definitions.  The LIVD implementation guide addresses Lab device manufacturers to document recommended mapping of test codes and result values used on their devices using proprietary/local code systems to (inter)national vocabularies such as LOINC and SNOMED.
  
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
+
EMA plan to use this for representing the devices that are commonly supplied with medication items, within the same packaging (e.g., syringe, spoon etc). This "SPOR" project is currently implementing, with a first release in early 2020.
  
==Content sources==
+
 
 +
 
 +
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->==Content sources==
 +
 
 +
*HL7 FHIR Device and DeviceMetrics
 +
*HL7 V2 EQU and DEV segments
 +
*EMA XEVPRM implementation of regulatory medications information
  
 
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
 
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
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==Example Scenarios==
 
==Example Scenarios==
 +
 +
Ordering supplies using SupplyRequest would typically reference DeviceDefinitions rather than specific devices.
 +
 +
Ordering DME would typically reference DeviceDefinitions rather than specific devices.
 +
 +
Standard vocabulary mappings for devices typically define common mappings based on device models, thus DeviceDefinition rather than for each individual device.
 +
 +
Submission by a pharmaceutical manufacturer of the details of a packaged medicinal product for licencing by regulators (e.g. EMA, FDA, MHRA) would typically include definitions of the devices included (description, dimensions, materials, manufacturer etc).
  
 
<!-- Provide a listing of the types of scenarios to be represented in the examples produced for this resource.  They should demonstrate the full scope of the resource and allow exercising of the resources capabilities (full element coverage, inclusion & omission of optional elements, repeating and singleton repeating elements, etc.) -->
 
<!-- Provide a listing of the types of scenarios to be represented in the examples produced for this resource.  They should demonstrate the full scope of the resource and allow exercising of the resources capabilities (full element coverage, inclusion & omission of optional elements, repeating and singleton repeating elements, etc.) -->
  
 
==Resource Relationships==
 
==Resource Relationships==
 +
 +
*Device
 +
*Composition
 +
*ObservationDefinition
 +
*PackagedMedicinalProductDefinition (contains devices as defined by DeviceDefinition)
  
 
<!-- What are the resources do you expect will reference this resource and in what context?
 
<!-- What are the resources do you expect will reference this resource and in what context?
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==Timelines==
 
==Timelines==
 +
September 2018 inclusion in FHIR R4.
  
 
<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
 
<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
  
 
==gForge Users==
 
==gForge Users==
 +
Eric Haas, Jose Costa Teixeira
  
 
<!-- Identify the userids who will require commit access to gForge to maintain the resource.  (Ensure all users have registered for gForge.) -->
 
<!-- Identify the userids who will require commit access to gForge to maintain the resource.  (Ensure all users have registered for gForge.) -->

Latest revision as of 20:06, 12 November 2019



DeviceDefinition

Owning Committee Name

Orders & Observations

Committee Approval Date:

Please enter the date that the committee approved this Resource proposal

June 12, 2018 - http://confluence.hl7.org/display/OO/OO+Conf+Call+Minutes+-+Device+-+20180612

Contributing or Reviewing Work Groups

Healthcare Devices

  • Work Group Name
  • or link
  • or "None"

FHIR Resource Development Project Insight ID

PI 952

Scope of coverage

This is a specialized resource that defines the characteristics and capabilities of a device. Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment and research for healthcare and public health, as well as devices such as an x-ray machine, lab analyzer, cellphone, computer, software/application, etc. A device may also be a simpler entity such as a syringe or applicator, provided with a medicinal product.

The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn

The DeviceDefinition is typically used in catalogs, publications, or other use cases where the reference to a device is generically to a type of device, not a specific instance of a device. For example, a catalog of orderable devices, or the mapping of device specific test codes and result values to industry standards.


RIM scope

There does not appear to be a DeviceDefinition concept in the RIM, rather only the Device instance is referenced The Common Product Model touches on elements, but not all.


Resource appropriateness

The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the manufacturer or a regulatory entity and allows defining valid hierarchical device configurations (devices as part of other devices).

Device vs DeviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location and operational status, which the DeviceDefinition resource does not have.

Separating the DeviceDefinition from Device enables clearer distinction, considering that a number of use cases primarily focus on Device, while others focus on DeviceDefinition. There will be many more Device instances than there will be DeviceDefinition instances. The DeviceDefinition would be used in catalogs and would have a different update lifecycle to the Device resource instances.


Expected implementations

Implementations of catalogs, e.g., LIVD as well as implementations needing to reference device definitions. The LIVD implementation guide addresses Lab device manufacturers to document recommended mapping of test codes and result values used on their devices using proprietary/local code systems to (inter)national vocabularies such as LOINC and SNOMED.

EMA plan to use this for representing the devices that are commonly supplied with medication items, within the same packaging (e.g., syringe, spoon etc). This "SPOR" project is currently implementing, with a first release in early 2020.


Content sources

  • HL7 FHIR Device and DeviceMetrics
  • HL7 V2 EQU and DEV segments
  • EMA XEVPRM implementation of regulatory medications information


Example Scenarios

Ordering supplies using SupplyRequest would typically reference DeviceDefinitions rather than specific devices.

Ordering DME would typically reference DeviceDefinitions rather than specific devices.

Standard vocabulary mappings for devices typically define common mappings based on device models, thus DeviceDefinition rather than for each individual device.

Submission by a pharmaceutical manufacturer of the details of a packaged medicinal product for licencing by regulators (e.g. EMA, FDA, MHRA) would typically include definitions of the devices included (description, dimensions, materials, manufacturer etc).


Resource Relationships

  • Device
  • Composition
  • ObservationDefinition
  • PackagedMedicinalProductDefinition (contains devices as defined by DeviceDefinition)


Timelines

September 2018 inclusion in FHIR R4.


gForge Users

Eric Haas, Jose Costa Teixeira


When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes