Difference between revisions of "LIVD FHIR IG Proposal"
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| − | = | + | =LIVD Implementation Guide= |
<!-- Resource names should meet the following characteristics: | <!-- Resource names should meet the following characteristics: | ||
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==Owning work group name== | ==Owning work group name== | ||
| − | + | Orders & Observations | |
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the IG. --> | <!-- The name of the committee that is proposed to have responsibility for developing and maintaining the IG. --> | ||
[[YourWorkGroupName]] | [[YourWorkGroupName]] | ||
==Committee Approval Date:== | ==Committee Approval Date:== | ||
| + | August 3, 2018 | ||
| + | |||
<i>Please enter the date that the committee approved this IGproposal</i> | <i>Please enter the date that the committee approved this IGproposal</i> | ||
==Contributing or Reviewing Work Groups== | ==Contributing or Reviewing Work Groups== | ||
| − | + | None. | |
<!-- Additional work groups that may have an interest in contributing to, or reviewing the content of the IG (optional) --> | <!-- Additional work groups that may have an interest in contributing to, or reviewing the content of the IG (optional) --> | ||
* Work Group Name | * Work Group Name | ||
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==Scope of coverage== | ==Scope of coverage== | ||
| + | The LIVD Implementation Guide addresses the ability for IVD device manufacturers to communicate for each of their devices the suggested mapping of the IVD (InVitro Diagnostic) Test Codes to one or more LOINC codes. | ||
| + | |||
| + | As the initial scope does not include for manufacturers to provide FHIR based service APIs, rather providing the relevant resources in a Bundle using some form of download/file transfer, the various operations otherwise necessary are not included. Future versions will address that scope. | ||
| + | |||
| + | The consuming application will present the data in a format and context suitable to those who configure devices to interact with a Laboratory Information System (LIS) to ensure the appropriate LOINC code is used when a result is communicated from the device to the LIS> | ||
<!-- Define the full scope of coverage for the IG. The scope must be clearly delineated such that it does not overlap with any other existing or expected HL7 Int'l-maintained IG. 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 IG. The scope must be clearly delineated such that it does not overlap with any other existing or expected HL7 Int'l-maintained IG. 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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==IG Purpose== | ==IG Purpose== | ||
| + | The IG enables consistent expression of the suggested mappings using an industry standard that enables consistency across manufacturers, as well as enabling a path to service based APIs to provide access to these mappings. | ||
<!-- Why is this IG necessary? --> | <!-- Why is this IG necessary? --> | ||
==Content location== | ==Content location== | ||
| + | Rob? | ||
<!-- What is the path within the HL7 github repository (i.e. https://github.com/HL7/xxx) or what is the Simplifier project name? --> | <!-- What is the path within the HL7 github repository (i.e. https://github.com/HL7/xxx) or what is the Simplifier project name? --> | ||
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==Proposed IG realm and code== | ==Proposed IG realm and code== | ||
| + | uv/livd | ||
<!-- What is the realm code (2-character country code or 'uv') and IG code to use for the path when the IG is published under http://hl7.org/fhir? E.g. us/ccda --> | <!-- What is the realm code (2-character country code or 'uv') and IG code to use for the path when the IG is published under http://hl7.org/fhir? E.g. us/ccda --> | ||
==Maintenance Plan== | ==Maintenance Plan== | ||
| + | The community (manufacturers, FDA, CDC, LIS vendors, and others) is already progressing scope to address suggested mapping of non-quantitative results for the device. As these and other capabilities are being addressed and service based APIs are being implemented, subsequent versions of the guide will be developed to address these requirements. | ||
<!-- What commitment does the WG have to maintaining this IG as the FHIR core specification continues to evolve - particularly if the initial project sponsors are no longer providing resources --> | <!-- What commitment does the WG have to maintaining this IG as the FHIR core specification continues to evolve - particularly if the initial project sponsors are no longer providing resources --> | ||
==Short Description== | ==Short Description== | ||
| + | The LIVD Implementation Guide provides a industry standard expression for an IVD device manufacturer's suggestions for a specific device's mapping from the internal, proprietary IVD test codes to suggested LOINC codes when a LIS manager is connecting and configuring a device to the LIS. | ||
<!-- 1-2 sentences describing the purpose/scope of the IG for inclusion in the registry --> | <!-- 1-2 sentences describing the purpose/scope of the IG for inclusion in the registry --> | ||
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==Long Description== | ==Long Description== | ||
| + | The LIVD Implementation Guide provides a industry standard expression for an IVD device manufacturer's suggestions for a specific device's mapping from the internal, proprietary IVD test codes to suggested LOINC codes when a LIS manager is connecting and configuring a device to the LIS. | ||
| + | |||
| + | As an LIS manager is configuring a device to be connected to the LIS, the suggested mappings can focus the LIS manager on the most likely LOINC codes to consider, thus enabling a choice relevant to the specific context of the device's use and purpose within the Laboratory that is more consistent across the industry. | ||
<!-- 1 paragraph describing the purpose/scope of the IG in more detail for inclusion in the version history --> | <!-- 1 paragraph describing the purpose/scope of the IG in more detail for inclusion in the version history --> | ||
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==Involved parties== | ==Involved parties== | ||
| + | The LIVD Implementation Guide is the result of a collaboration between representatives from the: | ||
| + | * IICC | ||
| + | * FDA | ||
| + | * CDC | ||
| + | * NLM | ||
| + | * CMS | ||
| + | * LIS vendors | ||
| + | * and other interested parties | ||
<!-- 1 paragraph describing who is sponsoring or involved in creating the IG for inclusion in the version history --> | <!-- 1 paragraph describing who is sponsoring or involved in creating the IG for inclusion in the version history --> | ||
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==Expected implementations== | ==Expected implementations== | ||
| + | Device manufacturers and LIS vendors are interested and expected to implement the initial version to publish LIVD mappings (manufacturers) and present the mappings in context of the LIS configuration process (LIS vendors). The initial version of the IG resulting from the For Comment ballot and connectathon will further inform the initial take-on by these parties. | ||
<!--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. --> | <!--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== | ==Content sources== | ||
| + | The LIVD Implementation Guide is based on the IICC whitepaper that describes an agreed to data set and format using JSON (not based on FHIR resource specifications) that is currently being published by various manufacturers. (WOULD BE GREAT TO PUT IN NAMES OF THOSE WHO HAVE DONE THAT). | ||
<!-- 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== | ||
| + | The primary scenario is for a manufacturer to post the LIVDBundle on a website and/or distribute it as part of their device documentation, upon which a consuming app will ingest the LIVDBundle and present it as they best see fit. | ||
<!-- Provide a listing of the types of scenarios to be represented in the examples produced for this IG. They should demonstrate the full scope of the IG and allow exercising of the IG's capabilities (all profiles, different types of applications, etc.) --> | <!-- Provide a listing of the types of scenarios to be represented in the examples produced for this IG. They should demonstrate the full scope of the IG and allow exercising of the IG's capabilities (all profiles, different types of applications, etc.) --> | ||
==IG Relationships== | ==IG Relationships== | ||
| + | None. | ||
<!-- Are there any IGs this resource depends on or that depend on this IG? --> | <!-- Are there any IGs this resource depends on or that depend on this IG? --> | ||
==Timelines== | ==Timelines== | ||
| + | The target is to provide an initial for comment ballot in September 2018, and based on feedback and connectathon experience have a second ballot in January 2019 to solidify content and enable maturation and refinement per FMM stages. | ||
<!-- Indicate the target date for having the IGcomplete from a committee perspective and ready for vetting and voting --> | <!-- Indicate the target date for having the IGcomplete from a committee perspective and ready for vetting and voting --> | ||
Revision as of 03:46, 3 August 2018
This page documents a Pending FHIR IG Proposal
Contents
- 1 LIVD Implementation Guide
- 1.1 Owning work group name
- 1.2 Committee Approval Date:
- 1.3 Contributing or Reviewing Work Groups
- 1.4 FHIR Development Project Insight ID
- 1.5 Scope of coverage
- 1.6 IG Purpose
- 1.7 Content location
- 1.8 Proposed IG realm and code
- 1.9 Maintenance Plan
- 1.10 Short Description
- 1.11 Long Description
- 1.12 Involved parties
- 1.13 Expected implementations
- 1.14 Content sources
- 1.15 Example Scenarios
- 1.16 IG Relationships
- 1.17 Timelines
- 1.18 When IG Proposal Is Complete
- 1.19 FMG Notes
LIVD Implementation Guide
Owning work group name
Orders & Observations YourWorkGroupName
Committee Approval Date:
August 3, 2018
Please enter the date that the committee approved this IGproposal
Contributing or Reviewing Work Groups
None.
- Work Group Name
- or link
- or "None"
FHIR Development Project Insight ID
Scope of coverage
The LIVD Implementation Guide addresses the ability for IVD device manufacturers to communicate for each of their devices the suggested mapping of the IVD (InVitro Diagnostic) Test Codes to one or more LOINC codes.
As the initial scope does not include for manufacturers to provide FHIR based service APIs, rather providing the relevant resources in a Bundle using some form of download/file transfer, the various operations otherwise necessary are not included. Future versions will address that scope.
The consuming application will present the data in a format and context suitable to those who configure devices to interact with a Laboratory Information System (LIS) to ensure the appropriate LOINC code is used when a result is communicated from the device to the LIS>
IG Purpose
The IG enables consistent expression of the suggested mappings using an industry standard that enables consistency across manufacturers, as well as enabling a path to service based APIs to provide access to these mappings.
Content location
Rob?
Proposed IG realm and code
uv/livd
Maintenance Plan
The community (manufacturers, FDA, CDC, LIS vendors, and others) is already progressing scope to address suggested mapping of non-quantitative results for the device. As these and other capabilities are being addressed and service based APIs are being implemented, subsequent versions of the guide will be developed to address these requirements.
Short Description
The LIVD Implementation Guide provides a industry standard expression for an IVD device manufacturer's suggestions for a specific device's mapping from the internal, proprietary IVD test codes to suggested LOINC codes when a LIS manager is connecting and configuring a device to the LIS.
Long Description
The LIVD Implementation Guide provides a industry standard expression for an IVD device manufacturer's suggestions for a specific device's mapping from the internal, proprietary IVD test codes to suggested LOINC codes when a LIS manager is connecting and configuring a device to the LIS.
As an LIS manager is configuring a device to be connected to the LIS, the suggested mappings can focus the LIS manager on the most likely LOINC codes to consider, thus enabling a choice relevant to the specific context of the device's use and purpose within the Laboratory that is more consistent across the industry.
Involved parties
The LIVD Implementation Guide is the result of a collaboration between representatives from the:
- IICC
- FDA
- CDC
- NLM
- CMS
- LIS vendors
- and other interested parties
Expected implementations
Device manufacturers and LIS vendors are interested and expected to implement the initial version to publish LIVD mappings (manufacturers) and present the mappings in context of the LIS configuration process (LIS vendors). The initial version of the IG resulting from the For Comment ballot and connectathon will further inform the initial take-on by these parties.
Content sources
The LIVD Implementation Guide is based on the IICC whitepaper that describes an agreed to data set and format using JSON (not based on FHIR resource specifications) that is currently being published by various manufacturers. (WOULD BE GREAT TO PUT IN NAMES OF THOSE WHO HAVE DONE THAT).
Example Scenarios
The primary scenario is for a manufacturer to post the LIVDBundle on a website and/or distribute it as part of their device documentation, upon which a consuming app will ingest the LIVDBundle and present it as they best see fit.
IG Relationships
None.
Timelines
The target is to provide an initial for comment ballot in September 2018, and based on feedback and connectathon experience have a second ballot in January 2019 to solidify content and enable maturation and refinement per FMM stages.
When IG Proposal Is Complete
When you have completed your proposal, please send an email to FMGcontact@HL7.org
