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Difference between revisions of "CRN FHIR IG Proposal"

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This page documents a [[:category:Pending FHIR IGProposal|Pending]] [[:category:FHIR IG Proposal|FHIR IG Proposal]]
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This page documents a [[:category:Approved FHIR IG Proposal|Approved]] [[:category:FHIR IG Proposal|FHIR IG Proposal]]
 
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[[Category:FHIR IG Proposal]]
 
[[Category:FHIR IG Proposal]]
[[Category:Pending FHIR IG Proposal]]
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[[Category:Approved FHIR IG Proposal]]
  
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Approved 2018-08-08
  
 
<!-- For additional guidance on considerations for resource creation, refer to [[FHIR IG Considerations]] -->
 
<!-- For additional guidance on considerations for resource creation, refer to [[FHIR IG Considerations]] -->
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==Scope of coverage==
 
==Scope of coverage==
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The project is relevant to the following Women's Health Registries which include
 +
 +
* COMPARE-UF,
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* PFDR,
 +
* CREST !!! ,
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* AUGS,
 +
* SUFU and other Sterilization Registries.
 +
 +
These registries will be monitoring Women's Health on the use of devices and implants and other procedures for conditions such as Uterine Fibroids, Pelvic Floor Disorders, Mesh treatments and other sterilization therapies related to Women's Health.
  
 
The IG is going to use the following resources to enable CRN work
 
The IG is going to use the following resources to enable CRN work
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* Device
 
* Device
 
* US Core profiles
 
* US Core profiles
 
The project is relevant to the following Women's Health Registries which include COMPARE-UF, PFDR, CREST !!! , AUGS, Sterilization Registries.
 
 
These registries will be monitoring Women's Health on the use of devices and implants and other procedures for conditions such as Uterine Fibroids, Pelvic Floor Disorders, Mesh treatments and other sterilization therapies related to Women's Health.
 
  
 
==IG Purpose==
 
==IG Purpose==
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==Proposed IG realm and code==
 
==Proposed IG realm and code==
  
U.S
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us/womens-health-registries
  
 
==Maintenance Plan==
 
==Maintenance Plan==
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==Expected implementations==
 
==Expected implementations==
  
Registry Pilots expected. (AUGS, SUFU etc)
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Registry Pilots expected.  
 +
 
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* AUGS,  
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* SUFU etc.
  
 
==Content sources==
 
==Content sources==
  
SDC FHIR IG
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SDC FHIR IG profiles for Questionnaire  and QuestionnaireResponse as needed.
PRO FHIR IG
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 +
US Core profiles for clinical data as applicable and needed.
  
 
==Example Scenarios==
 
==Example Scenarios==
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==IG Relationships==
 
==IG Relationships==
  
SDC IG
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Reuse the SDC FHIR IG profiles for Questionnaire  and QuestionnaireResponse as needed.
US Core IG
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Reuse the PRO FHIR IG APIs for Administering an instrument and collecting data.
 +
 
 +
Reuse the US Core profiles for clinical data as applicable and needed.
  
 
==Timelines==
 
==Timelines==
  
Comment Only Ballot for Sep 2018 WG Cycle.
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Ballot for Comment in September 2018 Cycle
STU Ballot for Janu 2019 WG cycle.
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 +
STU Ballot in January 2019 Cycle
 +
 
 +
The project timelines are driven by the registries planning to establish their infrastructure for data collection. Some of them have established infrastructure but are evaluating efficient mechanisms to use data collected during clinical care by EHRs. The IG will provide a target infrastructure for  these registries that are getting setup from an interoperable technology stand point. Lack of an official IG impacts the infrastructure planning for pilots and downstream activities.
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 +
The pilots are expected to start in the later part of the year and provide feedback to be incorporated into the IG prior to September 2019 at which point a robust IG is expected to exist that is implemented by many of the registries.
  
 
==When IG Proposal Is Complete==
 
==When IG Proposal Is Complete==
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==FMG Notes==
 
==FMG Notes==
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* Would like the non-data element piece broken out into a separate implmentation guide in the future.  This is consistent with proposed FDA direction

Latest revision as of 04:51, 9 August 2018

Approved 2018-08-08


PutProposedIGNameHere

Womens Health Technology Coordinated Registry Network

Owning work group name

BR&R

Committee Approval Date:

2018-06-12

Contributing or Reviewing Work Groups

  • O&O
  • CIC

FHIR Development Project Insight ID

1426

Scope of coverage

The project is relevant to the following Women's Health Registries which include

  • COMPARE-UF,
  • PFDR,
  • CREST !!! ,
  • AUGS,
  • SUFU and other Sterilization Registries.

These registries will be monitoring Women's Health on the use of devices and implants and other procedures for conditions such as Uterine Fibroids, Pelvic Floor Disorders, Mesh treatments and other sterilization therapies related to Women's Health.

The IG is going to use the following resources to enable CRN work

  • Questionnaire
  • QuestionnaireResponse
  • Device
  • US Core profiles

IG Purpose

A landscape analysis of women’s health related registries have identified the lack of standardization in the capturing and exchange of data elements that can be used for multiple outcome research related use cases. The ability to link and query multiple registries will increase the effectiveness of the registries when used by researchers. In order to make this feasible, an interoperable standards-based platform is essential so that one can administer instruments*, collect data and exchange data from EHRs and other Health IT systems with Registries. In order to achieve this the following specific needs have been identified: • Identify and define data elements in a common format that will be used for defining the instrument. • Identify and outline the mechanisms to create data collection instruments based on standards. • Identify and outline the mechanisms to administer the instrument and collect the data. • Identify and outline the mechanisms to store and exchange the captured data with Registries and other Researchers. • Identify and outline mechanisms that can be used to link registries to increase the efficiencies and effectiveness.


Content location

https://github.com/HL7/coordinated-registry-network

Proposed IG realm and code

us/womens-health-registries

Maintenance Plan

The current funding for the project expires in September 2019.

The intention is to follow the US Core Model, where the IG is developed and piloted by the various registries and then working with BR&R and CCRF transfer the ownership of the IG to the relevant HL7 WG as it has long term implications and can be used by registries in general beyond Women's Health Registries.

Short Description

The purpose of the IG to provide the necessary guidance to use FHIR to build registries specific to monitoring Womens Health.

Long Description

A landscape analysis of women’s health related registries have identified the lack of standardization in the capturing and exchange of data elements that can be used for multiple outcome research related use cases. The ability to link and query multiple registries will increase the effectiveness of the registries when used by researchers. In order to make this feasible, an interoperable standards-based platform is essential so that one can administer instruments*, collect data and exchange data from EHRs and other Health IT systems with Registries. In order to achieve this the following specific needs have been identified: • Identify and define data elements in a common format that will be used for defining the instrument. • Identify and outline the mechanisms to create data collection instruments based on standards. • Identify and outline the mechanisms to administer the instrument and collect the data. • Identify and outline the mechanisms to store and exchange the captured data with Registries and other Researchers. • Identify and outline mechanisms that can be used to link registries to increase the efficiencies and effectiveness.


Involved parties

FDA

ONC

Expected implementations

Registry Pilots expected.

  • AUGS,
  • SUFU etc.

Content sources

SDC FHIR IG profiles for Questionnaire and QuestionnaireResponse as needed.

US Core profiles for clinical data as applicable and needed.

Example Scenarios

  • WHT Registries would like to collect various data elements related to Uterine Fibroids for women who have specific device implants over a period of time and use it for research purposes.

IG Relationships

Reuse the SDC FHIR IG profiles for Questionnaire and QuestionnaireResponse as needed.

Reuse the PRO FHIR IG APIs for Administering an instrument and collecting data.

Reuse the US Core profiles for clinical data as applicable and needed.

Timelines

Ballot for Comment in September 2018 Cycle

STU Ballot in January 2019 Cycle

The project timelines are driven by the registries planning to establish their infrastructure for data collection. Some of them have established infrastructure but are evaluating efficient mechanisms to use data collected during clinical care by EHRs. The IG will provide a target infrastructure for these registries that are getting setup from an interoperable technology stand point. Lack of an official IG impacts the infrastructure planning for pilots and downstream activities.

The pilots are expected to start in the later part of the year and provide feedback to be incorporated into the IG prior to September 2019 at which point a robust IG is expected to exist that is implemented by many of the registries.

When IG Proposal Is Complete

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

FMG Notes

  • Would like the non-data element piece broken out into a separate implmentation guide in the future. This is consistent with proposed FDA direction