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CRN FHIR IG Proposal

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

  • Questionnaire
  • QuestionnaireResponse
  • Device
  • US Core profiles

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.

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

U.S

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 PRO FHIR IG

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

SDC IG US Core IG

Timelines

Comment Only Ballot for Sep 2018 WG Cycle. STU Ballot for Janu 2019 WG cycle.

When IG Proposal Is Complete

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

FMG Notes