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Background

The federal Women’s Health Technologies (WHT) Coordinated Registry Network (CRN) project aims to create a set of linked registries focused on women’s health through the use of data elements and measures expressed in standard structured definitions. It will also allow for the capability to capture and exchange data using national standards and the ability to support interoperability with other data sources via software apps and application programming interfaces (APIs), including those related to a unique device identifier (UDI). These linked registries would be valuable to researchers to design studies that are reflective of the real-world combination of multiple therapies. 

To learn more about the CRN project, download the Environmental Assessment and Pilot Analysis located here.

Scope

Clinical registries record information about the health status of patients and the health care they receive over varying periods of time. Registries can include data on patients receiving treatment involving medical devices. Registries also provide critical infrastructure that can be used for a variety of analyses related to patient care and outcomes. There are clinical conditions that uniquely affect women (e.g., pelvic floor disorders, uterine fibroids, and female sterilization). A consortium of registries focused on women’s health using data elements and measures expressed in standard structured definitions with the capability to capture and exchange data via software apps and application programming interfaces (APIs) including those related to a unique device identifier (UDI) would be valuable to researchers beyond what can be accomplished in a single registry. Currently researchers are not able to design studies that are reflective of the real-world combination of multiple therapies. The effort to be undertaken under the statement of work for this coordinated registry network project is leveraging the relationships of the federal partnerships to test the building of an infrastructure examining many clinical conditions that uniquely affect women (e.g., pelvic floor disorders, uterine fibroids, and female sterilization).

From a standards perspective, the project will outline the mechanisms that can be used to capture and exchange

  • Common or core data elements related to women’s health collected as part of the clinical care delivery eco-system

Specifically, the project will examine how to use the following FHIR Resources and IG’s to facilitate collection and exchange of data elements related to women’s health using the following:

  • Questionnaire
  • Questionnaire Response 
  • Device
  • Observations specific to Women’s Health
  • US-Core profiles and IG
  • Structured Data Capture IG

The Questionnaire and Questionnaire Response profiles will likely be used for administering data collection instruments related to women’s health. Any extensions that may be necessary for the project will be part of the overall profiles developed. Device Resources will be used to capture UDI and other Device related data and Observation will be used to capture observations collected during the care delivery.

For other clinical data that may be used for auto-population or exchanging CRN data within the context of EHRs the US Core FHIR profiles will be reused.

HL7 Sponsors

Primary: Biomedical Research and Regulation (BR&R) approved on 6/12
Co-Sponsors: Orders and Observation (O&O) approved on 5/3 and Clinical Interoperability Council (CIC) approved on 4/26

HL7 Artifacts

September 2018 Ballot Cycle (Comment Only Ballot)

January 2019 Ballot Cycle

May 2019 Ballot Cycle (STU 1 Ballot)

September 2019 Ballot Cycle

  • Atlanta WGM CRN BR&R WG Update: 

Implementation Guide Development Workgroup (WG)

We thank everyone for their participation in the CRN HL7 activities and for attending the IG WG calls. Now that we have reconciled all the CRN ballot comments, we have cancelled the IG WG calls and provide any further updates (as necessary) during the HL7 BR&R WG meetings.


Meeting DateMeeting Artifacts
June 29, 2018

WG Kickoff Presentation

Meeting Recording

Meeting Notes

July 10, 2018

Meeting Recording

Meeting Notes

July 11, 2018

Meeting Recording

Meeting Notes

July 17, 2018

Meeting Recording

Meeting Notes

CRN Working Group Variables

FDA Device Data Elements Template

July 24, 2018

Meeting Presentation

Meeting Recording

July 31, 2018Meeting Recording
August 14, 2018Meeting Recording
August 21, 2018

Meeting Recording

Current HL7 Timeline

August 28, 2018

Link to the CRN IG: http://hl7.org/fhir/us/womens-health-registries/2018Sep/

Meeting Recording: Walkthrough of CRN IG

Current CRN HL7 Timeline

September 18, 2018Meeting Notes
October 9, 2018

Meeting Recording

Current CRN HL7 Timeline

October 16, 2018Current CRN HL7 Timeline
October 30, 2018
November 13, 2018

Current CRN HL7 Timeline

Meeting Recording

Meeting Notes

December 5, 2018
December 18, 2018
January 15, 2019

Current CRN HL7 Timeline

Meeting Recording

Meeting Notes

January 22, 2019

Current CRN HL7 Timeline

Meeting Recording

Meeting Notes

January 29, 2019

Current CRN HL7 Timeline

Meeting Recording

Meeting Notes

February 05, 2019

Current CRN HL7 Timeline

Meeting Recording

Meeting Notes

March 05, 2019

Current CRN HL7 Timeline

Meeting Recording

Meeting Notes

March 12, 2019

Current CRN HL7 Timeline

Meeting Recording

Meeting Notes

BR&R WG Notes-Approval of Ballot

****IG WG Meetings will resume in mid-May*****

May 21, 2019

Meeting Recording

Meeting Notes

May 28, 2019

Meeting Recording

Meeting Notes

June 4, 2019

Meeting Recording

Meeting Notes

June 18, 2019

Meeting Recording

Meeting Notes

July 2, 2019

Meeting Recording

Meeting Notes

July 16, 2019

Meeting Recording

Meeting Notes

July 23, 2019

Meeting Recording

Meeting Notes

August 6, 2019

Meeting Notes

****CRN Ballot Reconciliations are complete and the IG WG meetings have been cancelled. We thank everyone for their participation*****




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