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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)

Implementation Guide Development Workgroup (WG)

The purpose of the WG is to discuss technical solutions for the CRN project and to create the CRN Implementation Guide that will be balloted with HL7. 

Weekly on Tuesday's from 2:00-3:00 pm ET

URL: https://esacinc.webex.com/esacinc/j.php?MTID=mf8cd921a3ebb603e7324876f1923ec35
Meeting number: 737 813 166
Meeting password: WHTCRN
Audio connection: +1-415-655-0001 US TOLL
Access code: 737 813 166

This meeting is open to anyone interested in working on the HL7 CRN project. If you or someone you know would like to be added to the meeting invite, please e-mail abdullah.rafiqi@esacinc.com





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