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.
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
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:
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.
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
September 2018 Ballot Cycle (Comment Only Ballot)
January 2019 Ballot Cycle
May 2019 Ballot Cycle (STU 1 Ballot)
September 2019 Ballot Cycle
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 Date||Meeting Artifacts|
|June 29, 2018|
|July 10, 2018|
|July 11, 2018|
|July 17, 2018|
|July 24, 2018|
|July 31, 2018||Meeting Recording|
|August 14, 2018||Meeting Recording|
|August 21, 2018|
|August 28, 2018|
Link to the CRN IG: http://hl7.org/fhir/us/womens-health-registries/2018Sep/
|September 18, 2018||Meeting Notes|
|October 9, 2018|
|October 16, 2018||Current CRN HL7 Timeline|
|October 30, 2018|
|November 13, 2018|
|December 5, 2018|
|December 18, 2018|
|January 15, 2019|
|January 22, 2019|
|January 29, 2019|
|February 05, 2019|
|March 05, 2019|
|March 12, 2019|
****IG WG Meetings will resume in mid-May*****
|May 21, 2019|
|May 28, 2019|
|June 4, 2019|
|June 18, 2019|
|July 2, 2019|
|July 16, 2019|
|July 23, 2019|
|August 6, 2019|
****CRN Ballot Reconciliations are complete and the IG WG meetings have been cancelled. We thank everyone for their participation*****