Women’s Health Technology Coordinated Registry Network (CRN)

The federal Women’s Health Technologies (WHT) Coordinated Registry Network (CRN) project will create a set of linked 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). This CRN 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 for this coordinated registry network project will leverage 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 implementation guides (IG’s) to facilitate collection and exchange of data elements related to women’s health using Questionnaire; Questionnaire Response; Device; Observations specific to Women’s Health; US-Core profiles and IG and the 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.