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Background

The Federal Women’s Health Technologies (WHT) Coordinated Registry Network (CRN) project was created to create a strategically coordinated registry network for women’s health technologies that will collect patient reported outcomes and other related data from clinical care delivery systems including electronic health records (EHRs) to both enhance existing registries and enrich PCOR data infrastructure pertinent to women’s health conditions. The WHT CRN project focuses on women’s health as there are many clinical conditions that uniquely affect women (e.g., pelvic floor disorders, uterine fibroids, and female sterilization). The project aims to 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 using the 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. 

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 Woman’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

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