Developing a Strategically Coordinated Registry Network (CRN) for Women’s Health Technology

Aligning existing registries of women’s health technologies through a Coordinated Registry Network and creating an infrastructure for evaluating medical devices in clinical areas unique to women.
Agency
  • Food and Drug Administration (FDA)
  • National Institutes of Health's National Library of Medicine (NIH/NLM)
  • Office of the National Coordinator for Health Information Technology (ONC)
Start Date
  • 2/15/2017
Functionality
  • Standardized Collection of Standardized Data

 

STATUS: Active Project

BACKGROUND

Clinical registries collect and maintain detailed clinical data on millions of patients receiving treatment involving medical devices. Registries also provide critical infrastructure that can be used for future analyses related to patient care and outcomes. There are clinical conditions that uniquely affect women (e.g., pelvic floor disorders, uterine fibroids, and elective 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) would be valuable to researchers beyond what can be accomplished in a single registry.

A number of federal partners have already begun work on registries to establish data collection and analysis infrastructure that provides a basis for postmarked surveillance of medical devices and for development of evidence to support medical device innovation. The data sets, methods, and tools developed are already being used for quality benchmarking, coverage decisions, and comparative effectiveness research. Three such registries will be the focus of the CRN for Women’s Health Technology. These registries include the National Pelvic Floor Disorder (NPFD) registry, the COMPARE UF registry for fibroid treatments and the Collaborative Registry of Sterilization Therapies.

PROJECT PURPOSE & GOALS

This collaborative project with FDA, ONC, and NLM will align existing registries of women’s health technologies through a Coordinated Registry Network (CRN). The registry network will include two existing nationwide registries: (1) COMPARE UF registry for fibroid treatments; (2) the National Pelvic Floor Disorder (NPFD) registry; and (3) the new Collaborative Registry of Sterilization Therapies. These registries will be linked to other major data networks including partners in the FDA’s Sentinel system, Medicare, and Medicaid data, PCORnet clinical data networks, and available state data. The CRN will incorporate data from patient reported outcomes (PRO’s) and employ HL7 Fast Healthcare Interoperability Resource (FHIR) standards for Structured Data Capture (SDC) from EHRs, to both enhance these registries and enrich PCOR data infrastructure used to treat or manage women’s health conditions. This resource will serve as infrastructure for evaluation of medical devices in clinical areas unique to women. The project is expected to reduce the complexity and certain costs of conducting comparative effectiveness research, and it will inform the evaluation of therapy combinations within defined cohorts of women.

There are two major aims for this project:

  • Establish a CRN for research on Women’s Health Technologies by developing a community of stakeholders interested in working together to make system changes in an area of women’s health device safety and effectiveness.
  • Develop tools to facilitate collection of data within registries, improve the value and sustainability of registries through leveraging electronic data, and demonstrating that the data in the registries can be reused to answer additional questions through the addition of new data elements and patient cohorts.