{"id":15981,"date":"2020-06-15T10:00:33","date_gmt":"2020-06-15T14:00:33","guid":{"rendered":"https:\/\/healthit-gov.go-vip.net\/buzz-blog\/?p=15981"},"modified":"2025-08-21T23:22:39","modified_gmt":"2025-08-21T23:22:39","slug":"pcor-coordinated-registry-network-for-womens-health-technologies","status":"publish","type":"post","link":"https:\/\/healthit.gov\/blog\/insights-updates\/pcor-coordinated-registry-network-for-womens-health-technologies\/","title":{"rendered":"PCOR Coordinated Registry Network for Women\u2019s Health Technologies"},"content":{"rendered":"\n<p>ONC recently <a href=\"https:\/\/healthit.gov\/wp-content\/uploads\/2025\/06\/Strategically-CRN-for-Womens-Health-Technologies.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">released results<\/a> from the Coordinated Registry Network for Women\u2019s Health Technologies project, a collaborative effort conducted with the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) to enable researchers to generate real-world evidence using data that address some women\u2019s health issues.<\/p>\n\n\n\n<p>The project\u2019s final report discusses the findings and lessons learned from development and testing of the <a href=\"https:\/\/build.fhir.org\/ig\/HL7\/coordinated-registry-network\">Women\u2019s Health Technologies Coordinated Registry Network FHIR\u00ae Implementation Guide<\/a>. The guide provides technical specifications and considerations for implementing a strategically coordinated registry network (CRN), including identifying the actors and technology for data exchange.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-enabling-research-across-registries\"><strong>Enabling Research Across Registries<\/strong><\/h2>\n\n\n\n<p>The use of <a href=\"https:\/\/www.fda.gov\/science-research\/science-and-research-special-topics\/real-world-evidence\">real-world data<\/a>\u2014information from many sources about a patient\u2019s health status and care\u2014enhances scientific research, post-market monitoring of approved interventions and technologies, healthcare decision making, and clinical study design. These data are increasingly stored in registries, which collect granular data at the point-of-care and information from multiple sources to create a robust data set for a specific disease or procedure or to track the performance of a medical device. However, the process of populating and extracting patient data stored in legacy registries to conduct research is often complex. Additionally, a lack of interoperability prevents linkages between legacy registries and other data sources.<\/p>\n\n\n\n<p>For example, physicians that conduct medical procedures for removal of fibroids or implantation of devices to treat pelvic floor disorders routinely collect information about the devices they use. By analyzing these data, which can include unique device identifiers across manufacturers, investigators may be able to rule out a manufacturing defect as the cause of a malfunction or conduct long-term follow-up studies about device performance.<\/p>\n\n\n\n<p>One way to address the challenges of accessing and using registry data is through a CRN, which can enable research across registries to study multiple interventions, better reflecting patients\u2019 experiences in the real world. The CRN concept relies on an interoperable set of common data elements that can be linked to other data sources, such as claims data, electronic health records, patient-reported outcomes, and other relevant sources.<\/p>\n\n\n\n<p>CRNs are part of a larger FDA strategy to develop the <a href=\"https:\/\/www.fda.gov\/about-fda\/cdrh-reports\/national-evaluation-system-health-technology-nest\">National Evaluation System for health Technology (NEST)<\/a>, and CRNs are also a strategic focus of <a href=\"https:\/\/www.mdepinet.net\/\">Medical Device Epidemiology Network Initiative<\/a> (MDEpiNet), which is a NEST network collaborator. CRNs and the data they enable access to play an important role in patient-centered outcomes research (PCOR). PCOR aims to produce scientific evidence on the effectiveness of prevention and treatment options with consideration of patients\u2019 preferences, values, and questions when making healthcare choices. In addition, the technology that enables CRNs supports a broader health IT infrastructure to improve interoperability and reduce the need for duplicative data collection efforts.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-establishing-a-women-s-health-crn\"><strong>Establishing a Women\u2019s Health CRN<\/strong><\/h2>\n\n\n\n<p>In 2017, ONC, FDA, and NIH\u2019s National Library of Medicine launched the Coordinated Registry Network for Women\u2019s Health Technologies project, which was funded by the <a href=\"https:\/\/aspe.hhs.gov\/patient-centered-outcomes-research-trust-fund-project-profiles\">Patient-Centered Outcomes Research Trust Fund<\/a>.<\/p>\n\n\n\n<p>The goals of this interagency project were (1) to establish a CRN that uses common data elements to assess technologies uniquely affecting women\u2019s health (e.g., long-acting reversible contraception, medical devices and treatments for conditions such as pelvic floor disorders and uterine fibroids) and (2) to develop tools to standardize and exchange data across multiple sources using health IT standards such as Health Level Seven International\u00ae (HL7\u00ae) Fast Healthcare Interoperability Resources\u00ae (FHIR\u00ae) specification.<\/p>\n\n\n\n<p>The project\u2019s Implementation Guide built upon existing specifications (<a href=\"https:\/\/www.hl7.org\/fhir\/us\/core\/\">U.S. Core Implementation Guide<\/a>, <a href=\"https:\/\/healthit.gov\/structured-data-capture-sdc\/\">Structured Data Capture<\/a>, <a href=\"https:\/\/healthit.gov\/patient-reported-outcomes-through-healthit-pro\/\">Patient-Reported Outcomes through Health IT<\/a>, and <a href=\"https:\/\/healthit.gov\/scientific-initiatives\/building-data-infrastructure-to-support-patient-centered-outcomes-research-pcor\/\/data-access-framework-daf\">Data Access Framework<\/a>) as well as technology such as application programming interfaces and mobile applications, giving users a base from which to tailor the technology to use cases beyond women\u2019s health technologies.<\/p>\n\n\n\n<p>To further advance the technical capability of registries to support FHIR\u00ae-enabled data exchange and adopt an interoperable framework, ONC announced an area of interest under the <a href=\"https:\/\/healthit.gov\/about\/funding-announcements\/leap-notice-of-funding\/\">Leading Edge Acceleration Projects (LEAP) in Health IT funding opportunity<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-s-next\"><strong>What\u2019s Next<\/strong><\/h2>\n\n\n\n<p>This project established a roadmap for building a CRN that FDA and MDEpiNet will continue to scale to enhance CRN maturity and the application of this model to multiple clinical areas. In addition, FDA will leverage this project\u2019s infrastructure for other use cases supporting future research and regulatory decision making, as outlined in the 21st Century Cures Act.<\/p>\n\n\n\n<p>Overall, the Coordinated Registry Network for Women\u2019s Health Technologies project illustrates the critical nature of partnerships in the generation of real-world evidence and the search for answers to complex and novel research questions that reflect the actual patient experience. We encourage you to leverage this project\u2019s findings and outputs to support interoperable data sharing for research, post-market surveillance, and clinical care using CRNs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ONC recently released results from the Coordinated Registry Network for Women\u2019s Health Technologies project, a [&hellip;]<\/p>\n","protected":false},"author":619,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_selected_menu":"","_show_breadcrumbs":"true","_blog_show_featured_image":false,"footnotes":""},"categories":[],"archived-category":[],"featured":[],"topics":[463,418,424],"class_list":["post-15981","post","type-post","status-publish","format-standard","hentry","topics-fhir","topics-interoperability","topics-scientific-initiatives"],"acf":{"blog_authors":[{"blog_author_profiles":"198684"},{"blog_author_profiles":"198696"},{"blog_author_profiles":"198695"},{"blog_author_profiles":"198667"}],"hp_news_hide":false},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.3 (Yoast SEO v24.8.1) - 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