Project Summary for Women’s Health Technology Coordinated Registry Network (CRN)
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Project Details
Number | 1426 View Ballot Items List (with NIBs) |
---|---|
Name | Women’s Health Technology Coordinated Registry Network (CRN) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | Clinical Interoperability Council Work Group, Orders and Observations Work Group |
Steering Division | Clinical |
Description | 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. |
Project Facilitator | Nagesh Bashyam / Martha Velezis / Rachael Roan/Richard Ballew |
Status | Active Project (Resources assigned to pjt) |
SD Approval Date | Jul 30, 2018 |
TSC Approval Date | Sep 27, 2018 |
Type | Ballot - STU to Normative |
Objectives / Deliverables | Submit for Comment Only Ballot - Target: 2018 August Ballot Complete Comment Only Ballot Reconciliation - Target: 2018 Sep WGM Submit for STU Ballot - Target: 2018 Nov Ballot Complete STU Ballot Reconciliation - Target: 2019 Jan WGM Submit for STU publication - Target: 2019 February STU Period - Target: 2019 May - 2020 May Submit for Normative Ballot - Target: 2020 April Complete Normative Ballot Reconciliation - Target: 2020 May WGM Submit for Publish Normative IG - Target: 2020 June |
Next Milestone Date | 2023 September WGM |
Project End Date | 2023 September WGM |
Project Intent | Implementation Guide |
Project Need | A landscape analysis of women’s health related registries have identified the lack of standardization in the capturing and exchange of data elements that can be used for multiple outcome research related use cases. The ability to link and query multiple registries will increase the effectiveness of the registries when used by researchers. In order to make this feasible, an interoperable standards-based platform is essential so that one can administer instruments*, collect data and exchange data from EHRs and other Health IT systems with Registries. In order to achieve this the following specific needs have been identified: - Identify and define data elements in a common format that will be used for defining the instrument. - Identify and outline the mechanisms to create data collection instruments based on standards. - Identify and outline the mechanisms to administer the instrument and collect the data. - Identify and outline the mechanisms to store and exchange the captured data with Registries and other Researchers. - Identify and outline mechanisms that can be used to link registries to increase the efficiencies and effectiveness. * FHIR Profiles of Questionnaire Resource will be used to create the data collection instruments for the project |
Implementers | 1) Still in the process of identification |
Security Risks | Don't Know |
External Drivers | None |
Common Names / Keywords/ Aliases | WHT (Woman’s Health Technology) CRN, Coordinated Registry Network |
Lineage | |
Dependancies | FHIR Release 4 publication. CCRF Work related to registries. |
Project Document Repository |
BR&R Confluence: http://confluence.hl7.org/pages/viewpage.action?pageId=19136854 |
Backwards Compatibility | N/A |
External Vocabularies | Don't Know |
Products | FHIR Implementation Guide |
Joint Copyright? | No |
External Pjt Collaborators | ONC, NIH, FDA. IMDRF (EU, Canada, Brazil, Japan, China, UK, South Korea, Taiwan, Russian Federation), GMDN, SNOMED, LOINC, CIIC Was the content externally developed (Y/N)? No, SDC FHIR IG. |
Realm | Realm Specific - Enter "U.S." or name of HL7 Affiliate below |
HL7 Affiliate | U.S. |
Stakeholders | Regulatory Agency, Standards Development Organizations (SDOs) |
Vendors | EHR, PHR; Health Care IT |
Providers | Local and State Departments of Health; Healthcare Institutions (hospitals, long term care, home care, mental health) |
Ballot Cycle Info | 2019 May Ballot Cycle Info: STU Ballot results: Did not meet basic vote requirements. 11 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Women’s Health Technology Coordinated Registry Network (CRN), Release 1 - US Realm 2018 Oct Ballot Cycle Info: COMMENT ONLY Ballot results: Did not meet basic vote requirements. 0 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Women’s Health Technology Coordinated Registry Network (CRN), Release 1 - US Realm |
Misc Notes | 2023 May: JDuteau: BRR to submit a withdrawal request. |
U.S. Govt Interest? | Yes |
USRSC Approval | Received |
FMG Approval | All Received |
ARB Approval | Not Needed |
Start Date | May 31, 2018 |
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