Regenstrief, Indiana CTSI, Datavant Team Up for NIH National COVID-19 Data Effort
A group of healthcare stakeholders has announced it is supporting the National Institutes of Health (NIH) in a national effort to securely gather data to help scientists understand and develop treatments for COVID-19.
The National COVID Cohort Collaborative (N3C) was launched as a centralized analytics platform to store and study vast amounts of medical record data from people tested for the virus. The N3C is a partnership among the National Center for Data to Health (CD2H) and National Center for Advancing Translational Sciences (NCATS)-supported Clinical and Translational Science Awards (CTSA) Program hubs, with stewardship by NCATS.
Specifically, the N3C aims to enable the rapid collection and analysis of clinical, laboratory and diagnostic data from hospitals and health plans. If successful, officials believe this approach will be applicable to other research questions and may serve as a model for addressing future public health emergencies. Back in July, after three months of rapid development work, the Cohort Collaborative said it was getting ready to open its enclave to researchers.
Now, Regenstrief Institute, the Indiana Clinical and Translational Sciences Institute (CTSI) and health data company Datavant are supporting NIH in this initiative. Backed by a contract from the NIH, the Indianapolis-based research organization Regenstrief will serve as the national project's Honest Data Broker, using specialized technologies and processes to create more complete and informative data sets.
Specifically, officials noted in a recent press release, the Honest Data Broker will handle requests for data and manage a process referred to as "privacy-preserving record linkage" (PPRL) using technologies and approaches that will aim to help ensure N3C data are shared safely, securely and privately, all in compliance with HIPAA standards. Such de-identified linkages of N3C data will help to address the challenges of securely assembling patient-level data that is traditionally fragmented and difficult to use across large-scale clinical research efforts, according to officials.
The N3C collects data from healthcare systems from across the U.S. and stores it in a secure enclave developed by the NCATS N3C Consortium. The data goes to the enclave without patient identifiers to maintain privacy, which usually prevents linkage. Regenstrief, Datavant and Indiana CTSI have created solutions that will enable the linking of data from different sources without the identifiers, which the group’s leaders believe will improve the quality and completeness of the information while still protecting patient identities. This process will make data more useful to researchers as they work to understand the virus and develop solutions to address it, leaders of the project say.
Datavant provides the privacy-preserving record linkage technology which underpins de-identified data contributions to the NIH COVID-19 Data Warehouse, including the N3C, aiming to ensure that the patient records are shared safely, securely, and privately in compliance with de-identification standards. De-identified data linkages within and with the N3C will look to address the challenges of assembling comprehensive patient records in large-scale clinical research due to care fragmentation and data fragmentation.
"We are proud to be selected as the N3C Honest Data Broker and of the recognition of the excellence of Regenstrief and our partners in trusted data management and stewardship," said Peter Embí, M.D., president and CEO of Regenstrief Institute and co-leader of the initiative. "This data project will provide great insight into the current pandemic and has the potential to change and improve how large-scale clinical research is conducted." Embí also serves as associate director of the Indiana CTSI.
Umberto Tachinardi, M.D., chief information officer for the Regenstrief Institute and director of informatics for Regenstrief and Indiana CTSI, led the development of the awarded contract proposal and is now the director of the N3C Honest Data Broker solution. Shaun Grannis, M.D., Regenstrief vice president for data and analytics and professor at Indiana University School of Medicine, is the scientific director and the domain expert for patient matching, which officials see as a critical component of the Honest Data Broker solution.
"We are honored to partner with the Regenstrief Institute and the Indiana CTSI in serving the NIH to advance medical research on COVID-19. The N3C initiative is an unprecedented open science effort that consolidates our nation's research response to the pandemic," said Travis May, co-founder and chief executive officer of Datavant. "The Datavant team has longstanding research collaborations with Drs. Embí, Tachinardi, and Grannis, and we look forward to their leadership as we embark on this impactful initiative."
