Regenstrief Institute, Indiana Clinical and Translational Sciences Institute (CTSI) and Datavant are 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.
Supported by a contract from the NIH, 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, 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 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.
“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., M.S., president and chief executive officer 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.” Dr. Embí also serves as associate director of the Indiana CTSI.
Umberto Tachinardi, M.D., MSc, 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., M.S., 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, a critical component of the Honest Data Broker solution.
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 created solutions that will enable the linking of data from different sources without the identifiers, improving 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.
Datavant provides the privacy-preserving record linkage (PPRL) technology which underpins de-identified data contributions to the NIH COVID-19 Data Warehouse, including the N3C, ensuring patient records are shared safely, securely, and privately in compliance with de-identification standards. De-identified data linkages within and with the N3C will address the challenges of assembling comprehensive patient records in large-scale clinical research due to care fragmentation and data fragmentation.
“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.”
This work is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number U24TR002306 and individual CTSA Program grants under PAR-18-940, PAR-18-464, PAR-15-304, RFA-TR-14-009.
In addition to NCATS, other NIH support for the N3C comes from the National Cancer Institute, the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of General Medical Sciences.
About Regenstrief Institute
Founded in 1969 in Indianapolis, the Regenstrief Institute is a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.
Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute’s research mission.
About Indiana CTSI
The Indiana Clinical and Translational Sciences Institute (CTSI) is a statewide institute supported by a Clinical and Translational Science Award from the National Institutes of Health’s (NIH) and the National Center for Advancing Translational Science.
Indiana CTSI has research partnerships with Indiana University, Purdue University, and the University of Notre Dame which also includes life sciences, businesses and community organizations. Furthermore, Indiana CTSI engages with the public at every level of research from basic science to patient care.
Datavant’s mission is to connect the world’s health data to improve patient outcomes. Datavant works to reduce the friction of data sharing across the healthcare industry by building technology that protects the privacy of patients while supporting the linkage of de-identified patient records across datasets. Datavant is headquartered in San Francisco. Learn more about Datavant at www.datavant.com.
Peter Embí, M.D., M.S.
In addition to serving as the president and CEO of Regenstrief Institute, Peter Embí, M.D., M.S. is the Leonard Betley Professor of Medicine and associate dean for informatics and health services research at Indiana University School of Medicine, associate director of informatics with Indiana Clinical and Translational Sciences Institute and vice president for Learning Health Systems with Indiana University Health.
Shaun Grannis, M.D., M.S.
In addition to his role as the vice president of data and analytics at Regenstrief Institute, Shaun Grannis, M.D., M.S., is the Regenstrief Chair in Medical Informatics and a professor of family medicine at Indiana University School of Medicine.
Umberto Tachinardi, M.D., MSc
In addition to being the chief information officer at Regenstrief Institute, Umberto Tachinardi, M.D., MSc, is the director of clinical research informatics for Regenstrief and the Indiana Clinical and Translational Sciences Institute and the chief informatics officer for the Indiana University Grand Challenge Precision Health Initiative. He is also the assistant dean for clinical informatics and a professor of biostatistics at Indiana University School of Medicine.
Cindy Fox Aisen