On Jun. 15, 2020, the National Institutes of Health (NIH) announced it had launched a centralized, secure enclave to store and study vast amounts of medical record data from people diagnosed with coronavirus disease across the country. It is part of an effort, called the National COVID Cohort Collaborative (N3C), to help scientists analyze these data to understand the disease and develop treatments. This effort aims to transform clinical information into knowledge urgently needed to study COVID-19, including health risk factors that indicate better or worse outcomes of the disease, and identify potentially effective treatments.

The N3C is funded by the National Center for Advancing Translational Sciences (NCATS), part of NIH. The initiative will create an analytics platform to systematically collect clinical, laboratory and diagnostic data from health care provider organizations nationwide. It will then harmonize the aggregated information into a standard format and make it available rapidly for researchers and health care providers to accelerate COVID-19 research and provide information that may improve clinical care.

Data access will be open to all approved users, regardless of whether they contribute data. The data are being provided to NCATS as a Limited Data Set (LDS) that retains only two of 18 HIPAA-defined elements: patient zip code and dates of service.

NCATS, which is serving as stewards of the data, is taking multiple security and privacy measures. For example, NCATS oversees the use of N3C through user registration, federated login, data use agreements with institutions and data use requests with users. The data reside and remain in NCATS’ secure, cloud-based database certified through the Federal Risk and Authorization Management Program, or FedRAMP, which provides standardized assessment, authorization, and continuous monitoring for cloud products and services ensuring the validity of the data while protecting patient privacy. Approved users must analyze data within the platform. In addition, the N3C data will be used only for COVID-19 research purposes, including clinical and translational research and public health surveillance.

The platform is built to enable machine learning approaches and rigorous statistical analyses, identifying connections and patterns more quickly than can be done through traditional methodologies. These advanced analytics approaches require large, robust datasets to generate statistically valid results and can lead to the simultaneous exploration of multiple questions – and the revealing of likely answers – on a powerful scale.