Biologics Effectiveness and Safety (BEST) Initiative - New and Innovative Methods for Automated Reporting

Provide FDA with indirect access to large-scale United States (US) health care data of millions of patients including administrative and claims as well as electronic health records (EHR) data sources. The data will be used to develop new or improved automated adverse events data collection and analysis techniques by using methods such as natural language processing, artificial intelligence, machine learning and others to conduct more sophisticated surveillance and automated adverse event reporting for CBER-Regulated Products.