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  5. Artificial Intelligence and Natural Language Processing
  1. CBER Biologics Effectiveness and Safety (BEST) System

Artificial Intelligence and Natural Language Processing

BEST is developing and validating innovative methods to obtain computable phenotypes of patients representing biologic product exposure/adverse event (AE) pairs from health records. The methods used include machine-learning, artificial intelligence, natural language processing, robotics, and other methods to develop and automatically generate post-market safety reports for CBER-regulated products. BEST developed a prototype for automating the detection, validation, and reporting of biologic product AEs. The prototype has features such as direct data access to electronic health records (EHR), AE detection through a flexible machine learning framework that can mine health data for adverse events, validation of AEs using a chart review tool, and semi-automated reporting of AE.

Tools

GitHub - FDA/Termset Generator

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