HealthIT Answers May 26, 2023

By Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research, FDA
Twitter: @US_FDA

Artificial intelligence (AI) and machine learning (ML) are no longer futuristic concepts; they are now part of how we live and work. The U.S. Food and Drug Administration uses the term AI to describe a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. ML is a subset of AI that uses data and algorithms, without being explicitly programmed, to imitate how humans learn.

AI/ML’s growth in data volume and complexity, combined with cutting-edge computing power and methodological advancements, have the potential to transform how stakeholders develop, manufacture, use, and...

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