Artificial Intelligence in Pharmaceuticals, Biologics, and Medical Devices: Present and Future Regulatory Models

Abstract

This Essay surveys the current legal and economic framework for drugs, biologics, and medical devices in the United States, and discusses some ways in which AI might disrupt that framework. It examines emerging policies at the FDA for in silico trials — trials conducted by computer models, often involving AI technologies — and AI-enabled medical devices. It also discusses how AI might stretch those policies over the next ten to twenty years and takes a speculative look at AI-enabled
drugs and devices in the year 2050.

Keywords: Artificial Intelligence, AI, big data, convergence, intellectual property, privacy, cybersecurity