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

37 Pages Posted: 11 Nov 2019

Date Written: October 30, 2019

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

Suggested Citation

Opderbeck, David W., Artificial Intelligence in Pharmaceuticals, Biologics, and Medical Devices: Present and Future Regulatory Models (October 30, 2019). Fordham Law Review, Vol. 88, 2019, Seton Hall Public Law Research Paper Forthcoming, Available at SSRN: https://ssrn.com/abstract=3478135

David W. Opderbeck (Contact Author)

Seton Hall Law School ( email )

One Newark Center
Newark, NJ 07102-5210
United States
973-642-8496 (Phone)

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