Navigating the Frontiers of MedTech

Authors

Benjamin Sundholm, St. John's University School of LawFollow

Document Type

Article

Publication Title

Arizona State Law Journal

Publication Date

2024

Volume

56

First Page

1403

Abstract

The medical community is increasingly focused on the rise of adaptive and opaque artificial intelligence tools. These systems improve over time but produce results through complex calculations that are difficult for humans to fully understand. Although promising, these features challenge existing legal doctrines. To date, efforts to overcome these challenges have been too fragmented and limited in scope. As a result, the full promise of adaptive and opaque artificial intelligence systems remains untapped.

This Article proposes a framework for unleashing the potential of these systems through a blend of forward- and backward-looking reforms. The ex ante feature of my framework calls on the U.S. Food and Drug Administration revise its existing regulatory approach, which is too rigid and retrospective. Alternatively, the agency should adopt a more flexible and forward-looking model. The ex post feature of my proposal recognizes that, pursuant to Supreme Court precedent, medical tools approved through the sort of regulatory model I recommend are not guaranteed protection from civil liability. The specter of liability is a problem because existing tort doctrines are ill-equipped to handle harms caused by opaque artificial intelligence systems. To address these challenges, I propose leveraging common enterprise liability. Doing so would complement the ex ante regulatory reforms I suggest by ensuring the availability of an adequate ex post framework for responding to harms resulting from the use of these promising artificial intelligence systems.

Comments

Available at: https://arizonastatelawjournal.org/2025/01/08/navigating-the-frontiers-of-medtech/