Flexible Regulation for Dynamic Products? The Case of Applying Principles-Based Regulation to Medical Products Using Artificial Intelligence

Law, Innovation and Technology 14(2) (Forthcoming)

25 Pages Posted: 7 Jun 2021

See all articles by Walter G. Johnson

Walter G. Johnson

Arizona State University (ASU), Sandra Day O'Connor College of Law, Students; RegNet, Australian National University

Date Written: May 20, 2021

Abstract

Emerging technologies including artificial intelligence (AI) enable novel products to have dynamic and even self-modifying designs, challenging approval-based products regulation. This article uses a proposed framework by the US Food and Drug Administration (FDA) to explore how flexible regulatory tools, specifically principles-based regulation, could be used to manage ‘dynamic’ products. It examines the appropriateness of principles-based approaches for managing the complexity and fragmentation found in the setting of dynamic products in terms of regulatory capacity and accountability, balancing flexibility and predictability, and the role of third parties. The article concludes that successfully deploying principles-based regulation for dynamic products will require taking serious lessons from the global financial crisis on managing complexity and fragmentation while placing equity at the centre of the framework.

Keywords: artificial intelligence, flexible regulation, health technology, meta-regulation, principles-based regulation

Suggested Citation

Johnson, Walter G. and Johnson, Walter G., Flexible Regulation for Dynamic Products? The Case of Applying Principles-Based Regulation to Medical Products Using Artificial Intelligence (May 20, 2021). Law, Innovation and Technology 14(2) (Forthcoming), Available at SSRN: https://ssrn.com/abstract=3850968 or http://dx.doi.org/10.2139/ssrn.3850968

Walter G. Johnson (Contact Author)

RegNet, Australian National University ( email )

Canberra, Australian Capital Territory 2601
Australia

Arizona State University (ASU), Sandra Day O'Connor College of Law, Students ( email )

Box 877906
Tempe, AZ
United States

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