Flexible regulation for dynamic products? The case of applying principles-based regulation to medical products using artificial intelligence

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 t...

Full description

Saved in:
Bibliographic Details
Published in:Law, innovation and technology innovation and technology, 2022-07, Vol.14 (2), p.205-236
Main Author: Johnson, Walter G.
Format: Article
Language:English
Subjects:
Artificial intelligence
Complexity
flexible regulation
Fragmentation
health technology
meta-regulation
New technology
Principles
principles-based regulation
Regulatory agencies
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1757-9961
1757-997X
DOI:10.1080/17579961.2022.2113665