TY - JOUR
T1 - Flexible regulation for dynamic products? The case of applying principles-based regulation to medical products using artificial intelligence
AU - Johnson, Walter
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
U2 - 10.1080/17579961.2022.2113665
DO - 10.1080/17579961.2022.2113665
M3 - Article
VL - 14
SP - 205
EP - 236
JO - Law, Innovation and Technology
JF - Law, Innovation and Technology
SN - 1757-9961
IS - 2
ER -