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

Walter G. Johnson*

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    1 Citation (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)205-236
    Number of pages32
    JournalLaw, Innovation and Technology
    Volume14
    Issue number2
    DOIs
    Publication statusPublished - 2022

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