1. Artificial Intelligence and Healthcare: Products and Procedures

    Artificial Intelligence and Healthcare: Products and Procedures

    This paper focuses on statutory regulation of learning machines that qualify as medical devices. After a brief case study, the article takes a procedural perspective and presents the main features of the European regulatory framework that applies to medical devices in order to identify the regulatory peculiarities in the use of machine learning. In this context, the Chapter will analyse the immanent risks of machine learning applications as medical devices as well as the role of machine learning in their regulation. The overall finding is that due to its lack of expertise and material equipment the state activates private companies ...

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