Artificial intelligence and healthcare: Products and procedures

Abstract

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 for market access control, which are commissioned with the preventive inspection of medical devices. As a result, security measures adopted by the authority are in principle limited to the period after market-entry. This leads to a structural information deficit for the authority, which has no systematic information about the products on the market. The authority is limited to a challenging overall market observation. This raises the question addressed in the fifth part of the paper: does the law guarantee sufficient instruments for the systematic transfer of knowledge from the risk actors to the authority about the potential risk of medical devices and does this in fact remedy the information deficit of the authority and ensure an effective post market-entry control of learning machines as medical devices?.