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The European Legal Framework for Medical AI

Abstract : In late February 2020, the European Commission published a White Paper on Artificial Intelligence (AI) and an accompanying report on the safety and liability implications of AI, the Internet of Things (IoT) and robotics. In its White Paper, the Commission highlighted the “European Approach” to AI, stressing that “it is vital that European AI is grounded in our values and fundamental rights such as human dignity and privacy protection”. It also announced its intention to propose EU legislation for “high risk” AI applications in the nearer future which will include the majority of medical AI applications.Based on this “European Approach” to AI, this paper analyses the current European framework regulating medical AI. Starting with the fundamental rights framework as clear guidelines, subsequently a more in-depth look will be taken at specific areas of law, focusing on data protection, product approval procedures and liability law. This analysis of the current state of law, including its problems and ambiguities regarding AI, is complemented by an outlook at the proposed amendments to product approval procedures and liability law, which, by endorsing a human-centric approach, will fundamentally influence how medical AI and AI in general will be used in Europe in the future.
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https://hal.inria.fr/hal-03414719
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Submitted on : Thursday, November 4, 2021 - 3:56:40 PM
Last modification on : Friday, September 30, 2022 - 9:32:08 AM
Long-term archiving on: : Saturday, February 5, 2022 - 7:06:24 PM

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Distributed under a Creative Commons Attribution 4.0 International License

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David Schneeberger, Karl Stöger, Andreas Holzinger. The European Legal Framework for Medical AI. 4th International Cross-Domain Conference for Machine Learning and Knowledge Extraction (CD-MAKE), Aug 2020, Dublin, Ireland. pp.209-226, ⟨10.1007/978-3-030-57321-8_12⟩. ⟨hal-03414719⟩

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