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10 Oslo L. Rev. 1 (2023-2024)

handle is hein.journals/oslo10 and id is 1 raw text is: Oslo Law Review j Universitetsforlaget Volume 10, No.1-2023, p.1-23 ISSN online: 2387-3299 SCIENTIFIC PUBLICATION DOI: https://do.org/10.18261/olr.10.1.1 Doctor Chatbot: The EU's Regulatory Prescription for Generative Medical Al Mathias Karlsen Hauglid Doctoral Research Fellow, Faculty of Law, UiT the Arctic University of Norway Norwegian Centre for Clinical Artificial Intelligence, University Hospital of Northern Norway mathias.khauQlid@uit.no Tobias Mahler Professor, Norwegian Research Center for Computers and Law, University of Oslo tobias.mahler@ ¾us.uioano Abstract This article analyses the EU's regulation of medical artificial intelligence (Al) from a product safety perspective, con- centrating on the interplay between the proposed Al Act (AIA) and the Medical Device Regulation (MDR). Recent advances in Al development illustrate the future potential of generative Al technologies, including those based on Large Language Models (LLMs). In a medical context, Al systems with different degrees of generativity are conceiva- ble. These Al systems can pose new types of risks that are specific to Al technologies, as well as more traditional risks that are typical of medical devices. The proposed AIA is intended to address AI-specific risks foreseen by the EU legis- lature, whereas the MDR addresses more traditional medical risks. Through two case studies which display different degrees of generativity, this article identifies regulatory lacunae in the intersection between the AIA and the MDR. The article suggests that the emerging regulatory framework for medical Al systems potentially leaves certain AI-specific risks as well as certain typical medical device risks unregulated. Finally, the article discusses possible solutions that are compatible with the intentions of the EU legislature pertaining to the regulation of medical Al systems. Keywords Al Act, medical devices, generative artificial intelligence, chatbots, large language models 1. Introduction In recent years, the development and use of technologies involving artificial intelligence (AI) has proliferated in the EU and internationally. In the health sector, the increased use of AI raises several legal and policy issues.1 With this article, we contribute to the discussion on the EU's regulation of medical AI from a product safety perspective. We focus on the EU's emerging product safety framework as it will exist after the future introduction of the 1. For example, the World Health Organization (WHO) discusses various issues in a guidance document: see World Health Organization, 'Ethics and governance of artificial intelligence for health: WHO guidance' (2021). Also, van Kolfschooten outlines potential impacts on patient rights: see Hannah van Kolfschooten, 'EU Regulation of Arti- ficial Intelligence: Challenges for Patients' Rights' (2022) 59(1) Common Market Law Review 81 <https://doi.org/ 10.54648/cola2022005>. Copyright © 2023 Author(s). This is an open access article distributed under the terms of the Creative Commons CC-BY 4.0 License (httns//creativecommonsorg/licensesbv/4.0).

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