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The AI Act is Coming: Are E-Health Manufacturers Ready?

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Machine Learning and Principles and Practice of Knowledge Discovery in Databases (ECML PKDD 2023)

Part of the book series: Communications in Computer and Information Science ((CCIS,volume 2133))

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Abstract

The Artificial Intelligence Act is on the verge of being published. It should be out by the end of 2023 or by the first semester of 2024 at the latest. Many innovations have been established relating to AI regulation, from the approach to AI ethics to AI classification on the market. But are manufacturers ready for the new rules that will possibly change the way their products access the EU market? This paper argues that there still are some uncertainties related to the interpretation of the new set of rules for AI. The main focus throughout the whole paper will be on the intersection with the Medical Device Regulation. What relation will be established between the Medical Device Regulation and the AI Act? To which obligation will manufacturers have to abide by? As the AI Act establishes a new set of rules for the AI systems, manufacturers of AI medical tools should be aware currently existing flaws of the innovative EU framework, even if in some cases they may be in their favour.

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Notes

  1. 1.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

  2. 2.

    Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

  3. 3.

    Proposal for a Regulation of the European Parliament and of the Council laying down harmonised ruled on Artificial Intelligence (Artificial Intelligence Act) and amending certain Union Legislative Acts. COM/2021/206.

  4. 4.

    Artificial Intelligence Act Proposal, COM(2021)206 final, Explanatory memorandum of the Artificial Intelligence Act, p.1 (2021).

  5. 5.

    Artificial Intelligence Act Proposal, COM(2021)206 final, recital 15 and 70.

  6. 6.

    Artificial Intelligence Act Proposal, COM(2021)206 final, recital 16.

  7. 7.

    “Scoring should only be used if there is a clear justification, and where measures are proportionate and fair. Normative citizen scoring (general assessment of “moral personality” or “ethical integrity”) in all aspects and on a large scale by public authorities or private actors endangers these values[...].".

  8. 8.

    Law Enforcement Directive (EU) 2016/680, Art. 10 (2016).

  9. 9.

    Artificial Intelligence Act Proposal, COM(2021)206 final, Recital 85.

  10. 10.

    As explained by Executive Vice-President Vestager at the press conference on fostering a European approach to Artificial Intelligence (Apr 2021), along with the “Pyramid of Risk" scheme introduced for AI systems.

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Authors and Affiliations

  1. Computer Science Department, University of Turin, Torino, Italy

    Marinella Quaranta & Ilaria Angela Amantea

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  1. Marinella Quaranta
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  2. Ilaria Angela Amantea
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Correspondence to Marinella Quaranta .

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Editors and Affiliations

  1. University of Turin, Turin, Italy

    Rosa Meo

  2. Sapienza University of Rome, Rome, Italy

    Fabrizio Silvestri

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Quaranta, M., Amantea, I.A. (2025). The AI Act is Coming: Are E-Health Manufacturers Ready?. In: Meo, R., Silvestri, F. (eds) Machine Learning and Principles and Practice of Knowledge Discovery in Databases. ECML PKDD 2023. Communications in Computer and Information Science, vol 2133. Springer, Cham. https://doi.org/10.1007/978-3-031-74630-7_26

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  • DOI: https://doi.org/10.1007/978-3-031-74630-7_26

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