Artificial Intelligence in medicine: an introduction to the AI Act approach to regulating the matter

Authors

  • Silvia Stefanelli National Agency for Artificial Intelligence Author

DOI:

https://doi.org/10.82015/NNR.2025.100109

Keywords:

AI Act; GPAI; Risk Based Approach; General purpose ai codes of conduct; High risk ai systems.

Abstract

The document addresses issues related to general artificial intelligence, with a specific focus on regulatory, ethical, and technological implications. It analyzes the main risks associated with the adoption of generative AI models, including aspects of security, transparency, and data protection. Particular attention is paid to the European regulatory framework, with reference to the AI Act and the General-purpose AI Code of Practice. The text also proposes guidelines for responsible AI governance, suggesting interdisciplinary approaches that balance innovation and the protection of fundamental rights. Finally, it discusses future scenarios and strategies for mitigating the systemic risks associated with rapid developments in AI technology.

Author Biography

  • Silvia Stefanelli, National Agency for Artificial Intelligence

    Lawyer, admitted to practice before the Supreme Court of Cassation and founder of the law firm Stefanelli &
    Stefanelli. She specializes in healthcare law, with particular expertise in digital healthcare, medical
    devices, healthcare advertising, public administration contracts, data protection, and artificial
    intelligence.

    Email: [email protected].

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Cover

Published

2025-11-18

How to Cite

Artificial Intelligence in medicine: an introduction to the AI Act approach to regulating the matter. (2025). Neuralnexux, 1(1), 125-151. https://doi.org/10.82015/NNR.2025.100109

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