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A blanket that leaves the feet cold : exploring the AI Act safety framework for medical AI

Sofia Palmieri (UGent) and Tom Goffin (UGent)
(2023) EUROPEAN JOURNAL OF HEALTH LAW. 30(4). p.406-427
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Abstract
The AI Act is based on, and at the same time aims to protect fundamental rights, implying their protection, while fulfilling the safety requirement prescribed by the AI Act within the whole lifecycle of AI systems. Based on a risk classification, the AI Act provides a set of requirements that each risk class must meet in order for AI to be legitimately offered on the EU market and be considered safe. However, despite their classification, some minimal risk AI systems may still be prone to cause risks to fundamental rights and user safety, and therefore require attention. In this paper we explore the assumption that despite the fact that the AI Act can find broad ex litteris coverage, the significance of this applicability is limited.
Keywords
AI Act, AI in healthcare, fundamental rights, MDR, medical AI, safety, patients rights

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MLA
Palmieri, Sofia, and Tom Goffin. “A Blanket That Leaves the Feet Cold : Exploring the AI Act Safety Framework for Medical AI.” EUROPEAN JOURNAL OF HEALTH LAW, vol. 30, no. 4, 2023, pp. 406–27, doi:10.1163/15718093-BJA10104.
APA
Palmieri, S., & Goffin, T. (2023). A blanket that leaves the feet cold : exploring the AI Act safety framework for medical AI. EUROPEAN JOURNAL OF HEALTH LAW, 30(4), 406–427. https://doi.org/10.1163/15718093-BJA10104
Chicago author-date
Palmieri, Sofia, and Tom Goffin. 2023. “A Blanket That Leaves the Feet Cold : Exploring the AI Act Safety Framework for Medical AI.” EUROPEAN JOURNAL OF HEALTH LAW 30 (4): 406–27. https://doi.org/10.1163/15718093-BJA10104.
Chicago author-date (all authors)
Palmieri, Sofia, and Tom Goffin. 2023. “A Blanket That Leaves the Feet Cold : Exploring the AI Act Safety Framework for Medical AI.” EUROPEAN JOURNAL OF HEALTH LAW 30 (4): 406–427. doi:10.1163/15718093-BJA10104.
Vancouver
1.
Palmieri S, Goffin T. A blanket that leaves the feet cold : exploring the AI Act safety framework for medical AI. EUROPEAN JOURNAL OF HEALTH LAW. 2023;30(4):406–27.
IEEE
[1]
S. Palmieri and T. Goffin, “A blanket that leaves the feet cold : exploring the AI Act safety framework for medical AI,” EUROPEAN JOURNAL OF HEALTH LAW, vol. 30, no. 4, pp. 406–427, 2023.
@article{01HPP0SN0D70P1Z6GJD1SZE5CJ,
  abstract     = {{The AI Act is based on, and at the same time aims to protect fundamental rights, implying their protection, while fulfilling the safety requirement prescribed by the AI Act within the whole lifecycle of AI systems. Based on a risk classification, the AI Act provides a set of requirements that each risk class must meet in order for AI to be legitimately offered on the EU market and be considered safe. However, despite their classification, some minimal risk AI systems may still be prone to cause risks to fundamental rights and user safety, and therefore require attention. In this paper we explore the assumption that despite the fact that the AI Act can find broad ex litteris coverage, the significance of this applicability is limited.}},
  author       = {{Palmieri, Sofia and Goffin, Tom}},
  issn         = {{0929-0273}},
  journal      = {{EUROPEAN JOURNAL OF HEALTH LAW}},
  keywords     = {{AI Act,AI in healthcare,fundamental rights,MDR,medical AI,safety,patients rights}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{406--427}},
  title        = {{A blanket that leaves the feet cold : exploring the AI Act safety framework for medical AI}},
  url          = {{http://doi.org/10.1163/15718093-BJA10104}},
  volume       = {{30}},
  year         = {{2023}},
}

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