Implications of the European Union's New Regulation on Artificial Intelligence (2024) on its Clinical Implementation (Preprint)

Abstract

<sec> <title>UNSTRUCTURED</title> On March 13, 2024, the Parliament sanctioned the inaugural comprehensive artificial intelligence (AI) statute globally. The European Union deems the governance of this technology as crucial, in light of potential infringements upon fundamental rights and public freedoms, detrimental impacts on the environment, and the integrity of democratic frameworks. Conversely, the undeniable advances in the medical domain necessitate the regulation of such technology to bolster investments and research, thereby providing the requisite legal certainty for users/patients, professionals, enterprises, and investors. The Regulation acknowledges the potential perils certain AI applications pose to fundamental rights, enacting prohibitions on practices such as biometric categorization, emotion recognition, and social scoring, among others. Nevertheless, the Regulation does not neglect the significance of medical research and, recognizing the imperative for support of new technologies and innovation, permits research with fewer constraints compared to the commercial use of AI algorithms in healthcare. </sec>

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