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The EU AI Act’s Impacts on Digital Health

Authors :
Djeffal Christian
Mehl Philipp
Müller Verena
Source :
Current Directions in Biomedical Engineering, Vol 10, Iss 4, Pp 191-195 (2024)
Publication Year :
2024
Publisher :
De Gruyter, 2024.

Abstract

The European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This paper examines basic regulatory choices of the AI Act relevant for the field of digital health innovations by contextualizing its main goals, key obligations, and addressed actors. In light of these considerations, we present a scoping literature review that identifies potential regulatory challenges for stakeholders engaged in research, innovation and healthcare. Building on this, we point to concepts and methodologies to overcome such challenges in a way fostering innovation while realizing key constitutional and societal interests at the same time.

Details

Language :
English
ISSN :
23645504
Volume :
10
Issue :
4
Database :
Directory of Open Access Journals
Journal :
Current Directions in Biomedical Engineering
Publication Type :
Academic Journal
Accession number :
edsdoj.479d87f4f4c24ec695cd9652980e6fa1
Document Type :
article
Full Text :
https://doi.org/10.1515/cdbme-2024-2046