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Faculty of law, University of Kragujevac , Kragujevac , Serbia
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Faculty of law, University of Kragujevac , Kragujevac , Serbia
Faculty of law, University of Kragujevac , Kragujevac , Serbia
Artificial intelligence (AI) represents a global phenomenon changing all spheres of human life. Biomedical engineering is no exception, as many AI systems are applied to biomedical engineering inventions. The European Union has enacted the new EU AI Act, one of the world’s first laws on AI. The main topic of this research is to examine what changes this new regulation brings to AI development in the field of biomedical engineering. An AI system applied in biomedical engineering is often considered a high-risk AI system, which means that AI developers are bound by a set of requirements and obligations to achieve a trustworthy, human-centric AI system. The authors analyze the impact and appropriateness of these requirements for developing AI systems in biomedical engineering using the legal dogmatic method, as well as by analyzing the secondary sources in the literature. The authors aim to present the current situation in AI regulation and make suggestions for further development.
Formal Analysis, S.D.; Methodology, S.D.; Supervision, S.D. and N.I.; Writing – original draft, S.D., N.I. and N.M.; Conceptualization, N.I. and N.M.; Data curation, N.I. and N.M.; Project administration, N.I.; Resources, N.I.; Validation, N.I.; Investigation, N.M. All authors have read and agreed to the published version of the manuscript.
This study was not supported by any sponsor or funder.
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
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