Kalodanis Konstantinos, Feretzakis Georgios, Rizomiliotis Panagiotis, Verykios Vassilios S, Papapavlou Charalampos, Koutsikos Ioannis, Anagnostopoulos Dimosthenis
Department of Informatics & Telematics, Harokopio University of Athens, Kallithea, Greece.
School of Science and Technology, Hellenic Open University, Patras, Greece.
Stud Health Technol Inform. 2025 Apr 8;323:66-70. doi: 10.3233/SHTI250050.
The integration of Artificial Intelligence (AI) into healthcare has the potential to revolutionize patient care, diagnostics, and treatment planning. However, this integration also introduces significant challenges related to data governance, privacy, and compliance with emerging regulations. The European Union's (EU) AI Act proposes a comprehensive regulatory framework aimed at ensuring that AI systems are trustworthy and respect fundamental rights. This paper provides an in-depth analysis of the data governance requirements stipulated by the EU AI Act specifically within the context of healthcare AI. Furthermore, it explores strategies for compliance, examines the interplay with existing regulations such as the General Data Protection Regulation (GDPR), and addresses the ethical considerations inherent in deploying AI in healthcare settings.
将人工智能（AI）整合到医疗保健领域有可能彻底改变患者护理、诊断和治疗规划。然而，这种整合也带来了与数据治理、隐私以及遵守新出现的法规相关的重大挑战。欧盟的《人工智能法案》提出了一个全面的监管框架，旨在确保人工智能系统是值得信赖的，并尊重基本权利。本文深入分析了欧盟《人工智能法案》规定的数据治理要求，特别是在医疗保健人工智能的背景下。此外，它还探讨了合规策略，研究了与现有法规（如《通用数据保护条例》（GDPR））的相互作用，并讨论了在医疗保健环境中部署人工智能所固有的伦理考量。
