Winkler Philipp W, Zsidai Bálint, Hamrin Senorski Eric, Pruneski James A, Hirschmann Michael T, Ley Christophe, Tischer Thomas, Herbst Elmar, Pareek Ayoosh, Musahl Volker, Oeding Jacob F, Oettl Felix C, Longo Umile Giuseppe, Samuelsson Kristian, Feldt Robert
Department for Orthopaedics and Traumatology Kepler University Hospital GmbH, Johannes Kepler University Linz Linz Austria.
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy University of Gothenburg Gothenburg Sweden.
J Exp Orthop. 2025 Apr 24;12(2):e70247. doi: 10.1002/jeo2.70247. eCollection 2025 Apr.
Artificial intelligence (AI) has been influencing healthcare and medical research for several years and will likely become indispensable in the near future. AI is intended to support healthcare professionals to make the healthcare system more efficient and ultimately improve patient outcomes. Despite the numerous benefits of AI systems, significant concerns remain. Errors in AI systems can pose serious risks to human health, underscoring the critical need for safety, as well as adherence to ethical and moral standards, before these technologies can be integrated into clinical practice. To address these challenges, the development, certification, and deployment of medical AI systems must adhere to strict and transparent regulations. The European Commission has already established a regulatory framework for AI systems by enacting the European Union Artificial Intelligence Act. This review article, part of an AI learning series, discusses key considerations for medical AI systems such as reliability, accuracy, trustworthiness, lawfulness and legal compliance, ethical and moral alignment, sustainability, and regulatory oversight.
Level V.
人工智能（AI）多年来一直在影响医疗保健和医学研究，并且在不久的将来可能会变得不可或缺。人工智能旨在支持医疗保健专业人员，使医疗系统更高效，并最终改善患者的治疗效果。尽管人工智能系统有诸多好处，但仍存在重大问题。人工智能系统中的错误可能对人类健康构成严重风险，这凸显了在这些技术融入临床实践之前，确保安全以及遵守伦理和道德标准的迫切需求。为应对这些挑战，医疗人工智能系统的开发、认证和部署必须遵守严格且透明的法规。欧盟委员会已通过颁布《欧盟人工智能法案》，为人工智能系统建立了监管框架。这篇综述文章是人工智能学习系列的一部分，讨论了医疗人工智能系统的关键考量因素，如可靠性、准确性、可信度、合法性和法律合规性、伦理和道德一致性、可持续性以及监管监督。
V级。
