Moulaei Khadijeh, Akhlaghpour Saeed, Fatehi Farhad
Health Management and Economics Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Iran; Artificial Intelligence in Medical Sciences Research Center, Smart University of Medical Sciences, Tehran, Iran.
School of Business, The University of Queensland, Brisbane, Australia.
Int J Med Inform. 2025 Jun;198:105872. doi: 10.1016/j.ijmedinf.2025.105872. Epub 2025 Mar 8.
BACKGROUND: The secondary use of health data for training Artificial Intelligence (AI) models holds immense potential for advancing medical research and healthcare delivery. However, ensuring patient consent for such utilization is paramount to uphold ethical standards and data privacy. Patient informed consent means patients are fully informed about how their data will be collected, used, and protected, and they voluntarily agree to allow their data to be used for AI models. In addition to formal consent frameworks, establishing a social license is critical to foster public trust and societal acceptance for the secondary use of health data in AI systems. This study examines patient consent practices in this domain. METHOD: In this scoping review, we searched Web of Science, PubMed, and Scopus. We included studies in English that addressed the core issues of interest, namely, privacy, security, legal, and ethical issues related to the secondary use of health data in AI models. Articles not addressing the core issues, as well as systematic reviews, meta-analyses, books, letters, conference abstracts, and study protocols were excluded. Two authors independently screened titles, abstracts, and full texts, resolving disagreements with a third author. Data was extracted using a data extraction form. RESULTS: After screening 774 articles, a total of 38 articles were ultimately included in the review. Across these studies, a total of 178 barriers and 193 facilitators were identified. We consolidated similar codes and extracted 65 barriers and 101 facilitators, which we then categorized into four themes: "Structure," "People," "Physical system," and "Task." We identified notable emphasis on "Legal and Ethical Challenges" and "Interoperability and Data Governance." Key barriers included concerns over privacy and security breaches, inadequacies in informed consent processes, and unauthorized data sharing. Critical facilitators included enhancing patient consent procedures, improving data privacy through anonymization, and promoting ethical standards for data usage. CONCLUSION: Our study underscores the complexity of patient consent for the secondary use of health data in AI models, highlighting significant barriers and facilitators within legal, ethical, and technological domains. We recommend the development of specific guidelines and actionable strategies for policymakers, practitioners, and researchers to improve informed consent, ensuring privacy, trust, and ethical use of data, thereby facilitating the responsible advancement of AI in healthcare.
背景:健康数据的二次利用以训练人工智能(AI)模型在推进医学研究和医疗服务方面具有巨大潜力。然而,确保患者对此类利用的同意对于维护道德标准和数据隐私至关重要。患者知情同意意味着患者充分了解其数据将如何被收集、使用和保护,并且他们自愿同意允许其数据用于AI模型。除了正式的同意框架外,建立社会许可对于促进公众对AI系统中健康数据二次利用的信任和社会接受至关重要。本研究考察了该领域的患者同意实践情况。 方法:在这项范围综述中,我们检索了Web of Science、PubMed和Scopus。我们纳入了以英文发表的、涉及感兴趣的核心问题的研究,即与AI模型中健康数据二次利用相关的隐私、安全、法律和伦理问题。未涉及核心问题的文章,以及系统评价、荟萃分析、书籍、信件、会议摘要和研究方案均被排除。两位作者独立筛选标题、摘要和全文,与第三位作者解决分歧。使用数据提取表提取数据。 结果:在筛选了774篇文章后,最终共有38篇文章被纳入综述。在这些研究中,共识别出178个障碍和193个促进因素。我们合并了相似的编码并提取出65个障碍和101个促进因素,然后将它们分为四个主题:“结构”、“人员”、“物理系统”和“任务”。我们发现对“法律和伦理挑战”以及“互操作性和数据治理”有显著强调。关键障碍包括对隐私和安全漏洞的担忧、知情同意过程的不足以及未经授权的数据共享。关键促进因素包括加强患者同意程序、通过匿名化提高数据隐私以及促进数据使用的道德标准。 结论:我们的研究强调了患者对AI模型中健康数据二次利用同意的复杂性,突出了法律、伦理和技术领域内的重大障碍和促进因素。我们建议为政策制定者、从业者和研究人员制定具体指南和可操作策略,以改善知情同意,确保数据的隐私、信任和道德使用,从而促进AI在医疗保健领域的负责任发展。
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