From the Department of Radiology, Stanford University School of Medicine, 300 Pasteur Dr, Stanford, CA 94305-5105.
Radiology. 2020 Jun;295(3):675-682. doi: 10.1148/radiol.2020192536. Epub 2020 Mar 24.
In this article, the authors propose an ethical framework for using and sharing clinical data for the development of artificial intelligence (AI) applications. The philosophical premise is as follows: when clinical data are used to provide care, the primary purpose for acquiring the data is fulfilled. At that point, clinical data should be treated as a form of public good, to be used for the benefit of future patients. In their 2013 article, Faden et al argued that all who participate in the health care system, including patients, have a moral obligation to contribute to improving that system. The authors extend that framework to questions surrounding the secondary use of clinical data for AI applications. Specifically, the authors propose that all individuals and entities with access to clinical data become data stewards, with fiduciary (or trust) responsibilities to patients to carefully safeguard patient privacy, and to the public to ensure that the data are made widely available for the development of knowledge and tools to benefit future patients. According to this framework, the authors maintain that it is unethical for providers to "sell" clinical data to other parties by granting access to clinical data, especially under exclusive arrangements, in exchange for monetary or in-kind payments that exceed costs. The authors also propose that patient consent is not required before the data are used for secondary purposes when obtaining such consent is prohibitively costly or burdensome, as long as mechanisms are in place to ensure that ethical standards are strictly followed. Rather than debate whether patients or provider organizations "own" the data, the authors propose that clinical data are not owned at all in the traditional sense, but rather that all who interact with or control the data have an obligation to ensure that the data are used for the benefit of future patients and society.
在本文中,作者提出了一个使用和共享临床数据以开发人工智能 (AI) 应用程序的伦理框架。其哲学前提如下:当临床数据被用于提供护理时,获取数据的主要目的就已经达到了。此时,临床数据应被视为一种公共利益,用于造福未来的患者。在他们 2013 年的文章中,Faden 等人认为,所有参与医疗保健系统的人,包括患者,都有义务为改善该系统做出贡献。作者将该框架扩展到围绕临床数据用于 AI 应用的二次使用的问题。具体来说,作者提出,所有可以访问临床数据的个人和实体都应成为数据管理者,对患者负有信托责任,谨慎保护患者隐私,并对公众负责,确保数据广泛用于开发知识和工具,以造福未来的患者。根据该框架,作者认为,提供者通过授予临床数据访问权限将数据“出售”给其他方是不道德的,尤其是在独家安排下,以超出成本的金钱或实物支付作为交换。作者还提出,只要建立了确保严格遵守道德标准的机制,在获得同意过于昂贵或繁琐而无法获得同意的情况下,无需在二次使用数据之前征得患者同意。作者建议,不要争论患者或提供者组织“拥有”数据,而是建议临床数据在传统意义上根本不属于任何人所有,而是所有与数据交互或控制数据的人都有义务确保数据用于造福未来的患者和社会。
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