Department of Philosophy and Bioethics, Faculty of Health Sciences, Jagiellonian University Medical College, Kopernika 40, Kraków, Poland.
Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Bangkok, Thailand.
BMC Med Ethics. 2022 Oct 29;23(1):104. doi: 10.1186/s12910-022-00848-y.
The ownership status of individual-level health data affects the manner in which it is used. In this paper we analyze two competing models of the ownership status of the data discussed in the literature recently: private ownership and public ownership.
In this paper we describe the limitations of these two models of data ownership with respect to individual-level health data, in particular in terms of ethical principles of justice and autonomy, risk mitigation, as well as technological, economic, and conceptual issues. We argue that undifferentiated application of neither private ownership nor public ownership will allow us to resolve all the problems associated with effective, equitable, and ethical use of data. We suggest that, instead of focusing on data ownership, we should focus on the institutional and procedural aspects of data governance, such as using Data Access Committees (DACs) or equivalent managed access processes, which can balance the elements of these two ownership frameworks.
Undifferentiated application of the ownership concept (private or public) is not helpful in resolving problems associated with sharing individual-level health data. DACs or equivalent managed access processes should be an integral part of data governance. They can approve or disapprove data access requests after considering the potential benefits and harms to data subjects, their communities, primary researchers, and the wider society.
个人层面健康数据的所有权归属会影响其使用方式。本文分析了近期文献中讨论的数据所有权的两种竞争模式：私有和公有。
本文描述了这两种个人层面健康数据所有权模式的局限性，尤其是在公正和自主、风险缓解的伦理原则方面，以及在技术、经济和概念问题方面。我们认为，不区分地应用私有或公有所有权都无法解决与数据有效、公平和合乎伦理地使用相关的所有问题。我们建议，不应关注数据所有权，而应关注数据治理的制度和程序方面，例如使用数据访问委员会（DAC）或等效的受控访问流程，这可以平衡这两种所有权框架的要素。
不区分地应用所有权概念（私有或公有）无助于解决与共享个人层面健康数据相关的问题。DAC 或等效的受控访问流程应成为数据治理的一个组成部分。它们可以在考虑数据主体、其社区、主要研究人员和更广泛社会的潜在利益和危害后，批准或拒绝数据访问请求。
