Data Safe Havens in health research and healthcare.
Data Safe Havens in health research and healthcare.
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DOI：
10.1093/bioinformatics/btv279
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发表时间：
2015-10-15
期刊：
影响因子：
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通讯作者：
Knoppers BM
中科院分区：
文献类型：
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作者：
Burton PR;Murtagh MJ;Boyd A;Williams JB;Dove ES;Wallace SE;Tassé AM;Little J;Chisholm RL;Gaye A;Hveem K;Brookes AJ;Goodwin P;Fistein J;Bobrow M;Knoppers BM
动机：将“证据”纳入“循证医学”的数据对公共卫生、初级和医院护理的发展至关重要。一个根本性的挑战是将这些数据存放在储存库中，在适当的技术和治理控制下可以很容易地访问这些数据，这些数据经过有效的审计，并被不同的利益攸关方视为值得信赖。这就需要社会技术解决方案，这些解决方案在遇到不同利益攸关方的规范、价值观、期望和关切时，很容易陷入旷日持久的辩论和争议。在这种情况下，所谓的“数据安全港”的发展至关重要。不幸的是，这一术语的起源和演变导致了不同群体对这一术语的各种不同定义。然而，那些以前没有遇到过这个术语的人往往会假设一种直观的有意义的解释：一个存储库，其中有用但可能敏感的数据可以在适合目的并适当定制所维护数据性质的治理和信息学系统下安全保存，并且可以由从事有助于生物医学、健康和/或保健系统的持续发展的工作和研究的合法用户访问和使用。结果如下：本审查探讨了一个基本问题：“如果数据储存库被视为符合这一解释，并被视为值得被主要数据库持有人授予'数据安全港'地位，那么数据储存库应该合理地满足哪些具体标准？”我们提出了12个这样的标准。联系人：paul. bristol.ac.uk
Motivation: The data that put the ‘evidence’ into ‘evidence-based medicine’ are central to developments in public health, primary and hospital care. A fundamental challenge is to site such data in repositories that can easily be accessed under appropriate technical and governance controls which are effectively audited and are viewed as trustworthy by diverse stakeholders. This demands socio-technical solutions that may easily become enmeshed in protracted debate and controversy as they encounter the norms, values, expectations and concerns of diverse stakeholders. In this context, the development of what are called ‘Data Safe Havens’ has been crucial. Unfortunately, the origins and evolution of the term have led to a range of different definitions being assumed by different groups. There is, however, an intuitively meaningful interpretation that is often assumed by those who have not previously encountered the term: a repository in which useful but potentially sensitive data may be kept securely under governance and informatics systems that are fit-for-purpose and appropriately tailored to the nature of the data being maintained, and may be accessed and utilized by legitimate users undertaking work and research contributing to biomedicine, health and/or to ongoing development of healthcare systems. Results: This review explores a fundamental question: ‘what are the specific criteria that ought reasonably to be met by a data repository if it is to be seen as consistent with this interpretation and viewed as worthy of being accorded the status of ‘Data Safe Haven’ by key stakeholders’? We propose 12 such criteria. Contact: paul.burton@bristol.ac.uk