Rumbold John M M, Pierscionek Barbara K
Faculty of Science, Engineering and Computing, Kingston University London, Penrhyn Road, Kingston upon Thames, KT1 2EE, UK.
School of Science and Technology School of Science and Technology, Nottingham Trent University, 50 Shakespeare Street, Nottingham, NG1 4FQ, UK.
BMC Med Ethics. 2017 Apr 8;18(1):27. doi: 10.1186/s12910-017-0184-y.
The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.
欧盟提供了一个合适的环境，可用于比较和协调不同语言、文化和司法管辖区（尽管有一个超国家法律框架）的医疗保健，这可能会提高整个欧盟的医疗保健标准。医疗保健研究中数据的使用存在特定的伦理法律问题，这就要求采取与其他形式研究不同的方法。长期使用医疗保健数据类似于生物样本库中组织的使用。对受试者的风险较低，但鉴于未来的研究可能性，不可能获得具体的知情同意。关于一个受试者的大量数据存在重新识别的有限风险。因此，在这种风险与保留数据的足够效用之间需要进行权衡。匿名化方法需要考虑数据共享的情况，以便在所有情况下实现适当的平衡。超越法律要求从而获得研究的社会许可具有伦理和政策优势。这一过程将需要审查和比较贸易集团内的数据保护法律，以制定一个符合所有成员国要求的伦理法律框架。本评论考虑了七个欧盟司法管辖区。
