The Effect of the General Data Protection Regulation on Medical Research
The Effect of the General Data Protection Regulation on Medical Research
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DOI：
10.2196/jmir.7108
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发表时间：
2017-02-24
影响因子：
7.4
通讯作者：
Pierscionek, Barbara
中科院分区：
文献类型：
--
作者：
Rumbold, John Mark Michael;Pierscionek, Barbara
背景：通用数据保护条例（GDPR）的颁布将对欧洲数据科学产生影响。人们提出了与严重限制医疗数据研究有关的同意要求的特别担忧。目的：我们的目标是解释适用于医学研究的数据保护法的变化并讨论其潜在影响。方法：分析 GDPR 施加的道德法律要求。结果：GDPR 使假名数据作为个人数据的分类更加清晰，尽管尚未完全解决。在未经同意的情况下对个人数据进行的生物医学研究必须具有重大公共利益。结论：GDPR 引入了对数据主体的保护，旨在实现整个欧盟的一致性。拟议的更改对生物医学数据研究影响不大。
Background: The enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent requirements that would severely restrict medical data research have been raised.Objective: Our objective is to explain the changes in data protection laws that apply to medical research and to discuss their potential impact.Methods: Analysis of ethicolegal requirements imposed by the GDPR.Results: The GDPR makes the classification of pseudonymised data as personal data clearer, although it has not been entirely resolved. Biomedical research on personal data where consent has not been obtained must be of substantial public interest.Conclusions: The GDPR introduces protections for data subjects that aim for consistency across the EU. The proposed changes will make little impact on biomedical data research.