The impact of the General Data Protection Regulation on health research
The impact of the General Data Protection Regulation on health research
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DOI：
10.1093/bmb/ldy038
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发表时间：
2018-12-01
影响因子：
6.7
通讯作者：
Chico, Victoria
中科院分区：
文献类型：
--
作者：
Chico, Victoria
背景资料：2018年5月25日，通用数据保护条例（以下简称GDPR或条例）生效，取代数据保护指令95/46/EC（《1998年数据保护法》就是基于此），并对处理欧盟公民数据的组织规定了新的责任。数据来源：这篇文章探讨了该条例对健康研究的影响。该条例旨在协调欧洲各地的数据隐私法，保护和授权所有欧盟公民的数据隐私，并重塑组织处理数据隐私的方式（参见GDPR门户网站：https：//www.欧洲民主共和国org/（2018年5月8日访问）。作为一项法规，GDPR直接适用于所有成员国，而不是要求国家实施措施的指令（在英国，1998年数据保护法是数据保护指令95/46/EC的实施立法）。争议领域：该条例是全部门性的，但其对各组织的影响是具体部门性的。在某些部门，该条例禁止处理个人数据，而在其他部门，它允许处理。该条例采取的立场是，“数据处理应旨在为人类服务”（叙文4）。虽然它没有详细说明这到底是什么意思，但它表明将采取相称的方法来保护个人数据，可以为医疗保健等公共商品处理这些数据。因此，对个人数据的保护不是绝对的，而是根据其在社会中的功能以及根据相称原则与其他基本权利的平衡来考虑的（叙文4）。对相称性的不同解释可能会偏离《条例》的协调目标。增长点：科学研究在《条例》中占有优先地位，这反映了对相称性的承诺。该条例通篇规定，为科学研究目的处理个人数据的组织应避免采取可能阻碍知识增长的限制性措施。然而，该条例的适用情况因卫生研究部门和司法管辖区而异。卫生研究部门的透明度和参与需要促进一致性。及时开展研究的领域：欢迎关注该法规应用于卫生研究时出现的特定问题的研究。特别是在本法规的运作以及保密义务和成员国之间方法的差异的背景下。
Background: On the May 25, 2018 the General Data Protection Regulation (hereafter the GDPR or the Regulation) came into force, replacing the Data Protection Directive 95/46/EC (upon which the Data Protection Act 1998 is based), and imposing new responsibilities on organizations which process the data of European Union citizens.Sources of data: This piece examines the impact of the Regulation on health research.Areas of agreement: The Regulation seeks to harmonize data privacy laws across Europe, to protect and empower all EU citizen's data privacy and to reshape the way that organizations approach data privacy (See the GDPR portal at: https://www. eugdpr. org/(accessed 8 May 2018). As a Regulation the GDPR is directly applicable in all member states as opposed to a directive which requires national implementing measures (In the UK the Data Protection Act 1998 was the implementing legislation for the Data Protection Directive 95/46/EC.).Areas of controversy: The Regulation is sector wide, but its impact on organizations us sector specific. In some sectors, the Regulation inhibits the processing of personal data, whilst in others it enables that processing. The Regulation takes the position that the 'processing of data should be designed to serve mankind' (Recital 4). Whilst it does not spell out what exactly is meant by this, it indicates that a proportionate approach will be taken to the protection of personal data, where that data can be processed for common goods such as healthcare. Thus, the protection of personal data is not absolute, but considered in relation to its function in society and balance with other fundamental rights in accordance with the principle of proportionality (Recital 4). Differing interpretations of proportionality can detract from the harmonization objective of the Regulation.Growing points: Reflecting the commitment to proportionality, scientific research holds a privileged position in the Regulation. Throughout the Regulation provision is made for organizations that process personal data for scientific research purposes to avoid restrictive measures which might impede the increase of knowledge. However, the application of the Regulation differs across health research sectors and across jurisdictions. Transparency and engagement across the health research sector is required to promote alignment.Areas timely for developing research: Research which focuses on the particular problems which arise in the context of the regulation's application to health research would be welcome. Particularly in the context of the operation of the Regulation alongside the duty of confidentiality and the variation in approaches across Member States.