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进展的信号标准:弥合数据保护法下使用患者数据的有效同意与普通法保密义务之间的差距。

Signalling Standards for Progress: Bridging the Divide Between a Valid Consent to Use Patient Data Under Data Protection Law and the Common Law Duty of Confidentiality.

作者信息

Dove Edward S, Taylor Mark J

机构信息

School of Law, University of Edinburgh, UK.

Melbourne Law School, University of Melbourne, Australia.

出版信息

Med Law Rev. 2021 Oct 8;29(3):411-445. doi: 10.1093/medlaw/fwab014.

DOI:10.1093/medlaw/fwab014
PMID:34270741
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8500295/
Abstract

In this article, we analyse the legal components of disclosing confidential patient information under the UK's common law duty of confidentiality (CLDoC) and processing personal (health) data under the UK's General Data Protection Regulation (GDPR) and Data Protection Act 2018. We describe the ostensible divide between the CLDoC and data protection law when it comes to the requirements of a valid signal of consent by a patient to use and disclose patient information, obtained by a health professional in the context of direct care, for health care and health research purposes. Ultimately, our analysis suggests that we are saddled, at least in the medium term, with two regimes operating with different standards of a valid consent-while putatively protecting similar interests. There is, however, opportunity for progress. It is possible to improve professional guidance on the interaction between the regimes and to achieve significant normative alignment without aligning the signalling standard for consent; this would promote consistent protection of reasonable expectations of patients across both regimes. Further coherence would require aligning not only the standard, but also the role played by consent under each regime. Here we argue that, in relation to direct care, any such shift should be away from consent as the normal justification. In relation to health research, on the contrary, it should be toward consent as the normal justification for use and disclosure of patient information under both the CLDoC and data protection law.

摘要

在本文中,我们分析了根据英国普通法保密义务(CLDoC)披露患者机密信息以及根据英国《通用数据保护条例》(GDPR)和2018年《数据保护法》处理个人(健康)数据的法律构成要素。我们描述了在患者有效同意信号的要求方面,CLDoC与数据保护法之间表面上的分歧,这种同意信号是医疗专业人员在直接护理过程中为医疗保健和健康研究目的获取和使用患者信息所必需的。最终,我们的分析表明,至少在中期,我们面临着两种以不同有效同意标准运作的制度——同时假定保护相似的利益。然而,仍有取得进展的机会。可以改进关于这两种制度之间相互作用的专业指导,并在不统一同意信号标准的情况下实现重大的规范协调;这将促进在两种制度下对患者合理期望的一致保护。进一步的协调不仅需要统一标准,还需要统一每种制度下同意所起的作用。在此我们认为,就直接护理而言,任何此类转变都应摒弃将同意作为常规理由。相反,就健康研究而言,应朝着将同意作为CLDoC和数据保护法下使用和披露患者信息的常规理由的方向发展。

相似文献

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Signalling Standards for Progress: Bridging the Divide Between a Valid Consent to Use Patient Data Under Data Protection Law and the Common Law Duty of Confidentiality.进展的信号标准:弥合数据保护法下使用患者数据的有效同意与普通法保密义务之间的差距。
Med Law Rev. 2021 Oct 8;29(3):411-445. doi: 10.1093/medlaw/fwab014.
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Using and Disclosing Confidential Patient Information and The English Common Law: What are the Information Requirements of a Valid Consent?使用和披露患者保密信息与英国普通法:有效同意的信息要求有哪些?
Med Law Rev. 2018 Feb 1;26(1):51-72. doi: 10.1093/medlaw/fwx038.
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Reasonable Expectations of Privacy and Disclosure of Health Data.健康数据隐私与披露的合理预期
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