This article analyses the balance which the GDPR strikes between two important social values: protecting personal health data and facilitating health research through the lens of the consent requirement and the research exemption. The article shows that the normative weight of the consent requirement differs depending on the context for the health research in question. This more substantive approach to consent is reflected in the research exemption which allows for a more nuanced balancing of interests. However, because the GDPR articulates the exemption at an abstract and principled level, in practice the balance is struck at Member State level. Thus, the GDPR increases difficulties for EU cross-border health projects and impedes the policy goal of creating a harmonised regulatory framework for health research. The article argues that in order to address this problem, the European Data Protection Board should provide specific guidance on the operation of consent in health research.

中文翻译：

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健康研究，同意书和GDPR豁免

本文分析了GDPR在两个重要的社会价值之间取得的平衡：通过同意要求和研究豁免的角度保护个人健康数据并促进健康研究。该文章表明，同意要求的规范权重因所研究的健康研究的背景而异。这种更实质性的同意方式反映在研究豁免中，该研究允许更细微的利益平衡。但是，由于GDPR在抽象和原则性级别上明确规定了豁免，因此实际上在成员国级别上达到了平衡。因此，GDPR增加了欧盟跨境卫生项目的难度，并阻碍了建立统一的卫生研究监管框架的政策目标。