Policy ForumData Governance

Scrutinizing the EU General Data Protection Regulation

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Science  04 May 2018:
Vol. 360, Issue 6388, pp. 496-498
DOI: 10.1126/science.aar5419

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On 25 May 2018, the European Union (EU) regulation 2016/679 on data protection, also known as the General Data Protection Regulation (GDPR), will take effect. The GDPR, which repeals previous European legislation on data protection (Directive 95/46/EC) (1), is bound to have major effects on biomedical research and digital health technologies, in Europe and beyond, given the global reach of EU-based research and the prominence of international research networks requiring interoperability of standards. Here we describe ways in which the GDPR will become a critical tool to structure flexible governance for data protection. As a timely forecast for its potential impact, we analyze the implications of the GDPR in an ongoing paradigmatic legal controversy involving the database originally assembled by one of the world's first genomic biobanks, Shardna.