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ARTICLE · 21 JULY 2026

EDPB Guidelines On Anonymisation: What Life Sciences Companies Need To Know

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The European Data Protection Board has released new guidelines that fundamentally reshape how life sciences companies can determine whether clinical trial data, genomic information, and real-world evidence qualify as truly anonymous under EU law. These guidelines introduce a perspective-relative framework where the same dataset can be considered anonymous for one recipient while remaining personal data for another, depending on their actual means of re-identification. The guidance establishes a structured t

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On 7 July 2026, the European Data Protection Board (“EDPB”) adopted its Guidelines 02/2026 on Anonymisation for public consultation (the “Guidelines”), replacing the Article 29 Working Party’s Opinion 05/2014 that served as one of the primary EU references on the topic for over a decade.

Since 2014, the legal landscape has, however, shifted considerably, most notably through the Court of Justice’s judgment in EDPS v SRB (Case C-413/23 P) (see our blog on that judgment), and the practical landscape even more so, with the proliferation of AI, large-scale data pooling, and cross-border research collaborations. For life sciences companies handling key-coded clinical data, safety reports, or real-world evidence, the Guidelines, once finalised and adopted, will set out a clear framework for determining when data is genuinely anonymous and therefore falls outside the GDPR’s scope.

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