Health Research Authority (HRA)

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On 4 September 2025, the Court of Justice of the European Union (“CJEU”) delivered a notable judgment on what is considered pseudonymised personal data under EU data protection law. While, technically speaking, the judgment concerns the interpretation of Regulation (EU) 2018/1725 (which governs the processing of personal data by the EU institutions and bodies), it fully applies to the interpretation of the concepts of personal data and pseudonymised data under Regulation (EU) 2016/679 (“GDPR”).

This question is essential for many companies operating in the EU, and in particular Life Sciences companies handling key-coded or otherwise pseudonymised patients’ personal data in the context of research and development, supply of healthcare products and related safety monitoring.Continue Reading CJEU clarifies the concept of pseudonymised data

Clinical research studies within the NHS in England and Wales require Health Research Authority (HRA) approval, which brings together the HRA’s assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee (REC). The HRA has recently changed the requirements for the UK GDPR transparency wording in new health and social care research applications submitted via the Integrated Research Application System (IRAS). The HRA service had previously provided a review service for sponsors’ GDPR transparency statements. In October last year, the HRA communicated its new updated GDPR template to all sponsors. The new HRA template was developed to ensure that research participants have all the information that they need to make an informed decision about the ways in which their personal data can be used during a clinical trial.Continue Reading UK Health Research Authority GDPR wording template to be used from 1 April