Jurisdiction(s):
European Union

EU GDPR in the life sciences: health data, research, consent, pseudonymisation, compliance, transfers, and interplay with pharmacovigilance, MDR/IVDR, EHDS, the Data Act and the AI Act

Published by a LexisNexis EU Law expert

Practice notes

The General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR)

The General Data Protection Regulation (Regulation (EU) 2016/679, the EU GDPR) has applied across the EEA since 25 May 2018. Organisations in the life sciences gather and/or handle volumes of personal information, including health data, relating to individuals (the ‘data subjects’), notably patients and participants in clinical trials. As such, the relevance of the EU GDPR to life sciences businesses is considerable. This Practice Note outlines elements within the EU GDPR framework that have a direct bearing on life sciences companies and their operations. It is not an exhaustive treatment of the EU GDPR and should be read alongside the following Practice Notes: Data protection principles; Processing personal data—standard of consent; and Processing personal data—obtaining, recording and managing consent. For further detail on how clinical trials interface with data protection rules, see Practice Note: Conducting clinical research—data protection implications. Note, this Practice Note addresses provisions of the EU GDPR that apply in EEA countries at the supranational level only—consult guidance from the competent national data protection authorities and domestic legislation for the approach in any given EEA jurisdiction. For a primer on the EU GDPR framework, bringing together key practical...

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Cristiana Spontoni

Jones Day

Cristiana Spontoni is internationally recognised as a leader in life sciences, including biotechnology, pharmaceuticals, medical devices, food and cosmetics, as well as in general EU product and industries regulation. She is also actively involved in the shaping and interpretation of EU legislation affecting many different regulated industries and has successfully represented clients in legislative challenges based on EU law. Cristiana frequently coordinates large international assignments and provides comprehensive one-stop-shop solutions for cross-border regulatory issues affecting clients' operations. She has coordinated projects in more than 80 countries worldwide.Cristiana advises clients from the pre-market phase, including clinical trials and pre-market authorisations, to post-market issues, including product liability, marketing/advertising, distribution, and compliance (including sector-specific antibribery and data privacy).Cristiana handles safety and compliance issues for a large variety of clients both in the life sciences and consumer products sectors, including in regards to product...

Justine Naessens

Jones Day

Justine Naessens advises clients on EU and national regulatory matters in the life sciences area, including biotechnology, pharmaceuticals, medical devices, and food and cosmetics.Justine assists companies in the entire lifecycle of products from early development stages to manufacturing, marketing, post-marketing, and pricing and reimbursement issues, as well as in M&A and other corporate transactions. Justine often assists clients in connection with regulatory matters involving the use of digital technologies in the health care sector, such as the classification of software as a medical device, the use of artificial intelligence (AI) in product development, and associated privacy (General Data Protection Regulation [GDPR]) requirements....

Web page updated on 21/05/2026

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