Data protection and life sciences

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Personal data is at the very core of every life science business. Life sciences companies handle significant amounts of personal data and are reliant upon the collection and use of personal data, which often includes sensitive health-related data, in order to carry out key business functions. For example, conducting clinical trials on patients, collecting data on drug safety and adverse reactions in order to comply with pharmacovigilance requirements, and collecting genetic information for the development of personalised medicines all rely on the collection and processing of data relating to individual data subjects. Consequently, it is vitally important that life sciences companies understand, and are in compliance with, the strict rules that apply to the processing of personal data.

This Overview provides an introduction to the application of the data protection regimes to key areas of the life sciences under the EU General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR) and the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR) (together the ‘GDPR regimes’).

Assimilated law is the name given to retained EU law (‘REUL’) which remains in force after

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Latest Life Sciences News

EMA and FDA publish joint AI principles for medicines development

The The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly published ten guiding principles for good artificial intelligence (AI) practice in medicines development on 14 January 2026. The principles apply across the entire medicines lifecycle and are intended to inform future regulatory guidance in multiple jurisdictions, including forthcoming EU guidelines.

Life Sciences weekly highlights—15 January 2026

This week's edition of Life Sciences weekly highlights includes news analysis by Lexis+ that discusses what the key developments were for life sciences lawyers in 2025 and looks ahead to what is coming in 2026. Also included, is news that data shows ‘a sharp rise’ in UK clinical trial applications and activity in 2025 in anticipation of the new clinical trial regulations and reforms to take effect from 28 April 2026, Dr Melanie Ivarsson has been appointed as the first CEO of the recently established Health Data Research Service (HDRS) to improve access to health data in preparation to be operational by December 2026, the MHRA also announced that certain commonly prescribed medicines will now be required to include a warning on their packaging against risks of dependence and addiction. It also includes news that techUK is seeking evidence to inform its response to the MHRA consultation on AI regulation, a judgment in the longstanding Abbott v Dexcom dispute has been handed down and Regulation (EU) 2026/78 amending Regulation (EC) 1223/2009 (the EU Cosmetic Products Regulation) to address the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) has been published in the Official Journal.

DHSC announces Dr Melanie Ivarsson appointed as CEO of Health Data Research Service

On its path to becoming operational by December 2026, the recently proposed Health Data Research Service (HDRS) to accelerate medical breakthroughs through improved access to health data for approved researchers has appointed its first CEO, Dr Melanie Ivarsson. Dr Ivarsson follows the appointment of Baroness Blackwood as Chair in November 2025. HDRS is supported by £600 million from the Government and Wellcome. The new service will be housed at the Wellcome Genome Campus in Cambridgeshire, where Wellcome is building a range of new R&D laboratory and office spaces to expand the current campus’s capacity for innovative genomics and biodata companies. The service builds on recent government reforms that have halved the time it takes to approve clinical trials from 91 to 41 days and the 10 Year Health Plan which aims to reduce commercial clinical trial times to 150 days or fewer by March 2026.

MHRA consultation on AI in healthcare regulation

techUK has opened a call for evidence to inform its response to the MHRA consultation on the regulation of artificial intelligence (AI) in healthcare which will close on 2 February 2026. This consultation seeks evidence to inform recommendations for a new regulatory framework for AI technologies within medicines.

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