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

Life Sciences weekly highlights—16 October 2025

This week's edition of Life Sciences weekly highlights includes analysis by Freshfields LLP of recent highlights in the UK's medical devices regulatory framework and an MLex analysis indicating that the European Commission will issue guidelines on how the EU AI Act interacts with other EU laws such as the EU GDPR. Also included is news that MedTech Europe submitted recommendations to the European Commission’s call for evidence on the forthcoming European Innovation Act, the MHRA announced an expanded partnership with the US Food and Drug Administration (FDA) to accelerate innovation in medical technologies and AI and published guidance on new medical device registration fee planned to come into effect on 1 April 2026, and the European Notified Bodies industry group (Team-NB) and the Association of British HealthTech Industries (ABHI) responded to the Commission’s call for evidence on the targeted revision of the MDR and IVDR. Also included, is news that the MHRA has awarded the first three Innovation Passports under its revised Innovative Licensing and Access Pathway (ILAP), and together with NICE have opened early access to the aligned streamlined approvals pathway six months earlier than projected, EU industry bodies have criticised the European Commission’s upcoming study on costs for implementing quaternary-level treatment upgrades under the Urban Wastewater Treatment Directive (UWWTD) and, together with Cosmetics Europe, called for a data-driven, substance-based Extended Producer Responsibility (EPR) scheme, and the European Commission opened a public consultation on its proposed European Research Area Act, among other stories.

MHRA selects seven AI healthcare technologies for AI Airlock programme Phase 2

The Medicines and Healthcare products Regulatory Agency (MHRA) has selected seven AI healthcare technologies for the second phase of its AI Airlock regulatory sandbox programme, scheduled to run until March 2026. These technologies include AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems. They address three key regulatory challenge areas: the scope of intended use extension and validation, AI-powered in-vitro diagnostic devices, and post-market surveillance with predetermined change control plans.

UK medical devices regulation—where are we now?

Life Sciences analysis: As anticipated, 2025 has proven to be a critical year in the UK’s journey towards a new medical devices regulatory regime post-Brexit (see our previous updates here and here). The Medicines and Medical Devices Act 2021 (MMDA 2021) conferred wide powers on the Secretary of State to introduce provisions amending or supplementing the existing rules. While we await details of the new draft core regulations, certain changes have already been implemented. The Life Sciences Team of Freshfields round-up some recent highlights, which are the result of various consultations by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and which show the direction of travel.

No Set-Off Clause Effective Against Defence of Circuity of Action (Alaska Airlines v Virgin Aviation)

Commercial analysis: The court granted summary judgment in favour of Virgin Aviation (Virgin) on a claim for sums due under a contract with Alaska Airlines (Alaska), notwithstanding a defence of circuity of action based on a claim in unjust enrichment. The court found that the basis for the unjust enrichment claim was flawed as a matter of construction. However, in the alternative, the court held that the no set off clause would have precluded Alaska from relying on a defence of circuity to resist summary judgment. Written by Joshua Crow, barrister at One Essex Court.

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