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

ICH adopts new guideline on real-world data studies for medicine safety assessment

The International Council for Harmonisation (ICH) has adopted its M14 guideline. The ICH M14 guideline establishes internationally harmonised principles for the planning, design, analysis and reporting of non-interventional pharmacoepidemiological studies that use real-world data (RWD) to assess the safety of medicines. It aims to improve the reliability and regulatory acceptance of such studies by providing a structured framework that includes feasibility assessments, protocol development, data management and statistical analysis. The guideline emphasises the importance of fit-for-use data, robust study design and early engagement with regulators to ensure that evidence generated is adequate for post-marketing safety evaluations. It also outlines considerations for bias, confounding and validation of key variables and encourages transparency through public registration and dissemination of study findings.

MDCG updates borderline and classification manual under EU medical device regulations

The Medical Device Coordination Group (MDCG) has updated its manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The September 2025 update introduces new sections addressing the qualification and classification of additional products, including red blood cell additive solutions containing adenine, dual action cream with menthol and capsaicin, lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers and mobile sterile air systems.

ABPI publishes report on UK's position in global pharma investment

The Association of the British Pharmaceutical Industry (ABPI) has published a report that assesses the UK’s attractiveness in global pharmaceutical investment, compared with 12 other countries across four key areas: pre-clinical research, clinical trials, manufacturing and distribution, and headquarters and affiliates. The report highlights both the UK’s strengths and weaknesses in pharmaceutical investment, while identifying areas for potential growth. It also reveals a 58% decrease in life sciences foreign direct investment (FDI), falling from £1.897bn in 2021 to £795m in 2023 and investment in pharmaceutical research and development (R&D) declining by almost £100m in the same year. In response to the report, the Health Research Authority (HRA) endorsed the report and highlighted the importance of accelerating research timelines to improve patient care, noting the HRA’s active role in the UK Clinical Research Delivery (UKCRD) programme to streamline and speed up clinical trial delivery.

DSIT announces £3.6m funding for regulated mental health tech devices

The Department for Science, Innovation and Technology (DSIT), alongside Innovate UK and the Department of Health and Social Care, has awarded £3.6m to 17 UK-based projects through Innovate UK’s Mindset XR for digital mental health programme, as announced by the Science Minister, Lord Vallance and Mental Health Minister, Baroness Merron. Other funded initiatives include a board game developed by Play Well for Life and the University of the West of England to help children build communication and social skills by exploring four themed ‘worlds’ designed to support friendship, problem-solving and emotional regulation, gradually reducing anxiety and building confidence. In Northern Ireland, the Life Process Program is developing a customisable virtual coach to support individuals with substance abuse issues through interactive environments that simulate real-life therapy sessions. In West Yorkshire, EcoGPX is combining extended reality with physical activity to connect people with nature and support adults experiencing generalised anxiety. Additionally, a world-first app is being developed that merges AI with augmented reality to enable young people to create therapeutic visual content. These breakthrough medical device technologies form part of a targeted investment to deliver digital health benefits to the NHS, supporting the government's recently launched 10 Year Health Plan.

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