Life sciences

Written by Florence Page

Key developments in 2025

This summer the UK Government published its plans for the healthcare sector and the Life Sciences industry in two policy papers: the 10 Year Health Plan for England^[1]; and the Life Sciences Sector Plan^[2]. The development and early adoption of new treatments and technologies is crucial for the success of both policies.

New technology is already being increasingly deployed in the diagnosis, treatment and prevention of mental health conditions, through the use of digital mental health technologies (DMHTs). DMHTs are "digital and software products that support mental health and wellbeing". Examples include online apps or websites accessed via computers, mobile phones, or virtual reality headsets. Where these technologies qualify as software as a medical device (SaMD) they must comply with the applicable regulatory regime.

Earlier this year, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), published regulatory guidance specific to DMHTs: Digital Mental Health Technology – Regulation for Safe and Effective Products^[3]. Aimed at helping developers and manufacturers of DMHTs to comply with UK medical device regulations, it includes important clarifications on:

• When a DMHT qualifies and therefore falls to be regulated as SaMD, along with the relevant device classification rules.
• The application of the regulatory regime to more complex DMHT systems which include different components or modules, only some of which qualify as SaMD.

In the UK, failure to comply with the relevant medical device regulations has serious consequences, including investigation and enforcement action by the MHRA as well as financial and/or criminal penalties.  No doubt this guidance will be welcomed by manufacturers and developers (and their insurers) attempting to navigate what can be exceptionally complicated regulatory terrain.

What to look out for in 2026

We predict that insurers in the Life Sciences sector will see increasing interest and activity around the opportunities presented by quantum technologies.

Using principles of quantum mechanics, quantum computing has the potential to surpass the capabilities of conventional supercomputers.  The transformational possibilities afforded by this technology in the healthcare sector have been, and continue to be, the subject of much scientific research. In 2023, the then UK Government published its National Quantum Strategy which set out a 10-Year vision to develop the quantum industry.  Earlier this year, the UK's National Quantum Computing Centre (NQCC) published an insights paper "The convergence of healthcare and pharmaceuticals with quantum computing: A new frontier in medicine".[4] The NQCC paper cites the rapid growth of the global market for quantum computing in healthcare and highlights the impact that it could have on the healthcare sector, particularly in driving breakthroughs in key areas such as: drug discovery, genomics and personalised medicine. It may also herald a new era for "historically under-served" areas of clinical research, such as rare diseases and women's health, where datasets are more limited.

In its report, the NQCC identifies "policy and regulatory preparedness" as one of the key steps to advancing quantum computing in healthcare and pharmaceuticals. It calls for pro innovation: proactive and internationally collaborative regulation combined with the development of ethical guidelines specific to quantum technology, and additional data protections.

If the current UK government adopts the recommendations in the NQCC report, those companies already making moves in the UK quantum healthcare market. and their insurers (without whom such technologies may never reach the market), are likely to have a real opportunity to shape the future of this dynamic industry.

[1] https://assets.publishing.service.gov.uk/media/6888a0996478525675738f3a/fit-for-the-future-10-year-health-plan-for-england-executive-summary.pdf

[2]https://assets.publishing.service.gov.uk/media/688c90a8e8ba9507fc1b090c/Life_Sciences_Sector_Plan.pdf

[3] https://assets.publishing.service.gov.uk/media/6866572fadfe29730ea3a9d5/MHRA_guidance_on_DMHT_-_Device_characterisation_regulatory_qualification_and_classification.pdf

[4] https://www.nqcc.ac.uk/