Digital Clinical Safety Gaps Threaten NHS Transformation

DIGITAL clinical safety compliance was found to be substantially deficient across NHS organisations in England, raising concerns about the safety infrastructure supporting planned digital transformation. A national cross-sectional analysis found that 70.1% of digital health technology deployments lacked documented assurance against statutory digital clinical safety standards. 

The analysis examined responses from 211 of 239 NHS trusts and integrated care boards, representing an 88.3% response rate. Mean Clinical Safety Officer (CSO) capacity was 1.1 whole-time equivalent (WTE), with NHS trusts reporting a mean of 1.3 WTE compared with 0.4 WTE among integrated care boards. 

However, qualitative responses suggested that these figures overstated effective capacity because safety responsibilities were commonly undertaken alongside existing clinical duties. 

Four Drivers of Digital Clinical Safety Gaps 

Analysis of the responses identified four interconnected drivers of non-compliance: limited understanding of digital clinical safety standards, immature governance and oversight, ineffective assurance processes, and workforce fragmentation. 

The findings indicated that these problems reinforced one another. Organisations that lacked clarity about which technologies required assessment were less likely to have governance structures capable of monitoring their digital portfolios. In turn, weak oversight meant assurance was often reactive rather than embedded within procurement and deployment. 

Limited workforce capacity compounded these challenges. The median CSO capacity was 1.0 WTE, while dedicated roles were uncommon. The analysis suggested that this model could be particularly problematic as healthcare organisations adopted increasingly complex technologies. 

Building Safer Digital Transformation 

The findings had implications for the NHS 10 Year Health Plan, particularly its ambitions for rapid adoption of technologies including artificial intelligence, genomics and robotics. Researchers argued that expanding digital services without strengthening clinical safety infrastructure could increase patient risk. 

Four reforms were proposed: regulatory enforcement of digital clinical safety standards, inclusion of digital safety within national quality frameworks, professionalisation of the CSO workforce, and national systems to support assessment and knowledge sharing. 

The researchers also highlighted the need to balance centralised safety assessment with local risk management, recognising that some digital safety risks depend on how technologies are implemented in individual organisations. 

The study excluded primary care and adult social care, leaving compliance in these settings unknown. The authors therefore called for further investigation while emphasising that digital transformation and patient safety should advance as concurrent priorities. 

Reference  

Roy-Highley E et al. Unfit for the future? Revisiting the national cross sectional study of digital clinical safety in England’s NHS to identify drivers of low compliance and implications for the 10 Year Health Plan. BMJ Innov. 2026. [Epub ahead of print]. 

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