NHS 10-Year Plan Risks ‘Patient Harm at Unprecedented Scale’

NHS organisations in England are systematically failing to comply with legislated digital safety standards potentially putting patients at risk, warned experts in an analysis published in the online journal BMJ Innovations. The government's 10-Year Health Plan pushes rapid digital and AI expansion, the authors pointed out, warning that the NHS was being asked to scale AI, genomics, and robotics on top of a safety architecture that was already failing for existing, simpler technology. In addition, they pointed out that most clinical safety officers (CSO) were clinicians who performed this role on top of their full-time job. The researchers proposed a new model that incorporated Care Quality Commission (CQC) regulatory enforcement, National Quality Board defined quality standards, workforce professionalisation, and a hybrid framework combining centralised safety assessment with local risk management. Without these changes, the digital transformation envisaged in the 10-Year Health Plan risked “propagating patient harm at unprecedented scale and speed”, they warned. Widespread Non-Compliance Despite statutory requirements under the Health and Social Care Act 2012 for digital health technologies to undergo formal clinical risk assessment, the authors highlighted that recent evidence indicated only 17% of digital deployments in England’s NHS had evidence of documented safety assurance against these standards. Their original national cross-sectional study had also found that among the 14,848 digital health technologies in use across NHS trusts and integrated care boards (ICBs) in England, 70.1% lacked documented safety assurance. For the new study, the researchers sought to identify drivers of low compliance to inform safety improvements. They analysed previously unpublished CSO workforce data, and performed a secondary analysis of their original survey of freedom of information responses received from NHS trusts and ICBs. The “widespread non-compliance” the researchers identified with statutory digital clinical safety standards — which are not routinely monitored or enforced — was driven by four major, mutually reinforcing factors: poor understanding of the standards; immature governance infrastructure and oversight; ineffective assurance processes; and the perception of the CSO role not as a dedicated, professionalised post but as an ancillary responsibility absorbed into existing roles. These themes did not operate in isolation, the researchers emphasised. No single component functions adequately, and the failure of each compounds the others, they said. “While embedding safety within senior clinical leadership may provide strategic visibility, it also means the individuals responsible for safety oversight are those with the least available time to undertake it; reducing effective capacity and impairing the development of experiential expertise,” the authors said in a press release. Professionalised CSO Workforce The 10-Year Health Plan’s ambition to rapidly adopt frontier technologies demanded a highly skilled CSO workforce with dedicated time to undertake risk assessments of increasing complexity. It also needed the embedding of digital safety knowledge at undergraduate and postgraduate level, which the researchers suggested hadn’t happened. The shift from hospital to community will also likely require expansion of digital services in primary care and other community settings — organisations that are likely to be smaller and less well-resourced than trusts and ICBs, with less access to specialist CSO capacity. To tackle these issues, the researchers proposed a number of solutions, including formal regulation, for which they said the CQC was uniquely placed, and a “professionalised CSO workforce”, which would bring the NHS into line with other safety critical industries. The paper's authors disclosed several competing interests. Co-author Keith Grimes is founder and owner of Curistica, a consultancy that provides clinical safety services to digital health organisations and NHS bodies, and co-author Youssof Oskrochi is Curistica's head of safety and data protection. Both acknowledged that the paper's subject — compliance with clinical safety standards — is directly relevant to Curistica's commercial activities. The authors reported no specific funding for the research. Rob Hicks is a retired National Health Service doctor. A well-known TV and radio broadcaster, he has written several books and has regularly contributed to national newspapers, magazines, and online publications. He is based in the United Kingdom.