Digital Health Technology Compliance With Clinical Safety Standards In the National Health Service in England: National Cross-Sectional Study.

Abstract

To be authorized for use in the National Health Service (NHS) in England, digital health technologies (DHTs) must meet 2 mandatory clinical risk management standards, Data Coordination Board (DCB) 0129 and 0160, demonstrating that risks from design and use have been assessed and mitigated. NHS organizations must not procure a DHT without DCB0129 assurance and must not deploy one without DCB0160 assurance. Despite legal requirement, no public data exist on how many DHTs are in use in the NHS or how many are assured. This study aimed to determine the number of DHTs in use in the NHS in England and assess their assurance status against mandated clinical safety standards. In early 2025, 239 NHS organizations in England received a freedom of information notice requesting information on the number of DHTs they were using and their assurance against DCB0129 and DCB0160 standards. Of the 239 NHS organizations, 204 (85.4%) responded, of which 178 (87.3%) provided full or partial data, covering 14,747 DHT deployments. The mean number of deployed DHTs per organization was 82.8 (SD 146.1; 95% CI 61.4-104.3) with substantial variation between NHS provider trusts (mean 107.1, SD 161.1; 95% CI 79.8-134.3), ambulance trusts (mean 13.0, SD 8.2; 95% CI 7.6-18.4), and integrated care boards (mean 8.1, SD 16.0; 95% CI 2.8-13.5). Overall organizational compliance rates were low, with a median of 25.6% (IQR 7.8%-55.7%) deployed DHTs being fully assured; for NHS provider trusts compliance was lower at 24.5% (IQR 8.1%-50%). A total of 13 (6.4%) of the 204 organizations reported that all their DHTs were fully assured, while 16 (7.8%) reported that none were assured. Across all DHTs with reported assurance data, 17.3% (95% CI 16.6%-18.1%) were fully assured against both standards, 13.3% were partially assured against one standard, and 70.1% (95% CI 69.1%-71.1%) had no documented assurance. This is the first study to quantify both the scale of DHT deployment in NHS organizations in England and the extent of compliance with mandatory safety standards. More than 10,000 DHTs currently in use lack documented assurance against clinical safety standards. In a typical NHS trust, 3 out of 4 digital tools influencing patient care do not demonstrate compliance with minimum legal or clinical safety requirements. These findings raise significant concerns about the risks posed to patients by these technologies; the capacity of organizations to assess and mitigate them; and the legal ramifications of when, not if, harm occurs. Crucially, failure to assure digital technologies poses a significant risk to one of the core ambitions of the NHS 10-Year Health Plan for England; safely transitioning from analogue to digital care models. These findings are unlikely to be unique to the NHS and should prompt health care systems worldwide to assess the risks posed by their DHT deployments.