More than 70% of NHS DHTs have no clinical safety assurance

A national study into NHS clinical safety found that more than 10,000 (70%) of reported digital health technologies (DHTs) in the NHS have no documented clinical safety assurance.

The study, published in JMIR Publications, began in early 2025 when 239 NHS organisations in England were sent a freedom of information notice requesting the number of DHTs they were using and their assurance against DCB0129 and DCB0160 digital clinical safety standards.

Researchers received 204 responses (85.4%), of which 178 (87.3%) provided full or partial data covering 14,747 DHT deployments.

Overall, organisational compliance rates were low, with a median of 25.6% deployed DHTs being fully assured. For NHS provider trusts compliance was lower at 24.5%.

The study was led by Youssof Oskrochi, head of safety at Curistica, and Elliott Roy-Highley, medical director at Unbound, and co-authored by Dr Keith Grimes, founder and clinical safety officer (CSO) at Curistica, and Sam Shah, director of health data at NEOM.

Oskrochi told Digital Health News: “Our findings reveal that patient care is being delivered through a patchwork of non-compliant technology creating potential for serious harm.

“The public rightly expects the NHS to provide care that is fundamentally safe, not just effective. If new medicines and medical devices must pass rigorous safety checks before reaching patients, then the digital tools now integral to their care deserve nothing less.”

Roy-Highley added: “The NHS has a digital-first ambition, but our findings show that the foundations are failing.

“It is deeply concerning that the safety of technologies already in widespread use is not being properly assured.

“To build a safe digital future, which includes complex tools like AI, we must first fix the basics. Pushing for more technology without fixing the safety infrastructure is a recipe for disaster.”

Only 13 (6.4%) of the 204 organisations 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% were fully assured against both clinical safety standards, 13.3% were partially assured against one standard, and 10,000 (70.1%) had no documented assurance.

Responding to the study results, Penny Kechagioglou, chair of the Digital Health Networks Chief Clinical Officer Officer Advisory Panel, said: “Digital health technology adoption is accelerating in the NHS which means the role of clinical safety officers (CSO) and information governance resource is as important as ever.

“It’s concerning to read that over 70% of DHTs have no documented clinical safety assurance and our role as healthcare leaders is to reinforce digital clinical safety as we digitally transform, through investing in training and dedicated CSO roles.”

Ben Jeeves, chair of the Digital Health CSO Council, told Digital Health News that the study’s findings were “alarming but not surprising”.

“As digital capabilities are going up, we’re getting more technologies, more things are getting deployed, and if there’s not a proportionate increase in CSOs or other supporting roles, that disparity is just going to remain,” he said.