Digital health technology compliance with clinical safety standards in the National Health Service in England (31 October 2025)

Summary

To be authorised for use in the National Health Service (NHS) in England, digital health technologies (DHTs) must meet two mandatory clinical risk management standards, DCB0129 and DCB0160. Meeting these standards is intended to demonstrate that risks from design and use have been assessed and mitigated. NHS organisations 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, published in the Journal of Medical Internet Research, aimed to determine the number of DHTs in use in the NHS in England and assess their assurance status against mandated clinical safety standards. Its findings indicated that more than 10,000 DHTs currently in use lack documented assurance against clinical safety standards, and that 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.