Digital health technology compliance with clinical safety standards In the National Health Service in England: national cross-sectional study (31 October 2025)

Summary

This study aimed to determine the number of digital health technologies (DHTs) in use in the NHS in England and assess their assurance status against mandated clinical safety standards.

This is the first study to quantify both the scale of DHT deployment in NHS organisations in England and the extent of compliance with mandatory safety standards. Findings include:

• 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 organisations 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.

Read the full paper via the link below.