Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jul 3, 2025
Open Peer Review Period: Jul 3, 2025 - Aug 28, 2025
Date Accepted: Oct 10, 2025
(closed for review but you can still tweet)
Digitally Unsafe? Digital health technology compliance with clinical safety standards within the NHS in England: a national cross-sectional study.
ABSTRACT
Background:
Digital Health Technologies (DHTs) used in the English NHS must demonstrate clinical safety assurance under two national standards: DCB0129 (for manufacturers) and DCB0160 (for deploying organisations). NHS bodies have a statutory duty to ensure all DHTs in use meet these requirements. However, compliance is neither routinely monitored nor enforced. This study assessed the assurance status of deployed DHTs and organisational compliance with these standards across the English NHS.
Objective:
Explore and quantify compliance with clinical risk management standards DCB0129 and DCB0160 in the NHS in England.
Methods:
In February–March 2025, 239 NHS organisations in England were issued a Freedom of Information (FOI) request regarding compliance of their deployed DHTs with DCB0129 and DCB0160.
Results:
Of the organisations contacted, 204 (85·4%) responded, with 179 (87·8%) providing either full or partial data. The mean number of deployed DHTs per organisation was 82.8 (median 27·5, IQR 81·5), with substantial variation between secondary care providers, Integrated Care Boards (ICBs), and ambulance trusts. Compliance was low: on average, only 34·7% (median 25·6%) of DHTs that an organisation deployed were fully assured against both standards. Thirteen organisations reported full compliance, while sixteen reported that none of their deployed DHTs were assured. 14,747 DHT deployments were reported across responding organisations. Of these, 17·4% were fully assured, 13·3% partially assured (compliant with either DCB0129 or DCB0160), and 70·1% had no documented assurance.
Conclusions:
More than 10,000 DHTs currently in use in the NHS lack documented compliance with clinical safety standards. For a typical NHS patient attending hospital, three in four of the digital tools influencing their care do not demonstrate the minimum legal or clinical safety requirements. These findings raise significant concerns about the safety of digital technologies in the NHS and the potential risk of patient harm arising from inadequate assurance.
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