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

ABSTRACT:

Background

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.

Objective

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.

Methods

In early 2025, 239 NHS organizations in England received a freedom of in

SUBMITTER: Oskrochi Y 

PROVIDER: S-EPMC12619009 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature