Digital clinical safety in the UK, an open and informed position: supporting CSOs to foster a culture of compliance with standards (March 2025)

Summary

Digital clinical safety is becoming increasingly embedded into organisations, and along with it, compliance with the Data Coordination Board standards DCB0129 and DCB0160, which are mandated under the Health and Social Care Act 2012. However, there exists a number of challenges that are limiting the potential impact of the process.

A Digital Health Networks CSO Council survey of clinical safety officers, conducted in 2024, highlighted key areas of concern, including a lack of understanding of the clinical safety process and importance of the CSO role, insufficient capacity for digital clinical risk management and lack of senior leadership buy-in.

This white paper provides actionable insights to address these concerns, foster a culture of compliance with standards and improve digital clinical safety.