Clinical Safety and Risk Management

Abstract This chapter examines how digital transformation intersects with patient safety, showing that new systems, algorithms, and connected devices can generate novel risks as well as benefits. It frames digital clinical safety as a complement to professional expertise, requiring vigilance to detect hazards embedded in software design, workflows, and data exchanges. Central to this discussion are the NHS Digital Technology Assessment Criteria and its domains—clinical safety, data protection, technical security, interoperability, and usability—alongside the statutory standards DCB0129 and DCB0160. The chapter outlines a structured methodology for managing risk across the technology life cycle, from hazard identification and scoring through to mitigation, evaluation, and residual risk assessment. It highlights the responsibilities of senior leaders, clinical safety officers, and multidisciplinary teams in embedding safety into system design and deployment. Practical approaches—including hazard logs, safety cases, pathway mapping, and simulation workshops—are explored as means of anticipating and addressing risks. Drawing on examples such as electronic health record configuration errors and algorithmic bias in diagnostic tools, the chapter illustrates the balance between technological benefit and potential harm. It emphasises the role of governance, clear acceptability criteria, and continuous post-deployment monitoring. Ultimately, clinical safety is presented as a shared organisational responsibility, essential for safeguarding patient trust and ensuring technology delivers safe, effective, and reliable care.