NHS England launches digital clinical safety standards review

NHS England has launched a review of digital clinical safety standards, requesting input from NHS stakeholders, IT manufacturers and those involved in digital risk assessment.

The review is of digital clinical risk management standards DCB0129 and DCB0160 to ensure they remain “up-to-date, practical and aligned with the latest advancements in healthcare technology and clinical practice”, NHSE said in a statement, published on 4 December 2024.

“We have committed to review the standards to ensure they remain practical for those that use them, and that they keep pace with the rapid technological advancements in healthcare IT,” the statement says.

Key reasons for the review include the acceleration of digital transformation in the NHS and the rollout of electronic patient record (EPR) systems, which NHSE says has meant “healthcare IT has become central to service delivery”.

Other drivers for the review include clinical risks around emerging innovations like AI and the “increasing complexity of cyber threats” and changing clinical workflows due to the “widespread integration of digital tools into daily clinical practice” which has “transformed how NHS staff interact with these systems”.

Dr Rosie Benneyworth, chief executive of the Health Services Safety Investigations Body, said: “We welcome the review of the digital clinical safety standards as technology has evolved rapidly since 2012.

“The review will provide a robust examination of how the standards can align with new and emerging technologies, especially in relation to the growth of AI.

“Whilst there are significant opportunities to improve patient care and efficiency in the NHS with digital innovation, many of our investigations have shown that safety risks are not always identified and therefore not managed in relation to the implementation of IT systems and digital products.

“Safety must be placed at the centre of all IT decision making.”

The consultation on the clinical risk standards for the use of digital health technologies was confirmed in September 2024 by Baroness Gillian Merron, minister for patient safety.

In a letter dated 17 September 2024, seen by Digital Health News, Baroness Merron said that clinical risk standards play a “crucial role” in patient safety when using EPRs.

“The standards, published in 2012, require organisations to ensure that clinical risk management is embedded in the deployment of EPRs and throughout the life cycle of the technology, including version upgrades.

“NHS England is responsible for ensuring the continued effectiveness of the clinical risk standards.”

The review begins with DCB0129, focusing on clinical risk management for IT manufacturers and is set to take place over two stages.

Stage 1 will see online focus groups take place in February 2025 to gather feedback from stakeholders across the NHS and beyond.

Stage 2 will see the insights from the focus groups shape proposed revisions to DCB0129. The proposals will then be subject to a subsequent public consultation, providing further opportunities for feedback.

To register interest in participating in a DCB0129 focus group, you can complete NHSE’s expression of interest form here by 10 January 2025.

The review of DCB0160 will commence later in 2025.