Poor safety compliance threatens ambitious NHS digital transformation
· News-MedicalDigital transformation is key to the realization of the NHS 10 Year Plan for England, "shifting from bricks to clicks," but compliance with statutory digital clinical safety standards is not routinely monitored or enforced, explain the researchers.
To better understand the drivers behind the poor compliance rates, the researchers carried out a secondary analysis of qualitative data from the original survey responses and additionally drew on previously unpublished quantitative data on Clinical Safety Officer (CSO) capacity.
CSOs are clinicians who are responsible for overseeing the clinical risk management of digital technologies used in the delivery of patient care.
Free text responses suggested the figures overstated actual capacity, with CSO duties typically performed alongside other substantive duties.
Of particular note were the exemptions claimed under prevention or detection of crime and health and safety, which indicate a fundamental misunderstanding of what is meant by clinical safety, they highlight.
"These themes do not operate in isolation," emphasise the researchers. "The result is a system in which no single component (ie, knowledge, governance, process or workforce) functions adequately, and the failure of each compounds the others."
This matters, say the researchers, because:
- The Plan's ambition to rapidly adopt frontier technologies, including AI, genomics and robotics, demands a highly skilled CSO workforce with dedicated time to undertake risk assessments of increasing complexity
- The shift from hospital to community will also likely require concomitant expansion of the community digital footprint, especially in primary care, which is likely to be smaller and less well resourced than trusts and ICBs, with less access to specialist CSO capacity
To tackle these issues, the researchers suggest:
- the development of mechanisms for sharing best practice, identifying standard deployment hazards and causes, and raising awareness of clinical incidents
Nevertheless, they conclude: "NHS organisations in England are systematically failing to comply with legislated digital safety standards…Before the UK Government pursues its ambitious digital future for the NHS, a new digital safety architecture must be established."
"Without these changes, the digital transformation envisaged in the 10 Year Health Plan risks propagating patient harm at unprecedented scale and speed."
Digital transformation is key to the realisation of the NHS 10 Year Plan for England, "shifting from bricks to clicks," but compliance with statutory digital clinical safety standards is not routinely monitored or enforced, explain the researchers.
To better understand the drivers behind the poor compliance rates, the researchers carried out a secondary analysis of qualitative data from the original survey responses and additionally drew on previously unpublished quantitative data on Clinical Safety Officer (CSO) capacity.
CSOs are clinicians who are responsible for overseeing the clinical risk management of digital technologies used in the delivery of patient care.
Free text responses suggested the figures overstated actual capacity, with CSO duties typically performed alongside other substantive duties.
Of particular note were the exemptions claimed under prevention or detection of crime and health and safety, which indicate a fundamental misunderstanding of what is meant by clinical safety, they highlight.
"These themes do not operate in isolation," emphasise the researchers. "The result is a system in which no single component (ie, knowledge, governance, process or workforce) functions adequately, and the failure of each compounds the others."
This matters, say the researchers, because:
- The Plan's ambition to rapidly adopt frontier technologies, including AI, genomics and robotics, demands a highly skilled CSO workforce with dedicated time to undertake risk assessments of increasing complexity
- The shift from hospital to community will also likely require concomitant expansion of the community digital footprint, especially in primary care, which is likely to be smaller and less well resourced than trusts and ICBs, with less access to specialist CSO capacity
To tackle these issues, the researchers suggest:
- the development of mechanisms for sharing best practice, identifying standard deployment hazards and causes, and raising awareness of clinical incidents
Nevertheless, they conclude: "NHS organisations in England are systematically failing to comply with legislated digital safety standards…Before the UK Government pursues its ambitious digital future for the NHS, a new digital safety architecture must be established."
"Without these changes, the digital transformation envisaged in the 10 Year Health Plan risks propagating patient harm at unprecedented scale and speed."
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