Quick Summary
Clinical safety officers (CSOs) have raised concerns that the historical non-compliance of NHS trusts with digital clinical safety standards may jeopardize patient safety. The Digital Health Networks CSO Council has issued a warning regarding the implications of failing to complete essential safety tasks.
Key Concerns
- CSOs highlight that many NHS trusts are burdened with “legacy debt” from outdated systems.
- A BBC investigation revealed 126 cases of serious harm related to IT problems across 31 trusts, including three fatalities.
- Faye Clough, a lead clinical safety engineer, emphasized the risks associated with inadequate safety assessments during software procurement.
Implications of Legacy Debt
- Failure to comply with digital clinical safety standards can lead to patient safety incidents and IT errors.
- Without proper safety case reporting, trusts may face reputational damage and increased risk of harm to patients.
- Clough compared the situation to purchasing a house without a survey, indicating a lack of assurance regarding software safety.
Regulatory Context
- NHS England is reviewing digital clinical safety standards, with potential updates expected in 2025.
- Unlike medical devices, software used in the NHS lacks a dedicated regulatory framework, raising concerns about safety oversight.
- Despite existing standards since 2012, enforcement has been inconsistent due to the absence of CSOs in some organizations.
Recommendations for Trusts
- The CSO Council advises conducting regular audits and maintaining a risk register to address legacy debt.
- Ben Jeeves, chair of the CSO Council, noted that achieving full compliance may be challenging due to the extensive retrospective work required.
- Organizations are encouraged to assess systems and prioritize those needing retrospective safety cases.
Conclusion
The ongoing challenges related to legacy debt in NHS trusts underscore the importance of adhering to digital clinical safety standards to protect patient safety. Proactive measures and regulatory updates are essential to mitigate risks associated with outdated systems.