Clinical safety and the NHS App
An overview of clinical risk management relevant to the NHS App.
The NHS App has been designed, built, tested and clinically reviewed with patient safety at its heart, in accordance with mandated safety standards DCB0129 and DCB0160. As part of this commitment to safety we need to be kept informed of any clinical incidents that may occur from use of the NHS App. This is so we can learn from them and prevent recurrence wherever possible.
If a clinical incident occurs, in addition to following standard operating procedures at practice level, incidents should be logged with the NHS Digital National Service Desk.
Email: [email protected]
Tel: 0300 303 5035
NHS App Clinical Safety Case
The NHS App Clinical Safety Case (CSC) contains the following live documents:
- Hazard Log
- Clinical Safety Case Report (CSCR)
Existing risks are reviewed alongside new features being assessed and added.
All integrations and developments for the NHS App are clinically reviewed by multi-disciplinary teams via hazard assessment workshops. Information about each feature and/ or supplier integration is updated and approved by the NHS App clinical safety team made up of a Clinical Safety Officer and Clinical Safety Engineer.
The context and premise of the feature/integration is condensed and provided in the supplementary approval document known as the Clinical Authority to Release (CATR) following Clinical Safety Group (CSG) approval. As a live document the CATR is kept under review.
The NHS App CATR on this page will be the most up to date version available for the product and is subject to regular review and update from the Clinical Safety Team.
Clinical Risk Management
Before any functions or features go live on the NHS App, NHS Digital undertakes a formal review of the clinical risk management activities. This is to ensure the requirements for the clinical safety management system have been addressed. This review is conducted by the Clinical Safety Group (CSG).
This review is consistent with the scale of the overarching clinical risk management process.
The review demonstrates that:
- the NHS App clinical risk management plan has been implemented and the outcomes recorded
- any remaining clinical risk for each hazard is acceptable
- appropriate methods are in place to make sure relevant post-deployment information is captured in the NHS App clinical risk management system
The CSG also needs to be satisfied that any outstanding defects that remain unresolved at release have been reviewed by the operational Clinical Safety Officer (CSO) and that the potential impact on clinical safety has been assessed.
If the risk of any outstanding defects remains unacceptable, the NHS App must consider implementing additional risk control measures. Where further risk control measures are considered impractical a clinical risk benefits analysis will be carried out to establish whether the benefits of the release outweigh the remaining clinical risk.
Once satisfied with the review, a Clinical Authority to Release (CATR) is issued.
Disclaimer
The CATR has been approved by NHS Digital Clinical Safety Group. The approval is limited to the product defined by the name NHS App and the functionality defined within the safety case for the product.
Unless specified otherwise within the supplier safety case and approval given by NHS Digital Clinical Safety Group, this endorsement must not be used beyond the scope of product functionality.
Where common elements of an approved product form part of a different product offered by the supplier, a separate or updated safety case is required.
Last edited: 30 March 2023 9:45 am