Clinical safety

Throughout each development cycle of the standard, the BaRS programme will consider and maintain patient clinical safety through ongoing clinical risk management activities. 

The Clinical Safety Standards listed below are mandatory under the Health and Social Care Act 2012. BaRS programme and supplier responsibilities for each of the standards are described underneath.

DCB0129: Clinical Risk Management: its application in the manufacture of health IT systems

• The BaRS programme is responsible for implementing DCB0129 to achieve endorsement from the NHS England Clinical Safety Group (NHSE CSG)
• Suppliers are responsible for implementing DCB0129 for each release of their BaRS conformant product
  • Suppliers supporting public beta deployments will submit their clinical safety case report and hazard log to NHSE CSG to attain Clinical Authority to Release

DCB0160: Clinical Risk Management: its application in the deployment and use of health IT systems

• Providers are responsible for compliance with DCB0160 to manage clinical safety for their local deployment

The BaRS programme has delivered, as part of the standard, a clinical safety case report and supporting hazard log in accordance with DCB0129. The purpose of the clinical safety case report and associated hazard log is to identify, assess and manage clinical safety hazards arising from the creation and implementation of the BaRS. It demonstrates that associated hazards have been identified and managed, where possible, to ensure they do not give rise to unacceptable risks to patients and delivery of care. Whilst this has informed the development of the BaRS, any APIs developed to work with BaRS are not within the boundaries of the BaRS Programme. Where risks have been identified that are outside of the BaRS Programme boundary, they are transferred to the relevant party in the hazard log.

For communication and management of risk, suppliers and providers must:

• review and integrate the risks identified into their own hazard log where risk(s) have been transferred
• implement the appropriate mitigation stipulated

The NHSE Clinical Safety Group has fully endorsed the clinical safety management approach followed by the BaRS programme in support of the development and publication of BaRS. The endorsement does not result in a transfer of risk to the NHSE CSG in respect of any part of the BaRS. The element of clinical risk management remains the responsibility of the manufacturer of the BaRS conformant solution and the deploying organisation.

The BaRS Clinical Safety Case Report and BaRS Hazard Log are available to download here.