A registered healthcare professional with clinical experience who is responsible for overseeing the clinical safety process and signing off documentation.
Through documented Safety Case Reports, Hazard Logs, CSO sign-off, and audits where required.
A structured register of all identified clinical risks, their likelihood and impact, and the mitigations in place.
While GDPR focuses on privacy and data security, DCB0129/DCB0160 focus on clinical safety. Both are required for compliance.
Whenever the system changes (e.g., new version, new workflows).Regularly as part of governance (e.g., annual review).
No. It is a continuous process throughout the system lifecycle (design, implementation, deployment, maintenance, decommissioning).
Yes if they must have adequate capacity, authority, and clinical understanding of each system.
Yes. Any digital system handling patient care or clinical decisions must comply with DCB standards.
Appointment of a Clinical Safety Officer (CSO).Development of a Clinical Safety Case and Hazard Log.Risk assessment and documentation of safety mitigations.Ongoing review as the product evolves.
Appointment of a Clinical Safety Officer (CSO) within the organisation.Production of a Clinical Safety Case Report.Completion and maintenance of a Hazard Log.Demonstrating how risks are mitigated in local use.
DCB0129: A clinical risk management standard that applies to manufacturers/developers of health IT systems to ensure their products are safe for clinical use.
DCB0129: A clinical risk management standard that applies to manufacturers/developers of health IT systems to ensure their products are safe for clinical use.DCB0160: A clinical risk management standard that applies to health organisations (NHS and providers) deploying and using health IT systems.
NHS England, NHS Digital (NHS Transformation Directorate), and local NHS organisations require suppliers and healthcare providers to comply before systems are procured or deployed.
NHS trusts, GP practices, and any organisation deploying or using digital health systems.
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