Both DCB 0129 and DCB 0160 require that a Clinical Safety Officer is appointed to oversee the clinical risk assessment of a health IT product. The Clinical Safety Officer will be expected to be involved in the risk assessment work and sign-off the documentation once it has been created. Often the Clinical Safety Officer will write the documentation itself. They must ensure that a suitable safety process is in place and that it has been followed correctly.
The Clinical Safety Officer needs to be a clinician with a current professional registration and experience in the application of risk management to clinical domains. The role comes with responsibilities and acting in the capacity of CSO should not be taken lightly. Training and experience in the area are essential.
Many organisations choose to outsource the role of the Clinical Safety Officer to an independent professional.