DCB0160 is the standard that deploying organisations must use when introducing Health Information Technology (HIT).
The standard provides a set of requirements structured to promote and ensure the effective application of clinical risk management by those health organisations that are responsible for the deployment, use, maintenance or decommissioning of the systems within the health and care environment.
If you are the manufacturer you do not need to complete the DCB0160, but you expected to be provide your DCB0129 documentation to deploying organisations that request it.
Kaleidoscope conduct and support compliance activities for DCB0160 including for nationally deployed health technology platforms. These activities are conducted independently to DCB0129 and include supporting the review of existing clinical safety documents, process and governance and leading hazard workshops to determine and produce a clinical safety opinion which is provided in the Clinical Safety Case Report. To comply with DCB1060 organisations will need to have appointed a Clinical Safety Officer. If you are a healthcare organisation deploying health technology software, please get in touch to hear more about who we can support you in the safe deployment of solutions.