Understanding clinical safety and governance

---

Information standards underpin national healthcare initiatives from the Department of Health, NHS England, the Care Quality Commission and other national health organisations. They provide the mechanism for introducing requirements to which the NHS, those with whom it commissions services and its IT system suppliers, must conform.

The following two standards, relating to clinical safety, are accepted for publication under section 250 of the Health and Social Care Act 2012 by the Data Coordination Board (DCB). In line with current DCB practice, each standard comprises:

• A specification, which defines the requirements and conformance criteria to be met by the user of the standard - how these requirements are met is the responsibility of the user
• Implementation guidance, which provides an interpretation of the requirements and, where appropriate, defines possible approaches to achieving them 

Compliance with DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012. 

The Digital Technology Assessment Criteria for health and social care (DTAC) brings this all together and gives staff, patients and citizens confidence that the digital health tools they use meet our clinical safety, data protection, technical security, interoperability and usability and accessibility standards.

We are experts in clinical safety, with experience of achieving DTAC accreditation for multiple digital systems previously as well has having our own Clinical Safety Officer in-house, critical to the success of any product into the health. 

Both DCB 129 and DCB 160 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, we maintain internal capability.