Supports the management of clinical risk and Patient/Service User safety.
Clinical Safety is a mandatory Overarching Standard. IT Solutions are an integral part of modern Health or Care Organisation, and the functionality provided is becoming more and more sophisticated. However, it must be recognised that IT failure, or incorrect use has the potential to cause harm to those Patients/Service Users that it is intended to benefit. Clinical Safety ensures that effective clinical risk management is carried out by organisations that are responsible fordeveloping and modifying IT Solutions, and purchasers are involved in the clinical risk management process.
The term ‘clinical risk’ is used to emphasise that the scope is limited to the management of risks related to Patient/Service User safety, as distinct from other types of risk such as financial. Clinical risk management may be conducted within the context of an overall risk management system operated by the Supplier and any wider health information governance processes. Wherever practical, existing risk management processes would be adapted, and used, to address the requirements for Clinical Safety.
This is not intended to be an exhaustive list of relevant regulations and standards and it is the responsibility of the Supplier to identify and comply with any that are not included here.
Please note that compliance with the Clinical Safety Standard requires Suppliers to have a Clinical Safety Officer (CSO) in place. Any Suppliers who don't currently have a CSO in place, will not be awarded compliance with this standard until this has been addressed.
Compliance with Clinical Risk Management: Its Application in the Manufacture of Health IT Systems
The Supplier shall be required to be compliant with the following Standard in respect of Clinical Safety: