111 Referral Standard: Clinical Safety Case Report

The clinical safety statement is based on the safety argument below, based on two of the following criteria:

1. Demonstration of adherence to a fit for purpose clinical safety process: The Clinical Safety process described in Section 4 has been carried out and is consistent with the NHS Digital’s Clinical Safety Management System (CSMS) and DCB 0129 outlined in reference 2.

2. The mitigation is deemed to be appropriate and commensurate with the scale of risk. Risk is deemed to be acceptable in most cases and tolerable in others.

All risks identified within the hazard log have been managed via their associated controls to either an ‘Acceptable’ or ‘Tolerable’ level, in line with the identified risk tolerance levels.

As previously stated, this clinical safety report is not directly related to software development or deployment. It has been designed to look at the clinical safety hazards and mitigate the risks in the creation and production of the social prescribing information standard itself. Suppliers developing software to implement these standards, will therefore need to undertake their own DCB0129 Clinical Safety Case and healthcare organisations involved in the deployment of such software will still be expected to apply DCB0160. From this perspective the Clinical Safety Officer considers the 111-information standard v0.4 safe to deploy.