Introduction
This document outlines the Clinical Risk Management System[1] (CRMS) for BrisDoc Healthcare Services, subsequently referred to as ‘BrisDoc’ and it applies to all Health IT Systems that it implements and maintains. This CRMS defines how BrisDoc will integrate the DCB 0160 [Ref 1] and/or DCB 0129 [Ref 2] requirements and associated Clinical Risk Management (CRM) processes within existing Organisational Risk Management structures and processes.
This CRMS provides a framework that promotes effective risk management of known and potential Hazards in Clinical Software solutions. It is a critical assurance component of both DCB compliance, and the associated requirement to demonstrate that effective CRM has underpinned all Health IT system development, deployments, and life-cycle management activities.
In general, software suppliers such as CLEO, EMIS and RiO are responsible for conforming to DCB0129 standards and providers such as BrisDoc are responsible for conforming to DCB1060 standards.
In most projects BrisDoc will be solely responsible for the activities and associated compliance for DCB 0160 only, however it is recognised that projects involving internal development may require BrisDoc to fulfil the obligations of DCB 0129 in addition to DCB 0160.
[1] Note: It is recommended that readers of this CRMS have read and understood the DCB 0160 and DCB 0129 Standards and associated Implementation Guidance [Ref 3 & Ref 4] prior to reviewing the document.