Software Testing in Clinical Risk Management

Abstract

Many controls in Health IT rely on requirements being verified through a process of testing. To ensure that the extent and granularity of testing is appropriate, safety case developers needs to understand the techniques employed to test software, its phases and constraints. When defects are found a view needs to be taken on whether the issue could compromise patient safety and, if so, to what extent. Fixes needs to be prioritise and this should take into account the assessed degree of clinical risk. When the plan is for systems to be deployed without safety-related defects being rectified, additional controls may need to be put in place and the residual risk carefully evaluated. This chapters looks at those techniques commonly employed to test software, the challenges of testing Health IT and how the outcome of testing can be used as evidence for the safety case.