CIS system hazards derived from literature using systems and human factors perspectives

Abstract

The FDA and other national regulatory agencies have expressed their intentions to begin enforcement of medical device regulations on Health Informatics Technology (HIT) vendors. A mechanism which might be employed to achieve this enforcement in the US is the Quality Systems Regulations (QSR), while similar legislation might be employed elsewhere. In order for vendors to achieve conformance with QSR regulations, they must first identify hazards which their products may pose. In order to identify these hazards we have undertaken a literature review from which we have extracted taxonomies of Clinical Informatics Systems (CIS) devices, systems and hazards. We present these three taxonomies, and a discussion of contemporary risk classification strategies which are being applied to HIT. The taxonomies which have been developed provide actionable hazards for HIT vendors, and provide a potential basis for best practices in the engineering of HIT systems.