Risk Classification of Data Transfer in Medical Systems

Abstract

Nowadays, the hospital IT network is increasingly used to transport data between medical devices and information systems. The increase in network integration and the importance of the transported data results in high dependency on the IT network in the clinical setting. Until now, risk classification methods focused on two individual components of a medical system: medical devices and medical software. In this paper, we present a tool to classify patient safety risks of data transfer in medical systems by indicating the dependency on the IT network. The new method shifts the focus from separate components to the intended use of the entire system. It supports communication about risks and enables us to link risk analysis techniques and safety measures to the classification. The tool can be used in the design phase and is the start of a risk management process to secure safe use of a medical system.