Using PVSio-web and SAPERE for rapid prototyping of user interfaces in Integrated Clinical Environments

Integrated clinical environments (ICEs) consist of interoperable medical devices that seamlessly exchange data and commands to create safety interlocks and closed loop controls to improve the quality of care delivered to the patient. Currently at the prototype stage, they promise to form the basis of a new generation of healthcare systems for high acuity patients. Regulators such as the US Food and Drug Administration are promoting the development of tools and techniques for verification and validation of essential safety requirements for ICEs. To date, little research has focused on the certification and assurance of their user interfaces with respect to use errors. In this work, we demonstrate how the PVSio-web prototyping tool can be conveniently used in combination with the communication framework SAPERE to generate realistic ICE systems prototypes from formal models. This approach is particularly suitable for exploring requirements, design, and regulatory issues of usability and safety of the user interfaces of ICE systems. An example ICE system prototype is presented, along with an example analysis demonstrating how the prototype can be used to explore subtle user interface design issues that could lead to usability and safety hazards in clinical scenarios.