An approach towards compositional behavior specification of medical device networks

As medical devices become increasingly complex and the amount of intraoperative information produced in the operating room becomes harder to monitor by hospital staff, the demand for an open communication standard allowing the exchange of data between medical devices, equipment and computer systems is in the rise. Above technical issues, regulatory preconditions pose major challenges: European guidelines oblige medical device manufacturers to specify a list of permissible equipment for each product along with the documentation of its intended use. Operating networks of medical devices beyond their intended use necessitates documented risk management activities. The aim of this article is the development of a methodology that facilitates the detection of risks arising from the dynamic composition of medical device networks. To this end, we describe a novel machine-readable description method, allowing automated threat detection of networks composed of so-described medical devices and equipment. We evaluate our approach in a novel interconnected medical device setup and discuss possible limitations of the strategy.