A Pragmatic Approach towards Safe and Secure Medical Device Integration

Compared to other safety-related domains, harmonizing efforts regarding electronic device integration and interaction – in terms of real-time and remote control – are conducted less ambitious in the medical device sector. There are a couple of reasons for this restrained progress. Traditionally, medical devices are either both small-sized and self-sufficient or they are highly integrated parts of a complete setup provided by one vendor. Especially when equipping critical care facilities such as intensive care units, producer and brand diversity is low, whereas the pressure of competition is high. The results are proprietary communication and control solutions when connecting devices in order to interact. On the other hand, any modern hospital heavily relies on highly available critical medical devices providing and sharing data but also on confidentiality and integrity of vitally important information.

This paper discusses a pragmatic risk-based approach to handle integration problems facing the current situation described above, while focusing on future development challenges. The background of this paper is a project for defining a safe and secure integration interface that – open to integration partners – enables to monitor and remote-control a critical medical device.