Design and deployment of wireless healthcare IT networks.

The concept of applying risk analysis tools such as failure mode, effects, and criticality analysis (FMECA) to the design and development process where human safety is a factor is nothing new to many industries such as nuclear power, aviation, and the automotive industry. Safety and reliability engineers are well versed in the implementation of risk management tools as critical components of addressing human safety in their product development process. The concept of applying risk management to medical information technology (IT) networks is the focus of ANSI/ AAMI/IEC 80001-1:2010, and the focus on the wireless portion of the network—the weakest link—is within the draft of an 80001 technical report (TR), Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks. The governance regarding the technology convergence of medical device connectivity and the IT network is still in its infancy. Generally speaking, the focus from an IT perspective is that networking IT professionals are not expected to be trained in the concepts of risk analysis of complex systems, nor are they fully aware of all the human safety issues associated with medical device connectivity. But that is precisely what is occurring when connecting medical devices (including the connected patient) to the healthcare wireless network. The draft IEC TR 80001-2-3 provides the framework by which the concepts of risk analysis can be applied to the design, deployment, and management of wireless medical IT networks in healthcare. This paper covers two topics related to wireless medical IT networks: 1. Some of the general challenges and solutions for the design and deployment stages of a wireless medical IT network 2. The fundamental principles of applying risk management during these stages as defined in the draft TR on wireless networks