Confronting systemic challenges in interoperable medical device safety, security & usability

Safety and security are negative goals. Safety, security and usability (SSU) are system properties. They cannot be isolated to a component or some layer of the system. All three are prerequisites for system effectiveness. Ensuring SSU of an integrated system requires a holistic view; a myopic view will mislead. Consider the following illustration of a cybersecurity breach among high profile industry players [1]. Three well-respected and well-trusted global industrial leaders (Google, Apple, and Amazon) made products involved in the 2013 hacking, theft, and destruction of an individual’s ‘‘digital life” – purportedly for no obvious economic or criminal reason. The victim, Mat Honan, briefly described the incident and summarized the source of the breach, as follows: