Smartphone in safety-critical applications (what is it good for?)

Team Discussion

Multiple authors

Many of us in the medical sector are looking at the role smartphones could play in healthcare provision. To be honest, discussions over m-health have been going on for years, although with the smartphone era that Apple kick started in 2007, research and development has stepped up a number of gears.

The smartphone has an important role to play in critical applications but not for the safety-critical part of the system. Instead they will be important for user-focused features that will enhance the experience, such as training, compliance aid, etc. You can’t trust them to run a critical algorithm that decides whether somebody requires drug or intervention because you can’t validate the operating system. In addition to the fact that batteries can die unexpectedly, updates can cause problems and new applications can crash a handset, iOS, Android and Windows are software of unknown provenance (soup), even though they are great operating systems. As a result, they are not suitable for running the control algorithm in a system.

I’m a systems engineer. If I’m going to create a closed-loop medical system I will design the software and electronics of the component that takes a measurement and then I will do the same with the part of the system that administers a drug or performs some action. In both cases I can test and verify that the algorithm is safety-critical, essential if I ever want to get it through the regulators.

The gap between recording and delivering needs to be bridged. In most cases this is the patient or healthcare professional who can, with their expertise and experience, weigh up the reading along with lots of other factors before making a decision. There is a lot of risk in allowing a piece of software to make this call, but I think closed-loop is achievable in the near future, just not with the smartphone as the integral part. It could provide a nice display or compliance monitor, but it plays no role in the critical path.

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