Reducing the footprint of certifiable health software during early stage development

Abstract

Due to its critical nature with respect to patient safety, privacy and other quality attribute, healthcare software is often subject to third party certification. To take a solitary example, Health Canada deems patient management systems (such as Electronic Medical Records) to be subject to mandatory certification and licensing. One strategy to reduce the cost of certifying large software products is to dislocate the implementation of functions that require certification from those functions that do not require certification. While this strategy has been recommended, no systematic method has been proposed on how to integrate this notion into the overall system design process. This paper addresses this gap. We present a process that takes a requirements specification and pertinent certification criteria as input and produces a set of constraints on potential architecture designs, ensuring that the size of software that must undergo certification is reduced. We demonstrate the approach using a real-world case study involving Electronic Health Record software in the context of the Canadian regulatory framework.