Software as a Medical Device (SaMD): Useful or Useless Term?

Abstract

Software as a medical device is a relatively new and expanding field in which patient safety must be a key concern. Regulation and standards regarding software as a medical device (subsequently referred to as “SaMD”) must incorporate all components that could potentially influence SaMD, both in its development and implementation. However, SaMD has been varyingly defined by organisations and individuals within the literature, therefore there is no clear boundary as to what is or is not SaMD, consequently, no clear definition of SaMD exists. Without a clear definition it therefore becomes impossible to create standards to regulate SaMD. Ultimately, this results in increased risks to patient safety. The purpose of this study was to identify SaMD concepts through a Scoping Review to establish the boundaries of SaMD. This has significant impact on new technology applications to support healthcare monitoring and healthcare service delivery. This will ultimately affect how new technology can be regulated in healthcare and will impact innovation and design in this field.