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

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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.
Original languageEnglish
Number of pages10
Publication statusPublished - 5 Jan 2021
Event54th Hawaii International Conference on System Sciences: Hawaii International Conference on System Sciences 2021 - , United States
Duration: 5 Jan 20215 Jan 2021
Conference number: 54th


Conference54th Hawaii International Conference on System Sciences
Country/TerritoryUnited States
Internet address

Bibliographical note

ISBN 978-0-9981331-4-0


  • software as a medical device
  • SaMD
  • International standards
  • IT Architectures and Implementations in Healthcare Environments
  • Patient safety
  • regulation
  • Scoping review
  • Standards


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