Can standards and regulations keep up with health technology?

Christopher James Vincent, Gerrit Niezen, Aisling Ann O'Kane, Katarzyna Stawarz

Research output: Contribution to journalArticle (Academic Journal)peer-review

33 Citations (Scopus)


Technology is changing at a rapid rate, opening up new possibilities within the health care domain. Advances such as open source hardware, personal medical devices, and mobile phone apps are creating opportunities for custom-made medical devices and personalized care. However, they also introduce new challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly and efficiently. Compared with the emergence of new technologies, health technology design standards and regulations evolve slowly, and therefore, it can be difficult to apply these standards to the latest developments. For example, current regulations may not be suitable for approaches involving open source hardware, an increasingly popular way to create medical devices in the maker community. Medical device standards may not be flexible enough when evaluating the usability of mobile medical devices that can be used in a multitude of different ways, outside of clinical settings. Similarly, while regulatory guidance has been updated to address the proliferation of health-related mobile phone apps, it can be hard to know if and when these regulations apply. In this viewpoint, we present three examples of novel medical technologies to illustrate the types of regulatory issues that arise in the current environment. We also suggest opportunities for support, such as advances in the way we review and monitor medical technologies.

Original languageEnglish
Pages (from-to)e64
JournalJMIR mHealth and uHealth
Issue number2
Publication statusPublished - 3 Jun 2015

Structured keywords

  • Digital Health


  • Digital Health


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