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Software-as-a-Medical Device: demystifying Connected Health regulations

Noel Carroll (ARCH – Applied Research for Connected Health Technology Centre, University of Limerick, Limerick, Ireland)
Ita Richardson (Lero – the Irish Software Research Centre, University of Limerick, Limerick, Ireland)

Journal of Systems and Information Technology

ISSN: 1328-7265

Article publication date: 9 May 2016




Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD).


Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation.


Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research.


A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.



This work was supported, in part, by ARCH – Applied Research for Connected Health Technology Centre (www.arch.i.e.), an initiative jointly funded by Enterprise Ireland and the IDA, SFI Lero Grant (www.lero.i.e.) 13/RC/2094 and SFI Industry Fellowship grant Number 14/IF/2530.


Carroll, N. and Richardson, I. (2016), "Software-as-a-Medical Device: demystifying Connected Health regulations", Journal of Systems and Information Technology, Vol. 18 No. 2, pp. 186-215.



Emerald Group Publishing Limited

Copyright © 2016, Emerald Group Publishing Limited

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