Software-as-a-Medical Device: demystifying Connected Health regulations
| Date | 09 May 2016 |
| Published date | 09 May 2016 |
| DOI | https://doi.org/10.1108/JSIT-07-2015-0061 |
| Pages | 186-215 |
| Author | Noel Carroll,Ita Richardson |
| Subject Matter | Information & knowledge management,Information systems,Information & communications technology |
Software-as-a-Medical Device:
demystifying Connected
Health regulations
Noel Carroll
ARCH – Applied Research for Connected Health Technology Centre,
University of Limerick, Limerick, Ireland, and
Ita Richardson
Lero – the Irish Software Research Centre, University of Limerick,
Limerick, Ireland
Abstract
Purpose – Connected Health is an emerging and rapidly developing eld never before witnessed
across the healthcare sector. It has the potential to transform healthcare service systems by increasing
its safety, quality and overall efciency. 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).
Design/methodology/approach – Through an extensive literature review, this paper demysties
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.
Findings – Several key issues are identied, 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.
Originality/value – 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 rst attempt towards recognising the impact of regulation and standards
compliance in Connected Health.
Keywords Regulation, Healthcare, Connected Health, Software-as-a-Medical Device
Paper type Literature review
1. Introduction
Connected Health is an emerging and rapidly developing eld which has the potential to
transform healthcare service systems by increasing their safety, quality and overall
efciency. While considered a disruptive technological approach (Christensen et al., 2000)in
healthcare, it is used by different industries in various sector contexts (e.g. healthcare, social
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.
The current issue and full text archive of this journal is available on Emerald Insight at:
www.emeraldinsight.com/1328-7265.htm
JSIT
18,2
186
Received 10 July 2015
Revised 20 January 2016
Accepted 22 January 2016
Journalof Systems and
InformationTechnology
Vol.18 No. 2, 2016
pp.186-215
©Emerald Group Publishing Limited
1328-7265
DOI 10.1108/JSIT-07-2015-0061
care and the wellness sector). Thus, various denitions for Connected Health exist with
different emphasis placed on healthcare, business, technology and support service
providers, or any combination of these. Within the research community, Connected Health is
not well-dened and remains an ambiguous concept. The ECHAlliance (2014) group
promote the concept of Connected Health to act as “the umbrella description covering digital
health, eHealth, mHealth, telecare, telehealth and telemedicine”. In addition, described by
Cauleld and Donnelly (2013), Connected Health refers to:
[…] a conceptual model for health management where devices, services or interventions are
designed around the patient’s needs, and health related data is shared, in such a way that the
patient can receive care in the most proactive and efcient manner possible.
Connected Health has been dened by Richardson (2015) as:
[…] patient-centred care resulting from process-driven health care delivery undertaken by
healthcare professionals, patients and/or carers who are supported by the use of technology
(software and/or hardware).
Therefore, Connected Health can be considered to be a socio-technical healthcare model that
extends healthcare services beyond healthcare institutions (Carroll et al., 2016). Through the
exploitation of technological innovations, healthcare providers can generate accurate and
timely information for patients and clinicians to make better decisions. Improved
decision-making tools can improve the likelihood of saving lives, saving money and
ensuring a better quality of life during and post treatment (Hunink et al., 2014). Regardless of
the various denitions, the key here is the process of connectedness and the manner in which
technological solutions enable healthcare solutions. In addition, the Food and Drug
Administration (FDA) (2014) describes Connected Health as:
[…] electronic methods of health care delivery that allow users to deliver and receive care
outside of traditional health care settings. Examples include mobile medical apps, medical
device data systems, software, and wireless technology.
Thus, Connected Health aims to utilise the connectivity of technologies to support
independent living to maximise its effects on society and, ultimately, to improve the lives of
citizens. In some cases, these technologies may be also considered as medical devices. The
regulatory environment is a critical aspect of all healthcare technologies and one which
presents the greatest challenge for many companies to understand its use to guide healthcare
innovations. From a Connected Health perspective, it is often unclear as to what constitutes
as a “wellness device” and a “medical device”. Even the concept of “connected” health
implies, for example, that peripheral devices may be considered to be the medical devices,
but the connectivity or the process of integrating them into one service solution may not.
Thus, the concept of “intended use” often determines whether a product is a medical device
or a general health wellness support service. Intended use or intended purpose refers to “the
use for which the device is intended according to the data supplied by the manufacturer on
the labelling, in the instructions and/or in promotional materials” (Article 1(2)g of Directive
93/42/EEC). While this is merely an example of some of the day-to-day issues companies face
with various healthcare innovations, we identied the need to undertake a study to examine
the regulatory landscape and how it potentially inuences Connected Health developments.
We attempt to demystify Connected Health regulation and focus on Software-as-a-Medical
Device (SaaMD) to guide our understanding of the regulatory environment in Connected
Health.
187
Connected
Health
regulations
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