TY - JOUR
T1 - Software-as-a-Medical Device
T2 - demystifying Connected Health regulations
AU - Carroll, Noel
AU - Richardson, Ita
N1 - Publisher Copyright:
© 2016, © Emerald Group Publishing Limited.
PY - 2016
Y1 - 2016
N2 - Purpose: 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). Design/methodology/approach: 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. Findings: 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. 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 first attempt towards recognising the impact of regulation and standards compliance in Connected Health.
AB - Purpose: 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). Design/methodology/approach: 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. Findings: 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. 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 first attempt towards recognising the impact of regulation and standards compliance in Connected Health.
KW - Connected Health
KW - Healthcare
KW - Regulation
KW - Software-as-a-Medical Device
UR - http://www.scopus.com/inward/record.url?scp=84977571163&partnerID=8YFLogxK
U2 - 10.1108/JSIT-07-2015-0061
DO - 10.1108/JSIT-07-2015-0061
M3 - Review article
AN - SCOPUS:84977571163
SN - 1328-7265
VL - 18
SP - 186
EP - 215
JO - Journal of Systems and Information Technology
JF - Journal of Systems and Information Technology
IS - 2
ER -