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Medientyp:
E-Artikel
Titel:
Software-as-a-Medical Device: demystifying Connected Health regulations
Beteiligte:
Carroll, Noel;
Richardson, Ita
Erschienen:
Emerald, 2016
Erschienen in:
Journal of Systems and Information Technology, 18 (2016) 2, Seite 186-215
Sprache:
Englisch
DOI:
10.1108/jsit-07-2015-0061
ISSN:
1328-7265
Entstehung:
Anmerkungen:
Beschreibung:
PurposeConnected 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/approachThrough 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.FindingsSeveral 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/valueA 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.