{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T15:26:05Z","timestamp":1766157965597,"version":"3.41.2"},"reference-count":29,"publisher":"Emerald","issue":"2","license":[{"start":{"date-parts":[[2016,5,9]],"date-time":"2016-05-09T00:00:00Z","timestamp":1462752000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.emerald.com\/insight\/site-policies"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JSIT"],"published-print":{"date-parts":[[2016,5,9]]},"abstract":"<jats:sec>\n<jats:title content-type=\"abstract-subheading\">Purpose<\/jats:title>\n<jats:p>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 \u2013 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 \u201cmedical devices\u201d, giving rise to Software-as-a-Medical Device (SaaMD).<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title content-type=\"abstract-subheading\">Design\/methodology\/approach<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title content-type=\"abstract-subheading\">Findings<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title content-type=\"abstract-subheading\">Originality\/value<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>","DOI":"10.1108\/jsit-07-2015-0061","type":"journal-article","created":{"date-parts":[[2016,6,3]],"date-time":"2016-06-03T08:30:59Z","timestamp":1464942659000},"page":"186-215","source":"Crossref","is-referenced-by-count":30,"title":["Software-as-a-Medical Device: demystifying Connected Health regulations"],"prefix":"10.1108","volume":"18","author":[{"given":"Noel","family":"Carroll","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ita","family":"Richardson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"140","reference":[{"issue":"69","key":"key2020121523595973100_ref001","first-page":"53","article-title":"Evolution of Health Web certification, through the HONcode 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