{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T10:58:46Z","timestamp":1771844326087,"version":"3.50.1"},"reference-count":0,"publisher":"IOS Press","isbn-type":[{"value":"9781643684567","type":"print"},{"value":"9781643684574","type":"electronic"}],"license":[{"start":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T00:00:00Z","timestamp":1706140800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,25]]},"abstract":"<jats:p>The application of digital interventions in healthcare beyond research has been translated in the development of software as a medical device. Along with corresponding regulations for medical devices, there is a need for assessing adverse events to conduct post-market surveillance and to appropriately label digital health interventions to ensure proper use and patient safety. To date unexpected consequences of digital health interventions are neglected or ignored, or at least remain undescribed in literature. This paper is intended to raise awareness across the research community about these upcoming challenges. We recommend that - together with developing a new research field of digitalovigilance - a systematic assessment and monitoring of adverse events and unexpected interactions be included in clinical trials, along with the reporting of such events and the conduct of meta-analyses on critical aspects.<\/jats:p>","DOI":"10.3233\/shti231011","type":"book-chapter","created":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T10:22:59Z","timestamp":1706178179000},"source":"Crossref","is-referenced-by-count":5,"title":["Digital Interventions and Their Unexpected Outcomes \u2013 Time for Digitalovigilance?"],"prefix":"10.3233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3011-0940","authenticated-orcid":false,"given":"Guillermo","family":"Lopez-Campos","sequence":"first","affiliation":[{"name":"Wellcome-Wolfson Institute for Experimental Medicine, Queen\u2019s University Belfast, Belfast, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elia","family":"Gabarron","sequence":"additional","affiliation":[{"name":"Norwegian Centre for E-health Research, University Hospital of North Norway, Troms\u00f8, Norway"},{"name":"Department of Education, ICT and Learning, \u00d8stfold University College, Halden, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernando","family":"Martin-Sanchez","sequence":"additional","affiliation":[{"name":"Digital Health Programme. Instituto de Salud Carlos III. Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Merolli","sequence":"additional","affiliation":[{"name":"Department of Physiotherapy, School of Health Sciences, the University of Melbourne, Melbourne, Australia"},{"name":"Centre for Digital Transformation of Health, The University of Melbourne, Melbourne, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolyn","family":"Petersen","sequence":"additional","affiliation":[{"name":"Department of Artificial Intelligence and Informatics, Mayo Clinic, Rochester, Minnesota, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerstin","family":"Denecke","sequence":"additional","affiliation":[{"name":"Bern University of Applied Sciences, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","MEDINFO 2023 \u2014 The Future Is Accessible"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI231011","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T10:23:00Z","timestamp":1706178180000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI231011"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,25]]},"ISBN":["9781643684567","9781643684574"],"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti231011","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"value":"0926-9630","type":"print"},{"value":"1879-8365","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,25]]}}}