Digital interventions and their unexpected outcomes - time for digitalovigilance?

Guillermo Lopez-Campos, Elia Gabarron, Fernando Martin-Sanchez, Mark Merolli, Carolyn Petersen, Kerstin Denecke

Research output: Chapter in Book/Report/Conference proceedingChapter (peer-reviewed)peer-review

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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.

Original languageEnglish
Title of host publicationMEDINFO 2023 — The future Is accessible
EditorsJen Bichel-Findlay, Paula Otero, Philip Scott, Elaine Huesing
PublisherIOS Press
Number of pages5
ISBN (Electronic)9781643684574
ISBN (Print)9781643684567
Publication statusPublished - 25 Jan 2024

Publication series

NameStudies in Health Technology and Informatics
PublisherIOS Press
ISSN (Print)0926-9630
ISSN (Electronic)1879-8365


  • Humans
  • Digital Health
  • Health Facilities
  • Patient Safety
  • Software


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