ISO/IEC-Standards on Quality and Safety of Telehealth Services and Mobile Medical Apps

Wouter Meijer, Alan Taylor

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

Abstract

This paper investigates consistency of ISO/IEC-standards on quality and safety of telehealth services and mobile medical apps. Since mobile medical apps are 'software as a medical device', requirements for these apps are in software standards, in particular health software standards, as well as in medical device standards. These requirements were analyzed within an analysis model that has three domains: quality and safety management, core healthcare processes and resources. Telehealth services are healthcare processes and mobile medical apps are resources. There is good alignment of the standards that pertain to quality and safety management, the healthcare processes and medical devices. However, there is a lack of alignment, consistency and transparency of the ISO/IEC-standards on quality and safety of telehealth services and mobile medical apps. An international effort to address these issues is recommended.

Original languageEnglish
Title of host publicationMEDINFO 2021
Subtitle of host publicationOne World, One Health - Global Partnership for Digital Innovation - Proceedings of the 18th World Congress on Medical and Health Informatics
EditorsPaula Otero, Philip Scott, Susan Z. Martin, Elaine Huesing
PublisherIOS Press BV
Pages508-511
Number of pages4
ISBN (Electronic) 978-1-64368-265-5
ISBN (Print)978-1-64368-264-8
DOIs
Publication statusPublished - 2022
Externally publishedYes
Event18th World Congress on Medical and Health Informatics: One World, One Health - Global Partnership for Digital Innovation, MEDINFO 2021 - Virtual, Online
Duration: 2 Oct 20214 Oct 2021

Publication series

NameStudies in Health Technology and Informatics
Volume290
ISSN (Print)0926-9630
ISSN (Electronic)1879-8365

Conference

Conference18th World Congress on Medical and Health Informatics: One World, One Health - Global Partnership for Digital Innovation, MEDINFO 2021
CityVirtual, Online
Period2/10/214/10/21

Keywords

  • medical device
  • standard
  • Telehealth

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