Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives.

Journal: Expert review of medical devices
Published Date: May 8, 2023

Abstract

INTRODUCTION: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed.

Authors

  • Alan G Fraser
    Wales Heart Research Institute, Cardiff University Cardiff UK.
  • Elisabetta Biasin
    Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium.
  • Bart Bijnens
    Department of Information and Communication Technologies, University Pompeu Fabra, Barcelona, Spain.
  • Nico Bruining
    Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
  • Enrico G Caiani
    Department of Electronics, Information and Biomedical Engineering, Politecnico Di Milano, P.zza L. da Vinci 32, 20133, Milan, Italy. enrico.caiani@polimi.it.
  • Koen Cobbaert
    Philips, Brussels, Belgium.
  • Rhodri H Davies
    Cardiac Imaging Department, Barts Heart Centre, St Bartholomew's Hospital, London, UK; Institute of Cardiovascular Science, University College London, London, UK.
  • Stephen H Gilbert
    Technische Universität Dresden, Else Kröner Fresenius Center for Digital Health, Dresden, Germany.
  • Leo Hovestadt
    Elekta, Stockholm, Sweden.
  • Erik Kamenjasevic
    Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium.
  • Zuzanna Kwade
    Dedalus HealthCare, Antwerp, Belgium.
  • Gearóid McGauran
    Health Products Regulatory Authority, Dublin, Ireland.
  • Gearóid O'Connor
    Health Products Regulatory Authority, Dublin, Ireland.
  • Baptiste Vasey
    Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
  • Frank E Rademakers
    KU Leuven, Leuven, Belgium.

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