Minimum labelling requirements for dermatology artificial intelligence-based Software as Medical Device (SaMD): A consensus statement.

Journal: The Australasian journal of dermatology
PMID:

Abstract

BACKGROUND/OBJECTIVES: Artificial intelligence (AI) holds remarkable potential to improve care delivery in dermatology. End users (health professionals and general public) of AI-based Software as Medical Devices (SaMD) require relevant labelling information to ensure that these devices can be used appropriately. Currently, there are no clear minimum labelling requirements for dermatology AI-based SaMDs.

Authors

  • Åsa Ingvar
    Victorian Melanoma Service, Alfred Health, Melbourne, Victoria, Australia.
  • Ayooluwatomiwa Oloruntoba
    School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
  • Maithili Sashindranath
    School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
  • Robert Miller
    Department of Hand and Plastic surgery department, Chelsea and Westminster Hospital, London, UK.
  • H Peter Soyer
    Dermatology Research Centre, The University of Queensland, The University of Queensland Diamantina Institute, Brisbane, Australia.
  • Pascale Guitera
    Sydney Melanoma Diagnostic Centre, Faculty of Medicine and Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia; Melanoma Institute Australia, Sydney, Australia.
  • Tony Caccetta
    Australasian College of Dermatologists, Sydney, Australia.
  • Stephen Shumack
    Australasian College of Dermatologists, Sydney, Australia.
  • Lisa Abbott
    Australasian College of Dermatologists, Sydney, Australia.
  • Chris Arnold
    BioGrid Australia Ltd, Melbourne, Australia.
  • Craig Lawn
    Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.
  • Alison Button-Sloan
    Australian Melanoma Consumer Alliance, Melbourne, Victoria, Australia.
  • Monika Janda
    Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
  • Victoria Mar
    Victorian Melanoma Service, Alfred Hospital, Melbourne, Victoria, Australia.