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

CONCLUSIONS: This study provides critical evidence for setting labelling standards by the Therapeutic Goods Administration to safeguard patients, health professionals, consumers, industry, and regulatory bodies from AI-based dermatology SaMDs that do not currently provide adequate information about how they were developed and tested.PMID:38419186 | DOI:10.1111/ajd.14222

Source: The Australasian Journal of Dermatology - February 29, 2024 Category: Dermatology Authors: Åsa Ingvar Ayooluwatomiwa Oloruntoba Maithili Sashindranath Robert Miller H Peter Soyer Pascale Guitera Tony Caccetta Stephen Shumack Lisa Abbott Chris Arnold Craig Lawn Alison Button-Sloan Monika Janda Victoria Mar Source Type: research