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

Åsa Ingvar1,2,3,4, Ayooluwatomiwa Oloruntoba2, Maithili Sashindranath2

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The Australasian Journal of Dermatology
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Summary
This summary is machine-generated.

Establishing clear labelling standards for artificial intelligence (AI) in dermatology is crucial. Experts agreed on essential information for AI-based Software as Medical Devices (SaMD) to ensure safe and appropriate use.

Keywords:
Delphi consensusartificial intelligencedermatologylabellingmedical device

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Area of Science:

  • Digital health and dermatology.
  • Regulatory science for medical devices.

Background:

  • Artificial intelligence (AI) offers significant potential to enhance dermatological care delivery.
  • AI-based Software as Medical Devices (SaMD) require clear labelling for appropriate use by health professionals and the public.
  • Current lack of minimum labelling requirements for dermatology AI-SaMD poses a risk.

Purpose of the Study:

  • To evaluate and establish minimum labelling requirements for AI-based dermatology SaMD.
  • To ensure end-users have adequate information for safe and effective use of AI dermatology tools.

Main Methods:

  • A modified Delphi consensus process involving Australian digital health and dermatology experts.
  • Evaluation of common AI-SaMD labelling recommendations using a nine-point Likert scale and expert voting.
  • Consensus defined as agreement by over 75% of experts.

Main Results:

  • Unanimous expert support for including all proposed items as minimum labelling requirements.
  • Key items include indication for use, user training, data sets, algorithm design, validation, performance, limitations, updates, and adverse events.
  • Consensus reached on uniform labelling criteria across all AI categories and risk classes regulated by the Therapeutic Goods Administration.

Conclusions:

  • The study provides essential evidence for the Therapeutic Goods Administration to establish robust labelling standards for AI-dermatology SaMD.
  • These standards will safeguard patients, clinicians, consumers, and industry by ensuring adequate information on AI device development and testing.
  • Implementing these standards is critical for responsible innovation and adoption of AI in dermatology.