Regulatory and Legal Considerations with Artificial Intelligence in Dermatology

Abstract

Artificial intelligence (AI) is increasingly being used in dermatology, particularly for image-based diagnostics. However, a number of regulatory and legal challenges remains unanswered. This article reviews the UK regulations for AI-driven medical devices with reference to international comparisons. We have also highlighted some liability concerns with clinical examples to illustrate the complexity. As AI deployment continues to rapidly expand, it is critical that health care practitioners ensure not only that these technologies are implemented with patient safety and ethical considerations at the forefront but that they are also aware of the importance of regulatory compliance and liability issues.

Keywords: Medical artificial intelligence; Medical device regulation; Medical liability.