Miss Tatiana De Campos Aranovich1, Dr Rita Matulionyte
1Macquarie University, Sydney, Australia
Biography:
Bio to come
Abstract:
The paper presents the findings of a research report for the Australian Therapeutic Goods Administration (TGA) on transparency and explainability for Artificial Intelligence (AI)-enabled medical devices. The research report aims to understand and propose parameters for defining AI, its transparency, and explainability to be employed in the TGA guidelines for AI-enabled medical devices in Australia. Relying on doctrinal and comparative legal methods, the report reviewed 78 policy documents and the relevant academic literature in order to determine the most suitable definition and parameters of AI transparency and explainability. It examines the relevance of AI transparency and explainability in ensuring the safety of AI devices as well as the barriers and limitations in achieving adequate transparency and explainability of AI-enabled medical devices. The results of the project are particularly relevant in the context of the Australian 2024 federal budget, which targets high-risk AI and calls for reforms to ensure the safety and reliability of these promising technologies.