ARTICLE SUMMARY:
The TGA’s policy development plans for AI medical device software. Excerpted from Pathways’ Picks July 30: User Fee Hike, Australia AI Plans, Notified Body Governance Proposal.
Australia’s device regulator pledged to reposition its software regulations and reassess definitions and available guidance in the context of rapidly advancing artificial intelligence technologies. The Therapeutic Goods Administration published a report outlying its policy development plans for AI medical device software in response to a 2024 consultation on the topic. The agency says it plans to advance a series of targeted consultations this year and next to refine its regulatory and compliance activities in the space. One priority will be to further integrate digital mental health tools into its device regulatory framework. Current regulatory exclusions for this type of software are “no longer appropriate and urgent review is needed,” TGA says. The agency also promised near-term guidance on technical requirements for adaptive and generative AI, as well to address the use of “open datasets and software of unknown provenance.” Other focus areas include updating key definitions in legislation or guidance and reconsidering how to apportion responsibility for acts of non-compliance in the context of AI.