As AI technology rapidly evolves, it presents significant opportunities to enhance patient outcomes, support surgical education, and optimise surgical care. However, RACS emphasises the need to address regulatory challenges, accountability for errors, and potential misinterpretations that could lead to incorrect clinical decisions.
"The surgical sector has experienced remarkable technological advancements in recent years," said Professor Mark Frydenberg, chair of the Health Policy and Advocacy Committee at RACS.
"AI has the potential to be an invaluable asset in surgical education, training, and decision-making. However, it is crucial that we implement a regulatory framework that prioritises clinical outcomes and mitigates risks. Ultimately, the responsibility for patient care lies with the surgeon, and issues related to consent, privacy, and data security must be effectively managed."
RACS has recently made two submissions aimed at promoting the safe integration of AI into the Australian healthcare system. These submissions were directed to the Australian Department of Health and Aged Care and the Therapeutic Goods Administration (TGA).
Submission highlights:
1. Regulation of AI in healthcare
This submission focuses on the necessity for regulations that allow AI's potential to be harnessed while addressing concerns related to patient safety, data security, dataset biases, and environmental impacts (PDF 321.05KB). A key issue raised is the question of accountability for errors arising from AI use—whether it lies with developers, providers, or surgeons. Current MDO advice is that it remains with the surgeon exclusively. The submission also highlights the risks of misinterpreting AI-generated research, which could lead to incorrect clinical decisions. RACS is committed to maintaining high surgical standards and prioritising patient care.
2. Classification of AI as a medical device
In this submission, RACS advocates for classifying AI as a medical device, ensuring rigorous pre- and post-market evaluations (PDF 396.8KB). Recognising the complexities and lack of clarity associated with AI technologies, RACS calls for enhanced transparency and data privacy protections. It includes a proposal for a surgical AI advisory group. RACS also urges for funds be allocated in the 2024-25 Federal Budget to support safe and transparent AI integration.
Professor Frydenberg said: “We believe there is a real potential for AI to enhance healthcare and are excited to see what advances this technology can bring. But we need to ensure there is no compromise to patient safety nor surgeon accountability”.
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