Lack of regulation poses risk to AI in surgery, experts say

4 minute read


The absence of tailored national guidelines and local data is stalling the implementation of AI tools in surgery across Australia.


A lack of localised, evidence-based guidelines and a clear regulatory framework could jeopardise Australia’s potential to become a “global leader” in AI implementation in surgery, South Australian researchers have said.

In a perspective, recently published in the MJA, researchers from The University of Adelaide and Flinders University said a lack of national and international guidelines and local data created barriers for validating and implementing AI tools in surgery in Australia.

Researchers identified a “paucity” of evidence evaluating the use of AI in surgical services across Australia and New Zealand, with only three of the 25 specialist medical colleges within the Australian Medical Council having published AI position statements.

Current evidence was also largely restricted to early phase studies that may not accurately reflect real-world practice, with a limited number of randomised trials exploring AI surgical applications worldwide, researchers said.

The authors outlined several concerns with the increasing degree of AI automation in surgery, including potential liability implications caused by biases embedded in algorithms, as well as ethical and patient safety issues with decreased sophistication in clinical decision making.

Researchers outlined a number of recommendations to guide the future implementation of AI within surgical services across Australia and New Zealand, including:

  • Review current opinions on AI held among non-surgical health care communities and the general public through serial evaluation;
  • Maintain a strict evidence-based approach when developing and implementing AI tools within Australian and New Zealand surgical services that adheres internationally recognised frameworks but also considers local factors, regardless of the aspect of surgical care;
  • Develop infrastructure to facilitate strict post-implementation monitoring and audit of AI tools to ensure ongoing patient and system benefit;
  • Ensure close and ongoing engagement with the regulatory bodies and laws of Australia and New Zealand to ensure adequate governance and maintain patient and staff benefit;
  • Be conscious of ethical risks associated with AI and take approaches to mitigate these risks when implementing AI tools;
  • Educate Australian and New Zealand surgical patients and staff on the use of AI, including its benefits and limitations;
  • Produce tailored guidelines relating to the use of AI by surgical services within Australia and New Zealand; and
  • Promote broad collaboration between the surgical services of Australia and New Zealand to ensure safe AI use at a national scale.

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In the absence of specific regulatory frameworks managing AI implementation in surgical practice, tailored to the Australian health system, researchers said local surgical technology assessment organisations were well placed to oversee adherence to AI implementation principles in surgery.

“Multiple statements have now been developed for reporting AI research and are listed by the EQUATOR network, [and] it is crucial that similar frameworks for AI use are developed specifically for surgical services in Australia and New Zealand, so that the present opportunities can be explored safely, while also ensuring optimal benefit for local patients and systems,” the authors wrote.

“Until these are more developed, local surgical technology assessment organisations, such as ASERNIP-S within the Royal Australasian College of Surgeons (RACS), can assist with ensuring adherence to evidence-based principles during the uptake of AI by Australian and New Zealand surgical services.”

According to Professor Guy Maddern, R.P Jepson Professor of Surgery at the University of Adelaide and senior author of the study, Australia had the opportunity to become a global leader in the safe and effective use of AI in healthcare, if sufficient attention was paid to implementing was paid to safeguard patients and clinicians from potential ethical and privacy concerns.  

“Australia has the opportunity to become a global leader in adopting this technology but there needs to be a strict evidence-based approach which reflects international frameworks as well as local factors,” said Professor Maddern.

“We recommend the development of infrastructure to monitor and audit AI tools so we can make sure they are benefiting both patients and the system. Patients and surgical staff also need to be educated on the benefits and limitations of this technology.”

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