AUSTRALIA Trends and Developments Contributed by: Robert Samut, Barry Nilsson
Goods Act 1989, it will need to be approved by the Therapeutic Goods Administration (TGA). In August 2024, the Australian Health Practitioner Regulation Agency (AHPRA) published guidelines on “Meeting your professional obligations when using artificial intelligence in healthcare”. In these guide - lines, AHPRA referred to the following, amongst other things. • AI being defined as computer systems able to perform tasks that normally require human intel - ligence. • Some AI tools used in healthcare being regulated by the TGA. The TGA regulates therapeutic goods that meet the definition of a “medical device”, which includes software if it has a therapeutic use and meets the definition. • Emphasising the principle that, regardless of what technology is used in providing healthcare, the practitioner remains responsible for delivering safe and quality care, and for ensuring that their own practice meets the professional obligations set out in their codes of conduct. • Healthcare practitioners must apply human judge - ment to any output of AI. • Healthcare practitioners should inform patients and clients about their use of AI and consider any concerns raised. • Healthcare practitioners must obtain informed con - sent from the patient and ideally note the patient’s response in the health records. • When using an AI scribing tool that uses generative AI involving the input of personal data, the health - care practitioner will require informed consent from the patient. Informed consent is particularly impor - tant in AI models that record private conversations, as there may be criminal implications if consent is not obtained before recording such conversations in some Australian states and territories. • The need to ensure confidentiality and privacy of patient/client information, as required by privacy and health record legislation. • The need to ensure that healthcare practitioners understand the inherent bias that can exist in data and algorithms in AI applications, for example in relation to Aboriginal and Torres Strait Islander people.
• The need to have and be aware of governance arrangements in place to oversee the implementa - tion, use and monitoring of AI. Are There Any Signs of Australia Heading Towards Higher Damages or More Litigious Jurisdiction, Similar to the USA? The cost of claims in Australia has increased signifi - cantly in the past few years, mostly due to economic factors. Ten years ago, the inflation rate in Australia was 1.5%, and wage growth was minimal. The coun - try has since moved to a higher inflation economy with rising wages. These changes eventually flow into the cost of claims. In addition, the amounts being claimed by plaintiff lawyers for legal costs – and the amounts charged by experts and other providers – have increased, on occasion significantly, in recent years. The relatively recent and often significant rise of claims reserves in Australia will, however, never extend to the claims reserves that one needs to hold in the USA. The high watermark in the USA was reached last year in the case of Michael E Sanchez v NuMale Medi - cal Centre LLC. The case involved Mr Sanchez, a 66-year-old widower visiting NuMale for fatigue and weight management, and ultimately being convinced into having a penile injection for erectile dysfunction. This procedure was botched. NuMale were found to have been negligent, and their conduct was found to have been unconscionable. Mr Sanchez received USD412 million, of which USD375 million was punitive damages. This type of result will never, and can never, happen in Australia. There are prohibitions in place in most Australian states and territories on punitive damages awards. There are some exceptions, however, including cases of intentional conduct and unlawful sexual assault. In Victoria, there is no statutory prohibition, but common law effectively restricts punitive damages to intention - al or reckless misconduct. Except for Victoria, Australian states and territories do not have jury trials in civil claims. Most states and territories also do not allow plaintiff lawyers to charge contingency fees (US trial lawyers can demand con -
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