Key takeaways
- Health practitioners should regularly review the Therapeutic Goods Administration (TGA) website to check whether any Artificial Intelligence (AI) they use or intend to use in practice is regulated, and that they understand their obligations for privacy, data, cyber security and advertising.
- When using AI, registered health practitioners must continue to meet their professional obligations under their respective Codes of Conduct and AHPRA’s guidance in this area.
- Practitioners need to consult their professional indemnity providers ahead of integrating AI in their practice, to ensure they are meeting any conditions on its use and implementation.
Introduction
With the prevalence of AI across a number of professions and industries, there is little doubt it is increasingly being integrated into the healthcare system.
According to the World Health Organisation (WHO):
“AI is already playing a role in diagnosis and clinical care, drug development, disease surveillance, outbreak response, and health systems management…The future in healthcare is digital, and we must do what we can to promote universal access to these innovations and prevent them from becoming another driver for inequity.” (Tedros Adhanom Ghebreyesus, WHO Director-General)
From administrative activities to applications involving diagnosis and treatment, it is crucial to understand how AI technology can be used safely.
In this Health Insight, we explore the role of the TGA in the regulation of AI in healthcare, as well as the recent guidance issued by the Australian Health Practitioner Regulation Agency (AHPRA) for AI use.
How is AI in healthcare regulated?
The TGA is responsible for regulating AI-enabled products when they are used in healthcare if they meet the definition of a “medical device”. Medical devices can include apps, software allowing access to imaging, and screening apps for health conditions, to name a few.
We recommend health practitioners regularly review the TGA website to check whether any AI they use or intend to use in practice is regulated, and that they understand their obligations for privacy, data, cyber security and advertising.
AHPRA’s key principles
In addition, AHPRA has recently issued guidance to health practitioners, which includes the following 5 key principles:
Accountability
AHPRA reminds practitioners to ensure their practice meets the professional obligations set out in their relevant Code of Conduct and to “apply human judgment to any output of AI”.
Understanding
AHPRA recommends practitioners “understand enough” about AI that is intended for use in practice. This includes reviewing information about the particular technology, how it is trained and tested, and its intended use and limitations.
Transparency
Practitioners are expected to inform their patients about their use of AI and address any concerns that are raised. The level of information a practitioner provides could vary depending on the extent of the involvement of AI in their management.
Informed consent
AHPRA reminds practitioners to involve their patients in the use of AI, obtain their informed consent and, ideally, document such discussions in the patient’s health record.
Ethical and legal issues
In addition to reviewing their obligations under their relevant Code of Conduct, practitioners are encouraged to:
- ensure they comply with applicable legislation (including relating to privacy and health records)
- familiarise themselves with the governance arrangements established by employers or places of practice that oversee the implementation of AI, and
- ensure they hold appropriate professional indemnity insurance for AI use.
AHPRA proposes to regularly review and update the above principles as developments in AI progress.
Conclusion
AI in healthcare is a swiftly-expanding area.
In this changing landscape, it is worthwhile noting that an individual patient’s right to make their own informed healthcare choices does not have to compete with the ability of health practitioners to use AI in supporting and enhancing the delivery of healthcare.
When using AI, registered health practitioners must continue to meet their professional obligations under their respective Codes of Conduct and AHPRA’s guidance in this area.
We also remind practitioners to consult their professional indemnity providers ahead of integrating AI in their practice, to ensure they are meeting any conditions on its use and implementation.
This article was written by Principal Shannon Mony and Special Counsel Puja Menon. Please contact Shannon or Puja if you have any questions or would like more information.
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