TGA focusing on the therapeutic use of AI in health care

The Therapeutic Goods Administration (TGA) has announced it is stepping up its efforts to make sure that software-based medical devices meet Australia’s regulatory requirements. This includes those using artificial intelligence (AI).

AI scribes using large language models (LLMs) are typically used to quickly transcribe and summarise discussions between patients and healthcare practitioners. Just transcribing a conversation does not constitute the actions of a ‘medical device’; however, some AI scribes are introducing more advanced features such as diagnostic and treatment suggestions. Such diagnostic features may cause the software to become a medical device under the Therapeutic Goods Act 1989.

According to the TGA, digital scribes meet the definition of a medical device if they are intended to:

• diagnose, monitor, predict, provide a prognosis, treat, alleviate or compensate for a disease, injury or disability
• investigate the anatomy or a physiological process
• control or support conception
• examine specimens derived from the human body for a medical purpose.
   

All digital scribes that meet this definition must be included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied in Australia.

Digital scribes intended only to transcribe and translate clinical conversations into written records without performing analysis or interpretation are not considered medical devices. However, if a digital scribe analyses or interprets clinical conversations — for example, by generating a diagnosis, differential diagnosis or treatment recommendation not explicitly stated by the healthcare practitioner — it is considered a medical device.

The TGA says it is already working closely with industry to:

• encourage voluntary compliance
• provide clear and consistent guidance
• respond to complaints and reports of non-compliance
• identify and address unlawful advertising and supply.
   

The TGA says it may take targeted action in response to alleged non-compliance, in accordance with the TGA’s regulatory compliance framework.

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