Government Reviews Oversight of AI Medical Scribes in Healthcare

Government Reviews Oversight of AI Medical Scribes in Healthcare

09 Jul 2026

The concerns were revealed in Government documents released under Freedom of Information laws, according to Source: newsGP.

Officials said many AI products, including AI medical scribes, currently sit outside existing medical device regulations. This has raised concerns about how these tools are used in healthcare and whether there is enough transparency around their operation.

The briefing documents also noted that some AI products are promoted as being outside current regulatory requirements or as privacy compliant, despite limited transparency. Officials warned that some suppliers may not realise their cloud platforms send patient data outside Australia, creating potential privacy and data security risks.

The review comes as AI scribes become more common in Australian general practice. These tools help clinicians create consultation notes, summaries and letters. Current TGA guidance does not classify AI scribes as medical devices if they only generate clinical documentation.

However, a previous TGA review found some digital scribes can suggest diagnoses or treatment options beyond simply recording consultations. It also found limited information is available about the data used to train these AI systems, prompting calls for a review to determine whether some products should be regulated as medical devices.

Dr Sean Stevens said AI scribes should only be considered medical devices if they assist with diagnosing conditions or recommending treatments. He said doctors must continue to review all AI-generated notes and remain responsible for clinical decisions.

Government documents also highlighted concerns that some AI scribe providers promote increased revenue through greater efficiency, which could affect Medicare spending. They also noted that patient consent processes vary widely, with officials stating patients should understand both the benefits and limitations of AI technology before agreeing to its use.

The Department of Health, Disability and Ageing confirmed the TGA's review is still underway and is focusing on AI scribe products widely used in Australia. The regulator is working with industry and plans to publish a summary of the review findings in the coming months. 

Government Reviews Oversight of AI Medical Scribes in Healthcare

Source: newsGP.

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