Doctors\u2019 offices were once private. But increasingly, artificial intelligence (AI) scribes (also known as digital scribes) are listening in. <\/p>\n
These tools can record and transcribe the conversation between doctor and patient, and draft structured clinical notes. Some also produce referral letters and admin outputs, and even update medical records<\/a> \u2013 but only after clinician review and approval.<\/p>\n Some estimates suggest about one in four Australian GPs<\/a> are already using an AI scribe. Major hospitals<\/a>, including children\u2019s hospitals<\/a>, are also trialling them.<\/p>\n The pitch is simple: less typing for doctors, more eye contact with the patient. But what about patients\u2019 privacy?<\/p>\n Until recently, the AI scribe market has been largely unregulated. But last month the Therapeutic Goods Administration (TGA) \u2013 Australia\u2019s medical device regulator \u2013 decided<\/a> some scribes meet the legal definition of a medical device.<\/p>\n Here\u2019s what this will change, and what patients should know \u2013 and ask \u2013 about AI scribes in the consult room. <\/p>\n What\u2019s changing<\/p>\n Until now, many AI scribe vendors, from Microsoft<\/a> to rising Australian startups such as Heidi<\/a> and Lyrebird<\/a> \u2013 and over 120 other providers<\/a> \u2013 have marketed their tools as \u201cproductivity\u201d software. <\/p>\n This means they have avoided the scrutiny of medical devices, which the TGA regulates<\/a>. <\/p>\n Now, the TGA has found some AI scribes<\/a> meet the definition of a medical device, especially if they go beyond transcription to suggest diagnoses or treatments. <\/p>\n Medical devices must be registered with the TGA, shown to be safe and do what they claim, and any safety problems or malfunctions must be reported.<\/p>\n The TGA has begun compliance reviews<\/a>, with penalties for unregistered AI scribes.<\/p>\n This follows similar developments overseas. In June 2025, the United Kingdom<\/a> health authorities announced tools that transcribe and summarise will be treated as medical devices. <\/p>\n Although still evolving, there are signs the United States<\/a> will move in a similar direction, and the European Union<\/a> may too. <\/p>\n In Australia, the TGA has only just begun reviewing AI scribes, so patients can\u2019t assume they\u2019ve been tested to the same standard as other medical products. <\/p>\n What patients should know about AI scribes<\/p>\n They can help \u2013 but they are not perfect. <\/p>\n Doctors report<\/a> spending less time on keyboards, and some patients report better conversations. <\/p>\n But tools built on large language models can \u201challucinate\u201d \u2013 add details never said. One 2024 case study<\/a> recorded casual remarks about a patient\u2019s hands, feet and mouth as a diagnosis of hand, foot and mouth disease. The potential for errors means clinicians still need to review the note before it enters your record.<\/p>\n Performance varies. <\/p>\n Accuracy dips with accents, background noise and jargon. In a health system as multicultural as Australia\u2019s<\/a>, errors across accents and languages are a safety issue. <\/p>\n The Royal Australian College of General Practitioners warns<\/a> poorly designed tools can shift hidden work back to clinicians, who then spend extra time correcting notes. Research has found<\/a> products\u2019 time-saving claims are often overstated once review and correction time is included, underlining the need for devices to be evaluated independently.<\/p>\n Privacy matters. <\/p>\n Health data is already a target for hackers and scammers, as the 2022 Medibank breach<\/a> showed. In recent research with colleagues, we found<\/a> unsecured third-party applications and lax data protection are among the leading causes of health data breaches. <\/p>\n Clinicians need a clear \u201cpause\u201d option and should avoid use in sensitive consults (for example, discussions about family violence, substance use or legal matters).<\/p>\n Companies must be explicit about where the audio and data are stored, who can access it, and how long it is kept. In practice<\/a>, policies vary: some store recordings on overseas cloud servers while others keep transcripts short-term and onshore. <\/p>\n A lack of transparency means it\u2019s often unclear whether data can be traced back to individual patients or reused to train AI<\/a>. <\/p>\n Consent is not a tick box. <\/p>\n Clinicians should tell you when recording is on and explain risks and benefits. You should be able to say no without jeopardising care. One recent case in Australia saw a patient<\/a> have to cancel a A$1,300 appointment, after they declined a scribe and the clinic refused to proceed. <\/p>\n For Aboriginal and Torres Strait Islander patients, consent should reflect community norms and data sovereignty<\/a>, especially if notes are used to train AI<\/a>.<\/p>\n Five practical questions to ask your doctor<\/p>\n Is this tool approved? Is it the clinic\u2019s standard practice to use this tool, and does it require TGA registration for this use?<\/p>\n Who can access my data? Where is the audio stored, for how long, and is it used to train the system?<\/p>\n Can we pause or opt out? Is there a clear pause button and a non-AI alternative for sensitive topics?<\/p>\n Do you review the note before it goes into my record? Is the output always treated as a draft until you sign off?<\/p>\n What happens if the AI gets it wrong? Is there an audit trail linking the note back to the original audio so errors can be traced and fixed quickly?<\/p>\n Safer care, not just faster notes<\/p>\n Right now, the burden of ensuring AI scribes are used safely rests disproportionately on individual doctors and patients. The TGA\u2019s decision to classify some scribes as medical devices is a positive move, but it is only a first step.<\/p>\n We also need:<\/p>\n the TGA, professional bodies and researchers to work together on clear standards for consent, data retention and training<\/p>\n independent evaluations of how these tools perform in real consults<\/p>\n risk-based rules and stronger enforcement, adapted to AI software rather than traditional devices.<\/p>\n Strong rules also weed out flimsy products: if a tool cannot show it is safe and secure, it should not be in the consult room.<\/p>\n","protected":false},"excerpt":{"rendered":"Doctors\u2019 offices were once private. 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