Along with the relentless rise in the popularity of AI scribes comes increasing risks to patient privacy and safety, the department warns.
igital scribes have little oversight and bring risks around patient safety, data security, informed consent and quality assurance, the Department of Health, Disability and Ageing has warned.
In a heavily redacted document obtained under Freedom of Information laws by Guardian Australia, DoHDA warns of concerns around the security of data stored outside Australia and whether clinicians and patients understand the risks and limitations of AI scribes.
While acknowledging that digital scribes improve productivity among doctors and reduce burnout, DoHDA warns there is limited peer-reviewed evidence of the benefits of the technology.
The warning comes as the TGA is in the midst of conducting a review of digital scribes used by Australian doctors.
DoHDA says some scribe suppliers advertise directly to health professionals that they can achieve a 30% revenue increase with no additional hours or patient consultations, which has implications for MBS costs.
When asked whether the department has modelled the impact of AI scribes on the MBS or how the department intends to track AI scribe usage as it relates to Medicare claiming patterns, a spokesperson told The Medical Republic:
“The department routinely undertakes analysis and modelling to support the sustainable operation of programs such as the Medicare Benefits Schedule (MBS) and provides advice to Government as part of normal budget and policy processes.
“The department briefs portfolio ministers on relevant issues as required, including developments in the use of artificial intelligence. The Department does not comment on internal government deliberations.”
DoHDA also says AI scribes increase productivity by automating some administrative or low complexity tasks and reducing burnout, adding that around 40% of GPs are now using the tools.
“Our team has estimated that, if primary care GPs in Australia saved just 10 minutes per day on administration tasks, this would be equivalent to 4,295,918 additional consultations per year,” DoHDA says.
A survey by the Royal Australian College of General Practitioners found that doctors’ use of AI scribes almost doubled from 22% in August 2024 to 40% in November 2025.
Productivity and efficiency gains are the most commonly cited benefits of AI scribes, DoHDA says, but adds there is “limited broad scale, peer reviewed evidence of benefits available currently”.
Among the key concerns and risks that DoHDA raises in the document are that medical scribes are developed on large language models (LLMs) and are impacted by the same limitations in terms of quality and accuracy.
“This has implications for patient safety, clinical accountability, and the integrity of data held within national digital health infrastructure,” the document read.
“Quality assurance relies on clinicians reviewing scribe outputs for accuracy before uploading consultation notes to a patient’s record.
“There is also significant variation in how clinicians and clinical practices are gaining consent for AI scribe use.
“Our position is that informed consent requires consumers to understand the benefits and limitations of the technology to which they are consenting.”
Advice from the Australian Commission on Safety and Quality in Health Care says that “clinicians need to understand the risks involved in using Al scribes, as they are accountable for ensuring the accuracy of any Al-generated clinical notes”.
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Clinicians need to ensure they have obtained informed consent, DoHDA says.
But the department adds that informed consent is obtained in vastly different ways across practices, and patients need to understand the benefits and limitations of digital scribes when they are consenting.
“Many AI products, such as AI medical scribes … have little oversight, raising concerns about the use of these tools within healthcare settings,” DoHDA says in the document from April this year.
“Anecdotally, some are marketed as outside regulatory levers (e.g., not a medical device) or as privacy‑compliant, often with limited transparency.
“Some suppliers may be unaware their cloud platforms send data outside Australia, raising risks for patient data security.”
Outputs from generative AI also have implications for patient safety, it says.
“Data quality held within digital health infrastructure which necessitates ongoing quality assurance.”
The TGA is conducting a review of AI and software-based medical devices, with a current focus on digital scribes.
A spokesperson for DoHDA said the review was currently ongoing and was prioritising products more widely used in Australia.
“The TGA is working with industry associations and individual companies to ensure regulatory requirements are understood, and we plan to publish a summary of the outcomes from the review in coming months,” the spokesperson told TMR.
“The TGA does not comment on the review of individual products.”
Digital scribes are regulated as medical devices under the Therapeutic Goods Act 1989 if they have a therapeutic purpose.
According to the TGA, digital scribes that only transcribe and translate clinical conversations into written records, without analysis or interpretation, are not considered medical devices.
But if a digital scribe analyses or interprets clinical conversations and generates a diagnosis or treatment that has not been stated by the healthcare practitioner, it is considered a medical device.
If a scribe meets that definition, it must be included in the Australian Register of Therapeutic Goods before it can be supplied in Australia.
