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Digital scribes

When digital scribes are regulated as medical devices.

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Digital scribes (also referred to as AI scribes or ambient scribes) are increasingly used in clinical settings to capture conversations between patients and healthcare practitioners. These tools generate clinical notes, summaries or letters which may be added to patient records. 

Digital scribes may use a range of software technologies including artificial intelligence. This can include large language models (LLMs) and deep learning technologies.

When digital scribes are medical devices

Digital scribes are regulated as medical devices under the Therapeutic Goods Act 1989 (the Act) if they have a therapeutic purpose and meet the definition of a medical device under section 41BD of the Act. 

Generally, 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.

Our regulatory approach

Digital scribes intended only to transcribe and translate clinical conversations into written records without performing analysis or interpretation are not considered medical devices. These products do not have a therapeutic use under the Act.

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. These products must:

  • meet all relevant regulatory requirements
  • be included in the ARTG before they can be imported, exported, or supplied in Australia.

Software developers and suppliers should refer to our guidance how we regulate software products for more information.

When digital scribes are not medical devices

In Australia, digital scribes for use in healthcare may need to comply with other regulatory frameworks, including the: 

Report non-compliant software products

Digital scribes that meet the definition of a medical device but are not included in the ARTG are being supplied illegally. We may take compliance action against anyone who supplies such products in Australia.

We encourage reporting of any concerns about non-compliance or questionable practices using the Report a perceived breach or questionable practices form. Include relevant screenshots or documents to help us assess your report.

For consumers

Healthcare professionals must tell you when they plan to use a digital scribe during your care. You have a right to know what it does and how it affects your privacy. 

Before using a digital scribe, your healthcare professional must give you enough information so you can provide informed consent. To help you decide you can ask: 

  • how your personal information will be kept private
  • when your information may be disclosed and with whom
  • whether the system makes any recommendations about your treatment or care.

You can withdraw your consent at any time and ask for another method for recording your consultation. You have the right to view the personal information collected during your consultations at any time.

If you feel uncomfortable or have concerns relating to how a digital scribe is being used, you can raise your concern directly with the health service, or with Ahpra. Visit the Ahpra website to learn more about How to raise a concern about a health practitioner.

For health professionals

As a healthcare professional, you are responsible for obtaining informed consent from patients and verifying the accuracy of information entered into a patient’s health record. 

Before using a software product in your clinical practice, regularly assess whether it remains appropriate and compliant. You should consider whether:

  • the product’s functionality aligns with its intended purpose
  • the intended purpose meets the definition of a medical device and if so, whether it is included in the ARTG
  • software updates have introduced new functionality that may change the intended purpose
  • appropriate data protection and privacy safeguards are in place for patient information
  • the product continues to perform as expected.

To determine if a software product is included in the ARTG, search using the manufacturer’s name as listed in the instructions for use. 

If you have concerns about a product’s compliance with TGA’s requirements, report them using the Report a perceived breach or questionable practices form. Include screenshots or other supporting evidence where possible.

Ahpra has published guidelines for Meeting your professional obligations when using Artificial Intelligence in healthcare to clarify existing responsibilities for healthcare professionals under the National Boards’ codes of conduct when using AI in clinical practice. 

The ACSQHC has also published an AI Clinical Use Guide to help clinicians understand what to consider before, during and after using AI in clinical care, with a separate AI Safety Scenario using Ambient scribes.

For more information relating to privacy, cybersecurity and adverse event reporting see:

For industry

Not all digital scribes are medical devices. Whether a product meets the definition of a medical device depends on its intended purpose. Refer to our guidance on how we regulate software products.

Developers must regularly assess whether changes to their product affect its intended purpose. If updates introduce functionality with a therapeutic use, the product becomes a medical device. In this case, the developer must either:

  • stop supplying the product until it is approved and included in the ARTG, or
  • remove the functionality that gives it a therapeutic use.
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