Key points
- Not all digital scribes are medical devices.
- Many digital scribes now include generative AI-enabled features.
- Some of these features may require regulation as medical devices.
- Some digital scribes may function as clinical decision support system (CDSS) software.
- We have published guidance to help manufacturers understand when regulations apply.
- We will conduct proportional compliance according to our regulatory compliance framework and continue to provide guidance and education to support industry.
Why we reviewed digital scribes
Digital scribes are rapidly being deployed across Australian healthcare settings and can offer significant benefits by reducing administrative burden or supporting clinical documentation. Many of these products were originally designed and marketed to support transcription, documentation and administrative tasks. However, these products are incorporating more complex features and increasingly include artificial intelligence (AI) features that analyse information and generate outputs that may influence clinical decisions. This means that some digital scribes may function as clinical decision support systems (CDSS).
At the start of our review, an apparent low awareness of regulatory requirements limited our visibility of digital scribe products supplied in Australia. Digital scribe developers and deployers were determining their products were administrative tools and not medical devices, and as a result did not include their product in the Australian Register of Therapeutic Goods (ARTG). The market is rapidly evolving, with product information often spread across multiple sources. This made it difficult to understand what products could do, how they were being used in practice and, whether some functions were performing as medical devices.
Where software generates clinical recommendations, conclusions or other patient-specific outputs that support clinical decision-making, those functions must be designed, validated and supported with appropriate safeguards. Ensuring appropriate safeguards, transparency and regulatory oversight, where needed, will help support the safe use of these medical devices in healthcare.
Healthcare professionals find themselves having to understand the role of the software, including the reliability, limitations and intended use of the generated outputs. When digital scribes make diagnostic or treatment recommendations, it may not always be clear how information has been selected, prioritised or generated. This makes it difficult for users to understand the basis of the output and assess its reliability.
Over the course of the review, some suppliers questioned whether their product is exempt CDSS software. A digital scribe may be an exempt CDSS if its only purpose is to provide a recommendation to a health professional about prevention, diagnosis, or treating a disease, and does not replace clinical judgment. To be exempt, the scribe cannot analyse information that came from another medical device and must display details of how the recommendation was generated. Exempt CDSS do not need to be included on the ARTG but are still regulated medical devices that must comply with regulatory requirements.
We conducted this review to:
- better understand the products available in Australia
- assess whether some functions may meet the definition of a medical device, and
- improve awareness of regulatory obligations and support compliance where needed.
What we did
We carried out an environmental scan of publicly available information and identified approximately 100 suppliers of digital scribes available in Australia.
A voluntary survey of these suppliers was undertaken to collect information about their products. We asked for product documentation, labelling, marketing material and descriptions of product functionality and intended purpose. We also considered information about these products provided to the TGA by clinicians and patients.
While we received responses from 40 suppliers, we focused our review on 12 products. This sample included products that hold greatest market share in Australia, as well as some smaller suppliers:
- Heidi Health
- Lyrebird Health
- Microsoft Dragon Medical One
- Abby Health
- mAIscribe
- AskSam
- VoiceBox Scribe
- Medilit
- VoiceboxMD
- ConsultNote AI
- Carepatron
- iMedX
Our review was designed to understand:
- how products included functionality that may meet the definition of a medical device, and
- whether product information and marketing material accurately reflected how the product functions according to the instructions for use
Of the 12 scribes we reviewed, none of the suppliers identified their products as medical devices.
However, on our review:
- eight included functions likely to meet the definition of a medical device
- two required additional information to determine their regulatory status
- two appeared unlikely to be medical devices based on the available information
What we did not do
We did not test any digital scribe products, check the safety and performance, or assess compliance with detailed medical device regulatory requirements as part of this review. We also did not assess the privacy or data protections associated with these products.
What we found
Large and rapidly evolving market
Our review identified a large and rapidly evolving market of digital scribe suppliers and use in Australia. Initial market scanning in 2025 identified around 100 products potentially supplied in Australia. Over the course of the review, we found existing products were launching new features, and several new products entered the market during 2026.
We found that AI-enabled digital scribes are embedded in clinical workflows and widely used across a range of clinical disciplines.
Not all digital scribes are medical devices
Digital scribes perform a variety of functions. Some products are limited to administrative and documentation activities, which are unlikely to meet the definition of a medical device.
Some digital scribes include functions that are more likely to be regulated as a medical device
Many digital scribes now include advanced generative AI-enabled functions that go beyond transcription and summarisation. These features analyse information, determine what is clinically relevant, or generate clinical conclusions, recommendations or other outputs that may influence diagnosis, monitoring, prognosis or treatment of a disease, injury, disability or condition. Products that perform these types of functions are likely to meet the definition of a medical device.
Understanding of regulatory boundaries
The review identified that suppliers had varying levels of awareness of when software meets the definition of a medical device. While none of the suppliers identified their product as a medical device our review found that many included functions likely to meet the definition of a medical device. It appeared that some suppliers may not have previously considered medical device regulatory requirements. The findings highlighted the need for clearer guidance on when digital scribes are regulated as medical devices and how suppliers can meet their obligations.
Disclaimers frequently used
Some products included statements that they were not a medical device, or they were not intended for diagnosis, treatment or other medical purposes. Statements or disclaimers are not sufficient in determining if a product is, or is not, a medical device.
What this does not mean
The review does not mean that all digital scribes are medical devices.
It also does not mean that all AI-enabled outputs of digital scribes have a therapeutic purpose.
Whether a digital scribe is regulated depends on its intended purpose and functionality, including whether it is intended to support or influence diagnosis, monitoring, prognosis or treatment of a disease, injury, disability or condition.
What we are doing
With the scale of adoption and the speed at which new products enter the market, addressing compliance requires a proportionate and risk-based approach. This approach needs to support patient safety while minimising unnecessary disruption to clinical practice and access to beneficial technologies.
We will use the findings of the review to:
- inform our regulatory approach to digital scribes, including how some functions of these products may fit within the existing conditional exemption for CDSS software.
- support continued education and regulatory guidance to help manufacturers, suppliers, developers, clinicians, and patients understand when a digital scribe may be regulated as a medical device and what regulatory obligations may arise
- guide targeted compliance activities where digital scribe functionality meets the definition of a medical device to ensure these products meet regulatory requirements to ensure patient safety and benefit are balanced appropriately.
More information
For information on how we determine whether a digital scribe is regulated as a medical device, including examples of common functions and regulatory pathways, refer to Digital scribes.