Digital scribes

Not all digital scribes are medical devices. Whether a product is regulated by the Therapeutic Goods Administration (TGA) depends on what it is intended to do.

We regulate digital scribes 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.

This means that a digital scribe is likely to be a medical device if, for example, it:

• identifies, recommends or suggests diagnoses
• identifies, recommends or suggests treatments or investigations
• prioritises, triages or monitors patients
• generates clinical conclusions or assessments.

All medical devices must:

• meet all relevant regulatory requirements; and
• be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported, exported, or supplied in Australia, unless they are exempt.

Software developers and suppliers can access further information in our guidance how we regulate software products.

Digital scribes intended only to perform administrative tasks are not a medical device. This means that digital scribes that only record, transcribe and translate clinical conversations into written records, without adding new clinical content or suggestions that were not explicitly stated by the health professional, are not considered medical devices. These functions do not have a therapeutic purpose under the Act.

Administrative functions are less likely to be a medical device if they do not suggest or recommend clinical conclusions. Examples of administrative functions include:

• recording conversations
• transcribing speech
• organising information
• summarising conversations or consultations
• drafting clinical documentation, such as clinical notes, referral letters, discharge summaries, clinical correspondence
• formatting information from transcripts or summaries into structured fields, such as problem lists, medication lists, clinical templates or electronic health record fields, for healthcare practitioner review, editing and confirmation
• providing administrative checks for incomplete documentation, such as identifying empty fields, incomplete forms, or missing administrative information.

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

• Privacy Act 1988 – administered by the Office of the Australian Information Commissioner (OAIC)
• Cyber Security Act 2024 – governed by the Australian Cyber Security Centre
• National Registration and Accreditation Scheme – administered by the Australian Health Practitioner Regulation Agency (Ahpra)
• Australian Consumer Law – administered by the Australian Competition and Consumer Commission (ACCC) with the states and territory agencies
• Pragmatic AI guidance for clinicians – published by the Australian Commission on Safety and Quality in Health Care (ACSQHC).
• State and territory Surveillance Devices Acts - for more information on manufacturer responsibilities, refer to guidance from the relevant regulatory agencies.

State and territory Surveillance Devices Acts For more information on manufacturer responsibilities, refer to guidance from the relevant regulatory agencies.

Report non-compliant software products

Digital scribes that meet the definition of a medical device must be included on the ARTG unless otherwise exempt. We may take compliance action against anyone who supplies non-compliant 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.

Intended purpose

We regulate digital scribes that meet the definition of a medical device, based on how the product is described and presented to users. This also applies to how a reasonable user would use the product based on its design, functionality, marketing and presentation. A digital scribe will meet the definition of a medical device if it makes clinical recommendations.

It is the manufacturer’s responsibility to ensure that the intended purpose of their product is clearly and consistently demonstrated to users. If a scribe has multiple functions, the intended purpose of each function must be described. A digital scribe may contain both medical device and non-medical device functions. 

The intended purpose is determined by claims made in the:

• product labelling
• instructions for use
• advertising and promotional materials
• product websites and other marketing materials
• technical documentation describing how the product works or is intended to be used
• how the product is presented to users. 

For example, a digital scribe that only summarises consultations may still be regulated as a medical device if the manufacturer claims the product is intended to support diagnosis, prognosis or treatment of a disease, injury, disability or condition. We may consider such claims as evidence that the product does have a therapeutic purpose.

General disclaimers (for example ‘this product is not for diagnosis’) are not acceptable to demonstrate a digital scribe is not a medical device if medical claims are made or the product includes features consistent with a medical device. Instead, developers and manufacturers should mitigate the risk of reasonably foreseeable misuse through design or other protection measures before considering warnings.

Introducing new features to your digital scribe

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, or
• determine if the product meets the criteria and conditions of exempt clinical decision support system (CDSS) software. 

See What to do if your digital scribe is a medical device for more information.

Functions to consider when determining regulatory status

The table below illustrates how the intended purpose of a function may affect whether it is regulated as a medical device.

Examples of digital scribes that are not a medical device

The examples below intend to provide further clarity on when digital scribes are not regulated by TGA. These are illustrative examples, not an exhaustive list.

Example 1: Transcript of a clinical conversation 

A digital scribe solely intended to help clinicians with the administrative task of documenting a clinical encounter. The transcript is provided for clinician review and editing or correction as needed. The product is not intended to provide clinical suggestions, recommendations, or other information beyond what was discussed during the encounter.

Explanation

This is because the product is solely intended to transcribe a conversation in a healthcare setting and is not intended to be used for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury, disability or condition, or for any other specific therapeutic purpose.

This digital scribe does not have a therapeutic purpose and is not a medical device.

Example 2: Summarise clinical conversations

A digital scribe intended to help health professionals with the administrative task of documenting and summarising a clinical encounter. The summary is provided for the health professional’s review and editing or correction, as needed, before it is saved to the patient’s electronic health record. The product is not intended to provide clinical suggestions, recommendations, or other information beyond what was discussed during the encounter. It is solely intended to help clinicians streamline the administrative work they must complete while meeting with a patient by producing a summary of the encounter for the clinician, for their review and use.

Explanation

This digital scribe is intended solely to summarise a conversation in a healthcare setting and is not intended to be used for, or to support, a health professional with the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or for any other specific medical purpose. 

This digital scribe does not have a therapeutic purpose and is not a medical device.

Example 3: Format information into structured notes

A digital scribe intended to help clinicians with the administrative task of organising patient information, such as information gathered from a clinical encounter, into a structured format. The digital scribe structures data for the health professional to review and confirm. The output may be presented as reminders or checks for potentially missing data. The health professional must then review and accept or reject the output. This helps to simplify their administrative workflow. 

Explanation

This digital scribe is solely intended to create structured data from patient information, such as a transcript of a clinician’s interactions with a patient and present it for the clinician’s review and confirmation. The product is not intended to derive or recommend any new information to impact the health professional’s clinical decision making.

This digital scribe does not have a therapeutic purpose and is not a medical device.

Example 4: Suggest clinical coding 

A digital scribe intended to help health professionals with the administrative task of coding by matching potential clinical codes to terms or information from the conversation (e.g. the name of a condition stated during discussion). All suggested codes are based only on explicitly mentioned clinical terms during the discussion. The codes must be reviewed and confirmed by the health professional.

Explanation

This digital scribe is intended to match direct language from a clinical conversation with relevant reference information (e.g. clinical codes) for the health professional’s review and administrative use. The product does not deduce diagnoses or codes from any implicit information during the encounter.

This digital scribe does not have a therapeutic purpose and is not a medical device.

Example 5: Draft a discharge summary or letter 

This digital scribe is intended to help health professionals with the administrative task of documenting a clinical encounter and drafting a formatted/templated summary or letter for review and approval by the health professional. The draft output may include information about the patient retrieved from their electronic patient record or transcripts/summaries of conversations from a given encounter. The output may take the form of discharge summaries or formatted letters for the health professional to review, edit, and use to help simplify their administrative workflow. The product is not intended to derive or recommend any new information to impact the health professional’s clinical decision making. The product does not determine what is relevant from the patient’s electronic health record. 

Explanation

The product is solely intended to summarise a health professional’s interactions with a patient and present existing medical information about that patient in a draft format. The treating health professional must review and approve the output prior to use. The digital scribe does not assign clinical significance to any of the information, including selecting relevance from a patient’s history.

This digital scribe does not have a therapeutic purpose and is not a medical device.

Examples of digital scribes that are a medical device

The examples below intend to provide further clarity on when digital scribes are regulated by TGA as medical devices. These are illustrative examples, not an exhaustive list.

Example 6: Generates insights for diagnosis, follow-up or treatment

A digital scribe that includes functionality for generating “insights”, based upon a clinical conversation between a health professional and a patient. The insights generated include suggesting a diagnoses, relevant follow-up or treatment options. The product is promoted through labelling or advertising as only being intended to:

• help health professionals with administrative tasks such as documenting and summarising a clinical encounter for subsequent review
• provide a summary for the health professional’s review and editing or correction, as needed
• includes a disclaimer that the tool does not provide clinical suggestions, recommendations, or other information beyond what was discussed during the encounter.

However, the product also includes functionality to allow users to request insights as part of the summary or an option to re-generate a summary with insights. While not included in the manufacture’s intended purpose description, the “insight“ feature is discussed in sales or user material. 

Explanation

The inclusion of the generated “insights” functionality indicates that the digital scribe is intended to provide suggestions and recommendations relating to diagnoses or treatments. Even if a manufacturer includes a disclaimer or warning in the product’s user interface that says, “the insights feature is not intended to replace diagnosis or treatment decisions by a health professional”, it does not negate the therapeutic purpose of this function. 

While the manufacturer states that the product is only intended to summarise a clinical conversation with a patient for the health professional’s review, it includes features intended to support the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, injury, disability or condition. 

This digital scribe does have a therapeutic purpose and is a medical device.

Example 7: Guides diagnosis and treatment planning and improves patient outcomes

A digital scribe that is intended to help health professionals with the administrative task of documenting and summarising a clinical encounter. The summary is provided for the health professional’s review and editing or correction, as needed, before it is saved to the patient’s electronic health record. It is intended to help clinicians streamline the administrative work they must complete while meeting with a patient by producing a summary of the encounter for the clinician, for their review and use. The functions are identical to the digital scribe described in Example 2.

However, the manufacturer is making specific claims that the product is intended to support and guide diagnosis and treatment planning and improve patient outcomes.

Explanation

While the product may only have administrative functionality (as described in Example 2), the manufacturer is making claims in the marketing of the product for a specific medical purpose. 

Since this digital scribe is marketed with a therapeutic purpose it is a medical device.

Example 8: A digital scribe agent that operates without requiring health professional review

A digital scribe agent that acts as a digital scribe and subsequently finalises and saves transcripts to the electronic patient record without requiring a clinician’s review. The digital scribe agent analyses the transcript to autonomously determine necessary follow-up tests and place the relevant orders without clinician input or confirmation. 

This product is intended to autonomously make judgements, treatment decisions and take actions that a health professional would otherwise take or oversee. The product is designed specifically with the intent of taking actions that would be considered diagnosing or treating a patient and, further, directly acts without required review by a health professional.

Explanation

The product’s behaviour extends beyond providing recommendations or reference information to a health professional. The product is intended to summarise a health professional’s conversation with a patient and aggregate existing medical information about that patient, and then to analyse that information and act upon it for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, injury, disability or condition. 

This Digital scribe, therefore, has a therapeutic purpose and is a medical device.

What to do if your digital scribe is a medical device

If your digital scribe has a therapeutic purpose and meets the definition of a medical device but is only intended to support the health professional to make clinical decisions, it may be medical device clinical decision support system (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 must 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 and must comply with other regulatory requirements. For more information, please refer to Understanding clinical decision support system software regulation. 

You need to:

• Determine if your product is eligible for the CDSS exemption 
• Ensure you can meet all the conditions of the CDSS exemption, including being able to demonstrate compliance with the Essential Principles for safety and performance
• You must notify us using the CDSS exemption notification form
• If you are not eligible for the CDSS exemption, or are unable to comply with all the conditions of the exemption, you will need to:
  • cease supplying your digital scribe; or
  • remove the functions of your digital scribe that have a therapeutic purpose, so you no longer meet the definition of a medical device; or
• If you want to continue supplying your digital scribe with functions that have a therapeutic purpose and meet the definition of a medical device and is not exempt, then you must apply to include it in the ARTG.

Supplying a medical device that is not included in the ARTG is a breach of the Therapeutic Goods Act 1989, unless it is exempt. 

Additional information:

• Understanding clinical decision support system software regulation|  
• Applying for ARTG inclusion
• Understand how we regulate software.

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 if you ask, the health professional should provide 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

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 intended purpose meets the definition of a medical device and if so, whether it is included in the ARTG or exempt from being 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
• there are alternative recording methods available for patients who request it.

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 our 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:

• Privacy when using commercially available AI products at the Office of the Australian Information Commissioner.
• Guidance on how to use AI systems securely at Cyber.gov.au, Australian Signals Directorate.
• Reporting adverse events.