Digital Scribes - Stakeholder Form

Overview

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods and forms part of the Australian Government Department of Health, Disability and Ageing. We are responsible for regulating medical devices, including software as a medical device, in accordance with Australian law.

We are reviewing the functionality of digital scribes supplied in Australia to understand their functionality and to consider how the regulatory framework may apply. For our review, a digital scribe is any software used in the healthcare sector that converts conversations held in a clinical setting, or dictation by clinicians, into written form.

Once simple transcription tools, digital scribes are rapidly evolving to include features such as clinical inferences, recommendations, and diagnostic suggestions. These functionalities may meet the definition of a medical device under the Therapeutic Goods Act 1989, introducing regulatory obligations and risks to public health due to unvalidated outputs potentially providing inaccurate or misleading information to clinicians.

Access to the digital scribe FORM is at the bottom of this page.

Resources to assist you

You can review the below information to help determine if the features offered in your digital scribe product might be a medical device.

• Digital scribes
• How the TGA regulates software based medical devices
• Artificial Intelligence (AI) and medical device software

Privacy & commercially confidential information

Information that you provide to the TGA, such as personal, business or commercially confidential information, is treated as official information. The TGA, as part of the Commonwealth, is required to take measures to protect this information under the Australian Government Protective Security Policy Framework (PSPF). For more information refer to the below links:

• Privacy
• How we treat your information
• Our approach to disclosure of commercially confidential information

Why your views matter

The information you provide will help us understand the features of your digital scribe product. This enables us to:

• assess regulatory requirements that may apply to your product.
• offer clarity to you on how we interpret and apply these requirements.

If you need clarification or cannot meet the due date, you are welcome to contact us to discuss or negotiate an alternative timeframe.

How You Benefit

By sharing information with us, you will:

• gain a clear understanding of how software products are regulated when they meet the definition of a medical device in Australia.
• identify any regulatory obligations that may apply to your product.

While we cannot provide tailored regulatory advice, we can outline:

• how we apply and interpret the requirements 
• if the requirements are likely to apply to your product.

Where necessary, we will guide you through the regulatory process to help you achieve compliance.

What happens next

We will review the information you provide and consider how the regulatory requirements for software as a medical device may apply to your product. We may request clarification, if needed. We will notify you of the outcome of our review, once completed.

Possible Outcomes

1. If we determine that your product is likely to meet the definition of a medical device, we will encourage you to meet with us to discuss the implications and pathways to achieving compliance. This could mean that you will need to:

• • stop providing the digital scribe device; or
  • remove the features that could make the digital scribe a medical device.

If the above occurs, you may want to resume supplying the product with the features that make it a medical device. However, before resuming supply, you may need to apply to include the product in the ARTG.

2. If we determine that your product is unlikely to meet the definition of a medical device, we may advise that there is no further action that you are required to take at this stage.

Continued vigilance

Regardless of the outcome of the review, you must consider regulatory obligations for any new feature included in your products to assess if it meets the definition of a medical device. For any new medical device functionality, you must apply for ARTG inclusion before supplying the medical device feature in Australia.

We welcome your feedback

If you have any questions or feedback, including suggestions, please contact us by email: digital.devices@TGA.gov.au