New information on digital scribes

We have published information to clarify when digital scribes – also referred to as AI scribes or ambient scribes – are regulated as medical devices in Australia.

This information outlines our regulatory approach to digital scribes that meet the definition of a medical device and provides links to further resources regarding:

• key responsibilities for safe and appropriate use, including informed consent
• consumer rights relating to privacy, personal information and the use of digital scribes in care
• the need to review software updates that could change how the product functions, and
• how to report safety concerns or suspected non-compliance.

Review our information on digital scribes.