Post Feed

New information on digital scribes

14 Aug 2025

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.