TGA
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.
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