The Therapeutic Goods Administration (TGA) Australia has released a guidance document on Exempt Clinical Decision Support Software (CDSS) for sponsors, manufacturers, suppliers, and software developers in August 2022.
For certain types of CDSS, there are some exemptions if the criteria are met. For example, this will include software that processes data from electronic medical records (EMRs), electronic health records (EHRs) or clinical information systems (CISs).
The exemption criteria are firstly, when the medical device is used by health professionals to explore further details about a disease and others. The medical device should not be used to process a medical image or signal from another medical device. The device cannot be used as an alternative to a clinical judgement by a health professional.
More details can be found in “Exemption for Certain Clinical Decision Support Software: Guidance on the exemption criteria, Version 1.0, August 2022”: https://www.tga.gov.au/sites/default/files/exemption-for-certain-clinical-decision-support-software.pdf