Categories of software-based devices exempted from TGA regulation
Consumer health products for preventing or managing conditions, monitoring vital signs, providing health and wellness coaching, and collecting patient-reported outcome measures (PROMs)
Digital mental health tools, including cognitive behavior therapy tools
Products designed to enable communications, management of health processes or facilities, clinical workflow management, or notification of health professionals
Software used solely to store or transmit patient images
Middleware used to connect applications within a healthcare system
Software designed to make calculations using clinical data
Electronic health records and data analytics software
Laboratory information management systems
Many of the software-based product descriptions include additional criteria that must be met if the products are to qualify for exemption from regulation, such as the requirement that the software is not intended to provide diagnosis, screening, treatment recommendations, etc.
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