If you have an exact title add ti= (eg. ti=Emergency Medicine)
Access guidelines from Australia and New Zealand, Canada, the USA, and the UK regarding informatics and digital health in Trip. Trip is a database that aggregates international clinical guidelines and evidence based synopses.
Standards Australia
Standards Australia has developed a number of standards that relate to informatics and digital health.
Topics covered include:
Monash Health employees can access Australian standards through the library.
Therapeutic Goods Administration (TGA)
The TGA regulates software based medical devices that incorporate software or are software. If a product is a medical device, it must be included in the Australian Register of Therapeutic Goods (ATRG).
Some software is exempt, such as:
However, software is regulated by the TGA when the intended purpose of the software is for use by health professionals for diagnosis, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability.
More information is available in the following documents.
TGA documents:
Legislation & Standards
IEC 82304-1:2016 - Health software - Part 1: General requirements for product safety - contact us at library@monashhealth.org to request a copy of this standard.
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