Blunt tool: MSIA rejects proposed TGA regulations on medical software

The proposed regulation of software as a medical device by Australia's Therapeutic Goods Administration has been rejected outright by the local industry, which cites the RACGP and Pharmacy Guild as supporting its stance.

The TGA is currently holding consultations on the regulation of software as a medical device (SaMD) in light of the explosion of health apps, artificial intelligence and machine learning in diagnostic software and its potential effect on patient safety.

Posted in Australian eHealth

Tags: MSIA, SaMD, TGA

Comments  

# Rodney Kurtzer 2019-04-05 11:48
It is about time that some one took some action.
Start with small steps first - all medical software for specialists and GP's alike must meet minimum standards such as secure messaging, eHealth Uploads, Standard format for Pathology (No PITT for god-sake), Standardized Demographics format. Will be the driver of long needed innovation in Medical Software. No compliance - no licence to sell. January 1 2020 should be the start date.

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