“T
he worst thing would be if somebody had a melanoma which [an app] said was fine, and then they didn’t go to the doctor when they would have before,” he said. “That’s doing harm.”
Source: Skin Monitoring Apps Fail to Detect Melanomas – IEEE Spectrum
TGA is proposing to treat software as a medical device in its own right. Presently it’s only regulated as part of another medical device used to treat patients if it could cause harm to patients. The new reforms would treat the software as a medical device directly if it’s used by medical practitioners to diagnose patient conditions (different levels for critical outcomes diagnosis or just screening). The new proposed regulations are based on
International Medical Devices Regulators Forum (IMDRF) guidelines.
See the following Source for further details.
Source: http://www.mondaq.com/article.asp?articleid=791862&email_access=on
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