The Australian Therapeutic Goods Administration (TGA) has published its guidance framework dealing with medical device cyber security for manufacturers and sponsors of medical devices, as well as for consumers, health professionals and other users. This is driven by a number of challenges that regulators face to protect users against cyber security risks, including the alteration of device function, loss to privacy and the alteration of personal health data.

The crux of the framework is based on the TGA view that knowledge is power, in that patients using connected medical devices should be informed about the potential cyber security risks those devices have, and take proactive measures to protect their devices and networks.

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