This appeared last week:
Therapeutic Goods Admin issues security guidance for medical devices
By Simon Sharwood on Jul 19, 2019 11:24AM
'Please do security right and see your doctor if pain persists' is the gist of it.
Australia’s Therapeutic Goods Administration (TGA) has published new guidelines for the security of medical devices and in vitro diagnostic (IVD) medical equipment.
Revealed on 18 July here, the new guidance comes in one version for Guidance for consumers, health professionals, small business operators and large scale service providers (pdf) and another for industry (pdf).
Neither go too far beyond generic advice, in part because legislation and regulations already offer more detailed advice.
The guidance for industry even points out that the “Essential Principles” it outlines “are not a prescriptive list of requirements for manufacturers to comply with and instead provide high level principles for flexibility according to the characteristics of the device.”
Device manufacturers are advised that they have a “responsibility to determine which essential principles are relevant and to demonstrate compliance with these.” And those principles are quite anodyne, as they call on manufacturers to make sure they design their products to take into account known security risks, maintain them well and make it hard for attacks to exploit them.
Guidance for users (pdf) gets a little meatier, as it addresses small and large businesses that deploy medical devices as part of their services.
More here:
It is worth knowing these documents exist and having browsed the User Guidance I can say what is said all seems pretty reasonable, pragmatic and sensible.
The document is well worth a browse – and I guess in the first instance – we should be grateful there is not too much heavy handed regulation.
David.
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