Re:“I Want to Know What Code Is Running Inside My Body”
by ikeboy on Monday August 08, 2016 @10:09PM
(#12252116)
>Skipping clinical trials would be a major competitive advantage (lower costs, quicker to market etc.), but we don't allow that for the same reason
About that ...
Have you seen http://www.fdareview.org/05_harm.php and http://www.fdareview.org/07_market_failure.php?
> 1> Loss of competitive advantage
Patient safety trumps business considerations. Skipping clinical trials would be a major competitive advantage (lower costs, quicker to market etc.), but we don't allow that for the same reason
> 2> Open source is not necessarily any safer (heartbleed bug ... )
I'll agree, in so far as saying making it open source doesn't necessarily make it safer. However, it should, at worst, be no less safe - the requirements on the manufacturer (testing etc.) should be the same regardless
> 3> If software for the pacemaker is allowed to be updated like that on a computer, someone will update it with buggy software that can cause adverse side effects.
You can open the code but, for example, required a signed binary before a device can be updated. The openness of the code and the openness of the device itself are linked but separate issues.