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FDA’s Use of AI to Fast-Track Drug Approvals is a Bellyflop

Move fast and break things. That should be the mantra of AI everywhere. AI is both good and here to stay, but you need to validate anything that you do with AI. At least at this point in its lifecycle. Imagine, just for one sad moment, you’re in a life-or-death situation. You’re terribly ill and […]

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Security News Update for April 7th, 2023

FDA Will No Longer Approve Digital Medical Devices That Are Vulnerable Starting last month, the FDA will REJECT all new applications for any cyber medical device that does not include a cyberattack protection plan. Of course this won’t be perfect, but at least manufacturers will have to make an effort at it. Given that the […]

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FDA Issues Medical Device Warning – But They Are Not Sure for What

Well that makes me feel a whole lot better. The FDA says that devices that use the decades old IPNet software are vulnerable to hacking, But they are not sure what devices that  may include.  Possibly insulin pumps.  Maybe pacemakers. They also don’t know how many devices are affected. Given that, I am not sure […]

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