FDA Medical Device Cybersecurity | Avast

FDA Medical Device Cybersecurity | Avast
David Strom, 16 February 2021

The FDA prioritizes medical device security with a plan for revamped cybersecurity guidance



Even if you don’t live in the US, you probably have heard about the Food and Drug Administration (FDA), the US federal agency responsible for regulating what we eat and what medicines we use. The FDA has been in the news during the pandemic, issuing emergency approval orders as Covid-related vaccines have come off their research trials and begun distribution to the public.
One lesser-known aspect of the FDA is their role in regulating medical devices such as insulin pumps and pacemakers. Several years ago, they issued their device safety plan. As they stated in the plan, “these devices can be vulnerable to security breaches and exploited,” in a way that could compromise patient safety. “Cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful,” as they stated in a 2018 draft document filled with cybersecurity guidance for new device makers. Indeed, this very issue was a plot point back in 2012 in the TV series Homeland, in which the vice president's character was killed by terrorists who hacked his pacemaker. While this scenario is unlikely, there is clearly a need for better cybersecurity standards with medical devices.
Further reading:Hospitals need to protect themselves from digita ..

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