Skip to main content

FDA issues final guidelines on keeping medical devices safe from cyberattack

fda cybersecurity guidance medical devices pacemaker 123rf
Image used with permission by copyright holder
Cyberattacks certainly have a negative impact on our lives. We lose data, productivity, money, and time whenever our technology is infected with spyware, viruses, ransomware, or other forms of malware.

However, malware that’s aimed at medical devices can have a particularly egregious impact. A cyberattack on someone’s pacemaker, for example, can result in the victim’s death, not just some lost productivity. It’s for that reason that the Food and Drug Administration (FDA) has singled out medical devices as being worthy of special protection against cyberattack, as Engadget reports.

Specifically, the FDA announced on its blog that the agency has issued its final guidance on how medical device companies should ensure that their devices are protected against attack. The essence of the FDA’s guidance is that threats should be managed throughout a device’s entire lifespan, starting with its design and development and extending across its entire lifespan, through continuous monitoring and protection.

The FDA wants medical device manufacturers to create methods for monitoring and detecting vulnerabilities in devices; assess the level of risk and potential impact; establish processes for working with cybersecurity researchers and others to ensure the flow of information; and be able to deploy mitigations early and as necessary. More specifically, the FDA stresses that everyone involved with the manufacture and use of medical devices should apply the core cybersecurity principles outlined by the National Institute of Standards and Technology (NIST).

According to the FDA, these guidelines are only the beginning of its efforts to address the security of medical devices. Going forward, the agency intends to work closely with all “medical device cybersecurity stakeholders” to ensure that threats are monitored, identified, and addressed. In short, the FDA wants to make sure that even if your PC remains easy to hack, your pacemaker won’t be.

Editors' Recommendations

Mark Coppock
Mark has been a geek since MS-DOS gave way to Windows and the PalmPilot was a thing. He’s translated his love for…
4 CPUs you should buy instead of the Ryzen 7 7800X3D
AMD Ryzen 7 7800X3D sitting on a motherboard.

The Ryzen 7 7800X3D is one of the best gaming processors you can buy, and it's easy to see why. It's easily the fastest gaming CPU on the market, it's reasonably priced, and it's available on a platform that AMD says it will support for several years. But it's not the right chip for everyone.

Although the Ryzen 7 7800X3D ticks all the right boxes, there are several alternatives available. Some are cheaper while still offering great performance, while others are more powerful in applications outside of gaming. The Ryzen 7 7800X3D is a great CPU, but if you want to do a little more shopping, these are the other processors you should consider.
AMD Ryzen 7 5800X3D

Read more
Even the new mid-tier Snapdragon X Plus beats Apple’s M3
A photo of the Snapdragon X Plus CPU in the die

You might have already heard of the Snapdragon X Elite, the upcoming chips from Qualcomm that everyone's excited about. They're not out yet, but Qualcomm is already announcing another configuration to live alongside it: the Snapdragon X Plus.

The Snapdragon X Plus is pretty similar to the flagship Snapdragon X Elite in terms of everyday performance but, as a new chip tier, aims to bring AI capabilities to a wider portfolio of ARM-powered laptops. To be clear, though, this one is a step down from the flagship Snapdragon X Elite, in the same way that an Intel Core Ultra 7 is a step down from Core Ultra 9.

Read more
Gigabyte just confirmed AMD’s Ryzen 9000 CPUs
Pads on the AMD Ryzen 7 7800X3D.

Gigabyte spoiled AMD's surprise a bit by confirming the company's next-gen CPUs. In a press release announcing a new BIOS for X670, B650, and A620 motherboards, Gigabyte not only confirmed that support has been added for next-gen AMD CPUs, but specifically referred to them as "AMD Ryzen 9000 series processors."

We've already seen MSI and Asus add support for next-gen AMD CPUs through BIOS updates, but neither of them called the CPUs Ryzen 9000. They didn't put out a dedicated press release for the updates, either. It should go without saying, but we don't often see a press release for new BIOS versions, suggesting Gigabyte wanted to make a splash with its support.

Read more