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FDA Calls On Medical Devicemakers To Focus On Cybersecurity

alphadogg writes "Medical device makers should take new steps to protect their products from malware and cyberattacks or face the possibility that U.S. Food and Drug Administration won't approve their devices for use, the FDA said. The FDA issued new cybersecurity recommendations for medical devices on Thursday, following reports that some devices have been compromised. Recent vulnerabilities involving Philips fetal monitors and in Oracle software used in body fluid analysis machines are among the incidents that prompted the FDA to issue the recommendations."

3 of 40 comments (clear)

  1. Simple standard? by Okian+Warrior · · Score: 3, Interesting

    Network security is an add-on, largely viewed as an externality by corporations.

    I think that it's largely because of this (and that mostly due to Microsoft) that people don't use good security features.

    Suppose the socket layer had a function to generate a key pair, and a function call to set the key used for encoding and decoding. (Possibly a bit in the protocol to send a message using or not-using encryption). If it was that simple most products would use it, certainly safety-certified products would use it.

    (There's Transport Layer Security, but it's not really simple to use.)

    Since there is no simple universal way to use good security, everyone ends up having to implement their own version, which costs time and money.

    Simple secure communications should be an OS feature.

    1. Re:Simple standard? by Darinbob · · Score: 3, Informative

      I suspect most of these devices have either minimal operating systems, home grown operating systems, or no operating system at all. Even if security is in the network stack it doesn't fix things. Ie, do you require your hospital to run IPsec everywhere for every device? Having a top of the line IPsec enabled networking doesn't prevent hacking things if there are bugs due to injecting packets of the right type (ie, it isn't breaking through security to read data, but it is crashing the machine or corrupting data).

      The other thing is that when these machines are hacked it is very often due to reverse engineering the machines. These don't run windows or linux, there's no pre-built hacker kit available, the attackers have access to actual machines and have cracked them open, read the flash or monitored the bus to figure out what the software is doing or what style of OS it has, scanned through to find out if there's a recognizable file system type, etc. When you're up against sophisticated attacks like that then your builtin OS security isn't going to be much defense.

      I suspect most of these successful attacks are happening on machines that use Windows internally; ie, an app on a turnkey system, or Windows bolted onto the side of a device to provide a front end. But Windows already has a built in securre communication feature.

  2. Re:Air gap the damned networks.... by Relic+of+the+Future · · Score: 3, Interesting
    Since I helped write a system that pulled live data from medical devices (during surgery) to update patient records on the fly, and that, eventually, those records have to be sent to someone else (using the internet): No. You can't just run an internal network with no access to the internet.

    Build layers of security. Don't use hard-wired passwords. I.e., Stop being stupid about security. But no, you can't just air gap.

    --
    Those who fail to understand communication protocols, are doomed to repeat them over port 80.