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FDA Releases New Cybersecurity Guidelines For Medical Devices (theverge.com)
An anonymous reader quotes a report from The Verge: The U.S. Food and Drug Administration released its recommendations for how medical device manufacturers should maintain the security of internet-connected devices, even after they've entered hospitals, patient homes, or patient bodies. Unsecured devices can allow hackers to tamper with how much medication is delivered by the device -- with potentially deadly results. First issued in draft form last January, this guidance is more than a year in the making. The 30-page document (PDF) encourages manufacturers to monitor their medical devices and associated software for bugs, and patch any problems that occur. But the recommendations are not legally enforceable -- so they're largely without teeth. The FDA issued an earlier set of recommendations in October 2014 (PDF), which recommended ways for manufacturers to build cybersecurity protections into medical devices as they're being designed and developed. Today's guidance focuses on how to maintain medical device cybersecurity after devices have left the factory. The guidelines lay out steps for recognizing and addressing ongoing vulnerabilities. And they recommend that manufacturers join together in an Information Sharing and Analysis Organization (ISAO) to share details about security risks and responses as they occur. Most patches and updates intended to address security vulnerabilities will be considered routine enhancements, which means manufacturers don't have to alert the FDA every time they issue one. That is, unless someone dies or is seriously harmed because of a bug -- then the manufacturer needs to report it. Dangerous bugs identified before they harm or kill anyone won't have to be reported to the FDA as long as the manufacturer tells customers and device users about the bug within 30 days, fixes it within 60 days, and shares information about the vulnerability with an ISAO.
BlackBerry may have conceded the mobile handset business but they own the automotive market. (Both Android Auto and CarPlay run as plug-in modules for BlackBerry's QNX Car OS) And for the last four years they have been quietly buying up medical electronic companies left and right and integrating them into QNX.
"A person is smart. People are dumb, panicky dangerous animals and you know it." - K
And yet all too many Medical systems I've seen are still running Windows XP. . . How do you remediate something that's out of support ???
Two different ways.
The first one is to go through certification with the entire operating system. If you have been proven that it is safe then you don't really need to do further updates.
The other way is hardware separation between the critical and non-critical parts.
Most likely the life critical function was done with a separate controller that either doesn't run an operating system at all or runs an operating system that has been certified for medical usage. The windows application you saw is just the GUI component and it doesn't matter if it crashes.
I can't imagine someone actually attempting to use Windows or Linux for a life critical part of a medical appliance.
I develop firmware for medical devices. Windows and Linux are used in medical devices in critical care devices.