Profusion of Malware Puts Patients at Risk

March 1, 2013 | Evaluations & Guidance

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Medical equipment is becoming increasingly vulnerable to infections from viruses and other types of malware, with the potential to introduce patient safety risks, according to an article in MIT Technology Review. This problem is exacerbated by the fact that many medical device manufacturers do not allow software modifications, updates, or patches that could prevent malware infection, due to concerns that the modifications will require FDA review.

Devices and systems are becoming increasingly interconnected, and many devices are on the hospital network, which in turn is connected to the Internet—a common route for the spread of malicious programs. Viruses and other malware may also be introduced by laptops or other devices brought into the facility. Malware infection can, among other things, cause devices to become unusable. Though this problem has not yet led to reported...

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