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PACS Hacking? Radiology Devices Vulnerable

October 22, 2012
Written by: , Filed in: Practice Management
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More and more medical devices, including radiological equipment, are connected to each other and to the Internet. According to a federal panel that met earlier this month, more and more are also vulnerable to infections from malware.

And many manufacturers block modifications, even something as basic as antivirus software, because they’re afraid the changes would be subject to Food and Drug Administration review.

At Beth Israel Deaconess Medical Center in Boston, a picture archiving and communication system was threatened by malware, according to the hospital’s chief information security officer, Mark Olson. He added:

We also worry about situations where blood gas analyzers, compounders, radiology equipment, nuclear-medical delivery systems could become compromised to where they can’t be used, or they become compromised to the point where their values are adjusted without the software knowing.

Olson spoke at a meeting of a medical-device panel at the National Institute of Standards and Technology’s Information Security and Privacy Advisory Board in Washington. He was quoted by Technology Review.

He said 664 pieces of medical equipment at Beth Israel Deaconess run on older Windows operating systems that manufacturers will not modify or allow to be modified. Those devices frequently are infected with malware, he said. One or two have to be taken offline each week to be cleaned.

Olson has warned about this problem before, calling on both the FDA and device makers to make more of an effort to protect computerized medical devices.

Manufacturers won’t allow changes or upgrades because they fear that any tinkering will trigger a full FDA regulatory review. The FDA has sought to allay such concerns, but manufacturers are still wary. Statements at the meeting by an FDA executive didn’t exactly clarify matters.

Brian Fitzgerald, deputy director of the FDA’s Division of Electrical and Software Engineering, said the agency is reviewing its regulatory stance on software. “This will have to be a gradual process,” he said, “because it involves changing the culture, changing the technology, bringing in new staff, and making a systematic approach to this.”

Faced with that sort of mushiness, we’d be scared to change even a single line of code too.

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