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FDA ups cybersecurity standards for medical devices

| Thursday, June 13, 2013, 5:15 p.m.

WASHINGTON — The Food and Drug Administration is tightening standards for a wide range of medical devices — from fetal monitors used in hospitals to pacemakers implanted in people — because of escalating concerns that the gadgets are vulnerable to cybersecurity breaches that could harm patients.

Increasingly, officials said, computer viruses and other malware are infecting equipment such as hospital computers used to view X-rays and CT scans as well as devices in cardiac catheterization labs.The security breaches cause the equipment to slow down or shut off entirely, complicating patient care. As more devices operate on computer systems that are connected to each other, the hospital network and the Internet, the potential for problems rises dramatically, they said.

“Over the last year, we've seen an uptick that has increased our concern,” said William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health. “The type and breadth of incidents has increased.” He said officials used to hear about problems only once or twice a year, but “now we're hearing about them weekly or monthly.”

The FDA, in an effort to reduce the risks, for the first time is directing device manufacturers to explicitly spell out how they will address cybersecurity. On Thursday, the agency issued draft guidelines that, when finalized later this year, will allow the agency to block approval of devices if manufacturers don't provide adequate plans for protecting the gadgets and updating their security protections over their commercial lifetimes. The FDA is also issuing a safety communication to manufacturers and hospitals.

The Department of Homeland Security, which is working with the FDA to reduce these vulnerabilities, recently received reports from two researchers that found potential weaknesses in 300 medical devices produced by about 50 vendors, an official said. The department also is planning to release an advisory on medical devices.

Government officials and patient safety advocates say they do not know of any cases in which patients have been directly injured because of a device compromised by a computer virus. And there is no evidence any implantable devices have been corrupted by viruses or other malware. Nor is there evidence that hackers have deliberately targeted a hospital network or medical device for malicious cyberattacks.

Still, experts say, hospitals and device manufacturers need to use multiple defenses to guard against the threats posed by the Internet.

“There's almost no medical device that doesn't have a network jack on the back,” said John Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston. “To fight the evils of the Internet, not only do you have to have a moat, you have to have a drawbridge, burning oil to pour on attackers, and guys with arrows.”

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