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[IP] Next health hazard: Hackable medical implants

Next health hazard: Hackable medical implants

By Nidhi Subbaraman

Wireless electric medical devices are getting sleeker and smarter, but their
security and privacy features are lagging behind.

Security experts showed on Tuesday that an insulin system, consisting of a
wireless insulin pump in combination with a glucose monitor - worn by
hundreds of thousands of diabetics in the US - is vulnerable to hack
attacks. Using off-the-shelf hardware, the user manual and publicly
available information, the scientists tapped into information on the system
- like insulin dosage and glucose readings. With the PIN access code of the
device, they showed that they could also wirelessly control the dosage of

Though wireless security is a well trodden path when it comes to cellphones
and home routers, tackling the issue for a medical device is a whole
different ball game.

"Not all [security] solutions will carry over to medical devices," Anand
Raghunathan, one of the lead researchers, told me. "That's where the
innovative thinking needs to be." 

Medical devices are getting smaller and lighter, so that they are easily
worn and carried around, and additional security features would put an
additional strain on the battery power and size. It's also possible that
they'd cost more. Those are issues device manufacturers will have to grapple


FDA investigates reports of insulin pump problems
March 4, 2010 by MassDevice staff

A March 5 meeting of the Food & Drug Administration's General Hospital and
Personal Use Devices Panel will look into risks posed by insulin pump

A Food & Drug Administration panel will convene March 5 to discuss risks
posed by insulin infusion pumps, after 18 recalls were issued for the
devices over a five-year period.

In particular, the agency's General Hospital and Personal Use Devices Panel
will discuss the the findings of an agency report that looks into possible
health risks related to insulin pump failures.

Among the more sobering statistics in the report, which was released to the
public in advance of the meeting, is the revelation that there have been
almost 17,000 adverse events reported for insulin pumps from 2006 to 2008.
Of those adverse reports, the agency says 310 deaths and 12,000 injuries
occurred, possibly as a result of problems caused by pump failures.

The agency does not directly link the deaths to malfunctions with the device
itself. For example, in 225 of the 310 deaths reported, the "device problem
was unknown and limited details of the event were provided and the root
cause of the device failure was not confirmed by the manufacturer,"
according to the report.

However, the FDA believes the findings warrant more research into the issue,
which will be one of the central themes of the panel's discussion. The
meeting is open to the public.

The agency says that more than 375,000 people in the U.S. use an insulin
pump to treat their Type I diabetes, up some 188 percent from the 130,000
people reported to use the devices in 2002.

Among the most prominent manufacturers of the popular diabetes treatment are
Minneapolis, Minn.-based medical device giant Medtronic Inc. (NYSE:MDT),
Johnson & Johnson (NYSE:JNJ) and Bedford, Mass.-based Insulet Corp.
(NSDQ:PODD), which produces the OmniPod insulin management system.
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