Medtronic Inc has asked software security
experts to investigate the safety of its insulin pumps, as a new claim surfaced
that at least one of its devices could be hacked to dose diabetes patients with
potentially lethal amounts of insulin.
While there are no known examples of such a cyber attack on
a medical device, Medtronic told Reuters that it was doing “everything it can”
to address the security flaws.
Security software maker McAfee, which has a health industry
business, exposed the new vulnerability in one model of the Medtronic Paradigm
insulin pump on Friday and believes there could be similar risks in others.
Medtronic and McAfee declined to say which model is involved
or how many such pumps are currently used by patients. It has two models of
insulin pumps on the market and supports six older versions, with about 200,000
currently in use by patients.
The finding points to a broader issue — the potential for
cyber attacks on medical devices ranging from diagnostic equipment to pumps and
heart defibrillators, which rely on software and wireless technology to work.
“This is an evolution from having to think about security
and safety as a healthcare company, and really about keeping people safe on our
therapy, to this different question about keeping people safe around criminal
or malicious intent,” Catherine Szyman, president of Medtronic’s diabetes
division, said in an interview.
Szyman, whose nephew uses a wearable Medtronic insulin pump,
said the company turned to McAfee rival Symantec Corp and other security firms
after an independent researcher exposed less serious vulnerabilities in the
pumps in August.
Since then, a research team at Intel Corp’s McAfee said it
has developed code that allows it to gain complete control of the functions of
one Medtronic insulin pump model from as far away as 300 feet.
“We found a way around all the restrictions and all the
limitations,” said Stuart McClure, a senior vice president with McAfee who
heads up the research team.
McClure, formerly a security expert at healthcare giant
Kaiser Permanente, says he is exposing such problems to draw them to the
attention of manufacturers and regulators.
McClure’s team used a Windows PC and an antennae that
communicates with the medical device over the same radio spectrum used for some
The type of vulnerability discovered by McAfee could
theoretically be used as a new cyber weapon. A hacker could launch a
“drive-by” attack aimed at a high-profile target, such as a
politician or corporate executive, who uses this type of insulin pump, McAfee
In August, Medtronic acknowledged that security flaws in its
implanted insulin pumps could allow hackers to remotely take control of the
The U.S. Food and Drug Administration noted that there is no
evidence of widespread problems from medical device security breaches. It says
that device manufacturers are responsible for the safety of their software.
“Any system with wireless communication can be subject
to interception of data and compromised privacy as well as interference with
performance that can compromise the safety and effectiveness of the
device,” FDA spokeswoman Erica Jefferson said. “We continue to
closely monitor for safety or security problems.”
Medtronic is a leading makers of insulin pumps along with Johnson &
Johnson’s Animas Corp and Insulet Corp. McAfee did not report vulnerabilities
in models from other manufacturers.
The fresh concerns over the pumps made by Medtronic, the
world’s largest medical device maker, follow a high-profile recall of heart
defibrillator leads in 2007 and a more recent Senate probe into whether doctors
it had paid failed to report problems from a spinal surgery product.
The company said it is also consulting with McAfee and has
informed patients, through its website, to check their insulin pumps if they
have a suspicious encounter with another person.
Medtronic officials have said it would be difficult to make
changes to pumps already in use because of FDA regulations that require device
makers to get agency approval before altering their products, including issuing
The company would likely have to first get FDA approval and
then recall each pump, which uses wireless communications technology dating
back 12 to 15 years, so that technicians could install the new software and
check the equipment to make sure that it still accurately delivers doses of
Szyman said she could not say how long it would take
Medtronic to come up with a fix for the vulnerabilities because its
investigation is still ongoing. It is also unclear how long it might take the
FDA to approve changes to the pumps.
“There’s different pathways to approval,” she told
Reuters, noting that the agency typically takes six to 12 months to approve a
new medical device.
Medtronic’s diabetes products, which includes its insulin
pumps, accounted for more than $1.3 billion in revenue in its last fiscal year,
out of a total of nearly $16 billion.
The Medtronic pump vulnerability was discovered by Barnaby
Jack, a well-known security expert who joined McAfee last year after gaining
notoriety by finding ways to hack into ATMs used at convenience stores, then
force them to literally spit out cash. The manufacturers have since fixed the
flaw by updating the software that runs those machines.
The nightmare scenario, according to McAfee, involves a
hostile actor launching a potentially fatal attack by taking control of an
insulin pump, then ordering it to dump all the insulin in its canister.
That is something that was hard to imagine when the product
was first designed – long before the recent rash of hacking attacks: “We
are talking about code that was written over ten years ago,” said Jack.
“They never expected anybody to pop these devices open and look under the
hood. We are trying to spark some change and get a secure initiative under way
and get these devices fixed.”
Insulin is a hormone secreted by the pancreas that converts
glucose into energy. In patients with diabetes, the body makes no insulin, or
insulin levels are too low. This can cause the amount of glucose in the
bloodstream to rise, a condition known as hyperglycemia.
When too much insulin is released into the blood stream, a
person’s blood sugar can become too low, a condition known as hypoglycemia.
Symptoms of hypoglycemia range from nausea and confusion to, in severe cases,
seizures, coma and death.
McClure declined to say how many models in Medtronic’s line
of insulin pumps were vulnerable. He said there is no evidence anybody else has
identified the flaw or tried to exploit it.
“We just tested one model number,” McClure said.
“But we believe that more than that are vulnerable.” His team
demonstrated the vulnerability at a McAfee users conference in Las Vegas on Friday.
McAfee has consulted with experts at the Department of
Homeland Security’s Industrial Control Systems Cyber Emergency Response Team,
or ICS-CERT. That agency works with private companies in industries including
healthcare to help investigate potential cyber vulnerabilities in their
Officials with ICS-CERT and Symantec could not be reached
(Reporting by Jim Finkle in Boston. Additional reporting by Toni Clarke in Boston, Anna Yukhananov in Washington and Susan Kelly in Chicago; Editing by Michele Gershberg, Edward Tobin and Martin Howell)