Johnson & Johnson is telling patients that it has learned of a security vulnerability in one of its insulin pumps that a hacker could exploit to overdose diabetic patients with insulin, though it describes the risk as low.
J&J executives told Reuters they knew of no examples of attempted hacking attacks on the device, the J&J Animas OneTouch Ping insulin pump. The company is nonetheless warning customers and providing advice on how to fix the problem.
“The probability of unauthorized access to the OneTouch Ping system is extremely low,” the company said in letters sent on Monday to doctors and about 114,000 patients who use the device in the United States and Canada.
The Animas OneTouch Ping, which was launched in 2008, is sold with a wireless remote control that patients can use to order the pump to dose insulin so that they do not need access to the device itself, which is typically worn under clothing and can be awkward to reach.
Jay Radcliffe, a diabetic and researcher with cyber security firm Rapid7 Inc, said he had identified ways for a hacker to spoof communications between the remote control and the OneTouch Ping insulin pump, potentially forcing it to deliver unauthorized insulin injections.
The system is vulnerable because those communications are not encrypted, or scrambled, to prevent hackers from gaining access to the device, said Radcliffe, who reported vulnerabilities in the pump to J&J in April.
J&J executives said they worked on the security issues with Radcliffe.
Company technicians were able to replicate Radcliffe’s findings, confirming that a hacker could order the pump to dose insulin from a distance of up to 25 feet, Levy said. He said such attacks are difficult to pull off because they require specialized technical expertise and sophisticated equipment.
J&J’s letter said that if patients were concerned, they could take several steps to thwart potential attacks. They include discontinuing use of a wireless remote control and programming the pump to limit the maximum insulin dose.
As its shares tumbled, St. Jude said the allegations were false, and the U.S. Food and Drug Administration began an investigation.
The FDA is preparing to issue formal guidance on how medical device makers should handle reports about cyber vulnerabilities.
An early draft of that guidance, which was released in January for public comments, called for device makers to work with security researchers, identify steps to mitigate risks, and provide patients with information about bugs so they can “make informed decisions” about device use.
The FDA declined to comment on J&J’s handling of the vulnerability in the insulin pump.
J&J said it had reviewed the matter with the FDA before sending the letters.
Radcliffe said he believed that OneTouch Ping users would be safe if they followed the steps outlined in the letters from
Radcliffe said he found vulnerabilities in the Animas OneTouch Ping, but not the Animas Vibe line of insulin pumps.
Suzanne Schwartz, an FDA official responsible for reviewing bugs in medical devices, said in a statement that she encourages collaboration between researchers and device manufacturers to identify, remediate and alert the public to vulnerabilities.
The FDA has said it knows of no cases where hackers have exploited cyber vulnerabilities to harm a patient.
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