Eshoo, Markey Welcome FDA Tightening of Security Standards for Medical Devices

Press Release

Reps. Anna G. Eshoo (D-Calif.), Ranking Member of the Subcommittee on Communications and Technology and Co-chair of the House Medical Technology Caucus, and Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, are welcoming action taken by the Food and Drug Administration (FDA) to tighten security standards for a wide range of medical devices with increased connectivity, such as pacemakers, in response to escalating risk of the devices being hacked and tampered with. The lawmakers called for more stringent security standards for implantable medical devices last year after the findings of a GAO report they requested revealed that some can be remotely controlled by a hacker, posing potentially serious health risks to patients.

The FDA is directing medical device manufacturers to specify in detail their plans to eliminate potential cyber threats in their products. The Agency will also be allowed to deny approval of medical devices that do not adequately address potential risks.

"I welcome the FDA's tightening of security standards for medical devices capable of connecting to each other, hospital networks and the Internet," Eshoo said. "Medical devices have resulted in tremendous benefits, but the demonstrated risk from malicious hackers that comes with enhanced connectivity requires a more stringent effort by the FDA and manufacturers to identify, evaluate and plug the potentially serious security holes that exist."

"We already protect our computers and other communications devices from hackers and other cyber threats, and it makes sense to extend those protections to patients and their medical devices," Markey said. "Patients should only have to worry about getting healthier and not about hackers tampering with their device or accessing their information. I have been concerned about this issue for years, and am encouraged that the FDA is taking action on this issue."

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