By Elise Viebeck - 09/27/12 07:55 PM EDT
"The demonstrated security risks require a renewed emphasis by the FDA and manufacturers to identify, evaluate and plug the potentially rare but serious security holes that exist in these devices."
Concerns about medical devices' vulnerability to hacking are not high on the FDA's list, the Government Accountability Office (GAO) said in a recent report.
Regulators and manufacturers have paid more attention to threats from unintentional interference, such as electromagnetic energy in the environment, the GAO said.
The report added that no incidents of medical-device hacking are known to have occurred outside the laboratory.
But Reps. Eshoo, Donna Edwards (D-Md.) and Edward Markey (D-Mass.) said the threat should not be overlooked.
"Patients need to be informed about whether the medical devices implanted in their bodies contain security vulnerabilities that could harm them so they can take appropriate precautions whenever possible," Markey said in a statement.
"This [GAO] report underscores the need to require manufacturers to acknowledge these threats and for FDA to address the risks before the devices are sold to the public."
Lawmakers urged the FDA to create a plan to ensure information security risks are considered during device approval.
They also called on the agency to consult related government standards on hacking and computer security for guidance.