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FDA ramps up efforts to prevent potential hacking of medical devices

Posted at 12:23 PM, Nov 28, 2018

Just about anything with a wireless connection could be a target for hackers to attack, including personal computers, tablets and even baby monitors. But what about medical devices?

The Food and Drug Administration (FDA) is monitoring that, too.

Cardiologist Cynthia Tracy, with George Washington University Medical Center, implants pacemakers into people’s bodies almost daily.

“In a typical situation, there might be two electrodes that pass through these veins and into the heart,” Tracy explains of the device.

The device, which is about the size of silver dollar, controls a patient's heart beat and sends data to doctors by using the internet.

"They have a Bluetooth connection somehow that allows the device to communicate with something external," Dr. Tracy says.

That wireless connection is where the concern comes in.

“There's no such thing as a medical device without vulnerabilities,” says Suzanne Scwarts, who leads medical device cyber security for the FDA.

Shwarts says after a series of security problems discovered in various medical devices, cyber security is front and center.

“We want patients to definitely be able to understand what are current risks today,” Shwarts says.

Dr. Tracy explains while security shortcomings may be there, an actual hack to something like a pacemaker would be a bit difficult.

“I couldn't from here reprogram someone that's out there in the lobby, Dr. Tracy says.

"They would have to be fairly close in order for me to do anything to their device."

Though there have been no direct hacks to patients to date, the threat is there, which is why the FDA is ramping up its efforts to make sure the hacking of medical devices doesn't become reality.