Executive Summary - Cybersecurity for Medical Devices

Intelligent Network Systems

Cybersecurity for Medical Devices

Overview

Tueor Technologies is a privately-held company that develops and licenses technology to decrease design time and prevent the hacking of critical devices in the consumer, aerospace and defense industries. Tueor’s first product is the patented Digital Current System (DCS), and the first iteration addresses cardiac pacemaker and medical device cybersecurity and is called Magloc.

Hacking is an inconvenient reality in the modern world, but altering or manipulating medical device programming can lead to injury or death. The reality of medical device hacking was recently demonstrated by a hacker remotely accessing drug delivery pumps through a hospital network which could result in, at worst, administration of lethal doses of intravenous medications. The FDA issued guidance regarding device cybersecurity in 2014, followed by a warning to hospitals in 2016 regarding a specific pump that was vulnerable to unauthorized user control. A specific and critical hacking susceptibility lies with cardiac pacemakers which are designed for remote communications and are necessary to maintain proper heart rhythm. A malicious, intentional remote reprogramming of a pacemaker could lead to death, making these devices particularly vulnerable.

Tueor has been developing the DCS for over two decades. The technology is licensed to a major micro-satellite designer/manufacturer for use in its satellites, and the Defense Advanced Research Projects Agency (DARPA) and the Department of Defense (DOD) have favorably evaluated the technology for use in the Stryker Combat Vehicle. The DCS is a hardware solution and it enabled the production of the first “non-hackable” computer (as demonstrated to DARPA). Other interested companies include General Dynamics, AM General, Rockwell International, Sumitomo, Lear, General Motors and Ford. The technology that provides hacking protection can also simplify and lighten wiring harnesses, hence the interest from harness, vehicle and satellite manufacturers.

How Does It Work?

Two components make up the Magloc system. The first is the Tueor Wafer, a two-inch-long, one-inch-wide and one-quarter-inch-thick piece of flexible ceramic. This unit can be placed near the clavicle, readily accessible to the physician or technician and is connected to the pacemaker via a thin wire. All pacemaker communication outside the body is performed by the Wafer. The Wafer has no power supply, draws no power from the pacemaker and lies dormant until powered up by the Tueor Wand.

The Tueor Wand is the second Magloc system component. The Wand provides power to the Wafer and handles all communications between the Wafer and the physician or technician accessing the pacemaker. Several security protocols are included in the Wafer/Wand interface to protect the system from intrusion or attack.

Benefits

While cybersecurity for implantable devices is the primary Magloc focus, the technology also provides a side benefit by eliminating pacemaker communication power consumption and providing the potential to recharge pacemaker batteries, thereby extending pacemaker life. Communications power requirements are a major drain on batteries in today’s devices.

Moving the medical device communications from the device to the Wafer provides additional flexibility in placement of the device. The Wafer can be placed anywhere the physician considers desirable and the medical device can be placed in a location that is optimal for performing its intended medical function without regard for placement to optimize communication.

Summary

The following are key features of the Tueor Magloc solution:

Pacemaker cybersecurity is greatly enhanced.
Communication with the medical device is enabled only when the Tueor Wand powers up the Tueor Wafer and creates a highly secure connection between the two devices and the physician or technician wishing to access the device.
Pacemaker battery life is extended.
The Tueor Wafer performs communications with the medical device and the Tueor Wand. The Wafer derives its power from the Wand and the medical device is relieved of the need to communicate outside the body, thereby preserving battery life.
Devices can become smaller, simpler and designed to consume less power.
Over time as this technology is adopted, medical devices can be designed without internal communications capabilities, resulting in devices that are smaller, simpler and consume less power.
Flexibility in medical device placement is increased.
The medical device can be placed in a location that is optimal for it to perform its medical function without regard for placement to support acceptable communications.

As medical devices have become and will become increasingly dependent on remote communications, the threat of hacking presents an ever-increasing risk. Ransomware applied to medical devices paints a chilling picture of what’s possible. The Tueor DCS Magloc solution will change that picture by creating an impenetrable barrier to hackers attempting to access medical devices and potentially doing harm.

Mike Arlitt
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