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Why Implantable Medical Devices Can Be Deadly?
 

As a result of increasing advanced techniques in hacking, there is a growing danger that a heart rhythm device, or an insulin pump to treat people with Type-1 diabetes, or any implantable device that can be accessed remotely, could be target for hacking.

For example, an ICD (implantable cardioverter defibrillator) is a device used to treat 2 life-threatening heart rhythms (ventricular tachycardia and ventricular fibrillation). It constantly monitors the heart rhythm of a heart disease patient. When a very fast, abnormal heart rhythm is detected, it delivers energy to the heart muscle to cause the heart to beat in a normal rhythm again.

Instead, a hacker can hack into that patient’s ICD to disturb the heart rhythms and hence ending the life of this patient without leaving behind any trace. Such scenario has been seen in some spy or crime movies. In reality, this can really happen to anyone with implantable device. While sophisticated technical skills are required to cause a device to misfire intentionally to harm a patient, people with such skills are still available.

A report that was released in 2012 by the Government Accountability Office (GAO), a non-partisan agency that works for Congress, suggested that the Food and Drug Administration (FDA) that approves and regulates such devices should set guidelines for manufacturers to help combat the threat of hacking.

The vulnerability of the medical technology was revealed in 4 separate demonstrations in controlled settings showing that the vulnerabilities could possibly be exploited in certain medical devices. Fortunately, no proven cases of people actually doing this for evil purposes have yet been discovered.

Using wireless communication, doctors can download diagnostic information and health status from the device to a computer and make changes in the performance of a device without surgery. But according to scientists, any system with wireless communication can be subject to interception of data and compromised privacy. In addition, interference with performance that can compromise the safety and effectiveness of the device is highly possible.

There was an incidence that a young lady with an insulin pump walked through a security device and her pump responded in an unanticipated way that could have killed her.

Of course, there are ways to prevent potential hacking. For example, people who need to communicate with the device require a password for access, or it is possible to limit the distance devices can send information back and forth, or install security software to prevent hacking.

In reality, enhancing security of a medical device might not as simple as it sounds. Installing security software might shorten battery life. Using password would rely on the patient’s ability to remember it and use it under emergency situation. The patient could possibly forget the password when he or she is panic.

World Society of Arrhythmias published a report in 2011 revealing that 133,262 defibrillators were implanted in patients in the United States in just one year, 2009. This shows how big is the number of potential victims of hacking, not including other implantable devices.

The GAO, therefore, recommended the FDA to adopt a more comprehensive security review process, including pressuring the manufacturers to identify and address potential security risks during the pre-market approval process and establishing responsibility for assessing the safety of wireless devices from potential hacking. FDA should also monitors during post-market review.

Medical device manufacturers are becoming increasingly aware of security risks. But the stepping in of FDA may mean that manufacturers who want to change the device might have to put in additional financial resources and more time to perfect it. Some smaller manufacturers could simply go out of business.

It is undoubtedly that implantable medical devices have resulted in tremendous medical benefits for the patients who use them, although the human body is vulnerable to attack from computer hackers. However, there is no need for users of these devices to unduly worry as the risk is really, really low, as indicated by technological experts.

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