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Tag: Pacemakers

Security Crisis of Cardiac Pacemakers Paves the Way for IoT Security Evolution in Cardiology

By INGA SHUGALO

While the healthcare IoT demand forecasts are more than generous, anticipating the market to hit $158.07B by 2022, there is still a certain delay in IoT adoption across the industry. Connected medical devices, especially those that are directly involved in patient care, are adopted cautiously due to potential security vulnerabilities and risks to patient safety.

One of the reasons behind the hesitant adoption of healthcare IoT in cardiology is preexisting concerns about the security of implantable medical devices, such as pacemakers.

The recent pacemaker crisis revealed the vulnerabilities in pacemaker software across several major vendors. If exploited, software vulnerabilities would allow hackers to take over the device and control it fully. The crisis led to device recalls, certain features disabled, and even remote updates cut off completely to avoid unacceptable health risks.

This series of events led to a cautious attitude toward the emerging cardiology IoT. Since we can’t be sure that all exploits and vulnerabilities are eliminated in less advanced systems, are we really ready to take a step forward to more elaborate healthcare software solutions at this point?

The fact of the matter is, cardiology is already taking these steps. The new generation of pacemakers has embedded sensors to monitor a patient’s blood temperature, sinus node rate, breathing, and other vitals. This data is used to flexibly alter the heart rate, slowing or speeding it depending on a patient’s current activity level. They also inherited remote control from their predecessors. Practically, next-gen pacemakers are IoT devices.

Accordingly, the industry can either stigmatize the security concerns or choose to adopt a new perspective, seeing the pacemaker crisis as an opportunity to create a solid platform for unbiased adoption of upcoming connected cardiac devices.

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The Economics of Reimplantation

From The Annals of Internal Medicine doctors from the US have shown that ICDs can be safely resterilized and re-used for indigent patients in another country. In their study, Pavri et al collected 106 ICDs with three or more years of estimated battery life from either deceased patients or patients having devices explanted because of “upgrades” or infection and implanted then in 81 patients in a single hospital in Mumbai, India. From the Methods section of their paper:

We deleted all identifying patient information and lead information; programmed them to nonpacing mode, when possible, or lowered the outputs to the minimum possible values; turned off all sensing and therapies for ventricular tachycardia (VT) and ventricular fibrillation (VF); and deactivated all ICD alerts (auditory and vibratory). When a sufficient number of devices were collected, they were transported to India in batches. Transport was most often done by physicians (or friends and family members of physicians) who were traveling from the United States. The devices were placed in checked-in baggage in a clear plastic bag, and 2 letters were placed in prominent view. The first letter was signed by the donating physician, stating that the devices were of no commercial value and that they were being donated for reuse in patients who could not afford such devices. The second letter was signed by the Chief Executive Officer of Holy Family Hospital, stating that the hospital was expecting the devices for donation to such patients. Contact information for all physicians was provided in the letters.

Attempts at sending explanted devices by courier or mail proved difficult; without precedent, it was simply not possible to describe the purpose and nature of the shipment to shipping authorities or to insure the contents. We finally resorted to carrying the devices during travel to India in our personal baggage, as described. Some difficulties (requiring lengthy explanations) were encountered during baggage screening and, especially, at Customs in Mumbai.

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How My iPhone Prevented an ER Visit

It’s one of those calls you never want to get as an electrophysiologist:

“Doc, I got four shocks from my device yesterday.”

“What were you doing at the time?”

“Working outside.”

“Wasn’t it about a 100 degrees and humid then?”

“Yes.”

“Were you lightheaded before the event?”

“Not too bad… I stopped what I was doing and got better. Should I come in to the ER?”

“This happened yesterday?”

“Yes.”

“Why didn’t you come in then?”

“Well I started to feel better…”

“Do you know how to upload the information from your device at home?”

“You mean using that thing next to my bed?”

“Yes.”

“I think so.”

“Okay, why don’t you go do this and we’ll call you right back after we have a chance to view the information you send us.”

“Okay. Thanks, doctor.”

So I waited about 15-20 minutes, then checked the Medtronic Carelink app on my iPhone.

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