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“liability insurance

Do I Need Liability Insurance for My Business If Customers Sign a Waiver?

This original post was published on 6/29/2021 and fully updated on 3/5/2024. Many business owners ask themselves do I need liability insurance for my business if my customers sign a waiver, and the answer is yes. A waiver or release form is a contract designed to shift liability away from the business with the consent of the customer. Waivers are meant to significantly alter the legal landscape from a place where the business is responsible for a place where responsibility lies more with the customer. However, if a customer makes a liability claim, release forms may not always be enforced.… Read More »Do I Need Liability Insurance for My Business If Customers Sign a Waiver?

Hacking of Pacemakers and Other Implanted Devices

On October 1, the Federal Drug Administration (FDA) issued a warning about the so-called URGENT/11 cybersecurity flaws that leave certain Wi-Fi-enabled medical devices vulnerable to being remote-controlled by hackers, such as cardiac pacemakers, implantable cardioverter defibrillators (ICDs) or insulin pumps.

The FDA indicated that devices potentially at risk are those utilizing IPnet, a decades-old software application that enables wireless networking. According to the statement, a successful cyberattack could allow a hacker to remotely change a device’s function, cause a denial of service, information leak or logic flaw that could lead the device to malfunction.

Although there have been no reports of such cyberattacks, the FDA pointed to a health risk for patients using one of the affected devices and advised healthcare providers to notify patients of potential risks and address the issue in conjunction with patients and device manufacturers.

Because device manufacturers have incorporated an array of configurations to IPnet and its components, the Department of Homeland Security (DHS) is unable to compile a list of affected devices. Therefore, the DHS has advised manufacturers to evaluate and report to the FDA what, if any, cybersecurity risks are posed by their devices.

“This illustrates a scale of digital risk that could not have been foreseen at the time these devices were manufactured,” said Neil Gurnhill, CEO, Node International, London, England. “Companies need to develop these products with security at the forefront of their minds. This is a potentially life or death situation that companies cannot afford to get wrong.”Read More »Hacking of Pacemakers and Other Implanted Devices