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Cybersecurity for Medical Devices

Technological advances have improved medical care in immeasurable ways, but technology has also created new vulnerabilities within the health care industry. Cybersecurity is a major concern for all industries, but cybersecurity is particularly important when it comes to medical devices since patient lives are at stake.

In attempt to curtail cybersecurity risks for medical devices and hospital networks, the Food and Drug Administration (FDA) recently announced that it is recommending that "medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks."

As this Forbes article points out, many medical devices are vulnerable to cybersecurity breaches through the internet, infected flash drives, or other wireless technology, which could result in malware accessing patient data, monitoring systems, and implanted devices. Older medical devices are the most vulnerable to cybersecurity risks, especially if medical device manufacturers fail to provide timely security updates or if the devices are not updated by the medical facility or the patient.

The FDA also reminded medical device manufacturers of their responsibility to identify risks and hazards associated with their medical devices and to put the appropriate protections in place to address patient safety and assure proper device performance. Accordingly, the FDA said that it expects medical device manufacturers to "take appropriate steps to limit the opportunities for unauthorized access to medical devices," specifically recommending that manufacturers "review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise of the security of the hospital network that may be connected to the device."

Although there have been no known cases in which a patient has been injured on account of a medical device compromised by malware or a computer virus, it is important that manufacturers, medical facilities, and patients remain vigilant about protecting medical devices with updated security protection since security risks and threats are not easily recognized.

The Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish are committed to protecting the public from dangerous medical products, including unsafe pharmaceuticals and defective medical devices. If you have been injured by an unsafe medicine or defective medical device, contact the Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish to schedule a free consultation to discuss a possible product liability or medical malpractice claim.


Steinberg Goodman & Kalish  ( is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.

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