Implantable Pacemakers & Defibrillator Devices Found Vulnerable to Hackers: FDA Investigation

A flaw detected in St. Jude Medical’s medical devices was under stringent investigation since the past year. Recently, the US FDA concluded the entire investigation on a flaw in certain medical devices by the company, which is reportedly responsible for making them susceptible to cyber security attacks.

Hacking has been one of the top cyber security issues recently and several medical devices have been identified to be prone to cyber hacking over the recent past. St. Jude Medical Inc., the American global medical device company based in Minnesota, has been apparently noticed by the FDA regarding the flaws in the company’s implantable pacemakers and defibrillator devices that make the medical devices vulnerable to cyber-attacks.

Cyber security of crucial medical devices has been a growing concern for cyber experts. The FDA has recently asked St. Jude Medical Inc. to fix a flaw identified in pacemaker implants and defibrillator devices manufactured by the company, as it is increasing the devices’ vulnerability to hacking.

The medical device manufacturer recently admitted that all the medical devices manufactured by St. Jude that use a remote monitoring system, are potentially vulnerable to cyber security attacks, such as hacking.

The company will now be deploying the latest cyber security updates release for a remote monitoring system generally used with the company’s pacemaker implants and defibrillator devices – Merlin remote monitoring system. The amendments will include updates regarding the device security, which will possibly combine best with the company’s existing measures and minimize hacking risks.

Rubicon Labs’ Rod Schultz says, “It is a good thing that the FDA is paying attention to such vulnerabilities without blaming the entire medical devices but considering only a part of them responsible for making them vulnerable to cyber-attacks such as hacking.” “The FDA has learned a lot from the automotive industry over the years and the transmitter is the new airbag. Let us hope that the FDA would take another page from the automotive industry in terms of security and safety, and starts acknowledging such vulnerabilities much faster in coming years,” the Vice President, Rubicon Labs further adds.

According to a cyber-security trainer, Ashton Mozano, there are several medical devices currently on the market that are prone to cyber security threats. If left without any remarkable improvement, most of the exiting medical devices in use can become vulnerable to cyber security attacks. He asks, “What exactly is the medical industry planning for overcoming the threat of cyber security and why is it taking a long time even after the identification of a number of vulnerable medical devices till date?”

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