Medical devices

Cybersecurity adds to medical device concerns

Cybersecurity has become a top concern for medical device companies as medical technology grows evermore connected.

The U.S. Food & Drug Administration has begun asking medtech manufacturers to take cybersecurity into account when they design new products, and submit to the agency plans for patching and protecting operating systems and software for their devices.

The FDA’s guidelines to companies — and they’re guidelines, not requirements — are meant, above all, to protect patient safety and push companies to be vigilant as they use connected technologies to improve health care.

“There is no such thing as a threat-proof medical device,” said Suzanne Schwartz, an FDA director of emergency preparedness and medical countermeasures.

As unnerving as it is to consider someone successfully hacking a device in a hospital, it’s medical device companies themselves that present more likely targets for hackers. The FBI has warned that they’re in cyber criminals’ sights.

Federal rules that required widespread adoption of electronic medical records by the start of this year, combined with the increased connectivity of medical devices, make it likely hackers would sharpen their focus on medtech, the FBI warned.

“The health care industry is not as resilient to cyber intrusions compared to the financial and retail sectors, therefore the possibility of increased cyber intrusions is likely,” the FBI said in letters sent to companies last year.

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