Latest in Science

Image credit:

FDA issues final guidance on medical devices' cybersecurity

The agency wants medical device manufacturers to protect their products from cyberattacks.
1224 Shares
Share
Tweet
Share

Sponsored Links

The Food and Drug Administration has issued its final guidance on protecting medical devices like pacemakers and insulin pumps from cyberattacks. To start with, it wants manufacturers to boost their cybersecurity measures by incorporating a way to monitor and detect vulnerabilities into the products they make. The FDA also wants them to establish a process for receiving information about potential vulnerabilities from cybersecurity researchers. If they do detect any exploitable flaw, the agency wants the companies to assess the risk it poses to patients. Finally, it wants the medical device makers to issue software patches to fix any vulnerability it finds.

According to the FDA, this final guidance "recognizes today's reality" that "cybersecurity threats are real, ever-present and continuously changing." It applies to all medical devices, including those already out on the market such as those manufactured by St. Jude Medical. The agency is currently investigating St. Jude's products after an investment firm and a cybersecurity company claimed that they lack even the most basic form of cybersecurity.

The FDA promises to adjust its guidance or even issue a new one if needed, since cyberthreats can evolve and hackers can become even more capable:

"Digital connections power great innovation -- and medical device cybersecurity must keep pace with that innovation. The same innovations and features that improve health care can increase cybersecurity risks. This is why we need all stakeholders in the medical device ecosystem to collaborate to simultaneously address innovation and cybersecurity. We've made great strides but we know that cybersecurity threats are capable of evolving at the same pace as innovation, and therefore, more work must be done."

All products recommended by Engadget are selected by our editorial team, independent of our parent company. Some of our stories include affiliate links. If you buy something through one of these links, we may earn an affiliate commission.
Comment
Comments
Share
1224 Shares
Share
Tweet
Share

Popular on Engadget

Amazon cuts the price of the 7-in-1 Ninja Foodi cooker to $125

Amazon cuts the price of the 7-in-1 Ninja Foodi cooker to $125

View
Polestar's latest concept EV is designed for sustainability

Polestar's latest concept EV is designed for sustainability

View
How exactly does 5G work?

How exactly does 5G work?

View
NASA says its InSight lander has detected over 450 'marsquakes'

NASA says its InSight lander has detected over 450 'marsquakes'

View
The Morning After: Netflix's new Top 10 lists tell you what's popular

The Morning After: Netflix's new Top 10 lists tell you what's popular

View

From around the web

Page 1Page 1ear iconeye iconFill 23text filevr