Let’s Talk About Cybersecurity: US FDA Wants Feedback On Safety Alerts
The FDA is convening a panel of experts in September to talk about how to craft cybersecurity communications that adequately alert patients about potential vulnerabilities while not creating a panic. The meeting comes as the agency has been putting out a growing number of cybersecurity alerts, including most recently a recall for certain vulnerable Medtronic insulin pumps.
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Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.
A public-private partnership board long touted by top US FDA officials to help address cybersecurity threats has hit a funding wall. The agency received less than half of what it asked for in the FY 2019 budget for its digital efforts, including its cybersecurity strategy, leading it to make some tough choices.
Heartburn: Yet Another Device-Maker Is Facing Cardiac Device Cybersecurity Worries – This Time, It's Medtronic
Medtronic cardiac devices are vulnerable to malicious hackers who could potentially not only intercept data between the patient and their provider, but also may be able to manipulate the implantable cardiac devices, possibly leading to serious adverse events and death. US FDA says patients should continue to use the devices as usual but should look out for telltale signs of an attack. Meanwhile, Medtronic claims it was aware of the issue and contends that patients shouldn't be concerned: “To date, no cyberattack, privacy breach, or patient harm has been observed," a spokesman says.