FDA Encourages Safeguards for Potential Cyberattacks
The FDA encouraged medical device manufacturers and health care facilities to have safeguards in place in case of cyberattacks on medical equipment and devices. While no cases have been reported to date, the FDA noted that the Agency recently became aware of the potential for cybersecurity-related incidents. “Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches,” noted the FDA. “In addition, as medical devices are increasingly interconnected, via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates.” The FDA is collaborating with other federal agencies and device manufacturers and has released draft guidance for manufacturers that covers cybersecurity and pre-market submissions. Guidance that addresses cybersecurity for products that use off-the-shelf software has also been released. The full FDA safety alert and recommended steps for evaluating your facility’s security are available here.
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