The US Food and Drug Administration (FDA) issued new guidance this week that requires all new medical device applicants to submit a plan on how to “monitor, identify, and address” cybersecurity issues. The guidance also mandates that manufacturers create a process that provides “reasonable assurance” that the device in question is protected against cyber threats. Applicants must make security updates and patches available on a regular schedule.
These new regulations are critical given the increasing number of cybersecurity threats targeting medical devices. Cyberattacks on medical devices can result in the compromise of sensitive patient information, the disruption of critical medical procedures, and even physical harm to patients.
Kajeet's Sentinel Platform Offers Comprehensive Cybersecurity for Medical Devices
For medical device manufacturers, compliance with these new regulations can be a daunting task and not every manufacturer is ready with resources to add this additional layer of regulatory transparency into their plans. Fortunately, Kajeet's Sentinel platform provides comprehensive cybersecurity right out of the box. Sentinel is a cloud-based platform that uses advanced machine learning algorithms to monitor, identify, and address cybersecurity threats in real-time.
By partnering with Kajeet, medical device manufacturers can save time and resources by integrating the Sentinel platform into their devices. This eliminates the need for costly and time-consuming research and development to physically add cybersecurity features to their devices.
In addition, Sentinel offers continuous monitoring and alerts, providing real-time notification of any cybersecurity issues. This ensures that manufacturers can quickly identify and address any potential vulnerabilities, thereby minimizing the risk of cyber-attacks and ensuring compliance with the new FDA regulations.
What can you do?
The new FDA guidance on cybersecurity for medical devices is an important step in ensuring the safety and security of patients. We can get you ready with the right tools and team to ensure cybersecurity protection for devices and patients. Here are several resources in which you might be interested:
To learn more about Sentinel and how it can help medical device manufacturers, check out our Sentinel page.
Developing a telehealth / RPM / IoMT device? Learn more about our IoT module initiative for developers.
To learn more about what Kajeet can do for companies in the connected health / IoMT space, head on over to our Connected Healthcare page.
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