These same features also increase potential cybersecurity risks. Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. The FDA clears, authorizes, and approves devices to be marketed when there is a reasonable assurance that the devices are safe and effective for their intended use. The video focuses on how to prepare for a cybersecurity event and help ensure patient safety during a prolonged cybersecurity event.įor more information about cybersecurity in medical devices, we recommend you consult our guidance documents and read Cybersecurity in Medical Devices Frequently Asked Questions (FAQs).Īll legally-marketed medical devices have benefits and risks. – the FDA has launched its third video: Tips for Health Care Facilities: Cybersecurity Incident Preparedness and Response. This guidance provides recommendations on medical device cybersecurity considerations and what information to include in premarket submissions. Septemupdate: The FDA issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. To mark the FDA cyber team’s 10-year anniversary, here is an infographic showing some of the ways they have contributed to patient safety over the past decade.
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