FDA's Role in Medical Device Cybersecurity: Dispelling Myths and Understanding Facts   [open pdf - 174KB]

"As medical devices become more digitally interconnected and interoperable, they can improve the care patients receive and create efficiencies in the health care system. Medical devices, like computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. By carefully considering possible cybersecurity risks while designing medical devices, and having a plan to manage emerging cybersecurity risks, manufacturers can reduce cybersecurity risks posed to devices and patients. The FDA has published premarket and postmarket guidances that offer recommendations for comprehensive management of medical device cybersecurity risks, continuous improvement throughout the total product life-cycle, and incentivize changing marketed and distributed medical devices to reduce risk. Even with these guidances, the FDA continues to address myths about medical device cybersecurity."

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U.S. Food and Drug Administration: https://www.fda.gov/
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