Tag Archives: cybersecurity

FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the…

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FDA Encouraging Hackers to Submit Medical Device Cybersecurity Flaws

On June 13, 2013, the Food and Drug Administration issued a safety communication to medical device manufacturers, hospitals, medical device user facilities, health care IT and biomedical engineers advising them to take steps to secure cybersecurity for medical devices and hospital networks.  The FDA warned that as medical devices are increasingly interconnected, via the internet or wireless devices, there is an increased risk of  cybersecurity breaches, which could affect how a medical device operates. The FDA advised that it has become aware of cybersecurity vulnerabilities…

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