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In an article titled, “The FDA Steps Up Efforts to Address Medical Device Cybersecurity,” published in American Health Lawyers Association’s PG Bulletin, Elizabeth Hodge analyzed the cybersecurity and patient concerns associated with medical devices using wireless, internet or network connectivity to function.

Particularly, Hodge explained the initiatives that the Food and Drug Administration (FDA) has taken to address the growing threats to medical device functionality, including recent reports by the U.S. Department of Health and Human Services Office of Inspector General; the FDA’s updates to the final guidance on premarket submission; the MITRE Corporation’s regional incident preparedness playbook; and a joint memorandum agreement by the Department of Homeland Security (DHS) and the FDA.

“The recent WannaCry ransomware and Petya/NotPetya attacks, along with demonstrations by ‘white hat hackers’ of how connected devices may be compromised, highlight how cybersecurity threats to the health care sector are increasing in frequency and severity and having a greater clinical impact on health care facility operations and patient safety,” Hodge said of the threats.

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