Search Results: Cybersecurity Preparedness & Response

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

I. OVERVIEW The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only for entities that service or remanufacture medical devices (“servicers” and “remanufacturers,” respectively), but also original equipment…

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NYDFS Issues Ransomware Guidance Aimed at Combatting Rising Cyber Threats

The exponential rise in ransomware attacks in the past year has everyone on high alert, not least of which are regulators. Following on the heels of a June 2, 2021 White House memo addressing ransomware prevention, on June 30, 2021 the New York Department of Financial Services (“NYDFS”) issued new ransomware guidance of its…

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Biden Executive Order Likely to Push Private Sector Forward on Cybersecurity

On May 12, President Biden signed an Executive Order on Improving the Nation’s Cybersecurity. The order comes on the heels of a number of recent widely reported cybersecurity crises, including the Solar Winds and Microsoft Exchange compromises, that brought renewed attention to the glaring gaps in supply chain security. By wading into the issue of software…

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