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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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There's a New Regulator in Town: China Passes an Omnibus Data Privacy Law

On August 20, the People’s Republic of China became the latest global economic powerhouse to pass an omnibus privacy law. Titled the Personal Information Protection Law (“PIPL”), the law was adopted by the Standing Committee of China’s National People’s Congress, China’s top legislative body, and is slated to take effect on…

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Europe Opts for Pragmatism with new SCCs and ICO Opens Consultations on UK SCC — What Companies Need to do Next

The dust has settled on the new EU standard contractual clauses for cross-border data transfers (“New SCCs”), but confusion still reigns on how the New SCCs cover data transfers and what companies need to do to take advantage of them and comply with regulatory implementation guidance, including in relation to…

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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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The Colorado Privacy Act Joins List of Comprehensive State Privacy Laws

On July 7, 2021, Colorado Governor Jared Polis signed the Colorado Privacy Act (“CPA”) into law. The CPA will take effect on July 1, 2023 and joins the California Consumer Privacy Act (“CCPA”), the California Privacy Rights Act (“CPRA”), and Virginia Consumer Data Protection Act (“VCDPA”) on a growing list of comprehensive state data privacy laws…

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Companies Can Protect Proprietary Data When Responding to CCPA Privacy Requests

Since its passage almost three years ago, the California Consumer Privacy Act (“CCPA”) has offered California-based consumers certain rights over the personal information companies collect and process about them. While responding to any request to exercise CCPA rights creates its own set of challenges, one right in particular – the right to…

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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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NYC Enacts Biometric Data Disclosure Rules and Restrictions

Millions of vaccinated Americans — now maskless — surely can’t wait to rekindle their love affair with their iPhone’s facial recognition technology. Meanwhile, these same people are probably less eager for the bars, restaurants, and theaters they visit to collect that same facial data and other biometric information without their…

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What To Expect From NYC’s Tenant Data Privacy Act

New York City tenants harboring “big brother” concerns over landlords abusing data collected through smart access (i.e., keyless entry) systems will soon be able to rest easier. Following California, Virginia, and the British Virgin Islands, the New York City Council recently became the latest legislative body to pass privacy legislation with the Tenant Data…

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