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Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Vedder Price

Taking Off: Financing the eVTOL Revolution

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Imagine waking up in a peaceful, spacious community free from traffic and congestion, yet commuting quickly and comfortably into the bustling city center or directly to the airport within minutes. Picture military operations...more

Hogan Lovells

How to leverage Advanced Purchase Agreements for military supply

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The EU is introducing new regulations (EDIRPA and EDIP) to structure military procurement through pooled orders coordinated by the European Commission. Advanced Purchase Agreements (APAs), inspired by COVID-19 contracts,...more

Baker Donelson

Top Five AI Procurement Questions General Counsel for Manufacturers Should Consider

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Artificial intelligence (AI) is reshaping the future of manufacturing. As manufacturing operations shift back to the U.S. in response to recent tariff policies, general counsels (GCs) in the manufacturing sector face a...more

McGlinchey Stafford

Defending Manufacturers Against PFAS Claims: Legal Strategies and Challenges

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As litigation involving per- and polyfluoroalkyl substances (PFAS) continues to rise, manufacturers of PFAS-containing products face significant legal and financial risks. Plaintiffs, including individuals, communities,...more

Holland & Knight LLP

EPA Issues a Final Revised Risk Determination for 1,4-Dioxane

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The U.S. Environmental Protection Agency (EPA) concluded its risk evaluation of 1,4-Dioxane under the Toxic Substances Control Act (TSCA) and issued a Notice of Availability of its Final Supplement to the Risk Evaluation and...more

Foley Hoag LLP - Global Business and Human...

A Human Rights Impact Assessment of Microsoft's Enterprise Cloud and AI Technologies Licensed to U.S. Law Enforcement Agencies

Microsoft is one of the world’s leading technology companies. Its products and technologies are in offices, classrooms, and homes. Additionally, governments use them to help conduct vital public services. Microsoft is also...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

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The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

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As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Thomas Fox - Compliance Evangelist

Exiger’s Fight to Secure Supply Chains: Spotlight on Information Technology and Telecommunications

Welcome to a blog post series on Exiger’s fight to secure supply chains, sponsored by Exiger LLC. In this series, we will explore the ongoing efforts of Exiger to lead the discussion and enhancement of Supply Chain Risk...more

King & Spalding

President Biden Orders Comprehensive Supply Chain Review

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Articulates Administration Policy And Reaffirms Need For “Strong, Resilient Supply Chains” For “Critical And Essential Goods And Materials” - On February 24, 2021, President Joseph R. Biden Jr. signed an Executive Order on...more

Wiley Rein LLP

2021 Preview: How the Private Sector Will be Impacted by IoT Cybersecurity Work at NIST

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The National Institute of Standards and Technology (NIST) has been an active driver of Internet of Things (IoT) cybersecurity efforts for several years, convening stakeholders from the federal government and the private...more

Nilan Johnson Lewis PA

Recent IoT Class Actions Highlight Need for Manufacturers & Vendors of Connected Products to Be Aware of Liability Risks

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The Internet of Things (IoT) products have become a way of life. There are huge benefits of “smart” products, which interact through the internet to gather and exchange data to provide additional functions, security, and easy...more

WilmerHale

Privacy Legislation Trends Connected Car Cos. Should Watch

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The automobile industry has been racing full speed ahead in recent years on its quest for increased connectivity and automation, but it may soon find itself swept up in the wave of privacy and data security laws and...more

Faegre Drinker Biddle & Reath LLP

NIST Unveils IoT Baseline of Core Cybersecurity Features for Comment

In a release aptly labeled “A Starting Point for IoT Device Manufacturers” the National Institute of Standards and Technology (NIST), an arm of the Department of Commerce, recently added to the discussion with the...more

Robinson+Cole Construction Law Zone

Business Email Compromises Bilking U.S. Companies Out of $301M Per Month

The United States Treasury Department came out with a report last week that concludes that business email compromises (BEC) are costing U.S. companies more than $301 million per month. The report confirms that the two...more

Bergeson & Campbell, P.C.

EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses

On March 15, 2019, the U.S. Environmental Protection Agency (EPA) published a signed final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and...more

Foley & Lardner LLP

Adoption of Artificial Intelligence in Manufacturing Accelerating

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The rapid adoption of Industry 4.0 technologies leaves manufacturers with a choice: accelerate with the market or be left behind. According to a 2019 Global Market Insights, Inc. report, the market for artificial intelligence...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Mintz

FDA Responds to Device Software Vulnerabilities by Releasing New Draft Cybersecurity Guidance

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On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more

Ballard Spahr LLP

California Poised to Enact Internet of Things Information Security Law

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California is once again poised to set the standard for privacy and data security by enacting the first state law directed at securing Internet of Things (IoT) devices. The law has passed the state legislature and is awaiting...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, February 2018

TSCA/FIFRA/TRI - Recording Available From “Chemical Regulation In 2018: A Sneak Preview Of Things To Come” Webinar: A recording is now available of “Chemical Regulation in 2018: A Sneak Preview of Things to Come,” the...more

Hogan Lovells

Filling in the Gaps on Medical Device Cybersecurity

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Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Hogan Lovells

China moves to implement security review of network products and services: but leaves foreign investor and manufacturer concerns...

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On 4 February 2017, the Cyberspace Administration of China issued a draft of the Network Products and Services Security Review Measures (“Draft Measures“) for public comment: the Draft Measures remain open for comments until...more

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