News & Analysis as of

Cybersecurity Reporting Requirements Manufacturers

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
A&O Shearman

Australia – new security standards for smart devices

A&O Shearman on

Established under the Cyber Security Act 2024 (the ‘Act’), the Cyber Security (security standards for smart devices) Rules 2025 (the ‘Rules’) set out the requirements for three security standards introduced to enhance the...more

Alston & Bird

D-Day for the EU Cyber Resilience Act

Alston & Bird on

Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more

Bradley Arant Boult Cummings LLP

Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule

As discussed in our previous blog post, the Cybersecurity and Infrastructure Security Agency (CISA) is proposing a significant new rule to bolster the nation’s cyber defenses through mandatory incident reporting. While...more

Jackson Lewis P.C.

Dealing With the Growing Threat of Cyberattacks in Manufacturing Sector: What Employers Need to Know

Jackson Lewis P.C. on

For the second year in a row, the manufacturing industry has fallen victim to more cyberattacks than any other major business sector. Indeed, according to IBM Security’s X-Force Threat Intelligence Index, nearly 25 percent...more

Gardner Law

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

Gardner Law on

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

Tucker Arensberg, P.C.

Biden Warns of Imminent Cyberattacks and New Regulations– Is Your Business Prepared?

Tucker Arensberg, P.C. on

Our clients in financial services, technology, and manufacturing industries, take note of this important new piece of legislation. On March 21, 2022, President Biden warned American businesses to prepare for imminent...more

King & Spalding

FDA FY 2021 Budget Foretells Medical Device Cybersecurity Reform

King & Spalding on

Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more

Robinson+Cole Data Privacy + Security Insider

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

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