News & Analysis as of

Manufacturers Cybersecurity

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

Gardner Law on

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Robinson+Cole Data Privacy + Security Insider

CISA Alert: Liteon Electric Vehicle Chargers

If you own an electric vehicle, keep an eye on cybersecurity issues that may affect your car and its accessories. You wouldn’t think that an electric vehicle charger could include a vulnerability that allows threat actors to...more

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

Foley & Lardner LLP on

In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

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

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

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

American Conference Institute (ACI)

[Event] 15th Forum on Global Encryption, AI, Cloud & Cyber Export Controls - March 26th - 27th, San Francisco, CA

As global trade policy evolves faster than ever, now is the time to connect with your peers, discover new strategies, and most importantly, hear from the regulatory agencies on the front lines of policy change. ACI’s 15th...more

Goodwin

EU Updates its Product Liability Regime: Important Considerations for Providers of AI Systems and Software

Goodwin on

The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more

Warner Norcross + Judd

Lessons from CES 2025: The Legal Side of Product Innovation — What Every Manufacturer and Supplier Needs to Know

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The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...more

Robinson+Cole Data Privacy + Security Insider

Ethical Hacker Uncovers Vulnerability in Subaru Starlink Service

Ethical hackers identified an arbitrary account takeover flaw in the administrator portal for Subaru’s Starlink service, which could allow a threat actor to hijack a vehicle through a Subaru employee account. This...more

Miller Nash LLP

What the U.S. Cyber Trust Mark Means for IoT Security and How to Prepare

Miller Nash LLP on

This year’s Data Privacy Week theme is “take control of your data.” That can be really challenging to do. Data is collected from everywhere—whether online or offline—and can be stored and used indefinitely (even if the...more

Foley & Lardner LLP

Cybersecurity Executive Order—Key Implications for the Manufacturing Industry

Foley & Lardner LLP on

On January 16, 2025, President Joe Biden issued the “Executive Order on Strengthening and Promoting Innovation in the Nation’s Cybersecurity,” a comprehensive directive designed to address the growing complexity and...more

Cozen O'Connor

The State AG Report – 12.19.2024

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Illinois AG’s and FTC’s Settlement Takes a $25 Million...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

Fish & Richardson

Introduction to SEP & FRAND Issues

Fish & Richardson on

Imagine your company designs, manufactures, or sells products that implement commonplace technologies like Wi-Fi, 5G, or video streaming. Did you know you might need a license to incorporate these technologies into your...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Akin Gump Strauss Hauer & Feld LLP

Three Questions with Sedgwick’s Jeremy Schutz

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

BCLP

Key Insights on the EU Cyber Resilience Act - What Businesses Need to Know

BCLP on

The Cyber Resilience Act (CRA) is a groundbreaking piece of legislation designed to enhance the cybersecurity of digital products and services made available in the EU. Published last week in the Official Journal of the...more

Robinson+Cole Data Privacy + Security Insider

Chinese Manufactured Batteries Pose Cybersecurity Threat to Critical Infrastructure

The U.S.-China Economic and Security Review Commission, released its annual report to Congress this month.  The 793-page report responds to the Commission’s mandate to “monitor, investigate, and report to Congress on the...more

Dickinson Wright

Plugged In: An EV Newsletter Vol. 2, No. 9

Dickinson Wright on

Editor’s Note - November’s edition of Plugged In concludes a three-part series focused on the impact of technology and AI on the automotive industry. DW Member Greg Ewing discusses the significant cybersecurity and privacy...more

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