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Manufacturers › Cybersecurity › Regulatory Oversight

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

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

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

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

Dorsey & Whitney LLP

AI regulation introduced in Europe - setting the way forward for the rest of the world or slowing down the adoption of new tech?

Dorsey & Whitney LLP on

The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...more

Venable LLP

Preparing for the EU Cyber Resilience Act

Venable LLP on

The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

Hogan Lovells

Harmonizing cybersecurity for medical devices: International collaboration moves forward

Hogan Lovells on

On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more

McDermott Will & Schulte

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Schulte on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

Foley & Lardner LLP

Navigating Cybersecurity Risk in the Age of the Connected Car

Foley & Lardner LLP on

A boom in automobile technology and connectivity in 2018 further boosted expectations of consumers regarding the integration and functionality of their devices and vehicles. Automobile manufacturers have responded by...more

Jones Day

Driverless, Networked Vehicles on the Rise, French Liability Regulations Lag Behind

Jones Day on

The Situation: Autonomous cars with incorporated artificial intelligence ("AI") are now a reality whereas French regulations have yet to adjust. The Issue: The phenomenon of new autonomous cars using AI gives rise to...more

Troutman Pepper Locke

California Becomes First State to Regulate IoT Devices

Troutman Pepper Locke on

On September 28, Governor Jerry Brown approved California Senate Bill 327, making California the first state in the country to regulate the security of Internet of Things (IoT) devices. ...more

Hogan Lovells

Legislative and Regulatory Update on Federal Supply Chain Risk Management

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The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. ...more

Foley & Lardner LLP

NHTSA and Motor Vehicle Safety

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The closing years of the Obama administration saw a whirlwind of regulatory activity from NHTSA, including multiple consent orders, record penalties, and soaring recall numbers. The more aggressive enforcement posture, hailed...more

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