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K&L Gates LLP

Brussels Regulatory Brief: April 2024

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Antitrust and Competition - European Commission Charges Company with Providing Incorrect, Incomplete, and Misleading Information During a Merger Control Proceeding - On 19 March 2024, the European Commission (Commission) sent...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

McDermott Will & Emery

UK Medical Device Regulator Proposes a 12 Month Delay for UKCA Requirements and the New Medical Device Regulations

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On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

Bradley Arant Boult Cummings LLP

Ten Legal Considerations When Starting a Hemp Business

So, you want to start a hemp company. You have your big idea and a business plan ready. At some point, though, you begin to wonder whether you should be thinking about any legal issues as you get your company off the...more

Seyfarth Shaw LLP

Future Enterprises and Environmental Impacts in the Cannabis Industry

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The continued efforts of federal, state, and local governments to legalize cannabis, both in medical and recreational uses, leaves many potential impacts, including environmental law and regulatory issues in the...more

Hogan Lovells

Harmonizing cybersecurity for medical devices: International collaboration moves forward

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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

Patrick Malone & Associates P.C. | DC Injury...

FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...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

California Becomes First State to Regulate IoT Devices

Troutman Pepper 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

How the Internet of Things could redefine product safety and liability in the EU

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How big is the Internet of Things (IoT)? It’s likely that there will be tens of billions of connected devices in use by 2020. As this massive network of “things” keeps expanding, so do the number of questions about...more

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