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Hot Topics in International Trade A Year in Review (Quickly)
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
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
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
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
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
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
On October 10, 2024, the European Council officially adopted the Cyber Resilience Act (CRA), a regulation designed to ensure that products with digital features are secure to use and resilient against cyber threats, and that...more
The agreed text of the AI Act was published on July 12, 2024, essentially starting the clock on the legal deadlines contained in it. Its obligations will apply in tiered phases, with the first key obligations being enforced...more
The FCC’s recent introduction of a new Voluntary Cybersecurity Labelling Program for consumer Internet of Things (IoT) products reflects the continued desire by U.S. regulators to bolster the security of the ever-increasing...more
Antitrust and Competition - The European Commission Fines Apple EUR 1.8 billion for Abusing Its Dominant Position in the Music Streaming Sector - On 4 March 2024, the European Commission (Commission) fined Apple EUR 1.8...more
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
The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more
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
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
The European Commission recently proposed the EU Cyber Resilience Act, a regulation on cybersecurity requirements for products with digital elements. The proposal introduces wide-ranging technical and governance measures that...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
Technology for autonomous vehicles (AVs) will continue to rapidly evolve in the next few years. This rise in innovation is accompanied by the emergence of new mobility players (new entrants) as well as commercial and...more
The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit...more
The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the...more
The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe. ...more
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
Advancements in technology may provide consumers with a continuous stream of upgraded products, but they’re also proving that current security and privacy regulations fall short within the Internet of Things (IoT)....more
Blockchain technology is most well-known for its use with cryptocurrencies, however, it has wider potential applications in other sectors beyond that of banking and financial services. It is being evaluated for uses in the...more
Given the pace of change in the automotive industry and related technologies, combined with increasing regulatory scrutiny, what risks and challenges can the global automotive industry expect to deal with in 2018 and beyond...more
As is our annual tradition, this is the first in a series of posts that provide industry and legal outlooks for manufacturers as we head into 2017. I will start with corporate compliance and litigation. Matt will follow...more