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FCPA Compliance Report-Episode 286-Use of Technology in Supply Chain Risk Management
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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
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
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
Welcome to Industrials Regulatory News and Trends. In this regular bulletin, DLA Piper lawyers provide concise updates on key developments in the industrials sector to help you navigate the ever-changing business, legal, and...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
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
On October 7, 2022, the Biden Administration announced new restrictions on exports to China of advanced integrated circuits (“ICs”), computers and components containing advanced ICs, semiconductor manufacturing equipment, and...more
On Friday, October 7, 2022, the Bureau of Industry and Security (BIS) released an interim final rule containing an enormous set of export controls that will likely damage the Chinese semiconductor, advanced computing, and...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
Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more
Combatting climate change and driving digital transformation of traditional industries are two key challenges of our times. Many industries are working hard to achieve the Paris Agreement climate goals, but with simultaneous...more
In November, Tyler wrote about insurance issues raised by both the European Union’s General Data Protection Regulation (GDPR) and the California Consumer Privacy Act, which goes into effect on January 1, 2020. California’s...more
The Situation: California is the first state to specifically regulate the security of connective devices, which are commonly referred to as internet of things ("IoT") devices. The Result: The new law mandates that...more
As the pace of innovation increases at an ever faster rate, many products that traditionally may not have been thought of as involving computers or software are incorporating these elements. In 2007, the iPhone revolutionized...more