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IP|Trend: New Era in Protection of Software by Intellectual Property Law?
On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....more
The Internet of Things (IoT) represents a transformative shift in how consumers interact with technology, integrating physical devices with sophisticated services to create interconnected ecosystems. As the adoption of IoT...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
On December 15, 2023, the Cybersecurity & Infrastructure Security Agency (CISA) issued a Secure by Design Alert and guidance on “How Manufacturers Can Protect Customers by Eliminating Default Passwords.”...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
Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more
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
The Situation: Whether warranties accompany software used in other products turns on many factors, including whether the designer is providing a "good" or "service," statements in advertising, representations made in sales...more
On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert") Pilot Program. The Pre-Cert Program is an effort by FDA to develop a new, more...more
The Washington Legislature released the state budget for the 2015-2017 biennium, which enhanced the state’s nexus standard, eliminated certain tax exemptions, extended some tax preferences, and made other tax changes:...more
You are the chief legal officer of a U.S. company. Your CEO walks into your office and announces that your company is about to conclude its first international sale. In addition, the company has just appointed distributors in...more