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Fenwick & West LLP

The EU Updates its Products Liability Directive to Include AI

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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

Troutman Pepper Locke

Consumer Advocacy Groups Urge FTC to Address Software Tethering Issues

Troutman Pepper Locke on

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

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

Robinson+Cole Data Privacy + Security Insider

CISA Alerts Manufacturers to Eliminate Default Passwords

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

Lippes Mathias LLP

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

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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

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

MoFo Life Sciences on

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

McDermott Will & Emery

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

McDermott Will & Emery 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

Jones Day

Be Wary of Warranties for Software Design

Jones Day on

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

Jones Day

FDA Releases Software Precertification Working Model

Jones Day on

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

K&L Gates LLP

Washington State Tax Update

K&L Gates LLP on

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

Williams Mullen

Export Control Laws for the General Counsel

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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

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