News & Analysis as of

Software Regulatory Oversight

Troutman Pepper Locke

Whistleblower Lawsuit Against METRC Raises Significant Compliance and Accountability Concerns for the Legal Cannabis Industry

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METRC, Inc., the predominant provider of seed-to-sale tracking software used by state regulatory bodies overseeing legal cannabis markets across the U.S., faces serious allegations detailed in a recent lawsuit filed in...more

Lathrop GPM

Transparency and AI: FTC Launches Enforcement Actions Against Businesses Promoting Deceptive AI Product Claims

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Numerous businesses today deploy artificial intelligence (AI) innovatively across various industries, with many companies eager to hop on the AI hype train and ride the momentum of new and innovative business tools. While...more

Troutman Pepper Locke

Consumer Advocacy Groups Urge FTC to Address Software Tethering Issues

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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

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

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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

Clark Hill PLC

Right To Know - October 2024, Vol. 22

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Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more

DLA Piper

Interstellar Insights - September 2024

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Space weather startup Perceptive Space raises USD2.8 million. Canadian startup Perceptive Space is developing new artificial intelligence (AI)-based software to forecast space weather more precisely. The company raised...more

K&L Gates LLP

Digital Operational Resilience in the Financial Services Sector: EU and UK Update

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With under six months to go until the European Union Digital Operational Resilience Act (DORA) becomes applicable on 17 January 2025, DORA implementation projects are running full steam ahead. DORA lays down uniform...more

White & Case LLP

Newly passed Colorado AI Act will impose obligations on developers and deployers of high-risk AI systems

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The Colorado Artificial Intelligence Act will impose mounting obligations on developers and deployers of high-risk AI systems in an effort to protect consumers from discriminatory consequential decisions by such systems....more

ArentFox Schiff

AI in 2024: What Every GC Needs to Know

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As we enter into this second full year of the artificial intelligence (AI) revolution, a clear understanding of the technology and its legal implications becomes crucial for every General Counsel (GC). From understanding...more

Venable LLP

Preparing for the EU Cyber Resilience Act

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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

Goodwin

What’s Next for AI? Six Areas to Watch in 2024

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Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more

DarrowEverett LLP

Prove It or Lose It: New York City Cracks Down on AI Hiring Software

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Artificial Intelligence (“AI”) programs have gained notoriety by injecting ease into otherwise burdensome and difficult daily tasks. However, as with most innovative advancements, AI has also drawn concern from skeptics...more

Dechert LLP

Artificial Intelligence: Legal and Regulatory Issues for Financial Institutions

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Over the last six months, artificial intelligence (AI) has captured the public imagination in a way it never has before. A new generation of AI-powered language models make use of a deep learning architecture known as a...more

Shipkevich PLLC

Metaverse Primer

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The term “metaverse” first appeared in 1992 as an abstract concept in Neal Stephenson’s dystopian novel Snow Crash. Two decades later, the Metaverse has since evolved from a mere idea to a figment of everyday reality, as it...more

Foley & Lardner LLP

Competing Interests: Data Ownership at the Crossroads of SaaS Stakeholders and Regulation

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Kicking off our series on topics concerning Software-as-a Service (SaaS) technology, it is important to lay a framework around the data managed by SaaS applications and issues that arise out of complex relationships among...more

Nelson Mullins Riley & Scarborough LLP

FDA Concludes Software Pre-Cert Pilot Program, Noting Federal Legislative Action is Needed

The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more

McDermott Will & Emery

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

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On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more

Faegre Drinker Biddle & Reath LLP

Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...more

Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed

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What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

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The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

McDermott Will & Emery

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

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The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

McDermott Will & Emery

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

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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

Shook, Hardy & Bacon L.L.P.

Highly Automated and Connected Vehicles Update - June 2019 #3

NVIDIA Unveils Supercomputer for Autonomous Vehicle Program’s AI Infrastructure - After three weeks of development, NVIDIA has unveiled a supercomputer capable of delivering 9.4 petaflops of processing, which can reportedly...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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Just months after Whole Foods raised prices on certain items after an initial Amazon-pushed lowering, Bezos & Co. are planning cuts on “hundreds of items” as early as this week in an effort to “change the chain’s high-cost...more

Hogan Lovells

FDA releases working model for Software Precertification Pilot Program

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Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The...more

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