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Orrick, Herrington & Sutcliffe LLP

The EU AI Act: What Life Sciences and Digital Health Companies Should Know

This update is part of our EU AI Act Series. Learn more about the EU AI Act here. Life sciences and digital health companies face obligations under the AI Act that vary depending on how they use AI – and the level of risk...more

Cooley LLP

Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

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Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more

DLA Piper

FemTech and the use of AI

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Due to an exponential growth in the investment in female health and wellbeing, Forbes and Dealroom reported that 2023 saw 1.14 billion USD raised collectively across 120 deals in ‘FemTech’. ...more

Ballard Spahr LLP

Life Sciences Industry Update: 2024 Mid-Year Report

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ARTIFICIAL INTELLIGENCE IN LIFE SCIENCES - Life sciences companies are forming AI-driven strategic collaborations with tech giants, creating synergy that promises to revolutionize the industry. Companies like NVIDIA,...more

Epstein Becker & Green

Unpacking Averages: Is It Too Soon to Study the Postmarket Experience of AI-Driven Medical Devices?

I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Wilson Sonsini Goodrich & Rosati

FDA Publishes Machine Learning Transparency Guiding Principles for Medical Devices

Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more

Foley & Lardner LLP

The Rise of GenAI in Personalized Medicine and Beyond

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GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more

Foley & Lardner LLP

Global Growth In GenAI Patenting Activity

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Between 2014-2023, China has filed more patent applications (38,000) covering Generative AI (GenAI) technology than another other country, six times more than second place United States, as reported by the World Intellectual...more

Troutman Pepper

The FDA's Response to AI Medical Innovation — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

Goodwin

Eight on AI: Quick Considerations on Patenting Drug Discovery Therapeutics using Artificial Intelligence (AI) and Life...

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Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

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The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

McDermott Will & Emery

International News: Spotlight on Innovation - Issue 60

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Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including: - The EU’s new Unified Patent Court...more

Fenwick & West LLP

Balancing AI-Powered Drug Discovery’s Risk and Reward

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AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more

Manatt, Phelps & Phillips, LLP

The Transformative Potential of AI in Health Care Delivery & Administration

An effective AI governance model will allow health systems to take advantage of innovative technologies, while mitigating risks to patients. There have been a lot of attention-grabbing headlines about AI replacing physicians,...more

Epstein Becker & Green

Unpacking Averages: Growth of AI/ML in Medicine as Evidenced by Clinical Trials

Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA. ...more

Manatt, Phelps & Phillips, LLP

Developing Effective Artificial Intelligence Governance Models - Key Insights for Health Systems

Introduction - The recent explosion of artificial intelligence (AI) innovation allows us to begin to imagine a world where patients don’t need a “second opinion” because the first is informed by a near-instantaneous...more

Troutman Pepper

Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this introductory episode, Brett is joined by Morgan Hague from...more

Fenwick & West LLP

Silicon Alley: 15 Must-Know Facts about NY's Tech Community

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As we countdown to NY Tech Week in just 15 days, here are 15 facts about the city's dynamic tech ecosystem....more

Manatt, Phelps & Phillips, LLP

Health Care, AI and Antitrust: Analysis and Next Steps

As artificial intelligence (AI) continues to permeate the health care industry (and every other part of American life), the industry should be attentive to the risk of anticompetitive conduct arising from reliance on AI and...more

Spilman Thomas & Battle, PLLC

Decoded Technology Law Insights, V 5, Issue 4, May 2024

MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more

Manatt, Phelps & Phillips, LLP

Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more

Robinson & Cole LLP

Health Law Diagnosis - April 2024

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Additional States Implement Notice Requirements for Healthcare Transactions - In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions....more

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

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As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Troutman Pepper

New FDA Guidance on AI and Medical Products

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n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

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