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Life Sciences Machine Learning Innovative Technology

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

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As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Hogan Lovells

FDA permits pre-approval for changes to AI devices via Predetermined Change Control Plans

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Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more

Troutman Pepper

Harnessing Generative AI: Innovations and Best Practices — 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 episode of The Good Bot, host Brett Mason is joined by Alison...more

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

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For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with...

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Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Igor Jablokov, an entrepreneur, former IBM director, and pioneer of the artificial intelligence industry who has been involved in several...more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

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Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

American Conference Institute (ACI)

How Can Companies Tackle Europe’s AI and Data Protection Rules?

Life science companies will have to grapple with unique questions in complying with the European Artificial Intelligence Act, including the scope of the law’s research exemption and the use of AI in personalized medicine and...more

American Conference Institute (ACI)

Operationalizing the EU AI Act: Five Compliance Steps to Take Now

Now that the European Union’s Artificial Intelligence (AI) Act has entered into force, the real work begins putting its obligations into practice. This article explores five compliance steps to take now to operationalize the...more

Troutman Pepper

Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — 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 Brent Hoard and Andrea...more

Orrick, Herrington & Sutcliffe LLP

Generative AI and Health Care: Key Takeaways

Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more

Blank Rome LLP

Tech-enabled Services in Healthcare – Challenges and Opportunities with Artificial Intelligence and Machine Learning

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In this episode of BRight Minds in Healthcare Delivery, Blank Rome partner Alex C. Nisenbaum talks with Rajni Natesan, MD, MBA, Chief Executive Officer of Clarified Precision Medicine, about how technology is rapidly changing...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

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

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

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

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

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Husch Blackwell LLP

Avoiding the Landmines on the Path to HealthTech Innovation

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Every year, I look forward to the SXSW Interactive Health & MedTech Track, which showcases and explores the future of healthcare technology being created by innovators, entrepreneurs, and tech enthusiasts. This year is no...more

Husch Blackwell LLP

Closing the Gap: Medical Device Innovation, Frontline Healthcare Workers, and the Role of AI

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The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by Southwest Conference (SXSW),...more

Morrison & Foerster LLP

Artificial Intelligence in Healthcare: New Avenues for Liability

Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more

Whiteford

New CMS Guidance on Use of Algorithms and AI in Prior Authorizations and Utilization Management

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Use of algorithms and artificial intelligence (AI) in prior authorization and utilization management is facing growing criticism and litigation. Notable lawsuits include alleged automatic authorization denials for tests that...more

Robinson+Cole Data Privacy + Security Insider

HHS Addresses the Growing Influence of Artificial Intelligence in Health Care

Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform­ its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions,...more

Polsinelli

Biden’s October 30, 2023, Executive Order on AI: Key Takeaways for Health Care Stakeholders

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The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI...more

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