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Machine Learning Healthcare Regulatory Requirements

Gardner Law

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

Gardner Law on

On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 2, February 2025

Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Husch Blackwell LLP

Virginia Legislature Passes High-Risk AI Developer and Deployer Act

Husch Blackwell LLP on

Keypoint: Virginia becomes the second legislature – after Colorado – to pass an algorithmic discrimination bill – although the bill still needs to get through the state’s Republican governor to become law. On February 20,...more

Mintz Edge

The State of the Funding Market for AI Companies: A 2024 - 2025 Outlook

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Artificial intelligence (AI) has emerged as an influential technology, driving notable investments across various industries in recent years. In 2024, venture capital (VC) funding for AI companies reached record levels,...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

Polsinelli on

With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

Gardner Law

Breaking the Ice: FDA-Focused Firm Leader Sees Benefits in AI

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Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations....more

DLA Piper

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

McDermott Will & Emery

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

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In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

Ankura

Enhancing Cross-Border e-Discovery and Data Breach Investigations with AI

Ankura on

Today’s interconnected world presents significant challenges for managing cross-border e-discovery and data breach investigations. These processes—critical for legal proceedings and cybersecurity—are often complicated by...more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Sheppard Mullin Richter & Hampton LLP

Texas Considers Comprehensive AI Bill

Texas is joining a growing number of states in considering comprehensive laws regulating use of AI. In particular, the Texas Legislature is scheduled to consider the draft “Texas Responsible AI Governance Act” (the “Act”),...more

Foley & Lardner LLP

The Intersection of Agentic AI and Emerging Legal Frameworks

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The evolution of artificial intelligence (AI) has introduced systems capable of making autonomous decisions, known as agentic AI. While generative AI essentially “creates” – providing content such as text, images, etc. –...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Sheppard Mullin Richter & Hampton LLP

California Passes Law Regulating Generative AI Use in Healthcare

On September 28, 2024, Governor Gavin Newsom signed into law California Assembly Bill 3030 (“AB 3030”), known as the Artificial Intelligence in Health Care Services Bill. Effective January 1, 2025, AB 3030 is part of a...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 6, July 2024

Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business....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

Sheppard Mullin Richter & Hampton LLP

Artificial Intelligence Highlights from FTC’s 2024 PrivacyCon

This is the second post in a two-part series on PrivacyCon’s key-takeaways for healthcare organizations. The first post focused on healthcare privacy issues. This post focuses on insights and considerations relating to the...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

Troutman Pepper Locke

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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