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Artificial Intelligence Regulatory Agenda Healthcare

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Benesch

AI Reporter - June 2025

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The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Husch Blackwell LLP

Big News in AI Policy: Proposed 10-Year Moratorium on State AI Regulation

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Artificial intelligence (AI) continues to dominate headlines—not just for its technological leaps, but also for the policies shaping its future. In a major development, a new Republican-backed tax bill, released by the House...more

McDermott Will & Emery

Colorado Fails to Amend Groundbreaking AI Law: What Happened and What’s Next

McDermott Will & Emery on

On May 5, 2025, the Colorado Senate rejected an attempt by state lawmakers to amend Colorado’s landmark artificial intelligence (AI) law, known as Senate Bill (SB) 205. Colorado State Senator Robert Rodriguez and State...more

Holland & Knight LLP

Holland & Knight Health Dose: April 8, 2025

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Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

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In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

DLA Piper

FDA in focus: 2024 in review and 2025 outlook

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In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a global supply chain, rapid...more

Baker Botts L.L.P.

Virginia Legislature Passes First AI Bill of 2025--Now Awaits Governor's Approval

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Virginia has become the first state in 2025 to pass comprehensive artificial intelligence regulation, with lawmakers approving the "High-Risk Artificial Intelligence Developer and Deployer Act" (HB 2094). The legislation,...more

Husch Blackwell LLP

Virginia Legislature Passes High-Risk AI Developer and Deployer Act

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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

Holland & Knight LLP

Holland & Knight Health Dose: February 19, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Rivkin Radler LLP

NYS OMIG Publishes 2025 Work Plan

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On January 29, the New York State Office of the Medicaid Inspector General (OMIG) published its 2025 Work Plan, which provides a preview of the OMIG’s program integrity initiatives for the upcoming year. While this post...more

Akin Gump Strauss Hauer & Feld LLP

Private Equity Deal Activity Review & 2025 Outlook

Despite initial expectations for a strong rebound in M&A activity driven by pent-up demand, private equity managers saw a slower recovery in 2024 than initially expected, with improvement in the latter half of the year....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 2, January 2025

Welcome to our second issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the effect of the decline of DEI on the healthcare industry, the fate of Medicaid under the...more

NAVEX

Exploring California’s AI Laws

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California sets the pace for all sorts of trends in the world – so perhaps compliance officers should take note of two recent advisories the state’s attorney general published on artificial intelligence. They capture a lot...more

McDermott Will & Emery

Preparing for a New US Administration: Insights and Resources

President Donald Trump has taken office, and organizations can stay ahead of US policy changes and strategic shifts that may impact operations under the new presidential administration. McDermott’s cross-practice team, along...more

Skadden, Arps, Slate, Meagher & Flom LLP

Executive Briefing: Latest Updates on Trump Executive Actions

As Trump administration directives emerge, it’s crucial for businesses and other stakeholders to stay informed and adapt their strategies accordingly. We will provide ongoing coverage of these developments and their potential...more

ArentFox Schiff

California Claps Back on Insurer Use of AI to Deny Needed Medical Care Decisions

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California is leading the way in ensuring that determinations of medically necessary health care services are made by licensed physicians and not artificial intelligence (AI) algorithms....more

Cozen O'Connor

California Passes Flurry of Year-End AI Legislation

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In 2024, the California legislature passed 17 laws related to artificial intelligence (AI). These new laws cover various themes and industries, including but not limited to deepfakes, training data disclosures, health care,...more

Ballard Spahr LLP

Key Takeaways From the 2025 J.P. Morgan Health Care Conference

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Cautious Optimism for Deal Making. The general consensus is that we will likely see an increase in M&A and capital market transactions in the life sciences sector in 2025....more

Skadden, Arps, Slate, Meagher & Flom LLP

2025 Insights: A First Look at Trump’s Second Term

As we step into a new year, the potential shifts under a second Trump administration loom large. Our 2025 Insights publication analyzes the impacts these changes could have on both U.S. and global business environments,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

DLA Piper

Supporting the Health of your Healthcare Organization

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Private equity sponsors and their healthcare portfolio companies are expected to ride the tailwind of an M&A rebound. Long-term capital gains tax rates will likely remain unchanged, or possibly drop. As a result, sellers may...more

Goodwin

Changes Expected as Trump Administration Continues to Take Shape

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As Washington prepares for new leadership in January 2025, significant policy changes appear on the horizon. The incoming administration’s agenda suggests a substantial shift in US economic and regulatory priorities, with...more

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