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Artificial Intelligence Healthcare Regulatory Requirements

Alston & Bird

New Maryland Law Regulates Use of AI in Health Care Utilization Management Reviews

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Our Health Care Group discusses what businesses need to know about a new law in Maryland that creates new requirements for health plans’ use of artificial intelligence in making coverage and treatment decisions....more

Holland & Knight LLP

New Illinois Law Restricts Use of AI in Mental Health Therapy

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Illinois has become one of the first states to formally regulate the use of artificial intelligence (AI) in therapy and psychotherapy services. Enacted Aug. 1, 2025, the Wellness and Oversight for Psychological Resources Act...more

Sheppard Mullin Richter & Hampton LLP

So You Want to Start a Concierge Medicine Practice? Here are Five Key Legal Considerations

With increased consolidation of traditional medical practices and declining reimbursement rates, many physicians are turning to alternative models like concierge medicine to preserve their independence. Concierge medicine...more

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Knobbe Martens

Cardiosense Obtains FDA Clearance for Wearable Cardiac Sensor

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Cardiovascular disease is a leading cause of death, with over 900,00 deaths reported in the United States in 2023. In this context many companies have pursued products to help diagnose or sense heart activity. In the last few...more

The Volkov Law Group

Episode 382 — AI Legal Compliance and Governance

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Given the real and significant potential benefits of AI, companies have to be careful in the rush to implement AI technology. Starting with a clear use case, companies have to weigh the potential benefits of AI technology and...more

Epstein Becker & Green

The AI Doctor Is Out? How California’s AB 489 Could Limit AI Development in Healthcare

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California’s Assembly Bill 489 (“AB 489”) signals more than just a tweak to existing healthcare law—it’s a glimpse into how the next generation of regulation may shape the future of AI development and deployment in...more

Jones Day

Coming January 2026: CMS Launches AI Program to Screen Prior Authorization Requests for Treatments

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New CMS program, WISeR, will leverage third parties to screen prior authorization requests using technologically enhanced processes....more

Quarles & Brady LLP

Risks and Regulations with the Use of AI in Behavioral Health

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As some studies estimate that nearly 23% of the adult population lives with a mental illness, the integration of artificial intelligence (AI) into mental health care has transformative potential in terms of accessibility,...more

Benesch

Dental/DSO Intelligence Monthly Report: July 2025

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As government scrutiny of the healthcare industry intensifies, enforcement agencies are casting wider nets to recover funds based on narrowly interpreted violations. This puts not only healthcare providers but also those...more

Verrill

Legal Readiness for AI in Healthcare: A Provider’s Quick Guide

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Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more

A&O Shearman

AI in healthcare: Legal and ethical considerations in this new frontier

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Can human beings cure all diseases in our lifetime? For centuries, humanity has strived to cure diseases. With the advent of Artificial Intelligence (AI), the dream of a disease-free world seems more attainable than ever...more

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

NAVEX

AI in Healthcare: Why Compliance Can’t Afford to Fall Behind

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The healthcare sector is rapidly embracing artificial intelligence (AI), from predictive diagnostics and clinical decision support to patient engagement and operational automation. With this innovation comes an urgent...more

Polsinelli

Regulatory Trend: Safeguarding Mental Health in an AI-Enabled World

Polsinelli on

Key Takeaways: New York is the first state to enact mental health-focused statutory provisions for “AI Companions,” requiring user disclosures and suicide prevention measures for emotionally interactive AI systems....more

Clark Hill PLC

Right To Know - July 2025, Vol. 31

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Texas Limits Punitive Damage Liability For Data Security Breach...more

Sheppard Mullin Richter & Hampton LLP

Countdown to 2026: What Will the Texas AI Law Mean for Businesses?

Texas is getting into the AI action, with a new law (the Texas Responsible Artificial Intelligence Governance Act) that will place restrictions not only on AI use by government agencies, but businesses as well. In particular,...more

MoFo Life Sciences

Key Developments in MedTech M&A: Momentum Despite Macroeconomic Uncertainty

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2024 was a challenging year for M&A activity in the medical technology (“MedTech”) industry. Although some sectors experienced a rebound in deal volume, MedTech dealmakers were disproportionately affected by a difficult...more

Robinson+Cole Data Privacy + Security Insider

Mastering Information Governance with the ARMA IGIM 2.1 Framework: Part 2 – Building the Foundation

Last week, we introduced you to the ARMA IGIM Framework. What’s next? Every successful Information Governance (IG) program starts with a strong base....more

Littler

Texas Governor Signs Host of Bills Impacting Employment

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Biennially, the Texas Legislature convenes from mid-January to June, to introduce, debate, and pass new laws impacting Texans across the state. Texas Governor Greg Abbott’s deadline to sign pending bills passed on June 22,...more

Fenwick & West LLP

The Buzz Around Femtech at New York Tech Week 2025

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The femtech sector's evolution presents opportunities for tech, healthcare, and life sciences companies that are both vast and largely untapped. What began as a narrow focus on period-tracking applications has blossomed into...more

Jackson Lewis P.C.

When Minor Variations in Prompts Lead to Problematic Outputs

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The Senate recently voting 99-1 to remove a 10-year moratorium on state regulation of AI says something about the impact of AI, but also its challenges. A new MIT study, presented at the ACM Conference on Fairness,...more

McGuireWoods LLP

Insights From the 21st Annual McGuireWoods Healthcare Private Equity and Finance Conference Part 5: Digital Health

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The McGuireWoods Healthcare Private Equity and Finance Conference brings together leading investors, operators and advisers to explore trends shaping the healthcare deal making landscape. With a focus on actionable insights...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 6, June 2025

Cybersecurity and Infrastructure Security Agency (CISA), National Security Agency’s Artificial Intelligence Security Center (NSA AISC), and the FBI have issued new AI data security guidelines. These new guidelines are aimed...more

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