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Regulatory Requirements Healthcare Artificial Intelligence

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

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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

Fenwick & West LLP

NY Tech Week 2025: The Future of Femtech

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Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more

Rivkin Radler LLP

Tennr’s AI Platform Targets Referral “Black Holes” with $101 Million in New Funding

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Tennr, a healthcare technology company focused on streamlining healthcare operations, recently announced the receipt of $101 million in funding. While the investment signals growing confidence in AI-enabled administrative...more

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

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The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

Foley & Lardner LLP

AI Contracts in Health Care: Avoiding the Data Dumpster Fire

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For AI companies in the health care space, data is everything. It fuels model performance, drives product differentiation, and can make or break scalability. Yet too often, data rights are vaguely defined or completely...more

Klein Moynihan Turco LLP

Let’s Be Real: AI TCPA Lawsuits Are on the Rise

Recently, an Artificial Intelligence (“AI”) Telephone Consumer Protection Act (“TCPA”) lawsuit was filed against a healthcare marketer in the United States District Court for the Northern District of Illinois. In Finley v....more

Benesch

Dialysis & Nephrology Digest - June 2025

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Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Epstein Becker & Green

HealthBench: Advancing the Standard for Evaluating AI in Health Care

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The Evolution of Health Care AI Benchmarking - Artificial Intelligence (AI) foundation models have demonstrated impressive performance on medical knowledge tests in recent years, with developers proudly announcing their...more

Sheppard Mullin Richter & Hampton LLP

The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more

White & Case LLP

AI Watch: Global regulatory tracker - Hong Kong

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Hong Kong lacks comprehensive AI legislative framework but is developing sector-specific guidelines and regulations, and investing in AI. Laws/Regulations directly regulating AI (the "AI Regulations") At present, Hong...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

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On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

McDermott Will & Emery

McDermott HealthEx 2025: McKinsey Key Takeaways

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McDermott HealthEx convened more than 1,300 of the most influential leaders in healthcare and life sciences. The event emphasized creativity, transformation, and growth, with sessions dedicated to innovation, AI-powered...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

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