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Gardner Law

The EU Data Act Has Arrived

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The EU AI Act has arrived, and the countdown to compliance is on. As of August 2, 2025, penalties, including administrative fines, are in force. ...more

Jackson Lewis P.C.

Florida AHCA Proposed Rules Would Establish New Breach Reporting, Continuity Planning Requirements

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On September 17, 2025, the Florida Agency for Health Care Administration (AHCA) will hold its first public meeting to discuss proposed rules designed to enhance transparency and preparedness around health care information...more

Gardner Law

Cybersecurity and the FCA: Illumina Signals "No Breach" Enforcement Risks

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A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to...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

Health Care Compliance Association (HCCA)

‘We Cannot Do It Alone’: Cutbacks in Federal Funds, Engagement Spur Cries for HIPAA Help, New Laws

At the very top of Fisher-Titus Medical Center’s website is a link to the Change Healthcare HIPAA notice informing visitors of the last day to register for credit monitoring related to the world’s largest breach, which...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

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

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

Greenbaum, Rowe, Smith & Davis LLP

Navigating New Jersey’s Medical Spa Regulatory Landscape: Key Compliance and Risk Management Considerations

The medical spa industry is thriving, but with growth comes complexity, particularly in New Jersey where healthcare and professional licensing rules intersect with business and real-estate regulations. For physicians, nurses,...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

CMS Proposes New Mandatory, Two-Sided Risk Model for Heart Failure and Low Back Pain

Polsinelli on

Key Takeaways - CMS has proposed a mandatory two-sided risk model for specialists treating heart failure and low back pain in outpatient settings....more

Morrison & Foerster LLP

NIS 2: Strengthening Europe’s Cyber Defenses

European cybersecurity risk management and reporting obligations have received a substantial facelift. The Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (“NIS 2”) became effective...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

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On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Dentons

Ep. 68 – Before You Audit—Why Pre-Audit Planning Matters

Dentons on

If you’re preparing to launch an audit within your healthcare organization, pause for a moment and consider this: how well you plan before the audit begins can significantly affect the outcome—and your risk exposure. This...more

Jackson Lewis P.C.

When Minor Variations in Prompts Lead to Problematic Outputs

Jackson Lewis P.C. on

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

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

Keating Muething & Klekamp PLL

OSHA’s Updated Inspection Program: What Employers Should Know and Expect

On May 20, 2025, the Occupational Safety and Health Administration (OSHA) updated its Site-Specific Targeting (SST) inspection program. The SST inspection program is OSHA’s primary planned inspection initiative for...more

Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Foley & Lardner LLP

Risk Bearing Entity Requirements: Massachusetts

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This blog discusses the regulatory requirements that apply to risk-bearing entities in Massachusetts, including recent updates introduced by Chapter 343 of the Massachusetts Acts of 2024 (the Act). This blog is part of Foley...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Proskauer - Health Care Law Brief

CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts

On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more

MoFo Life Sciences

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

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AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more

Bradley Arant Boult Cummings LLP

Colorado’s Artificial Intelligence Act (CAIA) Updates: A Summary of CAIA’s Consumer Protections When Interacting with Artificial...

During the 2024 legislative session, the Colorado General Assembly passed Senate Bill 24-205, which is known as the Colorado Artificial Intelligence Act (CAIA). This law will take effect on February 1, 2026, and requires...more

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