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Risk Management Compliance 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

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

ArentFox Schiff

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

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On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

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In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...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

Dentons

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

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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

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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

Dentons

Ep. 67 – Integrating Quality & Safety into Your Compliance Program (Replay of Ep. 18)

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If you’re trying to strengthen your organization’s compliance program, one of the most important recommendations from the Office of Inspector General’s (OIG) General Compliance Program Guidance is to integrate quality and...more

Dentons

Ep. 66 – Mid-year Compliance Check-in: Three New Enforcement Priorities to Add to Your 2025 Work Plan

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As we hit the halfway point of 2025, now is the perfect time to revisit your compliance work plan. While it’s always good practice to assess whether your organization is meeting its compliance goals, this year presents a...more

Foley & Lardner LLP

HIPAA Compliance Risks with AI Scribes in Health Care: What Digital Health Leaders Need to Know

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AI scribes are quickly becoming the digital sidekick of modern health care. They promise to reduce clinician burnout, streamline documentation, and improve the patient experience. But as health care providers and digital...more

Holland & Knight LLP

Podcast: Addressing Patient Complaints About Privacy Violations

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In the third and final episode of Florida Capital Conversations' healthcare privacy series, Tallahassee attorneys Shannon Hartsfield and Eddie Williams join hosts Nathan Adams and Mia McKown to discuss the challenges of...more

Dentons

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

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In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

Dentons

Ep. 62 – Encore Episode: Be a Problem Solver, Not a Prosecutor

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The compliance officer is one of the most important positions within a healthcare organization, but also one of the most challenging. You’re expected to be a teacher, a coach, a project manager, a good listener, and a role...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Health Care Compliance Association (HCCA)

Advancing shared accountability to reduce regulatory burden, promote well-being

Introduction: A different perspective - Within the compliance profession, Cecilia Fellouse has noted, “Under the weight of incessant regulatory demands, individuals and teams often fall prey to compliance fatigue. This...more

Dentons

Ep. 58 – Addressing Potential Discrimination in Patient Care Decision Support Tools

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Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more

Hinshaw & Culbertson - Health Care

Beyond the Glow: Key Medical Spa Compliance Challenges and Legal Pitfalls

The medical spa industry is rapidly growing, driven by technological advances and shifting consumer preferences for cosmetic and wellness services. While this growth offers many business opportunities for healthcare...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

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The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Axinn, Veltrop & Harkrider LLP

Axinn Associates at the Spring Meeting: Considerations on Data Privacy and AI Usage for Healthcare Companies

The February 2024 ransomware attack on Change Healthcare was the largest healthcare data breach in U.S. history. The attack disrupted operations—impacting patient care and provider finances—and potentially exposed the...more

Akerman LLP - HR Defense

Hospital Leaders: Are You Fully Prepared For the Rising Wave of H-1B Onsite Inspections in Healthcare Systems Nationwide? Let’s...

In recent months, hospitals and healthcare systems across the country have seen an increase in random and unannounced worksite inspections by immigration officers, particularly targeting H-1B nonimmigrant worker visa holders....more

Robins Kaplan LLP

The Robins Kaplan Justice Report - Vol. 19, No. 1 - March 2025

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A recent $2.75 million settlement by Robins Kaplan LLP has drawn attention to a troubling case of deliberate indifference to medical needs at Anoka County Jail (the “Jail”). Deyonta Green, who struggled with addiction issues,...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Troutman Pepper Locke

DOJ Addresses AI in Corporate Compliance Programs — The Good Bot Podcast

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Join Troutman Pepper Locke Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this episode of The Good Bot, Brett Mason and attorneys Michael S....more

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