News & Analysis as of

Healthcare Risk Management

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

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

Whiteford

Employment Law Update: Maryland’s Restrictions on Non-Compete Agreements for Healthcare Professionals, Among Other Employment...

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As of July 1, 2025, Maryland prohibits or restricts non-compete provisions for nearly all healthcare professionals. The prohibition applies to individuals: (1) required to be licensed under the Maryland Health Occupations...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

Polsinelli

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

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

Holland & Hart LLP

Navigating Utah's Expanded Peer Review Privilege: A Roadmap for Healthcare Providers

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The term “peer review privilege” generally refers to a discovery and evidentiary privilege that can be asserted by hospitals and other healthcare entities to protect the confidentiality of credentialing, quality improvement,...more

Alston & Bird

New York Department of Health Issues Urgent Cybersecurity Warning Following U.S. Strikes on Iranian Nuclear Facilities

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The New York State Department of Health has issued an urgent cybersecurity advisory (the Advisory) warning of increased threat levels and a higher likelihood of cybersecurity attacks from Iranian state-backed actors following...more

MG+M The Law Firm

New Study Suggests Human Gut Bacteria May Aid in PFAS Absorption

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A recent study published in Nature Microbiology by researchers at the University of Cambridge revealed that certain human gut bacteria may have the capacity to bioaccumulate per- and polyfluoroalkyl substances (PFAS) and...more

Sheppard Mullin Richter & Hampton LLP

Key Insights from Sheppard Mullin and Marsh McLennan’s Webinar on Navigating Healthcare Risks in a Rapidly Evolving AI Landscape

On June 10th, Sheppard Mullin partner Carolyn Metnick and associate Esperance Becton, in collaboration with Marsh McLennan, presented the CLE webinar, “Navigating Healthcare Risks in a Rapidly Evolving Patient and Provider...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

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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

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

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

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

Epstein Becker & Green

HealthBench: Exploring Its Implications and Future in Health Care

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As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...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

Dentons

Ep. 65 – Don’t Make This Mistake When Using Physician Compensation Benchmarks

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Physician compensation benchmarks like those from the Medical Group Management Association (MGMA) or the American Medical Group Associations) AMGA are commonly used in the healthcare industry. Organizations lean on them for...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

Mitratech Holdings, Inc

Recap: Building a Responsible AI Program — A Practical Framework for Legal and Risk Teams

You’ve heard the buzzwords: agentic AI, generative models, governance frameworks, risk mitigation… But what does any of that actually look like when you’re in-house and trying to lead an organization through the AI shift,...more

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