News & Analysis as of

Healthcare Compliance Regulatory Requirements

McNees Wallace & Nurick LLC

Navigating Pa.’s unique IBHS licensing requirement for ABA therapy providers

Per Autism Speaks’ “Autism by the Numbers: 2025 Annual Report” (see autismspeaks.org/ABN, last visited July 20, 2025), currently one in 35 children in the United States has autism....more

Cozen O'Connor

Washington Becomes First State to Require Premerger Notification Filing

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Washington AG Nick Brown announced that Washington is the first state to require companies to file a premerger notification with the state AG’s office concurrently with the federal filing required under the Hart-Scott-Rodino...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

Sheppard Mullin Richter & Hampton LLP

What Health Equity Means for CON — and Why It Matters Now

Following Sheppard Mullin’s recent webinar on Health Equity Impact Assessments (HEIAs), one thing is clear: providers and investors cannot afford to treat equity requirements as an afterthought in the Certificate of Need...more

McDermott Will & Schulte

Key updates on the US health benefits and reimbursement landscape

The world of health benefits is constantly evolving. Recent policy shifts and legislative developments are expected to impact the economic landscape and have significant implications for employer plan sponsors, insurers,...more

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...more

Fox Rothschild LLP

Court Vacates CFPB Medical Debt Rule: Key Takeaways for Providers

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Earlier this month, the United States District Court for the Eastern District of Texas approved a consent judgment vacating the Consumer Financial Protection Bureau’s (CFPB) Medical Debt Rule. The decision holds that the CFPB...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

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...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

Polsinelli

HCBS Update: Indiana Implements Home-Grown 70/30 Direct Caregiver Compensation Requirement

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Executive Summary: On July 10, 2025, Indiana Medicaid issued guidance to providers of attendant care and structured family caregiver services requiring providers to pass through a specific percentage of their Medicaid...more

Woods Rogers

Federal Court Strikes Down HIPAA Reproductive Health Privacy Rule Lifting Compliance Requirements for Regulated Entities

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In a sweeping decision published in June, a federal court in Texas struck down most of the HIPAA Rule to Support Reproductive Health Care Privacy (Reproductive Health Rule) enacted in 2024 under the Biden administration to...more

Cranfill Sumner LLP

Navigating Stark Law and the Anti-Kickback Statute (AKS) in 2025: A Snapshot Guide for Medical Practices

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In today’s healthcare environment, compliance with federal regulations is more than a legal necessity—it’s a cornerstone of ethical and sustainable practice management. Two of the most critical laws that medical practices...more

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

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On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....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

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

McDermott Will & Schulte

Partnering with Legal at the Critical AI/Healthcare Crossroads

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

Jackson Lewis P.C.

OFCCP Extends Enforcement Moratorium for VAHBP Providers Until 2027

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In a move the Agency reported is designed to maintain healthcare access for active and retired service members and their families, the Office of Federal Contract Compliance Programs (OFCCP) has announced a two-year extension...more

Stevens & Lee

Navigating Interstate Entity Issues: Corporate Practice of Medicine and Ownership Considerations

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Health care entities, such as professional corporations (PCs) and professional limited liability companies (PLLCs) (known as “restricted limited liability companies” in Pennsylvania), encounter a complex legal analysis when...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

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