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Health Care Compliance & Regulatory

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Overview

Participants in the complex, heavily regulated health care industry must comply with an ever-changing framework of regulations. Leveraging legal, consulting, government advocacy and policy experience, we bring in-depth knowledge and real-world action plans to address the federal and state requirements that impact your organization’s growth, operations and ability to serve your patients and your communities. We help assess and mitigate regulatory and compliance risks, reduce exposure and resolve compliance issues. We guide you through fraud investigations, whistleblower lawsuits, Stark and Anti-Kickback Statute voluntary disclosures, Medicare and Medicaid reimbursement audits, investigations and voluntary refunds. We also assist with investigations and reporting of HIPAA and other privacy law breach issues, including ransomware and malware attacks. And, as the health care industry continues to enhance its digital presence, we advise on evolving regulatory issues regarding e health, telemedicine and other forms of remote health care service delivery.

Insights & Events

Insights
May 2025

The Hidden Dangers of Alternative Funding Programs

1 min read  
Updates April 2025

Data Security Program, Medicare Advantage, Colorado Insurance Requirements & More

Artificial Intelligence Briefing
8 min read  
Updates April 2025

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

Biopharma & Medical Devices Briefing
5 min read  
Updates April 2025

DOJ Releases New Key Guidance on Its Data Security Program (DSP)

Substantial Compliance Obligations Related to Certain Foreign Transactions Involving Sensitive Personal and Government Data
16 min read  
Updates April 2025

Federal Court Strikes Down CMS Nursing Home Staffing Mandate

What’s Next for Operators & Investors?
5 min read  
Updates March 2025

The Latest on Pharmaceutical Company-Sponsored Diagnostic Testing Programs

OIG’s Second Favorable Opinion Regarding Free Genetic Testing and Counseling: Advisory Opinion No. 24-12
8 min read  
Updates March 2025

Trump’s EO Seeks to Eliminate ‘Unconstitutional’ Regulations; EU Commission Scraps AI Liability Directive; Lawsuit Alleges Racial Discrimination by Meta’s Ad Algorithms for Higher Education; and More

Artificial Intelligence Briefing
7 min read  
Updates March 2025

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

After the Department’s Recission of the Richardson Waiver, Drug and Device Industry Loses Powerful Check Against FDA Overreach
6 min read  
Updates March 2025

NIH Funding Guidance; FDA Reinstates Key Staff Amid Industry Pressure; Make America Healthy Again Commission; and the Latest on Tariffs

Biopharma & Medical Devices Briefing
7 min read  
Updates February 2025

Major Changes Proposed for Health Care Transactions in Indiana: From Attorney General Notice to Approval by State Merger Board

Indiana House Bill 1666 and Proposed ‘Health Care Entity Merger Approval Board’
9 min read