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Healthcare Reform › Regulatory Requirements › Risk Management

Verrill

Legal Readiness for AI in Healthcare: A Provider’s Quick Guide

Verrill on

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

Baker Donelson

Tennessee Allows Hospital-Based Physician Employment and Licensure of Anesthesiologist Assistants

Baker Donelson on

Tennessee Governor Bill Lee signed House Bill No. 979 into law on May 21, 2025, enacting significant changes to Tennessee's corporate practice of medicine prohibition. Prior to this law, certain hospital-based physicians –...more

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

White & Case LLP

Life Science Private Equity Risk

White & Case LLP on

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

Health Care Compliance Association (HCCA) on

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

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

McDermott+ on

This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more

McDermott Will & Schulte

FDA, OHRP Issue Joint Guidance on Collection of Tissue Biopsies in Clinical Trials

McDermott Will & Schulte on

On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

Butler Snow LLP on

Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

McDermott Will & Schulte

[Ongoing Program] Precision Health: Trends And Future Potential - Possibilities and Pitfalls: Reimbursement and Regulatory Issues...

McDermott Will & Schulte on

Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more

Polsinelli

Changes Coming For Prescribers To The Texas Prescription Drug Monitoring Program

Polsinelli on

In response to the opioid epidemic, many states, including Texas, created prescription drug monitoring programs to monitor high-risk patients and provider behaviors. The Texas Prescription Drug Monitoring Program (“PMP”) is...more

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