Compliance Tip of the Day: Why Engage in Pre-acquisition Due Diligence
Compliance Tip of the Day: Bringing Predictive Analytics into Your Compliance Regime
Compliance into the Weeds: Sanctions Compliance Failures: Lessons from Harman International and Interactive Brokers
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
Compliance Tip of the Day: Assessing Internal Controls
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Compliance Tip of the Day: COSO Objective 2 - Risk Assessment
FCPA Compliance Report: Fraud Risk Management - Insights and Experiences with Peter Schablik
#Risk New York Speaker Series – Inside Behavioral Insights: Tom Hardin on Compliance at #RiskNYC
Compliance Tip of the Day: COSO Framework
#Risk New York Speaker Series: Exploring AI Risks in Compliance with Gwen Hassan
Healthcare Enterprise Risk Management
Compliance Tip of the Day: Assessing Internal Controls in International Operations
Managing Sanctions Compliance
Regulatory Ramblings: Episode 68 - Why Geopolitical Risk Matters to Compliance and Legal Staff with Mark Nuttal and Chad Olsen
FCPA Compliance Report: Amanda Carty on a Due Diligence and Risk Management
Episode 364 -- Five Strategies to Mitigate a New Risk Environment
Strengthening Compliance: Lessons From the OCC's Consent Order With Patriot Bank — Payments Pros – The Payments Law Podcast
Compliance and AI: Ali Khan on Implementing AI Risk Management Systems
Compliance Tip of the Day: Superforecasting
On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more
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
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
On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more
If your organization uses Electronic Health Records (EHRs), the recent updates to the SAFER Guidelines (Safety Assurance Factors for EHR Resilience) are essential for helping you assess the potential safety issues posed by...more
To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
On March 25, 2025, U.S. Senators Bill Cassidy, M.S. (R-LA) and Jeff Merkley (D-OR) introduced the No Unreasonable Payments, Coding, or Diagnoses for the Elderly (No UPCODE) Act (the “Bill”)....more
Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more
As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more
Editor’s Note: PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was...more
As the new year continues, it is useful to review your practice’s processes and policies to ensure that the practice operates with efficiency and remains compliant with ever-changing healthcare regulations....more
Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more
Can you remember healthcare security 20+ years ago? It seems like a different world from now. Believe it or not, the HIPAA Security Rule has barely changed since it was first enacted in 2003 and has been long overdue for a...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
As the new year begins, it is useful to review your practice’s processes and policies to ensure that the practice operates with efficiency and remains compliant with ever-changing healthcare regulations....more
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) appears to have made cybersecurity its New Year’s resolution. The first few weeks of 2025 have already brought with them proposed amendments to...more
Today’s interconnected world presents significant challenges for managing cross-border e-discovery and data breach investigations. These processes—critical for legal proceedings and cybersecurity—are often complicated by...more
The evolution of artificial intelligence (AI) has introduced systems capable of making autonomous decisions, known as agentic AI. While generative AI essentially “creates” – providing content such as text, images, etc. –...more
As the ultimate decision-maker for your organization, your governing body needs to understand compliance and appreciate the compliance risks facing the organization as well as what is needed to mitigate those risks. This...more
Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more
The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”), which enforces HIPAA, recently announced a new enforcement initiative, the Risk Analysis Initiative, in conjunction with OCR’s seventh...more
As January 20, 2025, approaches, antitrust practitioners and the business communities are searching for clues whether the incoming Trump Administration and its antitrust officials will continue the Biden Administration’s...more
A recent OIG report found that diagnoses reported in 2022 Medicare Advantage (MA) encounter data based only on health risk assessments (HRA) and HRA-linked chart reviews resulted in CMS making additional risk-adjusted...more
The cyber breach at Change Healthcare in 2024 stands out as one of the most significant cyber-attacks in recent memory. Its repercussions extend far beyond immediate industry disruptions, resonating deeply in regulatory...more
As healthcare technology continues to evolve, so does the need for robust compliance strategies to safeguard patient information and ensure the integrity of medical devices. In a joint September 19, 2024 presentation, the...more