Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
Compliance Tip of the Day: Avoiding CCO Liability
Compliance Tip of the Day: COSO Governance Framework - Part 5, People
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Balch’s Consumer Finance Compass: How Standing Can Make or Break Certification for Class Action Lawsuits in Debt Collection
Top challenges with Compliance Management
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
Daily Compliance News: July 15, 2025, The Fighting Workplace Bullying Edition
Compliance Tip of the Day: Design - Centric Internal Controls
Treating Compliance Like an Asset
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
#Risk New York Speaker Series – Exploring Future Regulatory Trends and Compliance Strategies with Rory McGrath
The Capital Ratio Podcast | Entering the US Banking Market
SCOTUS Clean Air Act Cases: What’s New?
First 100 Days of the New HSR Rules with Antitrust Partner Kara Kuritz
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
From Permits to Penalties: A Deep Dive Into Coastal Development Law
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
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
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
Key Takeaways - CMS has proposed a mandatory two-sided risk model for specialists treating heart failure and low back pain in outpatient settings....more
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
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
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
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
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
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
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
This blog discusses the regulatory requirements that apply to risk-bearing entities in Massachusetts, including recent updates introduced by Chapter 343 of the Massachusetts Acts of 2024 (the Act). This blog is part of Foley...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more
AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more
During the 2024 legislative session, the Colorado General Assembly passed Senate Bill 24-205, which is known as the Colorado Artificial Intelligence Act (CAIA). This law will take effect on February 1, 2026, and requires...more
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
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
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
Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more
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
In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...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
In recent months, hospitals and healthcare systems across the country have seen an increase in random and unannounced worksite inspections by immigration officers, particularly targeting H-1B nonimmigrant worker visa holders....more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more