Taxing Intelligence: AI's Role in Modern Tax Administration
LathamTECH in Focus: Move Fast, Stay Compliant
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
Daily Compliance News: August 6, 2025, The Spanking Banks Edition
AI Today in 5: August 5, 2025, The AI at the SEC Episode
Compliance Tip of the Day: M&A – International Issues
From Forest to Fortune: Navigating Workplace Ethics With Robin Hood — Hiring to Firing Podcast
Under the Radar: DOJ's Data Security Rules and Their Impact on Payments Companies — Payments Pros – The Payments Law Podcast
Adventures in Compliance: The Novels - The Valley of Fear, Introduction and Compliance Lessons Learned
Episode 381 -- NAVEX's 2025 Annual Hotline Report
12 O’Clock High, a podcast on business leadership: Building Trust and Relationships: The Power of Compliance and Ethics with Jacqui Pruet
Data Driven Compliance: Understanding the ECCTA and Its Impact on Fraud Prevention with Vince Walden
Daily Compliance News: August 1, 2025, The All AI Edition
AI and the False Claims Act
Compliance Tip of the Day: AI, Continuous Monitoring and Compliance
Disparate Impact & Enforcement Rollbacks: What’s the Tea in L&E?
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
Compliance Tip of the Day: AI and 3rd Party Risk Management
Daily Compliance News: July 31, 2025 the Forgotten Generation Edition
A New Brand of Uncertainty? — PE Pathways Podcast
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...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
In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...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
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more
Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more
On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
In December 2024, New York Governor Kathy Hochul signed into law two bills (A8872A and S2376B; collectively, the “Bills”) that amend New York’s Data Breach Notification Law. The Bills introduce a maximum thirty-day timeframe...more
On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...more
Like many companies in other sectors, Life Sciences companies recognize that corporate social responsibility (CSR)–evaluated and measured by independent rating organizations and based on their compliance with any applicable...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
McDermott’s cross-functional team of life sciences professionals present the inaugural Bay-Area Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. ...more
This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more