AI and the False Claims Act
Compliance Tip of the Day: AI and 3rd Party Risk Management
FCPA Compliance Report: 10 Core Principles for Effective Internal Investigations with Michelle Peirce
Compliance Tip of the Day: Strategies for Embedding Compliance into your Organization
Compliance into the Weeds: Sanctions Compliance Failures: Lessons from Harman International and Interactive Brokers
Sanctions Compliance Failures: Lessons from Harman International and Interactive Brokers
Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Compliance Tip of the Day: COSO Governance Framework: Part 4, Culture
Compliance Tip of the Day: COSO Governance Framework: Part 1, Introduction
Compliance Tip of the Day: Internal Control Deficiencies
FCPA Compliance Report: Stay the Course: Ellen Lafferty on Navigating Anti-Corruption Compliance in 2025
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
Compliance Tip of the Day: Assessing Internal Controls
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Compliance Tip of the Day: COSO Objective 4 - Control Information and Communication
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Compliance Tip of the Day: COSO Objective 3 – Control Activities
Compliance Tip of the Day – COSO Objective 1 – Control Environment
Compliance Tip of the Day: Code of Conduct as an Internal Control
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...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
On September 24th and 25th, the National Institute of Standards and Technology (NIST) convened a symposium to generate new insights about the next steps needed to unleash AI innovations that will enable trust in this...more
The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more
In November 2018, Missouri voters passed Amendment 2, setting in motion state regulated medical marijuana. Over the last month, the Missouri Department of Health & Senior Services (DHSS) began approving license applications...more