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
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
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
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
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
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
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
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
The most successful compliance programs are constantly evolving and always in motion. They are both action-oriented and flexible. How do you build a program that’s action-oriented and flexible? You implement a detailed work...more
For the year ending September 30, 2023, federal False Claims Act settlements and judgments exceeded $2.5 billion, much of which came from the health care industry. The largest, at over $487 million, stems from a finding by a...more
New York has released proposed cybersecurity regulations for hospitals. The regulations, which were published in The State Register on Dec. 6 and will undergo a 60-day public comment period ending on Feb. 5, are designed to...more
Report on Patient Privacy 23, no. 10 (October, 2023) By 2016, it should have been clear to HIPAA covered entities that a security risk analysis—and corresponding risk management plan—were compliance basics. Yet, a new...more
Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...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
Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more
Illinois Supreme Court Allows Massive Damages in Biometric Privacy Cases - “The case involves Ohio-based fast-food company White Castle.” Why this is important: Illinois has the strictest biometric privacy law in the...more
The New Year energizes us to plan for success in the coming months. To increase the odds of meeting your business goals, we suggest taking a quick inventory of legal risks and brainstorming corrective actions for 2023...more
Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more
There is no such thing as compliance with the NIST Cybersecurity Framework (FTC). In September, the FTC dispelled a commonly held misconception regarding the NIST Framework: It “is not, and isn’t intended to be, a standard or...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
In a recent newsletter, the Office for Civil Rights (OCR) encourages health care organizations to review their procedures around authentication and “ensure that they have the appropriate safeguards in place.”...more
It has been over three years since the Centers for Medicare and Medicaid Services (CMS) announced its proposed rule and guidance on the development and implementation of Accountable Care Organizations. About four million...more