The U.S. Department of Justice’s Antitrust Division has intensified its scrutiny of healthcare platforms that integrate doctors with insurers, data, and other assets. Assistant Attorney General Jonathan Kanter described this trend as an “alarming” concentration of resources. In a significant move, the DOJ announced the establishment of the Task Force on Health Care Monopolies and Collusion. Kanter emphasized during a Washington Post Live event that...

It may seem like a Herculean task — but it can be done.  I regularly opine that mitigating sanctions risks for your third-party population is an easier task than doing so for your anti-corruption risks.  One big reason — geography is an important limiter on sanctions risks.  The ability to evade sanctions has to be financially practicable — for example, it makes no sense to...

While OFAC’s enforcement actions and guidance points to important steps exporters must take when relying on third-party distributors and other intermediaries, the “reason to know” and affirmative obligations to monitor resale and distribution of products to ultimate users does not appear to be unreasonable or impractical.  In terms of best practices, these are issues that need to be addressed. The supply chain and third-party risk...

Sorry to start a four-part series with a reference to music from our long-ago past.  The Four Tops sang the “Same Old Song, with a Different Meaning” (released in 1965 — Video Here). So, how does that relate to third-party risks?  Well, bear with me here for a little. Legal and Compliance bloggers, compliance vendors, prognosticators, Compliance Podcasters, and everyone in the Paparazzi have written,...

On April 29, 2024, the U.S. Department of Commerce officially published a final rule in the Federal Register that formally incorporates a medical device license exception into the Export Administration Regulations (“EAR”) for certain commodities bound for the Russian Federation, Belarus, and occupied regions of Ukraine.  New license exception MED—located at 15 C.F.R. Section 740.23—now authorizes the export, re-export, and transfer (in country) of certain EAR99...

By: Daniela Melendez, Associate at The Volkov Law Group, and Alex Cotoia, Regulatory Compliance Manager. Daniela can be reached at [email protected] and Alex can be reached out at [email protected]. On April 24, 2024, the European Union (“EU”) officially adopted Directive (EU) 2024/1226 on the definition of criminal offenses and penalties for the violation of Union restrictive measures and amending Directive (EU) 2018/1673 (the “Directive”). A copy of the...

In this new aggressive era of sanctions and export controls enforcement, companies need to understand the potential risks that DOJ and/or OFAC may identify a company for sanctions investigation. In a global economy, investigators from various countries have built coordination procedures by which they share intelligence and possible leads among each other.  This phenomena has created a complex web of investigators who can identify relevant...