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Cleveland Manufacturer Violated OFAC Sanctions By Allowing Shipments To Iran - Know Your Customer and Know Their Customer

Client Alert

Between 2013 and 2017, UniControl exported 21 shipments of its products to two European customers. These 21 shipments were subsequently reexported to Iran, which violated the Iranian Transactions and Sanctions Regulations (“ITSR”) listed in 31 CFR Part 560.

WARNING SIGNS

UniControl encountered multiple alerts before and during this period and failed to take proper actions. In 2010, several years prior to the first of these shipments, a European trade partner of UniControl inquired whether UniControl could supply a significant market it had identified in Iran. UniControl turned down the opportunity but did not confirm that the sales to this European partner were not then being shipped to the Iranian market.

In 2014, UniControl and a European customer entered a sales agreement that listed Iran as a country to which the partner could re-sell these products. In 2016, UniControl offered to ship products directly to a purported third-party European end user, but the customer refused this offer in an attempt to obfuscate the end user. At European trade conferences, UniControl had direct interactions with Iranian nationals, but did not question their European trade partner on the interest. Finally, UniControl received a request from its European partner to remove the “Made in USA” labels from its products with the explanation that the Iranian end user may have issues with the product origin.

FIXING THE PROBLEM

UniControl consulted with outside counsel and then voluntarily self-disclosed these violations. In total, UniControl engaged in 21 prohibited transactions with a total product value of $687,189. The maximum statutory penalty that UniControl faced was $5,423,766. However, once all mitigating and aggravating factors were weighed, UniControl was able to reach a settlement with OFAC for $216,464.

Parallel to UniControl’s cooperation with OFAC and ceasing all shipments to its European trade partners, the company also righted its own “compliance ship.” This began by retaining outside counsel to strengthen their export control procedures. End-user certificates were created to make sure that buyers are not reselling to prohibited end users. These certificates are also requested from second and third level buyers of reexported products. UniControl added a Destination Control Statement within the footer of many of their trade documents to remind recipients of the restrictions on reselling, transferring, manipulating, or otherwise disposing of their products.

For a review of your export policies and processes, or questions on trade compliance, please contact International Law Attorney Kevin Burwell at kdburwell@bmdllc.com or 330-253-3715. 


Ohio House Bill 537: Proposed Regulations for Midwives and Birthing Centers

House Bill 537, introduced in the Ohio House of Representatives, proposes a comprehensive regulatory framework for certified nurse-midwives, certified midwives, licensed midwives, and traditional midwives. The legislation would clarify scope of practice, establish licensure standards, and impose new requirements for freestanding birthing centers and home births. Healthcare providers and facilities should be aware of the proposed changes and their potential operational impact.

Proposed Health Information Privacy Reform Act Expands Protections Beyond HIPAA

The Health Information Privacy Reform Act (HIPRA) seeks to extend privacy protections to health data not covered under HIPAA, including data collected by apps and wearables. HIPRA introduces broader definitions of protected health information, strengthens privacy and security requirements, establishes patient notification rights, and sets national de-identification standards. Companies processing health data should monitor developments to ensure compliance.

Medicare Updates on Skin Substitutes: LCDs Withdrawn, Payment Changes Take Effect

Medicare’s planned Final Local Coverage Determinations (LCDs) for skin substitutes were withdrawn in late December 2025, meaning previous coverage rules remain in effect. The 2026 Medicare Physician Fee Schedule introduces a single payment rate of approximately $127.14 for these products. Providers should review implications for diabetic foot and venous leg ulcer treatments.

Understanding the Seven Core Elements of an Effective Healthcare Compliance Program

The Affordable Care Act requires healthcare providers participating in Medicare, Medicaid, and CHIP to maintain an effective compliance program. Guidance from the Department of Health and Human Services and the Office of Inspector General outlines seven core elements that form the foundation of these programs, from written policies and compliance oversight to auditing, training, and corrective action. This alert highlights each element and explains how practices can tailor compliance programs to their size and risk profile while meeting federal expectations.

Preventing a Board Investigation

Healthcare professionals in Ohio are subject to licensing board investigations that can lead to disciplinary action. Staying compliant with regulations, documenting carefully, and operating within your professional scope can help prevent issues. If contacted by a board, working with an attorney is critical to protect your license and rights.