• “Bulk” Has a New Definition: The volume thresholds under the U.S. Department of Justice’s (DOJ’s) Bulk Sensitive Data (BSD) Transfer Rule are surprisingly low—sharing genomic data on just 100 people can trigger compliance requirements, catching many organizations off guard.
• HIPAA Compliance Is Not Enough: The BSD Transfer Rule creates an entirely new compliance layer that goes beyond existing privacy frameworks, such as the Health Insurance Portability and Accountability Act (HIPAA), applying even when data has been de-identified or anonymized.
• It’s About Access, Not Just Transfers: Simply giving a foreign vendor, board member, or investor the ability to view sensitive data can trigger the BSD Transfer Rule—no formal data-sharing agreement is required.

In this episode of Diagnosing Health Care^®, Epstein Becker Green attorneys Laura DePonio, Elizabeth McEvoy, and Elena Quattrone walk health care and life sciences organizations through the DOJ’s BSD Transfer Rule—from scoping and compliance to enforcement risks and exemptions.

The bill would prohibit states from establishing or maintaining dietary supplement requirements that are different from or in addition to federal requirements, unless a state successfully applies for a specific exemption from FDA preemptive authority. Such exemptions would be limited to circumstances where a state requirement is more stringent than federal law or addresses a compelling local condition without placing a product out of compliance with federal standards.

In effect, the proposed legislation reinforces a uniform national regulatory framework for dietary supplements, while preserving a narrow pathway for state involvement under FDA oversight.

The regulation currently requires the DSHEA disclaimer—which states that the product has not been evaluated by FDA and is not intended to diagnose, treat, cure, or prevent disease—to appear on each panel of a product label where a qualifying structure/function claim is made.

Based on its initial review, FDA indicated that removing the “each panel” requirement would be consistent with the DSHEA, could reduce label clutter and unnecessary costs, and would align with the agency’s historical enforcement posture, noting that the requirement has rarely, if ever, been enforced. FDA further stated that, absent significant concerns, it is likely to propose formal rulemaking to amend the regulation.

The FDA also released nearly 40 untitled letters sent to specific drug manufacturers from its Office of Prescription Drug Promotion on September 9 and 23, similarly informing them that one or more direct-to-consumer TV ads misbrands a specific drug.

These actions follow the September 9th announcement that the U.S. Department of Health and Human Services (HHS) and the FDA would be targeting “misleading” DTC pharmaceutical advertisements—the same day that a presidential memorandum directed HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin A. Makary to act.

The letters also reflect a broader shift in the FDA’s oversight of pharmaceutical advertising, particularly in DTC channels. With regulators taking a more aggressive posture across both broadcast and social media platforms, companies should be prepared for shifting regulatory requirements and heightened enforcement risk.

DOJ touts this cross-agency initiative as being designed “to aggressively pursue enforcement actions against any parties who seek to evade tariffs and other duties”—promising “robust enforcement against importers and other parties who seek to defraud the United States.”

Created to further the administration’s “America First Trade Policy” announced on January 20, 2025, the Task Force will consist of civil and criminal components of the DOJ along with U.S. Customs and Border Protection and Homeland Security Investigations. It will focus on ensuring compliance with trade laws, including payment of all tariffs and duties (e.g., antidumping and countervailing duties, Section 301 tariffs, and other customs obligations). DOJ promises increased parallel civil and criminal actions under the False Claims Act (FCA), Tariff Act, and federal criminal statutes related to trade fraud and conspiracy.

The announcement of the Pilot Program signifies the intersection of several notable policy issues upon which stakeholders of the pharmaceutical supply chain have focused over the past few years, including drug manufacturer efforts to provide 340B discounts via retrospective rebates as opposed to upfront discounts, and the January 1, 2026 ...

Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness.

On this episode, special guests Noah Voreades of OLIPOP and Ivan Wasserman of Amin Wasserman Gurnani join Epstein Becker Green attorneys Jessika Tuazon and Ada Peters to explore how food is being integrated into health care to prevent and manage chronic diseases.

Sponsored tests are medical diagnostic tests or laboratory services whose cost is directly or indirectly paid for, in whole or in part, by a third party (often a pharmaceutical manufacturer or medical device company or related company), rather than by the patient, their insurance, or the health care provider performing the test. Typically, companies agree to pay for sponsored tests because they are necessary for a patient to access or use the company’s therapy but pose high out of pocket costs on the patient. Sponsored tests are frequently used to help match a patient to a specific drug or therapy available from the pharmaceutical manufacturer or medical device company, including true companion diagnostics, or to monitor therapeutic efficacy or to identify dangerous side effects of a prescribed therapy.  

The OIG previously issued two opinions, AO 24-12  and AO 22-06, that approved sponsored test arrangements in which pharmaceutical manufacturers offered free genetic testing and genetic counseling services to patients suspected of having rare conditions for which the manufacturers produced approved medications. Under the facts in these opinions, the genetic test results alone did not directly determine whether the manufacturer's drug would be prescribed.

The court’s judgment vacates the agency’s controversial final rule of May 6, 2024 (the “Final Rule”), regulating LDTs as medical devices, just weeks before the Final Rule’s initial implementation deadline and remands the issue back to the FDA for further consideration.

How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health agency funding cuts?

On this episode, Epstein Becker Green attorneys Richard Hughes, Spreeha Choudhury, and Will Walters, as well as Anna Larson of EBG Advisors, discuss vaccine-related topics ranging from the measles outbreak and the reduction of the federal workforce to decreased government funding of public health programs.