On May 1, 2026, Pennsylvania’s State Board of Medicine (or “Petitioner”) filed a lawsuit in the Commonwealth Court of Pennsylvania—alleging that an artificial intelligence (“AI”) chatbot developed by Character Technologies, Inc. (or “Respondent”) engaged in the unlawful practice of medicine.
On April 30, 2026, the newly constituted National Fraud Enforcement Division (NFED) of the U.S. Department of Justice announced the formation of a West Coast Health Care Fraud Strike Force. This new Strike Force combines the resources of DOJ’s Health Care Fraud Unit (which was recently placed under operational control of NFED, as discussed below) and the U.S. Attorney’s Offices (USAOs) for the Districts of Arizona, Nevada, and the Northern District of California.
On April 30, 2026, the Department of Justice (DOJ) announced plans to prioritize “high quality” actions by data miners filing False Claims Act (FCA) qui tam complaints, indicating an ever-growing reliance on FCA whistleblowers as well as technology to uncover fraud, waste, and abuse.
On April 30, 2026, the U.S. Food and Drug Administration (FDA) announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List (“503B Bulks List”)—finding no clinical need for outsourcing facilities to compound the three drugs from bulk substances absent a drug shortage.
Epstein Becker Green (“EBG”) has previously advised U.S. organizations that share data in bulk or otherwise grant access to U.S. sensitive data to countries of concern or covered persons to “Know Their Data” and “Know Their Vendors.” In this post, we discuss why U.S. organizations across all industries with cross-border operations – including health care / life sciences, finance, e-commerce, and research – must “know their reporting requirements,” to fully comply with the BSD Rule and its brand-new reporting obligations.
The Dietary Supplement Listing Act of 2026 (H.R. 8370, 119th Congress) (the “Act”), introduced in the U.S. House of Representatives on April 20, 2026, has the potential to significantly impact the dietary supplement industry. The Act proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”), via a new Section 403D, and create the first mandatory FDA product-listing regime for dietary supplements.
New York has passed sweeping food additive legislation that, if signed by the Governor, will fundamentally reshape how food manufacturers and suppliers operate in the state. The Food Safety and Chemical Disclosure Act (S1239F) (the “Act”) would establish the first state-level disclosure and database regime for substances that companies have independently determined to be “Generally Recognized as Safe” (“GRAS”). The bill represents a significant escalation in state-level food safety regulation with far-reaching consequences for food manufacturers, ingredient suppliers, and consumer products companies operating in the New York market.
Anthropic’s new initiative—“Project Glasswing,” announced in April 2026—reflects a significant development in the cybersecurity landscape that should command the immediate attention of every C-suite leader, privacy officer, information security professional, and compliance executive in health care and life sciences, financial services and other critical infrastructure industries, and their legal counsel.
On March 12, 2026, Microsoft officially launched Copilot Health — a dedicated, secure space within its Copilot AI platform designed to aggregate a user’s health records, wearable data, and lab results into a single, personalized health profile. While the product has drawn considerable excitement in the health-tech space, it also raises significant legal considerations for individual adopters and their healthcare providers.
On April 3, 2026, the director of the Office of Management and Budget submitted to Congress President Donald Trump’s budget for 2027—proposing $111.1 billion in discretionary budget authority for the U.S. Department of Health and Human Services (HHS) for Fiscal Year 2027, beginning October 1, 2026, and ending September 30, 2027. The number represents a $15.8 billion or 12.5 percent decrease from the 2026 enacted level and suggests ongoing emphasis on combatting improper payments and practices in health care. The proposed budget investments also signal potential shifts that will impact service delivery for certain communities and business operations for entities that contract with the federal government or federal government grantees. We’ve noted the following key takeaways from the HHS Budget in Brief on these points, below.
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Recent Updates
- ‘Emilie’ Is Not a Psychiatrist: Pennsylvania Board of Medicine Alleges Unlawful Practice of Medicine by an AI Chatbot
- DOJ’s West Coast Strike Force to Target Health Care Fraud in Arizona, Nevada, and Northern California
- DOJ FOCUS Initiative Prioritizes “High Quality” Data Miner Actions by FCA Whistleblowers
- FDA Proposal Would Leave Semaglutide, Tirzepatide, and Liraglutide Off 503B Bulks List
- The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Reporting Requirements”