Health Law Advisor

So, I had some free time today and decided to work with AI on an assessment of comments submitted to FDA’s November 2023 Proposed Rule (the “proposed rule”) to classify antimicrobial wound dressings and washes. The final rule was slated to be published in May 2026, and though that time has passed, the absence of a withdrawal notice, or any other information on FDA plans, is undoubtedly disconcerting to the wound care community.

The project included various prompts and refinements on my part, and time reviewing and confirming or adjusting inferred or borderline findings manually. The proposal, for those who don’t know, aims to create new device classifications covering hundreds of currently marketed antimicrobial wound dressings—devices that primarily incorporate ingredients like hypochlorous acid or silver, have been staples of wound care for decades, and have excellent safety and efficacy profiles. 

In April 2026, a complaint alleging “one of the most egregious examples of piracy in the medical technology industry” landed on the docket of the U.S. District Court for the Eastern District of Texas.

The 180-page patent infringement lawsuit by Heartflow, Inc.—a California-based medical company that advances coronary care through artificial intelligence (AI)-powered three-dimensional models of a patient’s heart—alleges that a former Heartflow consultant founded a rival company, Cleerly, Inc., using Heartflow’s “revolutionary cardiovascular diagnostic technology, trade secrets, and confidential business information” while still bound by contractual obligations.

“By this action, Heartflow seeks to protect the extraordinary investment—measured in hundreds of millions of dollars, decades of research protected by hundreds of patents, and the contributions of countless scientists, engineers, and physicians—that created the world’s first AI-powered, non-invasive cardiac diagnostic platform, as recognized by the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS),” the Heartflow complaint states.

Cleerly issued a statement on April 17, calling the filing a “lawsuit to limit competition.”

“We strongly disagree with the allegations and will vigorously defend against these baseless claims,” Cleerly wrote. The company’s answer is due July 8, 2026.

We discuss this patent infringement case in further detail below.

The Highlights

• Accelerated FCA Investigative Timeline: The U.S. Department of Justice (DOJ) is taking new steps to implement the directives of Executive Order 14395 of March 16, 2026, “Establishing the Task Force To Eliminate Fraud,” by expediting the review for newly filed False Claims Act (FCA) qui tam actions involving federally funded state-administered benefits programs. The May 27, 2026, memorandum from Assistant Attorney General Brett A. Shumate (“Shumate Memo”) states that all newly filed state-administered benefits program fraud qui tam actions will now be reviewed by DOJ in 60 to 120 days after filing to determine if the government will continue its investigation, permit the whistleblower to proceed, or act to dismiss the case.
• DOJ Reaffirmation of Relator Authority: The Shumate Memo reaffirms DOJ’s position that whistleblowers may “stand in the shoes” of the government and indicates that the agency will let relators lead litigation subject to DOJ’s “oversight and ultimate control.”
• Automatic Criminal and Administrative Referrals: New benefits program fraud qui tam matters will be automatically referred to the Criminal Division and/or the National Fraud Enforcement Division for evaluation of potential criminal violations and to the affected agency for potential administrative action, including payment suspension.

Pharmaceutical and biotech manufacturers using artificial intelligence (AI) to support compliance with Food and Drug Administration (FDA) regulations should take note: the lack of human oversight of AI quality tools can constitute a current good manufacturing practice (CGMP) violation.

[This material was presented as part of Epstein Becker Green’s Counsel to Counsel Roundtable on Monday, May 4, 2026. Co-presenters were Professor Kathleen M. Boozang and Professor David W. Opderbeck of Seton Hall School of Law.]

In 2026, several federal cases are poised to shape regulatory risk, reimbursement, and False Claims Act exposure, as well as innovation pathways across the health care and life sciences sectors. These include cases decided in 2024 and 2025 that continue to have ongoing impacts, as well as more recent cases involving cutting-edge technology. This article highlights five cases to monitor (or their progeny), why these cases matter to in-house legal teams, and practical steps for health care and life sciences general counsel (GC) to consider.

On May 13, 2026, the Centers for Medicare and Medicaid Services (CMS) announced an aggressive nationwide crackdown on fraud—with the start of six-month moratoria on new Medicare enrollment for hospices and home health agencies (HHAs) and on changes in majority ownership that would require a new enrollment under 42 C.F.R. §450(b).

Behavioral health providers in the District of Columbia (“District” or “D.C.”) are operating in an environment of heightened government scrutiny. In recent months, federal and District authorities have signaled an intensified focus on Medicaid fraud in the behavioral health space, combining criminal prosecutions by the U.S. Attorney’s Office with aggressive program integrity actions by the D.C. Department of Health Care Finance (“DHCF”). These efforts have included criminal and civil investigations into alleged billing irregularities and, at an increasing rate, the suspension of Medicaid payments to providers based on suspected fraud. Such suspensions are implemented in almost all cases, as permitted by regulations, before any final determination on the merits. These developments raise significant legal, financial, and operational risks for behavioral health providers in D.C.

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.