This post is the first in our three-part series, Gearing Up for HTLH USA 2025, where our team of attorneys will share insights on intellectual property, equity, and exit strategies and how these issues intersect in the transactional context.
Physicians are driving much of today’s health innovation. From new devices and digital tools to
Later this month, members our Healthcare group will be presenting at the HLTH USA 2025 conference in Las Vegas. We have the 8 a.m. session on Tuesday, October 21, 2025, titled “Clinic to Cap Table: IP, Equity, and the Path to Exit,” where we will talk about how to turn clinical insight into
On August 8, 2025, Governor Tony Evers signed Senate Bill 14, now 2025 Wisconsin Act 22, which establishes new informed consent requirements for pelvic examinations. This Act requires hospitals to obtain written informed consent from a patient prior to performing a pelvic examination solely for educational purposes while the patient is under general anesthesia or otherwise unconscious. This legislation also mandates that hospitals implement written policies and procedures for obtaining informed consent prior to performing pelvic exams on unconscious patients.
In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a range of actors including alleged transnational criminal organizations, providers of allegedly fraudulent wound care, alleged prescription opioid traffickers, alleged telemedicine, and genetic testing fraudsters, among others. DOJ also introduced the creation of a Health Care Fraud Data Fusion Center, designed to enhance the detection, investigation, and prosecution of healthcare fraud.
In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review, mandated by the Protecting Access to Medicare Act of 2014 (PAMA), focuses on analyzing the top 25 laboratory tests by Medicare expenditures for the previous calendar year. For clinical laboratories and healthcare providers, this announcement signals the need to pay close attention to billing practices, compliance programs, and potential audit risks.
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at strengthening the government’s civil enforcement of the False Claims Act (FCA) in the healthcare space. While the DOJ and HHS have long worked together to combat fraud, this Working Group marks a formalized, tightly coordinated effort focused on high-impact enforcement areas.
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national health priorities and potentially marking a significant shift in the U.S. regulatory landscape for drug development. For life sciences companies, this program presents both a unique opportunity and new strategic considerations; however, while the promise of a much shorter review window is enticing, life sciences innovators would be wise to proceed with caution.
Since the 2022 overhaul of Colorado’s restrictive covenant statute, C.R.S. § 8-2-113, the Colorado legislature has made ongoing amendments to the law which continue the trend of limiting the effectiveness of restrictive covenants in the state. Most recently, the 2025 General Assembly took aim at the provisions of the statute regarding restrictive covenants’ applicability to select healthcare providers as well as buyers and sellers of a business.
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key personnel on current regulations and any changes, and involve them in risk identification and mitigation strategies. Foster a culture of shared responsibility through ongoing training and open communication. Keep detailed documentation of the reasoning behind your procedures and policies, and store all standard operating procedures (SOPs) in a central, easily accessible location. Finally, implement a robust system for managing data and documents to ensure that all necessary information is readily available for internal and external monitors, as well as regulatory agencies.
Recently, Attorney General Pam Bondi purportedly issued an internal memorandum in response to Executive Order 14187 (“Protecting Children from Chemical and Surgical Mutilation”) concerning the treatment of transgender minors by medical practitioners, hospitals, clinics, and pharmaceutical companies. The memo set forth guidance for all Department of Justice (DOJ) employees to investigate individuals and entities who provide gender-affirming care to minor patients. To be clear, the memorandum—which has been posted in various locations on the internet and widely reported on by various media outlets but has not been verified as authentic by Husch Blackwell—is an internal policy statement directed to DOJ personnel and is not law. While it purports to issue “guidelines” pursuant to an executive order from the President, that executive order is itself under scrutiny (and has been partially enjoined).