Telehealth

The legal and regulatory landscape for ketamine clinics is shifting once again, as the Drug Enforcement Administration (DEA) prepares to release its “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” While the full text of this rule is not yet public, its very existence signals that the DEA may continue the pandemic-era telehealth flexibilities that have proven vital for many clinics and patients. For owners and operators of ketamine clinics, understanding what’s at stake and how to prepare is more important than ever.

California Governor Gavin Newsom has signed a pair of highly anticipated bills that will affect healthcare transactions involving private equity groups and hedge funds, effective January 1, 2026. The new legislation will expand the authority of the California Office of Health Care Affordability (“OHCA”) to review transactions previously excluded from reporting for their impact on healthcare costs and markets and will reinforce prohibitions on lay interference with the delivery of physician and dental services under the California’s corporate practice of medicine laws.

This post is the third 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.

HLTH USA is a whirlwind—partnering, investor meetings, and press all compressed into a few fast-moving days. That intensity can be great, but it can also be risky for protecting and maximizing the value of your intellectual property. In the rush to network, pitch, and show off your innovation, it is easy to jeopardize your patent or trade secret rights by disclosing too much detail in a conversation or showing more than you should at your booth.

As HLTH approaches, it is worth pausing to consider how a thoughtful IP strategy can protect your company’s most valuable assets not only during HLTH itself, but long afterward.

Capturing innovation is just as important as protecting it. A simple invention disclosure form — recording the technical problem, your solution, key data, and alternative embodiments — can become the backbone of a provisional patent filing. Filing quickly, before public disclosures, is critical. But speed shouldn’t come at the expense of substance. A well-prepared provisional application, rich with enabling detail and variations, buys you time to refine claims and sequence international filings. Resist the temptation to file a “skeleton” provisional unless you have no other option.

In medtech and life sciences, it is often valuable to cover not just the device or system, but also methods of use (including physician workflows), manufacturing or assay methods, and the software or algorithms that deliver a concrete technical improvement. Enabling disclosure for a variety of embodiments can make all the difference when it comes to enforcement or licensing down the road.

This post is the second 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.

The healthcare industry is undergoing a rapid transformation, with startups driving innovation in patient care, diagnostics, data management, and telemedicine.

In today’s rapidly evolving healthcare industry, startup companies face significant hurdles in bringing innovative solutions to market. Licensing software and intellectual property provides a practical pathway for startups to overcome high development costs, regulatory complexities, and the need for advanced technology. By understanding various licensing models and the strategic importance of partnerships, healthcare startups can accelerate growth while ensuring compliance and security. This guide aims to empower entrepreneurs with the knowledge needed to make informed decisions about licensing, ultimately supporting innovation and better patient outcomes.

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.

Sign at the United States Department of Justice in Washington, DC

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.

Laboratory Testing

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.

Sign at the United States Department of Justice in Washington, DC

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.