Compliance

Doctor writing survey, insurance and claim form for medical paperwork, document and script for patient records, test result and research in a hospital. Physician hands signing and planning healthcare

This post is part of our The Top 2025 Privacy and Security Issues Still Shaping Healthcare series, in which our team of attorneys provides essential strategies and insights for healthcare privacy and security.

Reproductive health privacy rule vacated.

On June 18, 2025, the U.S. District Court for the Northern District of Texas vacated the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule (Privacy Rule). As a result, the additional privacy protections that had been granted to reproductive healthcare information through President Biden’s Executive Order 14076, (“Protecting Access to Reproductive Health Care Services”), are no longer enforceable or required.

The Colorado General Assembly is back in session and has introduced legislation (SB26-041) that, if enacted, would create new notification requirements and antitrust review processes for healthcare transactions. While Colorado already requires state-level notification of transactions that trigger federal notifications under the Hart-Scott-Rodino Act and notification of certain hospital transactions under the Hospital Transfer Act (“HTA”) of 2023, the proposed bill would create new notification requirements for a broader set of healthcare transactions, and would authorize the Colorado attorney general (“COAG”) to block or delay closing of transactions. The proposed bill also expands the scope of hospital transactions that must be reported under the HTA.

HC Privacy & Security Top 10 Graphic

The 2025 Top Ten list reflects a regulatory environment in significant transition. Last year’s healthcare privacy and security landscape presented extraordinary challenges for compliance professionals, marked by sweeping regulatory changes on the federal and state level, intensified enforcement activity, and a growing and evolving environment that demanded constant vigilance. The volatile landscape demanded adaptability, careful attention to the regulatory details, and comprehensive compliance programs. The Top Ten list offers a capsulized version of the year’s highlights—and what it all means for healthcare privacy and security professionals moving forward.

Doctor working on laptop computer

In my November 2025 blog post, I discussed the uncertainty surrounding the DEA’s then-pending telemedicine rule and its implications for ketamine clinics. At that time, the future of pandemic-era telehealth prescribing flexibilities was unclear, and clinics across the country were bracing for the possibility of a significant regulatory shift at the end of 2025.

Judge's gavel on table in office

The Wyoming Supreme Court began the year 2026 with a landmark decision in State v. Johnson, 2026 WY 1, delivering a ruling with implications that extend far beyond its immediate outcome. While headlines will focus on the Court’s decision to strike down Wyoming’s comprehensive abortion restrictions—the Life is a Human Right Act (“Life Act”)[1] and the Medication Ban[2]—as unconstitutional, the true significance lies elsewhere. The Court held that Wyoming’s constitutional amendment guaranteeing adults the right to make their own healthcare decisions is a fundamental right protected by the highest level of judicial scrutiny.

This holding may ultimately have more far-reaching consequences, setting the stage for future challenges to a wide range of healthcare regulations across Wyoming.

CMS has extended its Provisional Period of Enhanced Oversight (PPEO) and its Expanded Prepayment Review (EPR) enforcement efforts to Georgia and Ohio. The enhanced enforcement efforts can lead to the revocation of a hospice’s Medicare billing privileges, termination of Medicare/Medicaid enrollment, and/or the prepayment review of 100% of a hospice’s claims.

The regulatory landscape for substance use disorder (SUD) treatment records is changing—and the impact will extend far beyond traditional addiction treatment programs. With treatment options for SUD limited, some providers are exploring ketamine as a potential therapy due to its effects on glutamatergic neurotransmission.[i] Additionally, psychedelic-assisted therapies involving certain Schedule I substances – such as psilocybin, ibogaine, and MDMA – are currently being studied by researchers as potential treatments for SUDs.[ii] While these investigational therapies are not yet available in clinical practice and the new federal privacy rules do not apply to research records, providers should be aware of the evolving treatment landscape as these therapies move closer to potential approval and clinical use.

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.