A Final Rule updating Section 504 of the Rehabilitation Act of 1973 recently published by the Department of Health and Human Services (HHS) issued new mandates stipulating that every facility, program, or activity with 15 or more employees that receives HHS funding will need to comply with new digital accessibility guidelines.
To align its requirements
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.
On March 27, 2025, the U.S. Department of Health and Human Services (HHS) announced a sweeping reorganization under the Department of Government Efficiency Workforce Optimization Initiative. The plan consolidates 28 divisions into 15, reduces the number of regional offices from 10 to 5, and introduces a new entity: the Administration for a Healthy America (AHA). This transformation aims to modernize HHS’s structure and operations, improve efficiency, and strengthen oversight across federal health programs.
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.
Overview
On February 28, 2024, President Biden signed Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” This order, implemented through the Department of Justice (DOJ) regulations (28 C.F.R. Part 202) and Cybersecurity and Infrastructure Security Agency (CISA) requirements, creates sweeping new restrictions on the transfer of Americans’ health data to certain foreign countries and entities.
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.
HHS Ramps Up Enforcement Against Information Blocking
2025 marks a significant turning point in federal enforcement against “information blocking” in healthcare. In a series of announcements this September, the U.S. Department of Health and Human Services (“HHS”) signaled a major crackdown on healthcare entities—especially health IT developers, health information networks, and certain providers—that restrict patient access to their electronic health information (“EHI”).
Under the direction of Secretary Robert F. Kennedy, Jr., HHS has dedicated increased resources and issued clear warnings that enforcement of information blocking rules is now a top priority. This includes the threat of substantial civil monetary penalties (“CMPs”)—up to $1 million per violation—for certain actors, as well as program-specific disincentives for providers who participate in Medicare and other federal programs.
UPDATE (May 2026): To align its requirements with what DOJ has mandated, HHS extended the Rules compliance deadline to May 11, 2027 for entities with 15 or more employees and May 10, 2028 for those with fewer than 15 employees.
On May 9, 2024, the Department of Health and Human Services (“HHS”) published a Final Rule (“the Rule”) updating Section 504 of the Rehabilitation Act of 1973 (“Section 504”) regulations. As part of the Rule, every facility, program, or activity with 15 or more employees and receiving HHS funding will need to comply with new digital accessibility guidelines by May 11, 2026. Those with fewer than 15 employees will need to comply by May 10, 2027.
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.
The Health Insurance Portability and Accountability Act (HIPAA) has long been the cornerstone of patient privacy and data protection. Among its most patient-centric provisions is the Right of Access rule, which guarantees individuals timely access to their medical records. This right is not just a regulatory requirement—it’s a fundamental principle of patient empowerment, enabling individuals to make informed decisions about their health.
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.
A federal judge has issued a preliminary injunction halting the Department of Health and Human Services’ (HHS) 340B Rebate Model Pilot Program, which was scheduled to take effect on January 1, 2026. The December 29, 2025 ruling temporarily prevents implementation of the rebate program that would have fundamentally changed how safety-net hospitals and clinics purchase discounted drugs under the 340B Drug Pricing Program.
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.
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.