Healthcare Regulatory

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

On April 24, 2024, the Department of Justice (DOJ) published a final rule to adopt the Web Content Accessibility Guidelines, version 2.1 Level AA (WCAG 2.1) as the compliance standard for web and mobile app accessibility for Title II entities under the Americans with Disabilities Act (ADA).

This is the fourth in a six-part series on incentive design, deal structure, and how these issues surface in transactions and enforcement. Other relevant topics will be discussed in our upcoming presentation, Physician Owner Mindset, Compliance Guardrails: Growth Without the Gotchas, to be given at the American Alliance of Orthopaedic Executives on Tuesday, April 21.

This is the first in a six-part series on incentive design, deal structure, and how these issues surface in transactions and enforcement. Other relevant topics will be discussed in our upcoming presentation, Physician Owner Mindset, Compliance Guardrails: Growth Without the Gotchas, to be given at the American Alliance of Orthopaedic Executives on Tuesday, April 21.

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.

In December 2024, the FTC announced two separate settlements against Mobilewalla, Inc. and Gravy Analytics, Inc., asserting that the two companies were unlawfully tracking and selling sensitive location data from users without consent, including data related to visits to health centers. 

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 is the third in a series of articles designed to provide SXSW and LSI USA ’26 attendees and other MedTech professionals with practical considerations for efficiently executing mission-critical life science deals. On March 15, during SXSW, Husch Blackwell’s healthcare team will host two panels, bringing together founders and investors from healthcare, technology, and early-stage companies for candid discussion, practical insights, and plenty of time to connect.

Register here.

Department of Justice Bulk Sensitive Personal Data Transfer Rule (28 CFR Part 202) 

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.