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.
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.
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 healthcare sector continues to grapple with an unrelenting wave of cyberattacks, with a notable shift in 2024 and 2025 toward targeting third-party vendors and business associates entrusted with sensitive protected health information (“PHI”). This trend has led to a surge in data breaches, affecting tens of millions of Americans and prompted heightened regulatory scrutiny over how healthcare providers manage and oversee their vendor relationships.
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.
Innovations in artificial intelligence (AI), including advances in generative AI (GenAI) and machine learning, provide new opportunities for healthcare providers, promising improved efficiency in areas such as medical record keeping and billing, as well as advances in clinical decision-making, diagnosis, and treatment.
A new law, the Consolidated Appropriations Act, went into effect on February 3, 2026, issuing new Medicare reimbursement guidelines for off-campus provider-based hospital outpatient departments (HOPDs). As of January 1, 2028, hospitals will be required to make certain operational changes to maintain OPPS reimbursement eligibility for their off-campus provider-based locations. These include such measures as
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.
In 2025, eight new U.S. state privacy laws took effect and several states tightened existing regulations, significantly impacting healthcare organizations. Major changes