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1.13.26
2026 Year in Preview: AI Regulatory Developments for Companies to Watch Out For
In 2026, businesses will face an increasingly complex regulatory environment for Artificial Intelligence (AI). With new state laws and various federal action on the horizon, here’s our top 10 list of what businesses should watch out for in the AI regulatory space in 2026:
Alerts
12.19.25
ASTP/ONC Issues an RFI Seeking Input on How HHS Can Accelerate Adoption and Use of AI in Clinical Care
On December 19, 2025, the Office of the Deputy Secretary and Assistant Secretary for Technology Policy (ASTP) and Office of the National Coordinator for Health Information Technology (ONC) (ASTP/ONC) announced the release of a Request for Information (RFI) seeking broad public input on questions for how the U.S. Department of Health and Human Services (HHS) can accelerate the adoption and use of artificial intelligence (AI) as part of clinical care.
Alerts
12.19.25
Navigating CMS’s ACCESS Model and FDA’s TEMPO Pilot: Opportunities for Digital Health Companies
Since the publication of this Alert, CMS has officially released the Request for Applications (RFA), which provides clarifications and significantly more detail on eligibility criteria, application timelines, requirements for each ACCESS Participant’s Medical Director, eligibility for inclusion in the Tools Directory, and the model’s financial structure. Interested organizations should carefully review the RFA for specific requirements that were not available at the time this Alert was published and may contact Wilson Sonsini’s Digital Health practice with any questions.
Alerts
12.16.25
Trump Administration Issues Executive Order on National AI Policy and Deregulation
On December 11, 2025, the White House issued an Executive Order (EO), “Ensuring a National Policy Framework for Artificial Intelligence,” that establishes a new federal policy on artificial intelligence (AI). The EO states that it is “the policy of the United States to sustain and enhance the United States’ global AI dominance through a minimally burdensome national policy framework for AI.” The EO asserts that leadership in AI is critical to U.S. national and economic security and dominance and that “AI companies must be free to innovate without cumbersome regulation.” To accomplish this, the EO seeks to challenge “onerous” state AI laws through various federal actions.
Alerts
9.08.25
HHS Announces Increased Resources to Enforce Information Blocking Prohibition
On September 3, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS would increase resources to enforce the information blocking prohibition under the 21st Century Cures Act. Generally, the information blocking prohibition applies to certified health IT developers (e.g., electronic health records), offerors of certified health IT, health information networks and health information exchanges, and healthcare providers (collectively, “Actors”). Information blocking amounts to a practice by these Actors that interferes with authorized access, exchange, or use of electronic health information, unless the practice is required by law, or an exception applies. Certified health IT developers, entities offering certified health IT, health information exchanges, and health information networks are subject up to $1 million penalty per information blocking violation. Providers that are found to have committed information blocking are subject to disincentives that include not being a meaningful user under the Medicare Promoting Interoperability Program and under the Quality Payment Program in the applicable calendar year or may be deemed ineligible to participate in a Medicare Shared Savings Program for at least one year, as applicable. These disincentives can result in significant negative financial implications for such healthcare providers.
Alerts
8.01.25
CMS Announces Creation of Health Tech Ecosystem for Improving Access to Patient Data
During a “Make Health Tech Great Again” event on July 30, 2025 at the White House, the Centers for Medicare & Medicaid Services (CMS) announced its intent to create a digital health ecosystem, in partnership with private industry, to improve patient outcomes, reduce provider burden, and drive value by making it easier to access and share patient data.
Alerts
7.03.25
Texas District Court Vacates 2024 HIPAA Rule Designed to Enhance Reproductive Healthcare Privacy, Effective Nationwide
On June 18, 2025, the United States District Court for the Northern District of Texas vacated most of the rules designed to enhance reproductive healthcare privacy promulgated by the U.S. Department of Health and Human Services (HHS) in 2024. More specifically, the court ruled in Purl v. United States Department of Health and Human Services et al, No. 2:2024cv00228 (N.D. Tex. 2025) (the Decision) that the “Health Insurance Portability and Accountability Act Privacy Rule to Support Reproductive Health Care Privacy” (the “2024 HIPAA Rule”) is contrary to law because it unlawfully limits state public health laws; impermissibly redefines certain terms in contravention of federal law and in excess of statutory authority; and exceeds HHS’s authority. Regulations promulgated under HIPAA prior to the 2024 HIPAA Rule remain unchanged.