The role of artificial intelligence (AI) in health care has been of increased interest to recent federal administrations. Under the Biden Administration, AI in health care policy was generally characterized by a focus on risk mitigation. Under the second Trump Administration, the focus of AI in health care policy has generally shifted more toward rapid development and implementation of such tools.
Toward the close of the Biden Administration, E.O. 14110, entitled "Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence," was released. This E.O. included direction for various federal agencies to develop and promote standards for AI safety and security and specifically tasked the HHS Secretary (Secretary) with multiple initiatives (E.O. 14110 §8(b)). Pursuant to this E.O., on January 10, 2025, HHS released the U.S. Department of Health and Human Services: Strategic Plan for the Use of Artificial Intelligence in Health, Human Services, and Public Health (HHS AI Strategic Plan).
On January 20, 2025, the Trump Administration released E.O. 14148, "Initial Rescissions of Harmful Executive Orders and Actions," which in part rescinded E.O. 14110 (E.O. 14148 §2(ggg)). Thereafter, on January 23, 2025, the Trump Administration released E.O. 14179, "Removing Barriers to American Leadership in Artificial Intelligence." Though E.O. 14179 did not explicitly mention health, it did state that "it is the policy of the United States to sustain and enhance America's global AI dominance in order to promote human flourishing, economic competitiveness, and national security." E.O. 14179 also called for the development of an AI action plan to achieve this articulated policy, to be submitted to President Trump within 180 days of the E.O.'s release. Subsequently, the National Science Foundation (NSF) published in the Federal Register on February 6, 2025, a request for information (RFI) entitled "Request for Information on the Development of an Artificial Intelligence (AI) Action Plan." The RFI stated that E.O. 14110 "hampered the private sector's ability to innovate in AI by imposing burdensome government requirements restricting private sector AI development and deployment." The RFI "s[ought] input on the highest priority policy actions that should be in the new AI Action Plan," and noted that "responses can address any relevant AI policy topic."
Thereafter, in July 2025, the Trump Administration published Winning the Race: America's AI Action Plan (Plan), which outlines multiple policy goals and associated recommendations. The introduction of the Plan states that America "needs to innovate faster and more comprehensively than our competitors in the development and distribution of new AI technology across every field, and dismantle unnecessary regulatory barriers that hinder the private sector in doing so." The introduction then outlines three central pillars of the plan relating to (1) innovation, (2) infrastructure, and (3) international diplomacy and security. The Plan has implications for AI in health care, though AI in health care settings is infrequently referenced.
For example, one of the policy goals listed under the "Innovation" pillar discusses enabling AI adoption. Regarding this goal, it is stated that delays in utilizing AI come not necessarily from a lack of technologies, but rather from the slow adoption of such technologies. It is noted that certain critical sectors, including health care, "are especially slow to adopt due to a variety of factors, including distrust or lack of understanding the technology, a complex regulatory landscape, and a lack of clear governance and risk mitigation standards." Thus, the Plan proposes that coordinated federal actions could facilitate a "dynamic, 'try-first' culture for AI across American industry." To this end, one of the policy recommendations provided for enabling AI adoption is that the U.S. Food and Drug Administration (FDA) participate in the creation of "regulatory sandboxes or AI Centers of Excellence around the country where researchers, startups, and establishing enterprises can rapidly deploy and test AI tools while committing to open sharing of data and results."
On July 23, 2025, three additional executive orders were released, each intersecting with components of the Plan. The first, E.O. 14318, "Accelerating Federal Permitting of Data Center Infrastructure," seeks to reduce federal barriers to the creation of AI data centers and infrastructure in the United States (E.O. 14318 §1). The second, E.O. 14319, "Preventing Woke AI in the Federal Government," stipulates that the federal government shall generally not procure AI large language models (LLMs) that incorporate "ideological biases or social agendas" (E.O. 14319 §1). E.O. 14319 states "one of the most pervasive and destructive of these ideologies is so-called 'diversity, equity, and inclusion' (DEI)," which the E.O. notes includes "the suppression or distortion of factual information about race or sex … [and] concepts like critical race theory, transgenderism, unconscious bias, intersectionality, and systemic racism" (E.O. 14319 §1). Instead, LLMs procured by the federal government must, where consistent with law and related guidance, adhere to the "Unbiased AI Principles" of being "truth seeking" and "ideological[ly] neutral" (E.O. 14319 §3). In turn, the third, E.O. 14320, "Promoting the Export of the American AI Technology Stack," in part directs the establishment of a program to facilitate the global spread of American AI technologies and resources suitable for multiple use cases, with health care listed as an example (E.O. 14320 §3(i)(E)).
Thereafter, on September 30, 2025, E.O. 14355, entitled "Unlocking Cures for Pediatric Cancer With Artificial Intelligence," was issued. This E.O. directs actions to build upon the Childhood Cancer Data Initiative (CCDI), including the use of "advanced technologies such as AI to unlock improved diagnoses, treatments, cures, and prevention strategies for pediatric cancer" (E.O. 14355 §2). It also stipulates the prioritization of expanding pediatric cancer research and care advancement through the identification and implementation of strategies related to increased federal investment in initiatives addressing pediatric cancer and encouraging those in the private sector to utilize advanced technologies, like AI, to find cures for pediatric cancer (E.O. 14355 §3). Lastly, the E.O. tasks select federal actors with "work[ing] to ensure that AI innovation is appropriately integrated into current work on interoperability to maximize the potential for electronic health record and claims data to inform private sector and academic research and clinical trial design, while ensuring that patients and parents control their health information," as well as finalizing appropriate interoperability standards for patient data used in AI (E.O. 14355 §4).
On November 24, 2025, the Trump Administration released E.O. 14363, entitled "Launching the Genesis Mission." The Genesis Mission is described as "a national effort to accelerate the application of AI for transformative scientific discovery focused on pressing national challenges" (E.O. 14363 §2(a)). In an associated article released by the White House, the Assistant to the President for Science and Technology and Director of the White House Office of Science and Technology Policy, Michael Kratsios, is quoted as saying, "the Genesis Mission connects world-class scientific data with the most advanced American AI to unlock breakthroughs in medicine … and beyond."
Robert F. Kennedy, Jr., was sworn in as Secretary of Health and Human Services on February 13, 2025, and President Trump established the Make America Healthy Again (MAHA) Commission, to be chaired by the Secretary (E.O. 14212 §3(a)). Secretary Kennedy has expressed an ongoing interest in harnessing AI to a greater degree in both health care generally and within HHS. The MAHA Commission has since published two documents, the Make Our Children Healthy Again Assessment (MAHA Report) and the Make Our Children Healthy Again Strategy (MAHA Strategy), both of which reference leveraging AI to address chronic diseases.
In addition to these documents, HHS officials have announced the development of new AI tools for integration into agency functions. For example, on June 2, 2025, FDA announced the launch of Elsa, a generative AI tool intended to assist FDA employees with more efficiently synthesizing information for a variety of tasks, including clinical protocol reviews. Thereafter, on June 27, 2025, the Centers for Medicare & Medicaid Services (CMS) announced the launch of a new initiative, known as the WISeR (Wasteful and Inappropriate Service Reduction) Model, which is to test the use of enhanced technologies, like AI, to conduct prior authorization reviews for selected services in six states under original Medicare.
On December 4, 2025, HHS published the U.S. Department of Health and Human Services Artificial Intelligence (AI) Strategy (HHS AI Strategy); this document describes a "framework to establish robust HHS-wide AI infrastructure, accelerate AI innovation, and promote and ensure AI security throughout the health care and human services sector while respecting the privacy of Americans' identifiable information and complying with applicable law on the privacy and security of such information." The HHS AI Strategy largely outlines five pillars that undergird its efforts to pursue a "OneHHS" approach to AI that seeks to "eliminat[e] … information silos where appropriate" and increase intra-agency coordination and collaboration.
The second Trump Administration has generally pursued a deregulatory approach regarding AI. For example, in addition to calling for the development of an AI action plan, E.O. 14179 directs specified officials to review "all policies, directives, regulations, orders, and other actions taken pursuant to the revoked Executive Order 14110" for consistency with the policy that America maintain global AI dominance (E.O. 14179 §5(a)). E.O. 14179 also directs that measures found inconsistent with this policy "shall, as appropriate and consistent with applicable law … [be] suspend[ed], revise[d], or rescinde[d]," or the proposal be made for such actions (E.O. 14179 §5(a)).
In health care, there remain a number of considerations regarding the creation and deployment of AI tools. Some stakeholders have expressed interest in developing guardrails for AI in health care related to multiple topics (e.g., assessing AI models throughout their lifecycles, transparency, and balancing innovation with guardrails).
As a foundational matter, Congress may consider which parties should be involved in discussions regarding innovation in, and guardrails for, AI in health care. There are myriad stakeholders who could be involved in shaping such efforts, with many initiatives already launched. For example, 2025 has seen numerous state-level legislative efforts regarding the creation of guardrails regarding AI in health care. Additionally, while there are currently no comprehensive federal standards for AI in health care, multiple bills pertaining to AI in health care generally have been introduced in the 119th Congress. Some health care stakeholders have called for joint efforts between industry stakeholders and policymakers to develop and strengthen guardrails. Simultaneously, a number of industry stakeholders have engaged in independent projects to facilitate guardrails (e.g., the Joint Commission's and the Coalition for Health AI's [CHAI's] guidance document and the Utilization Review Accreditation Commission's [URAC's] health care AI accreditation program).