Trump Administration (2025)
DEC 11, 2025	⬤	Attempts to Preempt State AI Regulation Through Executive Order
		The Trump Administration signed a sweeping Executive Order establishing a national policy framework for AI, aimed at preempting state AI regulations and promoting U.S. leadership in AI innovation. The Executive Order directs creation of an AI Litigation Task Force to challenge state laws on constitutional grounds, instructs the Secretary of Commerce to identify and refer onerous state AI laws for scrutiny, and tasks federal agencies with considering preemptive reporting and disclosure standards. It also imposes restrictions on federal funding for states with conflicting AI laws and calls for legislative recommendations to broadly preempt state regulation, with exceptions for child safety and certain state functions. [See Ropes & Gray’s Insight on this topic]
NOV 24, 2025	⬤	Launches the “Genesis Mission”
		The Trump Administration issued an Executive Order establishing the “Genesis Mission,” a national initiative to accelerate AI-driven scientific discovery by leveraging federal scientific datasets and resources. The Assistant to the President for Science and Technology leads interagency coordination, while the Department of Energy operates the American Science and Security Platform, which provides national laboratory supercomputers, secure cloud-based AI computing environments, access to proprietary and open scientific datasets, and other resources. The initiative is designed to support large-scale model training and experimentation, marking a shift toward centralized federal innovation and emphasizing national security, public-private partnerships, and progress in priority scientific sectors.
JUL 10, 2025	⬤	“America’s AI Action Plan”
		The Trump Administration released its federal strategy to promote AI innovation and deregulation across industries, including healthcare. This action plan directs agencies to identify and roll back federal regulations that may impede AI development, contemplates limiting federal funding to states with “burdensome” AI laws, and tasks federal entities with reassessing investigations or orders that could restrict AI progress. The approach emphasizes investment and enablement rather than sector-specific guardrails for use of AI in health care.
JUL 1, 2025	⬤	“Big Beautiful Bill” Enacted Without Proposed Moratorium on State Regulation of AI
		Congress considered enacting federal legislation that would have blocked states from regulating AI for a decade. Specifically, provisions of the Big Beautiful Bill passed by the House would have broadly preempted state regulation of AI technologies for a 10-year period; however, these provisions were removed in the Senate version following significant pushback, including concerns from states.  The lack of a moratorium on state AI legislation in the enacted “Big, Beautiful Bill” leaves the state patchwork of AI regulatory activity untouched, at least for now.
JUN 27, 2025	⬤	CMMI Announces WISeR Model
		The Center for Medicare & Medicaid Innovation (“CMMI”) launched the Wasteful and Inappropriate Service Reduction (“WISeR”) Model, a six-state pilot program using AI and machine learning to streamline prior authorization and reduce unnecessary care reimbursed by Medicare, with implementation set for 2026. Specifically, the program contemplates the use of AI-supported claims analytics to make prior authorization and utilization review determinations, though requires human clinicians to make final denial decisions.
APR 15, 2025	⬤	CMS Finalizes Payment Policies Without AI Provisions
		Centers for Medicare & Medicaid Service (“CMS”) finalized key payment policies without AI-specific provisions that had been contemplated in Biden-era proposed rules, reflecting the broader federal pivot toward deregulation.  Specifically, CMS had proposed requirements to ensure that Medicare Advantage (“MA”) plans’ use of AI did not exacerbate health disparities or impede equitable access to health care services; however, the rule was finalized without any AI-focused provisions.
APR 3, 2025	⬤	OMB Issues Government-wide AI Guidance on Use and Procurement
		The Office of Management and Budget (“OMB”) issued new memoranda to encourage federal agencies to adopt AI technologies, reduce regulatory barriers, and promote competition. In these memoranda, OMB contemplates implementation of minimum risk management practices for “high-impact” uses of AI by government, including in medical devices, patient diagnosis and treatment, insurance decisions and utilization review, and other healthcare contexts.  However, the OMB reiterates the Trump Administration’s chief goals of accelerating the adoption of AI and removing barriers to such adoption, in part by providing agencies with increased flexibility in determining how to meet such minimum requirements.  This represents a sharp divergence from the Biden-era more prescriptive requirements specified below.
JAN 31, 2025	⬤	Executive Order: “Removing Barriers to American Leadership in Artificial Intelligence”
		The Trump Administration issued an Executive Order rescinding Biden-era AI directives and reoriented federal policy toward deregulation and agency enablement, marking a shift away from the Biden-era’s emphasis on risk mitigation and cross-agency safeguards, and previewing a broader deregulatory trajectory for federal health program interactions with AI.  The Executive Order requires an extensive review of AI policies promulgated by the Biden administration and rescission of any found to be “inconsistent with, or present obstacles to” the new focus.  The Executive Order also requires that various key agency officials develop and submit an AI Action Plan “regarding minimizing regulatory obstacles to the development of AI.”
Biden Administration (2022-2024)
OCT 17, 2024	⬤	Senate Spotlights Medicare Advantage AI Denials
		A Senate investigation highlighted concerns about how three major Medicare Advantage (“MA”) plans leverage AI to automate or inform denials of post-acute care, prompting recommendations to the Centers for Medicare & Medicaid Services (“CMS”) for increased data collection, audits, and safeguards to ensure fairness and transparency.
SEP 24, 2024	⬤	OMB Issues Guidance on Responsible AI Acquisition in Government
		Office of Management and Budget (“OMB”) issued new guidance establishing best practices for managing AI risks in federal acquisitions, with requirements for transparency, ongoing monitoring, and incident reporting, applicable to federal agencies and contractors.
MAR 28, 2024	⬤	OMB Issues Binding Guidance on Federal AI Risk Management
		Pursuant to Executive Oder 14110, Office of Management and Budget (“OMB”) issued binding guidance requiring agencies to implement minimum safeguards for high-risk AI use cases, which included algorithmic impact assessments, transparency requirements, and human oversight, with additional obligations for AI use cases implicating individuals’ health, safety, and legal rights.
OCT 30, 2023	⬤	Executive Order: “Safe, Secure, and Trustworthy Development and Use of AI”
		The Biden Administration issued an Executive Order directing agencies to adopt NIST standards and risk assessments for development and use of AI, with reporting requirements for unsafe health care AI practices.
APR 2023	⬤	CMS Issues Guidance Medicare Advantage Plans’ Use of AI
		CMS issued guidance clarifying that Medicare Advantage (“MA”) organizations may not rely solely on AI or algorithmic tools to make coverage determinations, including denials of care.  Plans must ensure that a human clinician reviews any decision to deny coverage based on AI-assisted tools.  Additionally, the use of such tools must comply with federal rules regarding non-discrimination, medical necessity, and access to care.  These requirements continue to influence how AI is used in prior authorization and utilization management workflows across payors.
OCT 2022	⬤	Blueprint for an AI Bill of Rights
		The Biden Administration published non-binding principles for an AI Bill of Rights, which included requirements for safe and effective automated systems, algorithmic discrimination protections, data privacy considerations, disclosure obligations, and options for seeking human alternatives. While not enforceable, the blueprint influenced agency guidance relevant to health programs and payors during the Biden Administration’s tenure.