These orders include withdrawing the U.S. from the World Health Organization (WHO), freezing regulatory actions pending review, and rescinding policies from the previous administration.
Here are the details of these Trump administration actions and their potential relevance to medtech:
Withdrawal from the WHO
One of Trump’s first executive orders formally initiates the withdrawal of the U.S. from WHO, a part of the United Nations that focuses on combatting global public health emergencies. In the executive order, the administration cited the organization’s handling of the COVID-19 pandemic, failure to adopt reforms, and perceived political bias.
The executive order directs:
- The Secretary of State to notify the United Nations and WHO leadership of the withdrawal.
- A pause on all U.S. government funding, support, and resources directed to the WHO.
- The reassignment of U.S. personnel working with WHO.
- The identification of alternative partners for global health initiatives.
The withdrawal also stops the U.S. from participating in negotiations on the WHO Pandemic Agreement and amendments to the International Health Regulations.
Trump actions related to medtech include regulatory freeze pending review
Another executive order mandates a freeze on federal regulatory activity, including those under the FDA and CMS, until appointees of the new administration review and approve them. The administration said that this freeze is intended to ensure that all pending and newly issued rules align with its policy priorities. Trump seeks to reduce perceived regulatory burdens and promote what his administration calls “common sense” governance.
The order states:
- A stop on proposing or issuing new rules until reviewed by department heads appointed by the President.
- The withdrawal of rules submitted to the Office of the Federal Register but not yet published.
- A potential 60-day postponement of rules already published but not yet effective.
The regulatory freeze applies to “rules” that are broadly defined in the executive order to include actions taken by federal agencies, such as the FDA and CMS. This includes any regulatory action that has not yet been finalized or is currently under review.
While the specific rules impacted are not detailed in the order, it could include updates to Medicare payment models, FDA guidance on medical device approvals, and other regulations relevant to the medtech industry.
Rescission of executive orders from the Biden Administration
Trump actions related to medtech also include rescinding several executive orders issued during the Biden administration. Trump criticized prior policies as “unpopular” and “inflationary.”
The executive order targets diversity, equity, and inclusion (DEI) initiatives, claiming they created a “divisive” preferential hierarchy, and climate-related regulations, which the administration alleges have contributed to inflation and overburdened businesses. These moves are part of the Trump’s broader effort to reorient federal policies toward economic growth and deregulation.
Here are three executive orders the Trump Administration is rescinding:
- Executive order 14007: Established the President’s Council of Advisors on Science and Technology (PCAST), a group of experts who advised the federal government on policies related to science, technology, and innovation. The council focused on areas such as pandemic preparedness, advanced manufacturing, and climate change solutions to support evidence-based policymaking.
- Executive order 14009: Directed federal agencies to strengthen and expand Medicaid and Affordable Care Act (ACA) provisions. This order emphasized increasing access to affordable health coverage, improving healthcare equity, and reducing barriers to enrollment, particularly for underserved populations.
- Executive order 14110: Set guidelines for the safe, ethical, and trustworthy development of artificial intelligence (AI). It aimed to address risks associated with AI technologies, including bias, misuse, and security vulnerabilities, while promoting development and maintaining global leadership in AI development.
The rollback of executive order 14009 removes a directive aimed at strengthening Medicaid and Affordable Care Act (ACA) provisions. The specific effects on medtech reimbursement under these programs are not detailed, but the rollback of them could cause reviews or changes to policies impacting healthcare access and reimbursement structures. The removal of guidance on safe AI development eliminates a prior administration’s framework for promoting trustworthy AI, which could alter the regulatory approach to AI-driven medical devices overseen by the FDA.
Tariffs on Canada, Mexico, China
Trump has threatened to impose tariffs on three of America’s largest trading partners — Canada, Mexico, and China — starting Feb. 1. The proposed tariffs include a 25% levy on products from Canada and Mexico, and a 10% tariff on Chinese imports.
The president cited concerns over “mass numbers of people and fentanyl” entering the U.S. as justification for the actions, according to the New York Times.
Collectively, Canada, Mexico, and China account for more than one-third of U.S. trade, with goods and services totaling over $2.5 trillion in 2023. Canada and Mexico’s economies are closely intertwined with the U.S., with supply chains often crossing borders multiple times before a product is completed.
Trade experts warn that the tariffs could dramatically increase the cost of goods for American consumers and disrupt supply chains integral to industries such as manufacturing, the New York Times reports.
Medtech analysts, on the other hand, are wondering what the tariffs would mean for companies like Intuitive that are expanding internationally. The analysts don’t know if the tariffs would apply to all products coming out of Mexico for Intuitive. They wonder if it applies just to products shipped back and sold in the U.S. If so, they say it would reduce the exposure to around 70% of the estimated impact.
FDA scrubs clinical trial diversity from its website
STAT reported earlier this week that the FDA has removed certain web pages related to diversity, equity, and inclusion in clinical trials.
The removal of mentions of clinical trial diversity follows Trump’s executive order that banned DEI initiatives within the federal government.
