Digital Health Disrupted: Trump Administration's First 100 Days - What You Need to Know
The digital health landscape has evolved rapidly in recent years, marked by increasing adoption of telehealth services, the integration of AI into various aspects of healthcare, and a growing focus on leveraging technology to improve patient outcomes and access to care. Prior to the current administration, there was a discernible trend towards expanding digital health through policy initiatives aimed at fostering innovation, ensuring data privacy and security, and promoting equitable access.1 The COVID-19 pandemic further accelerated the adoption of telehealth, leading to temporary flexibilities in regulations and reimbursement policies.1 These flexibilities aimed to ensure continuity of care during a public health crisis and highlighted the potential of virtual care to address geographical barriers and enhance patient convenience. As the Trump administration commenced its term, the digital health community watched closely, anticipating potential shifts in these established trends and policy priorities. This analysis will delve into the key actions undertaken during the administration's first 100 days, examining their immediate and future impact on the digital health ecosystem, spanning executive orders related to AI and health, initiatives by HHS and the Centers for Medicare & Medicaid Services (CMS), regulations from the Drug Enforcement Administration (DEA), and relevant activities within Congress.
Impact of the Executive Order Rolling Back Federal AI Policy on Digital Health:
A significant action with potential long-term implications for digital health was the Trump administration's decision to roll back the federal AI policy established by the previous administration. On his first full day in office, President Trump revoked Executive Order 14110, the Biden administration's directive on the safe, secure, and trustworthy development and use of artificial intelligence.2 This earlier order had outlined a comprehensive vision for AI governance, emphasizing principles such as safety testing for high-risk AI systems, addressing algorithmic bias, ensuring nondiscrimination, and safeguarding the use of individuals' data.4 The swift revocation of this order on the first day of the new administration signaled a clear departure from the previous focus, indicating a strong commitment to a different approach to AI policy.2 This immediate action suggests that the administration believes the prior framework may have posed unnecessary obstacles to technological advancement.
Following this initial move, President Trump issued his own Executive Order 14179, titled "Removing Barriers to American Leadership in Artificial Intelligence".3 This subsequent order articulated a national AI policy centered on sustaining and enhancing America's global dominance in AI to promote human flourishing, economic competitiveness, and national security.3 It directed key administration officials to immediately review all policies, directives, regulations, orders, and other actions taken pursuant to the revoked Executive Order 14110, with the goal of identifying and potentially rolling back those deemed inconsistent with or presenting obstacles to the new policy of enhancing America's global AI leadership.5 This emphasis on "American leadership" over risk management indicates a prioritization of national competitiveness in the AI race, potentially leading to a reduced emphasis on some of the safety and ethical considerations that were central to the Biden administration's approach.2 The language used in the order suggests a belief that the previous policies hindered progress and imposed "onerous and unnecessary government control".4
To further implement this new direction, the White House Office of Management and Budget (OMB) released two revised policies on federal agency use of AI and federal procurement: OMB Memorandums M-25-21 and M-25-22.4 These memos provide updated guardrails for AI use and acquisition within the government, replacing the Biden administration's directives on the same topics.16 While these revised guidelines maintain some core AI governance requirements for federal agencies, including governance structures and risk management practices for high-risk systems, they also introduce new language aimed at "maximizing" the use of AI that is made in the United States.16 The memos emphasize three priorities for accelerating federal AI use: innovation, governance, and public trust, aligning with an executive order from the first Trump administration.16 Although some continuity in AI governance appears to be maintained on paper, the shift in emphasis towards maximizing US-made AI and the stated goal of eliminating "harmful barriers" to American AI leadership suggest a potentially less stringent regulatory environment in practice.6
The rollback of federal AI policy has generated both opportunities and uncertainties for the digital health sector. Medical device developers, in particular, face potential confusion regarding how the Food and Drug Administration (FDA) will regulate AI in medical devices under the new policy direction.19 The firing of FDA staff with expertise in AI devices further compounds these concerns.19 Despite this uncertainty, many companies in the digital health space are reportedly moving forward with their AI-related strategic plans, albeit with "healthy anxiety" and a focus on risk mitigation strategies.19 These strategies include looking at predicate devices already authorized by the FDA and preparing for a wide range of questions from the agency.19 The administration's emphasis on deregulation could potentially lead to faster innovation and adoption of AI-powered digital health tools by removing perceived regulatory hurdles.11 However, the absence of clear and robust federal guidelines on critical issues such as safety, algorithmic bias, and data privacy raises concerns about potential risks and the need for ethical frameworks to guide AI development and deployment in healthcare.11 Additionally, the focus on AI made in the US could have implications for international collaborations and supply chains within the digital health sector, potentially leading to a preference for domestic solutions.16
The "Make America Healthy Again" Commission and Its Potential Influence on Digital Health:
Another significant development during the first 100 days was the establishment of the "Make America Healthy Again" commission through an executive order signed by President Trump.20 The commission's primary purpose is to advise and assist the President on how best to address the childhood chronic disease crisis, while also tasked with rethinking policy on a broad range of issues including nutrition, physical activity, healthy lifestyles, over-reliance on medication and treatments, the effects of new technological habits, environmental impacts, and food and drug quality and safety.20 This broad mandate, particularly the inclusion of "new technological habits," suggests a potential area of scrutiny for digital health tools and their impact on health, especially among children.20 The commission is expected to produce an initial assessment within 100 days (by May 24, 2025) and a comprehensive strategy within 180 days (by August 12, 2025).21
The commission's potential recommendations are anticipated to align with publicly stated priorities of key figures in the administration, including Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., particularly concerning vaccine safety, reducing food additives, and the consumption of ultra-processed foods.20 While the commission's focus is not explicitly on digital health innovation, its recommendations in areas such as nutrition, physical activity, and healthy lifestyles could indirectly influence the development and adoption of digital health interventions designed to support these goals.20 For instance, if the commission emphasizes the importance of physical activity, digital health tools like fitness trackers and exercise apps might see increased interest and potential policy support. Furthermore, the executive order establishing the commission places a strong emphasis on transparency, open-source data, and avoiding conflicts of interest in federally funded health research.24 This focus could significantly impact how digital health research is conducted and shared, potentially fostering more collaborative innovation and accelerating the translation of research findings into practical digital health solutions.
Analyzing the Request for Information (RFI) on a New AI Action Plan and Its Potential Impact on Digital Health:
In line with the administration's focus on AI, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) on the "Development of an Artificial Intelligence (AI) Action Plan".31 This RFI, mandated by President Trump's Executive Order on Removing Barriers to American Leadership in AI, sought public input on priority policy actions that should be included in the plan, with a particular emphasis on how the plan can help remove obstacles to American leadership in AI technology development and deployment.31 The RFI garnered significant response, with over 10,000 comments submitted by various stakeholders, including academia, industry groups, private sector organizations, and state, local, and tribal governments.31
Recommendations from respondents covered a wide range of topics, including the prioritization of risk management and human rights in AI development, the expansion of open-source AI offerings, and the support of AI for scientific discovery.31 The consistent emphasis on "removing barriers" throughout the administration's AI-related actions suggests that the forthcoming AI Action Plan will likely continue the trend of deregulation, potentially leading to a faster pace of AI development in digital health. While this could be seen as a positive for accelerating innovation, it also raises concerns about the level of oversight and the need for safeguards to address potential risks such as bias and lack of transparency.31
Notably, several responses to the RFI specifically addressed the healthcare sector. The Bipartisan Artificial Intelligence Task Force had previously released a report recognizing AI's potential to reduce administrative burdens in healthcare, accelerate drug development, and enhance clinical diagnosis, also recommending guidance to encourage risk management, strengthen privacy, enhance security, and prevent disparate health outcomes.11 The Healthcare Leadership Council (HLC) and the Confidentiality Coalition submitted a joint response detailing various AI applications within the healthcare industry and strongly supporting the removal of unnecessarily burdensome requirements that could restrict AI development and deployment.39 Similarly, the Healthcare Trust Institute (HTI) emphasized the critical need for a strong national privacy standard for health information as a foundational element to protect sensitive data and spur medical innovation in the age of AI.40 These specific responses from healthcare-focused organizations demonstrate that the digital health community is actively engaged in shaping the future of AI policy, advocating for an environment that fosters innovation while also prioritizing data privacy, security, and ethical considerations.39 The RFI itself indicated that the AI Action Plan could address various relevant topics, including hardware, data centers, energy consumption, model development, open source initiatives, and the application and use of AI in both the private sector and by government agencies.33 The explicit inclusion of "application and use" suggests that the plan will likely consider how AI is being implemented across different sectors, including healthcare, potentially leading to the development of guidance or specific initiatives tailored to the unique needs and challenges of digital health AI.
Tariffs and Their Potential Threat to Virtual Care Access and Affordability:
The first 100 days also saw the implementation of new tariffs with potential ramifications for the accessibility and cost-effectiveness of virtual care. The Trump administration introduced a baseline tariff of 10% on all imported goods worldwide, which took effect on April 5, 2025.41 Additionally, goods imported from China face significantly higher tariff rates, reaching up to 245% in some cases.41 Given the global nature of healthcare supply chains, these broad tariffs are likely to increase costs across the board, impacting the affordability of medical devices that are essential for remote monitoring and various aspects of virtual care.41 Healthcare industry groups and analysts have expressed concerns that these tariffs will test the already fragile healthcare supply chain, potentially disrupting patient care due to increased costs and volatility.42
The US healthcare system relies heavily on imported medical devices, with a substantial percentage manufactured outside the country, including a significant portion from China.41 The new tariffs directly impact these imported goods, potentially leading to increased prices for essential devices like syringes, diagnostic tools, glucose sensors, and even larger equipment such as X-ray machines.41 This rise in costs could make these devices less affordable for both healthcare providers and patients, potentially hindering the expansion and accessibility of virtual care services that rely on remote monitoring and diagnostics. Furthermore, the threat of new pharmaceutical tariffs looms, with President Trump announcing plans to introduce "major tariffs" on imported pharmaceuticals.41 Considering the global manufacturing of drugs and the sourcing of active pharmaceutical ingredients (APIs) often from countries like China, these tariffs could significantly drive up medication costs for health systems and patients alike.41 Increased costs of pharmaceuticals could directly affect virtual consultations where medication prescriptions are a key component of treatment, potentially making follow-up and ongoing management more expensive for patients utilizing virtual care.41 While the primary concern highlighted in the available information revolves around medical devices and pharmaceuticals, it is plausible that tariffs on electronic components could indirectly increase the cost of virtual care platforms and the devices used to deliver virtual services, although this is not as directly emphasized in the provided snippets.44 A temporary pause on reciprocal tariffs (excluding those on China) is in effect until early July, intended to facilitate negotiations, but this also prolongs a period of uncertainty for the healthcare industry.41
Implications of the Repeal of the "Richardson Waiver" for the Digital Health Landscape:
A policy change with potential implications for the transparency and public participation in the development of digital health regulations was the HHS's decision to rescind the "Richardson Waiver".48 This long-standing policy, in place since 1971, had voluntarily committed HHS to following the notice-and-comment rulemaking procedures of the Administrative Procedure Act (APA) for a broader range of regulations, including those related to public benefits such as Medicare and Medicaid, even when the APA did not strictly require it.48 The repeal of this waiver means that HHS will now only conduct notice-and-comment rulemaking when legally mandated by the APA, which exempts rules concerning agency management, personnel, public property, loans, grants, benefits, or contracts.48
HHS justified the rescission by stating that the Richardson Waiver was contrary to the clear text of the APA and imposed obligations beyond its requirements, leading to unnecessary costs and hindering the department's operational efficiency and flexibility.48 This repeal signals a potential reduction in transparency and the opportunity for public input on HHS regulations that could significantly impact digital health programs and reimbursement policies related to Medicare and Medicaid.49 Advocacy groups have voiced concerns that this shift will lead to regulatory changes without sufficient engagement from stakeholders, including those in the digital health industry.49 While the change does not directly affect the Medicare payment rule processes, which have their own statutory requirements for public comment, other aspects of digital health policy under HHS, such as grant programs for telehealth initiatives or interoperability standards, could see changes with less opportunity for public feedback.50 The waiver had previously extended public input to these areas within HHS, and its absence could streamline the policymaking process but potentially at the expense of stakeholder involvement.50
Impact of HHS Employee Cuts on the Agency's Capacity to Support and Regulate Digital Health Initiatives:
The first 100 days also witnessed a significant reduction in the workforce at HHS as part of a restructuring and workforce optimization effort led by the Department of Government Efficiency (DOGE).64 Tens of thousands of employees were reported to have been cut across various agencies within HHS, including the FDA, Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH).16 This large-scale staff reduction has raised concerns about the agency's capacity to effectively support and regulate digital health initiatives. Senator Jacky Rosen, for instance, expressed concern about the impact on IT and cybersecurity staff, highlighting the potential threat to the functionality and security of HHS systems and the vast amounts of data they hold.64
Employees within HHS have also voiced fears that the mass layoffs will lead to a loss of critical expertise in areas such as IT, policy development, and contracting, potentially destabilizing the agency's ability to carry out its essential functions.68 A reduction in IT staff could directly impact HHS's capacity to support and secure the digital health infrastructure and manage the increasing volumes of health data, potentially slowing down the implementation of new digital health initiatives and hindering the maintenance of existing systems.64 Similarly, staff reductions within agencies like the FDA and NIH could affect their ability to regulate digital health technologies, review applications for new digital health tools, and fund critical research in the field.19 While HHS claims that the restructuring will streamline operations and save taxpayer money without impacting critical services, many observers remain skeptical, fearing that the loss of experienced personnel across various HHS agencies could lead to delays in regulatory processes, a reduced capacity for funding digital health research, and an overall slowdown in the advancement of the digital health sector.65
Scrutiny on Remote Monitoring Programs: Analyzing the Scope and Potential Consequences of OIG Audits:
The Office of Inspector General (OIG) within HHS announced its intention to conduct audits of Part B remote patient monitoring (RPM) services throughout 2025.72 These audits aim to determine whether healthcare providers furnished and billed for RPM services in accordance with Medicare requirements.72 The decision to increase scrutiny over RPM programs is motivated in part by a 2023 fraud scheme involving RPM services that caught the OIG's attention, as well as broader concerns about improper billing practices and the appropriate utilization of these services.72
The OIG audits signal a heightened focus on ensuring compliance within the rapidly growing field of remote patient monitoring. Healthcare providers offering RPM services will need to ensure strict adherence to coding and billing rules, as well as comprehensive documentation practices to avoid potential penalties or reimbursement takebacks.72 Key areas that auditors are expected to focus on include the proper documentation of practitioner orders for RPM services and documented beneficiary consent to receive these services.73 Additionally, auditors will likely scrutinize the medical necessity of the RPM services provided, the details included in patient treatment or care plans, and the appropriate qualifications and scope of practice of clinical staff involved in delivering monitoring and care management.73 The type of devices used for RPM will also be under review, with an emphasis on ensuring that they meet the FDA's definition of a medical device and are capable of real-time data transmission.72 Furthermore, the OIG is expected to pay close attention to the "interactive communication" requirement for certain RPM billing codes, emphasizing that asynchronous communication methods like text messaging do not meet this requirement and that synchronous, two-way interactions via phone or video are necessary.72 The outcome of these audits could lead to stricter enforcement of existing RPM guidelines and potentially impact future reimbursement rates or coverage policies if widespread instances of non-compliance or misuse are identified.72
CMS Decision on CTeL-Backed AI Civil Rights Protections and CTeL's Broader Efforts to Strengthen Digital Health:
The Center for Telehealth & e-Health Law (CTeL) expressed significant concern regarding the Centers for Medicare & Medicaid Services' (CMS) decision not to finalize key language in its finalized Contract Year 2026 Policy and Technical Changes to the Medicare Advantage (MA) Program rule.79 The omitted language would have clarified the applicability of civil rights laws to algorithmic decision-making within federally funded health programs like Medicare Advantage.79 Earlier in the rulemaking process, CTeL had submitted comments supporting CMS's proposal to explicitly state that AI systems used by Medicare Advantage plans must comply with existing civil rights statutes such as Section 1557 of the Affordable Care Act and Title VI of the Civil Rights Act of 1964.79 CTeL emphasized the potential for algorithmic bias to exacerbate health injustices if left unaddressed.79
Despite acknowledging stakeholder concerns about the regulation of AI, CMS chose not to finalize the proposed provision in its final rule, stating that it will continue to consider the extent to which it may be appropriate to engage in future rulemaking in this area.79 CTeL views this as a missed opportunity to reinforce patient protections and promote equity in the increasing use of AI within healthcare delivery.79 This decision represents a setback for efforts to explicitly address algorithmic bias and discrimination in AI used within federal healthcare programs, despite the advocacy efforts of organizations like CTeL.79 CTeL continues to urge CMS and other federal agencies to remain vigilant and proactive in monitoring the use of AI in Medicare and Medicaid programs and calls on policymakers to explicitly affirm the applicability of civil rights laws to AI-driven healthcare decisions, promote algorithmic transparency, require bias testing, and hold MA plans accountable for outcomes generated by automated systems.79 CTeL is actively working on these issues through its Artificial Intelligence Blue Ribbon Collaborative, which brings together experts from law, ethics, technology, and healthcare.79
Beyond this specific advocacy effort, CTeL has been a leading source of legal, regulatory, and policy intelligence for the telehealth community for over 25 years.81 As a non-profit, vendor-agnostic research institute, CTeL's work spans a wide range of digital health policy areas, including licensure and interstate practice, practitioner-patient relationships established via telemedicine, reimbursement policies across various payers, compliance with the Health Insurance Portability and Accountability Act (HIPAA), requirements for physical exams conducted remotely, policies related to Public Health Emergency (PHE) waivers, and the evolving landscape of mental and behavioral telehealth.83 CTeL actively engages in research, hosts digital health summits and webinars, and forms working groups and coalitions to shape impactful policy and legislative advancements in the field.81 Membership in CTeL provides stakeholders with access to exclusive policy insights, direct engagement opportunities with regulators, an unparalleled industry network, and the ability to influence the future of digital health policy.84 CTeL plays a crucial role in the digital health ecosystem by providing expertise, fostering collaboration among diverse stakeholders, and advocating for policies that support the development and implementation of equitable and high-quality virtual care for all.81 The importance of CTeL membership is underscored by situations like CMS's decision on AI civil rights protections, highlighting the ongoing need for collective advocacy and action to ensure that digital health policies are not only innovative but also ethical and equitable.79
Telehealth Flexibility Waivers Extended Through September 30, 2025:
A significant development providing short-term stability for the digital health sector was the extension of telehealth flexibility waivers through September 30, 2025.1 This extension, enacted by Congress, provides a six-month reprieve for healthcare providers, hospitals, and patients who have come to rely on telehealth services since the onset of the COVID-19 pandemic.97 The waivers cover several key areas, including the removal of geographic restrictions and the expansion of originating sites for telehealth services, allowing Medicare beneficiaries to receive virtual care in their homes and other locations.97 The extension also broadens the eligibility of practitioners who can furnish telehealth services and allows Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to continue serving as distant site providers for non-behavioral/mental telehealth services.97 Furthermore, the use of audio-only communication platforms for certain non-behavioral/mental telehealth services is extended, ensuring access for patients without video technology.97 Notably, the requirement for an in-person visit within six months of initiating a behavioral/mental telehealth service, and annually thereafter, has been waived through September 30, 2025, and even longer for FQHCs and RHCs under specific circumstances.97
While this extension provides continued access to telehealth services for Medicare beneficiaries and offers a degree of stability for providers, its temporary nature underscores the ongoing uncertainty surrounding the long-term policy framework for virtual care.98 Organizations like CTeL and the American Telemedicine Association (ATA) continue their advocacy efforts, urging Congress to establish permanent telehealth policies that reflect the advancements and reliance on virtual care observed during the pandemic.93 The elevation of Senator John Thune, a known telehealth champion, to Senate Majority Leader could potentially have a positive influence on the future of telehealth legislation.115 Additionally, the House Energy & Commerce Committee sent the SUPPORT for Patients and Communities Reauthorization Act of 2025 to the House floor.117 This legislation includes provisions that extend DEA flexibilities for telehealth prescribing of Medication for Opioid Use Disorder (MOUD), indicating continued bipartisan support for leveraging telehealth to address the opioid crisis.117
Conclusion:
The first 100 days of the Trump administration have laid the groundwork for significant shifts in the digital health policy landscape. The strong emphasis on AI deregulation presents a dual-edged sword, potentially accelerating innovation in digital health AI while raising concerns about oversight and the need for ethical guidelines. The "Make America Healthy Again" commission's broad mandate, particularly its focus on technology habits and research transparency, could indirectly shape the future of digital health solutions. The imposition of tariffs poses a tangible threat to the affordability of medical devices and pharmaceuticals essential for virtual care. The repeal of the "Richardson Waiver" and the substantial employee cuts at HHS raise legitimate concerns about transparency in policymaking and the agency's capacity to effectively support and regulate the digital health sector. Increased scrutiny of remote patient monitoring programs through OIG audits signals a focus on ensuring compliance and preventing misuse. While CMS's decision on CTeL-backed AI civil rights protections represents a setback, the ongoing advocacy efforts of organizations like CTeL remain crucial for fostering ethical and equitable digital health policies. The extension of telehealth flexibility waivers provides a temporary lifeline for virtual care access, but the digital health community continues to advocate for permanent policy solutions. Looking ahead, the digital health sector will likely see a continued push for deregulation in certain areas, coupled with increased scrutiny in others, particularly around program integrity. The long-term policy framework for telehealth and the integration of AI in healthcare will be key areas to watch as the administration progresses.
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