In a transformative move to streamline healthcare and reduce bureaucratic burdens, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a Request for Information (RFI) on May 13, 2025, to identify and eliminate outdated or unnecessary regulations. This initiative, driven by President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation,” aims to lower costs, enhance transparency, and free healthcare providers to focus on patient care. With a bold 10-to-1 deregulatory policy, HHS is poised to reshape the regulatory landscape, prioritizing efficiency and innovation.
A New Era of Deregulation
The RFI marks a cornerstone of HHS’s commitment to Operation Deregulation, aligning with the broader federal goal of reducing regulatory overreach. Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the department has adopted a 10-to-1 rule: for every new regulation proposed, at least ten existing ones must be rescinded. This aggressive approach is designed to cut red tape, lower the cost of living, and empower doctors, nurses, and other providers to prioritize patient care over paperwork.
“To Make America Healthy Again, we must free our doctors and caregivers to do what they do best—prevent and treat chronic disease,” Kennedy said. “We cannot allow their time and talent to be wasted on bureaucratic red tape and paperwork.”
The initiative responds to long-standing concerns that excessive regulations inflate healthcare costs and stifle innovation. A 2023 Health Affairs study estimated that administrative burdens account for up to 30% of U.S. healthcare spending, diverting resources from patient care. By targeting outdated rules, HHS aims to redirect these resources to improve access and outcomes.
Key Features of the Deregulatory Plan
The HHS and FDA plan, guided by Executive Order 14192, includes several groundbreaking measures:
- 10-to-1 Rule: For every new regulation, HHS must eliminate at least ten existing ones, ensuring a net reduction in regulatory burden.
- Regulatory Cost Cap: The total cost of new regulations in fiscal year 2025 must be significantly less than zero, meaning deregulatory actions must outweigh any new costs.
- Broad Scope: The initiative targets not only formal regulations but also guidance documents, memoranda, and policy statements—often referred to as “soft rules”—that impose hidden burdens.
- Radical Transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset, fostering accountability and public trust.
FDA Commissioner Marty Makary, M.D., M.P.H., emphasized the practical benefits: “By cutting outdated red tape, we can lower costs, increase access to innovation, and let clinicians spend more time with patients—not paperwork.”
Public Input: A Call to Action
The RFI opens a 60-day public comment period, inviting stakeholders—providers, patients, industry leaders, and the public—to propose regulations for elimination. Comments can be submitted via the Regulations.gov docket (AHRQ-2025-0001) or a new user-friendly portal at Regulations.gov/Deregulation, which offers tools to help draft formal proposals.
This inclusive approach reflects the initiative’s commitment to transparency and collaboration. Whether it’s a burdensome reporting requirement, an outdated compliance rule, or a guidance document that stifles innovation, HHS wants to hear from those directly affected. The portal’s tools make it easier for non-experts, like small-practice physicians or patients, to contribute ideas, democratizing the deregulatory process.
Why This Matters
The healthcare sector is drowning in red tape. Providers spend an estimated 15–20 hours per week on administrative tasks, according to a 2024 American Medical Association survey, reducing time for patient care. This burden disproportionately affects small practices and rural providers, exacerbating access disparities. Patients, too, feel the impact through higher costs and longer wait times.
The deregulatory plan aligns with broader goals to Make America Healthy Again, a mantra Kennedy has championed. By removing barriers, HHS aims to:
- Lower Costs: Reducing administrative overhead could save billions annually, easing financial pressures on providers and patients.
- Boost Innovation: Streamlined regulations could accelerate the approval of new treatments and technologies, like advanced diagnostics or telehealth platforms.
- Enhance Care: Freeing providers from paperwork allows more time for personalized care, critical for managing chronic diseases like diabetes or heart disease.
Challenges and Opportunities
The initiative is ambitious but not without challenges:
- Balancing Safety: Critics may argue that deregulation risks weakening patient protections. HHS must ensure rescinded rules are truly outdated and not essential to safety or quality.
- Stakeholder Resistance: Some industry groups or advocacy organizations may defend existing regulations, fearing unintended consequences. The RFI’s public comment period will be crucial for addressing these concerns.
- Implementation: Identifying and rescinding ten regulations per new rule requires rigorous analysis to avoid disrupting care delivery.
Yet, the opportunities are immense:
- Provider Relief: Simplified regulations could reduce burnout, with 60% of physicians citing administrative burdens as a key stressor (2024 Medscape survey).
- Patient Access: Lower costs and faster innovation could improve access, especially in underserved areas where 20% of Americans lack adequate healthcare, per a 2023 Health Affairs report.
- Economic Impact: Deregulation could stimulate job creation and economic growth by easing burdens on healthcare businesses.
A Step Toward a Healthier America
The HHS and FDA’s RFI is a bold call to rethink healthcare regulation. By prioritizing efficiency, transparency, and patient care, the initiative could transform how providers operate and how patients access services. As Makary noted, “This is about restoring common sense to health care regulation.”
The public has until July 12, 2025, to submit comments. Whether you’re a doctor frustrated by compliance paperwork, a patient facing high costs, or an innovator stifled by regulatory hurdles, now is the time to act. Visit www.Regulations.gov/Deregulation to share your ideas and help shape a leaner, more effective healthcare system.
HHS’s annual transparency reports will keep the public informed on progress, ensuring accountability. As the deregulatory plan unfolds, it promises to unleash prosperity, empower providers, and put patients first—paving the way for a healthier, more resilient America.
By Barby Ingle
Published by International Pain Foundation, Team IPain, iPain Blog
Disclaimer: This article is based on the HHS/FDA press release dated May 13, 2025
