On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) "Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again," which HHS describes as "the largest deregulatory effort in the history of the Department." HHS is requesting input from a full range of interested stakeholders – from health care providers and suppliers to governments and individuals – regarding reducing the cost and burden of regulatory compliance.
This RFI reflects deregulatory initiatives in two 2025 executive orders issued by President Donald Trump:
- Executive Order 14192, "Unleashing Prosperity Through Deregulation,"which introduces a "10-to-1" policy directing agencies to identify 10 existing regulations to be repealed, unless prohibited by law, for every new regulation proposed.
- Executive Order 14219, "Ensuring Lawful Regulation and Implementing the President's Department of Government Efficiency Deregulatory Agenda," which iterates the Trump administration's policy that the federal enforcement resources of the executive branch should be focused on regulations directly authorized by the U.S. Constitution and federal statute.
HHS Secretary Robert F. Kennedy Jr. states that through the RFI the agency seeks to alleviate burdensome regulatory requirements so providers and caretakers can focus on patient care. The secretary expresses concern with regulations that impose significant costs or burdens that are not outweighed by a benefit to the public or have "no clear health benefit," citing specifically to excessive reports and unnecessary or unreasonable recordkeeping requirements.
The RFI invites stakeholders to identify any such inefficiencies and alternative approaches, including suggestions for new technologies to update compliance requirements. Specifically, HHS has delineated the following categories of regulations on which it seeks input:
- Regulations that are inconsistent with a statute
- Regulations that are inconsistent with the U.S. Constitution
- Regulations for which the cost outweighs the benefit
- Regulations that no longer reflect the current state of technology
- Regulations that are "bad policy, unreasoned or unsound"
For legal and compliance professionals, this RFI presents a unique opportunity for stakeholders to provide input on the day-to-day impact of current regulatory requirements. Key considerations should include:
- Impact review: Organizations should assess which HHS regulations impose the greatest compliance costs or operational inefficiencies. This is an opportunity for those most familiar with the processes to highlight those issues and suggest more efficient and impactful approaches.
- Risk management: While deregulation may reduce compliance obligations, it may also introduce uncertainty. Legal teams should evaluate how potential changes could impact an organization's risk exposure, particularly in areas such as data privacy.
- Stakeholder engagement: Stakeholders may consider coordinating in industry associations or coalitions to submit joint comments, thereby aligning with broader sector priorities.
- Future rulemaking: Comments submitted in response to this RFI may shape the regulatory landscape for years to come. Compliance teams should monitor follow-up actions by HHS and be prepared to adapt to any resulting changes, particularly where implementation of a new technology may be required.
The public comment period is open until 11:59 p.m. ET, Monday, July 14. BakerHostetler is able to assist health care entities in comment submission. Please contact Kathryn Childress at kchildress@bakerlaw.com or Lynn Sessions at lsessions@bakerlaw.com. Comments may also be submitted electronically via the following site: https://www.regulations.gov/deregulation.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
