On Jan. 20, 2021, President Joe Biden’s Chief of Staff Ronald Klain issued a Memorandum for the Heads of Executive Departments and Agencies outlining immediate steps they should take to implement a regulatory freeze and review of pending regulatory actions.
Biden’s objective is to ensure his appointees have the opportunity to review any new or pending regulations that were issued in the final days of the Trump Administration.
The memo explains that regulations that have been sent to the Office of the Federal Register (OFR) but have yet to be published are to be immediately withdrawn for review and approval. Agencies with regulations that have been published in the Federal Register or regulations that have been issued in any manner but have not taken effect are advised to consider postponing the regulations’ effective dates for 60 days from the date of the Jan. 20 memo. In addition, agencies have the opportunity to conduct an additional 30-day public comment period for certain regulations and consider pending petitions for reconsideration involving such regulations.
From the HIMSS perspective, the two major regulations that this impacts are regulatory actions from the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Civil Rights (OCR).
CMS issued a Proposed Regulation focused on additional steps to reduce burden and promote patient electronic access to health information in December 2020 and finalized it in January 2021. Biden’s Administration will have to review and approve it before it becomes “final” and could open it up for an additional public comment period.
The HHS OCR issued Proposed Modifications to the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in December 2020 that Biden’s team will review and determine if they want to proceed with the current public comment period scheduled to run until March 22.
Different circumstances and follow-up actions are described for regulations that raise “substantial questions of fact, law, or policy.” Exclusionary exceptions to this memo appear to include regulations that may affect critical health, safety, environmental, financial or national security matters. However, should those perceived exceptions arise, discretion is left to the Office of Management and Budget Director, following a review, to determine whether such an exclusion is appropriate under the circumstances.
HIMSS will continue to monitor communications released by the White House that impact specific regulations related to health information and technology policy. Please reach out to email@example.com with specific questions on pending regulatory policies.
The HIMSS policy team works closely with the U.S. Congress, federal decision makers, state legislatures and governments, and other organizations to recommend policy, and legislative and regulatory solutions to improve health through information and technology.