Agencies create regulations (also known as "rules") under the authority of Congress to help government carry out public policy. Learn about HHS' top regulations and how you can make your voice heard.
Policy on Redundant, Overlapping, or Inconsistent Regulations
The Immediate Office of the Secretary has issued a Request for Information (RFI) to solicit input from the public to help identify duplicative regulations and the problems they create.
HIPAA Privacy Rule
The HIPAA Privacy Rule protects personal health information and gives patients a variety of rights.
Human Subjects Research Protections
Institutions engaging in most HHS-supported human subject research must have an approved assurance of compliance with protective HHS regulations.
The Health Information Technology for Economic and Clinical Health (HITECH) Act supports the development of a nationwide health IT infrastructure.
Comment on Open Rules
You can play an important role in the Department’s decisions by commenting on proposed rules.
Find Rules by Operating Division
Rules and Notices from each HHS Operating Division are available on Regulations.gov.
Additional HHS Laws & Regulations
Find laws and regulations on civil rights, privacy rights, research, fraud prevention and detection, freedom of information, tribal matters, employment, and more.
Complaints & Appeals
Find out how to file a complaint or appeal a decision related to health information privacy, civil rights, Medicare, and more.
Learn about Public Readiness and Emergency Preparedness (PREP) Act declarations and explore related advisory opinions and guidance.
Each fall and spring, the Department publishes a semiannual regulatory agenda in the Federal Register. It lists all HHS regulations under development or review.
As part of the Unified Agenda of Federal Regulatory and Deregulatory Actions, HHS publishes a statement of our regulatory priorities for the coming year.
HHS Guidance Portal
HHS Guidance Portal is a searchable database for HHS guidance documents currently in effect. Guidance documents may include interpretive memoranda, policy statements, manuals, bulletins, advisories, and more.
Help HHS Review Existing Regulations
We invite suggestions of regulations to review – this helps us decide if they should be eliminated or modified.
Regulatory Flexibility Act Section 610 Reviews
The Regulatory Flexibility Act, 5 U.S.C. 610, directs HHS to periodically review regulations that have a significant economic impact upon a substantial number of small entities (“SEISNOSE”).