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  2. Laws & Regulations

Laws & Regulations

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.

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  • How to file a Medicare complaint or appeal a decision
  • Filing a complaint online
  • Registering an institutional review board (IRB) or obtaining a Federalwide Assu…

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.

HITECH Act

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.

PREP Act

Learn about Public Readiness and Emergency Preparedness (PREP) Act declarations and explore related advisory opinions and guidance.

Regulatory Actions

Learn about HHS proposed regulatory actions, agenda and priorities in the Federal Register.

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”).

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.

Whistleblower Complaints on the Chemical and Surgical Mutilation of Children

Report a tip or complaint related to the chemical and surgical mutilation of children.

Content created by Assistant Secretary for Public Affairs (ASPA)
Content last reviewed April 14, 2025
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