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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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HHS rules open for comment
Submitting a complaint or appealing a decision
Registering an institutional review board (IRB) or obtaining a Federalwide Assurance (FWA)

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.

Regulatory Agenda

Each fall and spring, the Department publishes a semiannual regulatory agenda in the Federal Register. It lists all HHS regulations under development or review.

Regulatory Priorities

As part of the Unified Agenda of Federal Regulatory and Deregulatory Actions, HHS publishes a statement of our regulatory priorities for the coming year.

Help HHS Review Existing Regulations

We invite suggestions of regulations to review – this helps us decide if they should be eliminated or modified.

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Washington, D.C. 20201

Toll Free Call Center: 1-877-696-6775​

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