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.

EO 13891 Extension Request

Advisory Opinions

Advisory Opinion on the Public Readiness and Emergency Preparedness (PREP) Act and the March 20, 2020 Declaration under the Act. (April 17, 2020, as Modified on May 19, 2020)
Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness (PREP) Act and The Secretary’s Declaration under the Act (May 19, 2020)

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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.

Executive Order 13891, Promoting the Rule of Law through Improved Agency Guidance Documents, requires HHS to establish a single, 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.