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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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U.S. Department of Health & Human Services
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Toll Free Call Center: 1-877-696-6775​
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Other files
| File | Type | Posted |
|---|---|---|
| 4-FAR_52.212-5_Jan_2018.docx | DOCX document |
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