Skip to main content
U.S. flag

An official website of the United States government

Return to Search

The Patient Safety Rule

The Patient Safety Rule

Final

Issued by: Office for Civil Rights (OCR)

Issue Date: June 30, 1905

The Patient Safety Rule

The Patient Safety Rule, published in the Federal Register on November 21, 2008, effective on January 19, 2009, is codified at 42 C.F.R. Part 3 (73 FR 70732).  The Patient Safety Rule implements select provisions of PSQIA.

OCR has responsibility for interpreting and implementing the confidentiality protections described in Subpart C and the enforcement provisions described in Subpart D.

AHRQ has responsibility for listing and delisting of patient safety organizations (PSOs) described in Subpart B.

Subpart A defines essential terms, such as patient safety work product, patient safety evaluation system, and PSO.

Subpart B provides the requirements for listing PSOs.  These entities offer their expert advice in analyzing the patient safety events and other information they collect or develop to provide feedback and recommendations to providers.

Subpart C describes the privilege and confidentiality protections that attach to patient safety work product and the exceptions to the protections.

Subpart D establishes a framework to enable HHS to monitor and ensure compliance with the confidentiality provisions, a process for imposing a civil money penalty for breach of the confidentiality provisions, and hearing procedures.
 

Read the Patient Safety Rule - PDF (73 FR 70732, Nov. 21, 2008).

Read the Patient Safety Notice of Proposed Rulemaking - PDF (73 FR 8112, Feb. 12, 2008). 

 

Agency for Healthcare Research and Quality (AHRQ)

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.