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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.

Health care professionals 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 (73 FR 70732, Nov. 21, 2008).

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

Learn more about the Patient Safety Rule Penalty Inflation Adjustment.