Patient Safety and Quality Improvement Rule (Patient Safety Rule)

To implement the Patient Safety Act, the Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement Rule (Patient Safety Rule).

The rulemaking process for the Patient Safety Rule included a Notice of Proposed Rulemaking (NPRM) published in the Federal Register (FR) at 73 FR 8111 (February 12, 2008). Discussions in the first part of the NPRM, called the preamble, may be helpful to understanding provisions in the NPRM that were later incorporated unchanged into the final Patient Safety Rule.

The Patient Safety Final Rule was published on November 21, 2008 (73 FR 70732). The preamble (73 FR 70732–70796) addresses each provision of the rule, providing a summary and brief discussion of public comments received and how HHS responded to those comments in the Final Rule. The second part (73 FR 70796–70814) is the final regulatory text that serves as the legal basis on which the Department will interpret and enforce the provisions of the Patient Safety Act. This is the regulatory text that is published in the official version of the Code of Federal Regulations (CFR) as 42 CFR Part 3 and in the Electronic Code of Federal Regulations (e-CFR), the web version of the Code of Federal Regulations (CFR) that is updated regularly.

42 CFR Part 3

  • Subpart A defines essential terms, such as patient safety work product, patient safety evaluation system, and PSO. The definitions apply to all of the other Subparts.
  • Subpart B provides the requirements to become and remain listed as a PSO and related agency procedures.
  • Subpart C describes the privilege and confidentiality protections that attach to patient safety work product (PSWP) and lists the only circumstances in which PSWP can be permissibly disclosed.
  • 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.


Page last reviewed August 2022
Page originally created January 2014

Internet Citation: Patient Safety and Quality Improvement Rule (Patient Safety Rule). Content last reviewed August 2022. Agency for Healthcare Research and Quality, Rockville, MD.

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