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Information Regarding the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule)

The Department of Health and Human Services (HHS) issued the Patient Safety Rule (PDF file, 760 KB. PDF Help) to implement the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), which authorizes the creation of Patient Safety Organizations (PSOs). Clinicians and health care providers can work voluntarily with PSOs to assemble, aggregate, and analyze data—within a legally secure environment of privilege and confidentiality protections—to improve quality and safety by identifying and reducing patient care risks and hazards.

The Patient Safety Rule establishes the requirements that an entity must meet to become and remain listed as a PSO. It also establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, and the procedures for the imposition of civil money penalties for knowing or reckless violation of these confidentiality protections.

The Patient Safety Rule became effective on January 19, 2009. For more information on the Patient Safety Rule, please go to the press release: Patient Safety Rule Issued for Patient Safety Organizations.