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Patient Safety and Quality Improvement Act of 2005 Statute and Rule


The Patient Safety Act establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues.  To encourage the reporting and analysis of medical errors, the Patient Safety Act provides Federal privilege and confidentiality protections for patient safety information, called patient safety work product.  The Patient Safety Act authorizes HHS to impose civil money penalties for violations of patient safety confidentiality.  The Patient Safety Act also authorizes the Agency for Healthcare Research and Quality (AHRQ) to list patient safety organizations (PSOs).  PSOs are the external experts that collect and review patient safety information.

Learn more about the Patient Safety Act and read the statute.

Implementing Regulations

The Patient Safety Rule implements select provisions of the Patient Safety Act.  

Subpart C of the Patient Safety Rule establishes the confidentiality provisions and disclosure permissions for patient safety work product and the enforcement procedures for violations of confidentiality pursuant to section 922 of the statute.  OCR enforces these confidentiality protections.

AHRQ lists patient safety organizations pursuant to section 924 of the Patient Safety Act and has responsibility for common formats and network of patient safety databases pursuant to section 923.

Learn more about the Patient Safety Rule and read the regulations.

For more details about AHRQ's activities, visit the AHRQ PSO web site.