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Understanding Patient Safety Confidentiality

The regulation implementing the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) was published on November 21, 2008, and is effective on January 19, 2009.  View the Patient Safety Rule  (42 C.F.R. Part 3).

The Patient Safety Act establishes a voluntary reporting system 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. Patient safety work product includes information collected and created during the reporting and analysis of patient safety events.

Health care workers and X-rays The confidentiality provisions will improve patient safety outcomes by creating an environment where providers may report and examine patient safety events without fear of increased liability risk.  Greater reporting and analysis of patient safety events will yield increased data and better understanding of patient safety events.

OCR works in close collaboration with the Agency for Healthcare Research and Quality (AHRQ) which has responsibility for listing patient safety organizations (PSOs), the external experts established by the Patient Safety Act to collect and analyze patient safety information.

Learn more about the Patient Safety Act and Rule.