Skip to main content


U.S. flag
      An official website of the United States government
              Here’s how you know
        Here’s how you knowDot gov**Official websites use .gov**
                 A **.gov** website belongs to an official government organization in the United States.
                  HTTPS**Secure .gov websites use HTTPS**
                 A **lock** (A locked padlock) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 
  Menu Close
          Enter the terms you wish to search for.
    Search
        








  
  
    

  
      

                                      About HHS
    
                        
                              
      
      
      Programs & Services
    
                        
                              
      
      
      Grants & Contracts
    
                        
                              
      
      
      Laws & Regulations                  
Health Information Privacy
  HIPAA for Individuals
    
                        
                                            
      
      
      Filing a Complaint
    
                        
                                            
      
      
      HIPAA for Professionals
    
                        
                                            
      
      
      Newsroom

              

    



Breadcrumb
    HHS
                              HIPAA Home
                              For Professionals
                              Understanding Patient Safety Confidentiality
                              Patient Safety and Quality Improvement Act of 2005 Statute & Rule


    

    

    Navigate to:
  HIPAA for Professionals
    
                                    
                                            
            
      
      
      
      Regulatory Initiatives
    
                                                  
                                                                  
            
      
      
      
      Privacy
                                            
            
            Summary of the Privacy Rule
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                            
            
      
      
      
      Combined Text of All Rules
    
                                                  
                                            
            
      
      
      
      HIPAA Related Links
    
                                                  
                                                                  
            
      
      
      
      Security
                                            
            
            Summary of the Security Rule
    
                                                  
                                            
            
      
      
      
      Security Guidance
    
                                                  
                                            
            
      
      
      
      Cyber Security Guidance
    
                                                  
                                                                  
            
      
      
      
      Breach Notification
                                            
            
            Breach Reporting
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                            
            
      
      
      
      Reports to Congress
    
                                                  
                                            
            
      
      
      
      Regulation History
    
                                                  
                                                                  
            
      
      
      
      Compliance & Enforcement
                                            
            
            Enforcement Rule
    
                                                  
                                            
            
      
      
      
      Enforcement Process
    
                                                  
                                            
            
      
      
      
      Enforcement Data
    
                                                  
                                            
            
      
      
      
      Resolution Agreements
    
                                                  
                                            
            
      
      
      
      Case Examples
    
                                                  
                                            
            
      
      
      
      Audit
    
                                                  
                                            
            
      
      
      
      Reports to Congress
    
                                                  
                                            
            
      
      
      
      State Attorneys General
    
                                                  
                                                                  
            
      
      
      
      Special Topics
                                            
            
            HIPAA and Part 2
    
                                                  
                                            
            
      
      
      
      HIPAA and COVID-19
    
                                                  
                                            
            
      
      
      
      HIPAA and Reproductive Health
    
                                                  
                                            
            
      
      
      
      HIPAA and Telehealth
    
                                                  
                                            
            
      
      
      
      HIPAA and FERPA
    
                                                  
                                            
            
      
      
      
      Research
    
                                                  
                                            
            
      
      
      
      Public Health
    
                                                  
                                            
            
      
      
      
      Emergency Response
    
                                                  
                                            
            
      
      
      
      Health Information Technology
    
                                                  
                                            
            
      
      
      
      Health Apps
    
                                                  
                                                                                        
                          
      
      
      
      Patient Safety
                                            
            
            Statute & Rule
                          
            
            PSQIA Statute
    
                                                  
                                            
            
      
      
      
      Patient Safety Rule
    
                                                  
                                            
            
      
      
      
      Enforcement
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                                                  
            
      
      
      
      Covered Entities & Business Associates
                                            
            
            Business Associate Contracts
    
                                                  
                                            
            
      
      
      
      Business Associates
    
                                    
                                            
            
      
      
      
      Training & Resources
    
                                    
                                            
            
      
      
      
      FAQs for Professionals
    
                                    
                                            
            
      
      
      
      Other Administrative Simplification RulesText resize icon

                    




Patient Safety and Quality Improvement Act of 2005 Statute and Rule








  
  
    

  
      



Statute

The Patient Safety and Quality Improvement Act of 2005 (PSQIA) 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, PSQIA provides Federal privilege and confidentiality protections for patient safety information, called patient safety work product.  PSQIA authorizes HHS to impose civil money penalties for violations of patient safety confidentiality.  PSQIA 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 PSQIA and read the statute.

Implementing Regulations

The Patient Safety Rule implements select provisions of PSQIA.

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 PSQIA 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.

                    
  


Content created by Office for Civil Rights (OCR) Content last reviewed December 23, 2022Back to top
    Contact HHS
    
                        
                                            
      
      
      Careers
    
                        
                                            
      
      
      HHS FAQs
    
                        
                                            
      
      
      Nondiscrimination NoticeHHS Archive
    
                        
                                            
      
      
      Accessibility
    
                        
                                            
      
      
      Privacy Policy
    
                        
                                            
      
      
      Viewers & PlayersBudget/Performance
    
                        
                                            
      
      
      Inspector General
    
                        
                                            
      
      
      Web Site Disclaimers
    
                        
                                            
      
      
      EEO/No Fear ActFOIA
    
                        
                                            
      
      
      The White House
    
                        
                                            
      
      
      USA.gov
    
                        
                                            
      
      
      Vulnerability Disclosure Policy
        Sign Up for Email Updates

Receive the latest updates from the Secretary, Blogs, and News Releases.

Sign Up
  HHS Headquarters
          200 Independence Avenue, S.W.
                  Washington, D.C. 20201
                  Toll Free Call Center: 1-877-696-6775​