DHS Guidance On The PSQIA

Question 1

What is the outline of the HHS Guidance Regarding PSWP and Providers’ External Obligations?

Answer 1

• Summary
• Background
• HHS Approach to Patient Safety Act Interpretation
• How Information Becomes PSWP
• Information that Is Not PSWP
• Purpose for Which the Information Was Assembled or Developed
• Meeting External Obligations

Question 2

What is the purpose of the HHS Guidance Regarding PSO’s Reporting Obligations to the FDA, and who does it apply to?

Answer 2

Addresses questions regarding the obligations of PSO’s where they or the organizations they are a part of are legally obligated under the Federal Drugs and Cosmetics Act (FDCA) (21 USC §201 et. seq.), and its implementing regulations to report certain information to the FDA and to provide the FDA access to its records, which may contain PSWP.

Applies to all PSO’s that:
1. Have mandatory FDA reporting obligations under the FDCA; OR
2. Are organizationally related to such FDA-regulated reporting entities.