• Regulation
  • Published May 2016

Patient Safety and Quality Improvement Act of 2005—HHS guidance regarding patient safety work product and providers' external obligations.

Patient Safety Organizations (PSOs) were formed with provisions to protect voluntarily submitted incident data to enhance transparency and learning from medical error. Despite those expectations, PSOs still have obligations to report certain situations to external organizations. This guidance aims to clarify what and when external reporting should take place for PSOs to remain in compliance with federal requirements while appropriately protecting incident data.

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