The creation of Patient Safety Organizations (PSOs), called for by the Institute of Medicine, will help improve the quality and safety of health care for all Americans. PSOs are private entities recognized by Health and Human Services Secretary Michael O. Leavitt.

The organizations would allow for the voluntary reporting of patient safety events without fear of new tort liability. Furthermore, they would encourage clinicians and health care organizations to voluntarily share data on patient safety events more freely and consistently. Under the proposal, PSOs can collect, aggregate, and analyze data and provide feedback to help clinicians and health care organizations improve health care quality.

The authority to list, or formally recognize, PSOs was established by the Patient Safety and Quality Improvement Act of 2005. Although the statute makes patient safety event reporting privileged and confidential, it does not relieve clinicians or health care organizations from meeting reporting requirements under federal, state, or local laws. The statute and the proposed regulation, however, address an important barrier that currently exists—the fear of legal liability or sanctions that can result from discussing and analyzing patient safety events.