June 23, 2016
On May 24, 2016, HHS published guidance regarding questions that have arisen about the Patient Safety and Quality Improvement Act of 2005, 42 USC 299b-21–b-26 (Patient Safety Act), and its implementing regulation, the Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety Rule). The Guidance Regarding Patient Safety Work Product and Providers’ External Obligations is intended to provide clarity in response to recurring questions about what information that a provider creates or assembles can become patient safety work product (PSWP). This Guidance also clarifies how providers can satisfy external obligations related to information collection activities consistent with the Patient Safety Act and Patient Safety Rule.
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