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Proposed Reg Offers Doctors More Discreet Way To Report Adverse Events

This article was originally published in The Gray Sheet

Executive Summary

A proposed federal rule could increase the number of adverse event reports available for public analysis

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Patient safety organizations

HHS on Nov. 21 finalized a 1regulation establishing patient safety organizations - third-party groups certified by the government to accept patient safety event information from health care practitioners on a confidential basis. Required by the Patient Safety and Quality Improvement Act of 2005, PSOs are intended to give practitioners a way to report events without fear that the information will be used against them in lawsuits or professional sanctions. They do not negate FDA adverse event reporting requirements for devices and drugs (2"The Gray Sheet" Feb. 18, 2008, p. 7)

Patient safety organizations

HHS on Nov. 21 finalized a 1regulation establishing patient safety organizations - third-party groups certified by the government to accept patient safety event information from health care practitioners on a confidential basis. Required by the Patient Safety and Quality Improvement Act of 2005, PSOs are intended to give practitioners a way to report events without fear that the information will be used against them in lawsuits or professional sanctions. They do not negate FDA adverse event reporting requirements for devices and drugs (2"The Gray Sheet" Feb. 18, 2008, p. 7)

FDA Launches Public Web Site Highlighting Device Safety Problems

A new public FDA Web site offering information about device safety issues observed by hospitals in the MedSun adverse event reporting network went live Nov. 14

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