Regulatory

World Privacy Forum files comments on proposed rules regarding Patient Safety Organizations

Patient Safety Organizations | Proposed rulemaking — The World Privacy Forum filed extensive comments today regarding privacy protections for patients whose health care information will be shared with patient safety safety organizations under newly proposed Department of Health and Human Services regulations. After a landmark Institute of Medicine report on the prevalence of medical errors and their harmful impact on patients (To Err is Human), the U.S. Congress eventually passed the Patient Safety Act (2005). The Patient Safety Act allows extensive health care data of patients to go to patient safety organizations. The idea is to provide a form of quality control. The Agency for Heathcare Research and Quality (AHRQ), part of HHS, has published its proposed regulations implementing the Act. The World Privacy Forum has made 14 recommendations for substantive changes in the proposed rules to protect patient privacy. The World Privacy Forum asked the Agency to expressly mandate that all patient data be de-identified or anonymized to the greatest extent possible, that the proposed rule should expressly require data use agreements for any data sharing, that the patient information be labeled as subject to the Patient Safety Act, and strongly urged that patient safety organizations be required to maintain an accounting of disclosures at least equal to HIPAA, among other recommendations.

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