Fewer cardiac patients provided researchers with follow-up information about their conditions after new federal privacy protections took effect, resulting in "selection bias" in the data, University of Michigan researchers said in the Archives of Internal Medicine. Ninety-six percent of patients contacted between May 1999 and August 2001 agreed to answer questions for a cardiac-outcomes research project, but participation fell to just 34% between September 2001 and March 2003 after researchers began following a new protocol for contacting patients. The new protocol, designed to comply with privacy protections under the Health Insurance Portability and Accountability Act, required researchers to mail a letter to patients to obtain written consent prior to asking follow-up questions. Previously, written consent was not required, and researchers could ask follow-up questions on the phone with patients' verbal consent. The additional steps to comply with HIPAA added $8,705 to startup and first-year administrative costs, the researchers said. Read the study. -- by Joseph Conn
Privacy protections hinder outcomes research: study
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