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Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome.

Arch Intern Med

May 2005

Division of Cardiovascular Medicine, Department of Internal Medicine, and the Cardiovascular Center of the University of Michigan Health System, and Health Services Research and Development Center of Excellence, Ann Arbor, USA.

Background: Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule has the potential to affect data collection in outcomes research.

Methods: To examine the extent to which data collection may be affected by the HIPAA Privacy Rule, we used a quasi-experimental pretest-posttest study design to assess participation rates with informed consent in 2 cohorts of patients eligible for the University of Michigan Acute Coronary Syndrome registry. The pre-HIPAA period included telephone interviews conducted at 6 months that sought verbal informed consent from patients.

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