Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome
Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome
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DOI：
10.1001/archinte.165.10.1125
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发表时间：
2005-05-23
影响因子：
--
通讯作者：
Eagle, KA
中科院分区：
文献类型：
--
作者：
Armstrong, D;Kline-Rogers, E;Eagle, KA
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. in the post-HIPAA period, informed consent forms were mailed to ask for permission to call to conduct a telephone interview. The primary outcorric measure was the percentage of patients who provided consent. Incremental costs associated with the post-HIPAA period were also assessed.Results: The pre-HIPAA period included 1221 consecutive patients with acute coronary syndrome, and the post-HIPAA period included 967 patients. Consent for follow-up declined from 96.4% in the pre-HIPAA period to 34.0% in the post-HIPAA period (P
