Influence of the HIPAA privacy rule on health research
Influence of the HIPAA privacy rule on health research
复制标题
DOI：
10.1001/jama.298.18.2164
复制
发表时间：
2007-11-14
影响因子：
120.7
通讯作者：
Ness, Roberta B.
中科院分区：
文献类型：
--
作者：
Ness, Roberta B.
背景轶事报告表明，健康保险便携性和责任法案隐私规则（HIPAA Privacy Rule）可能正在影响美国的健康研究。目的调查流行病学家对HIPAA Privacy Rule的体验。设计、设置和参与者13个流行病学学会分发了一份全国性的基于Web的调查; 2805名受访者访问了调查网站，1527名合格的专业人士匿名回答了问题。主要结果测量与隐私规则实施后的研究延迟和增加的成本，与隐私规则相关的机构审查委员会修改的频率和类型，获得去识别数据和豁免的难度水平、多中心研究的经验以及根据规则感知的参与者隐私益处。受访者排名他们的看法隐私规则的影响力5点李克特scales.Results-共875（67.8%）受访者报告说，HIPAA隐私规则的研究更加困难，在4至5级的李克特量表，其中5表示大量的额外成本和时间来完成研究。共有684（52.1%）的受访者确定了“最受影响”的协议。受访者表示，在机构审查委员会的申请中，隐私规则对人类受试者（参与者）保护产生负面影响的比例明显高于其产生正面影响的比例（P
Context Anecdotal reports suggest that the Health Insurance Portability and Accountability Act Privacy Rule (HIPAA Privacy Rule) may be affecting health research in the United States.Objective To survey epidemiologists about their experiences with the HIPAA Privacy Rule.Design, Setting, and Participants Thirteen societies of epidemiology distributed a national Web-based survey; 2805 respondents accessed the survey Web site and 1527 eligible professionals anonymously answered questions.Main Outcome Measures Responses related influences such as research delays and added cost after Privacy Rule implementation, frequency and type of Privacy Rule related institutional review board modifications, level of difficulty obtaining deidentified data and waivers, experiences with multisite studies, and perceived participant privacy benefits under the rule. Respondents ranked their perceptions of Privacy Rule influence on 5-point Likert scales.Results A total of 875 (67.8%) respondents reported that the HIPAA Privacy Rule has made research more difficult at a level of 4 to 5 on a Likert scale, in which 5 indicates a great deal of added cost and time to study completion. A total of 684 (52.1%) of respondents identified a "most affected" protocol. Respondents indicated that the proportion of institutional review board applications in which the Privacy Rule had a negative influence on human subjects ( participants) protection was significantly greater than the proportion in which it had a positive influence ( P