Morris Marilyn C, Mechem C Crawford, Berg Robert A, Bobrow Bentley J, Burns Starla, Clark Lani, De Maio Valerie J, Kusick Monique, Richmond Neal J, Stiell Ian, Nadkarni Vinay M
Department of Pediatrics, Division of Pediatric Critical Care, The Children's Hospital of New York-Presbyterian, Columbia University, New York, New York 10032, USA.
Prehosp Emerg Care. 2007 Jul-Sep;11(3):272-7. doi: 10.1080/10903120701348123.
The Privacy Rule, a follow-up to the Health Insurance Portability and Accountability Act, limits distribution of protected health information. Compliance with the Privacy Rule is particularly challenging for prehospital research, because investigators often seek data from multiple emergency medical services (EMS) and receiving hospitals.
To describe the impact of the Privacy Rule on prehospital research and to present strategies to optimize data collection in compliance with the Privacy Rule. Methods. The CanAm Pediatric Cardiopulmonary Arrest Study Group has previously conducted a multicentered observational study involving children with out-of-hospital cardiac arrest. In the current study, we used a survey to assess site-specific methods of compliance with the Privacy Rule and the extent to which such strategies were successful.
The previously conducted observational study included collection of data from a total of 66 EMS agencies (range of 1-37 per site). Data collection from EMS providers was complicated by the lack of a systematic approval mechanism for the research use of EMS records and by incomplete resuscitation records. Agencies approached for approval to release EMS data for study purposes included Department of Health Institutional Review Boards, Fire Commissioners, and Commissioners of Health. The observational study included collection of data from a total of 164 receiving hospitals (range of 1-63 per site). Data collection from receiving hospitals was complicated by the varying requirements of receiving hospitals for the release of patient survival data.
Obtaining complete EMS and hospital data is challenging but is vital to the conduct of prehospital research. Obtaining approval from city or state level IRBs or Privacy Boards may help optimize data collection. Uniformity of methods to adhere to regulatory requirements would ease the conduct of prehospital research.
隐私规则是《健康保险流通与责任法案》的后续规定，限制了受保护健康信息的传播。对于院前研究而言，遵守隐私规则极具挑战性，因为研究人员常常需要从多个紧急医疗服务（EMS）机构和接收医院获取数据。
描述隐私规则对院前研究的影响，并提出符合隐私规则优化数据收集的策略。方法。美加儿科心肺骤停研究小组此前开展了一项多中心观察性研究，涉及院外心脏骤停儿童。在本研究中，我们通过一项调查评估了各研究点遵守隐私规则的具体方法以及这些策略的成功程度。
之前进行的观察性研究共收集了来自66个EMS机构的数据（每个研究点1 - 37个）。由于缺乏针对EMS记录用于研究的系统审批机制以及复苏记录不完整，从EMS提供者处收集数据变得复杂。为研究目的申请批准发布EMS数据的机构包括卫生部机构审查委员会、消防专员和卫生专员。观察性研究共收集了来自164家接收医院的数据（每个研究点1 - 63个）。由于接收医院对患者生存数据发布的要求各不相同，从接收医院收集数据也变得复杂。
获取完整的EMS和医院数据具有挑战性，但对于院前研究的开展至关重要。获得城市或州一级的机构审查委员会或隐私委员会的批准可能有助于优化数据收集。遵守监管要求的方法的一致性将便于院前研究的开展。
