Krishna Rajeev, Kelleher Kelly, Stahlberg Eric
Columbus Children's Research Institute, Columbus, Ohio 43205, USA.
Am J Public Health. 2007 Apr;97(4):654-8. doi: 10.2105/AJPH.2006.090902. Epub 2007 Feb 28.
Electronic medical record keeping has led to increased interest in analyzing historical patient data to improve care delivery. Such research use of patient data, however, raises concerns about confidentiality and institutional liability. Institutional review boards must balance patient data security with a researcher's ability to explore potentially important clinical relationships. We considered the issues involved when patient records from health care institutions are used in medical research. We also explored current regulations on patient confidentiality, the need for identifying information in research, and the effectiveness of deidentification and data security. We will present an algorithm for researchers to use to think about the data security needs of their research, and we will introduce a vocabulary for documenting these techniques in proposals and publications.
电子病历记录使得人们对分析患者历史数据以改善医疗服务的兴趣日益浓厚。然而,对患者数据的这种研究用途引发了对保密性和机构责任的担忧。机构审查委员会必须在患者数据安全与研究人员探索潜在重要临床关系的能力之间取得平衡。我们考虑了在医学研究中使用医疗机构患者记录时所涉及的问题。我们还探讨了当前关于患者保密的规定、研究中识别信息的必要性以及去识别化和数据安全的有效性。我们将提出一种算法,供研究人员用于思考其研究的数据安全需求,并且我们将引入一种词汇表,用于在提案和出版物中记录这些技术。