Image Data Sharing for Biomedical Research-Meeting HIPAA Requirements for De-identification
Image Data Sharing for Biomedical Research-Meeting HIPAA Requirements for De-identification
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DOI：
10.1007/s10278-011-9422-x
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发表时间：
2012-02-01
影响因子：
4.4
通讯作者：
Jaffe, C. Carl
中科院分区：
文献类型：
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作者：
Freymann, John B.;Kirby, Justin S.;Jaffe, C. Carl
数据共享越来越被认为是跨学科研究和确保科学有效性的关键。尽管美国国立卫生研究院和国家科学基金会的政策鼓励受资助者共享数据，但实际上很少发生临床数据的数据共享。通常给出的一个主要原因是可能无意中违反了《健康保险携带和责任法案》的隐私规定。虽然法规规定了应受保护的私人健康信息的组成部分，但没有普遍接受的方法来去识别临床数据对象（如图像）。这导致机构在数据共享方面采取保守的风险规避立场。在根据医学数字成像和通信（DICOM）标准对图像进行编码的成像试验中，数据对象的复杂性和DICOM标准的灵活性使得满足隐私保护目标特别困难。最近发布的关于图像去识别的DICOM补充142已经消除了大部分这种障碍。本文描述了一个开源软件套件的开发，该软件套件实现了DICOM补充142，作为国家生物医学成像档案馆（NBIA）的一部分。它还描述了作者从NBIA获得的20多个图像集合中吸取的经验教训，其中包括3000多万张图像。
Data sharing is increasingly recognized as critical to cross-disciplinary research and to assuring scientific validity. Despite National Institutes of Health and National Science Foundation policies encouraging data sharing by grantees, little data sharing of clinical data has in fact occurred. A principal reason often given is the potential of inadvertent violation of the Health Insurance Portability and Accountability Act privacy regulations. While regulations specify the components of private health information that should be protected, there are no commonly accepted methods to de-identify clinical data objects such as images. This leads institutions to take conservative risk-averse positions on data sharing. In imaging trials, where images are coded according to the Digital Imaging and Communications in Medicine (DICOM) standard, the complexity of the data objects and the flexibility of the DICOM standard have made it especially difficult to meet privacy protection objectives. The recent release of DICOM Supplement 142 on image de-identification has removed much of this impediment. This article describes the development of an open-source software suite that implements DICOM Supplement 142 as part of the National Biomedical Imaging Archive (NBIA). It also describes the lessons learned by the authors as NBIA has acquired more than 20 image collections encompassing over 30 million images.