This report addresses the technical aspects of de-identification of medical images of human subjects and biospecimens, such that re-identification risk of ethical, moral, and legal concern is sufficiently reduced to allow unrestricted public sharing for any purpose, regardless of the jurisdiction of the source and distribution sites. All medical images, regardless of the mode of acquisition, are considered, though the primary emphasis is on those with accompanying data elements, especially those encoded in formats in which the data elements are embedded, particularly Digital Imaging and Communications in Medicine (DICOM). These images include image-like objects such as Segmentations, Parametric Maps, and Radiotherapy (RT) Dose objects. The scope also includes related non-image objects, such as RT Structure Sets, Plans and Dose Volume Histograms, Structured Reports, and Presentation States. Only de-identification of publicly released data is considered, and alternative approaches to privacy preservation, such as federated learning for artificial intelligence (AI) model development, are out of scope, as are issues of privacy leakage from AI model sharing. Only technical issues of public sharing are addressed.
翻译:本报告涉及到对人类主体和生物样本的医学图像的去识别的技术方面,使得伦理、道德和法律关注的再识别风险得到充分的减少,从而使得其可以无限制地进行公开共享,而无论源站和分发站所在的法域如何。所有的医学图像,不论其获取方式如何,都应被考虑在内,尤其是那些附带数据元素的图像,特别是以数字成像和通信医学(DICOM)为编码格式的图像。这些图像包括类似于图像的对象,如分段、参数化图和放射治疗(RT)剂量对象。范围还包括相关的非图像对象,如放射治疗结构集、计划和剂量体积直方图、结构化报告和演示状态。仅限考虑公开发布数据的去识别,隐私保护的替代方法,如用于人工智能(AI)模型开发的联合学习,以及来自AI模型共享的隐私泄漏问题,均属于范围以外。仅考虑公共共享的技术问题。