ABSTRACT
Online public repositories for sharing research data allow investigators to validate existing research or perform secondary research without the expense of collecting new data. Patient data made publicly available through such repositories may constitute a breach of personally identifiable information if not properly de-identified. Imaging data are especially at risk because some intricacies of the Digital Imaging and Communications in Medicine (DICOM) format are not widely understood by researchers. If imaging data still containing protected health information (PHI) were released through a public repository, a number of different parties could be held liable, including the original researcher who collected and submitted the data, the original researcher's institution, and the organization managing the repository. To minimize these risks through proper de-identification of image data, one must understand what PHI exists and where that PHI resides, and one must have the tools to remove PHI without compromising the scientific integrity of the data. DICOM public elements are defined by the DICOM Standard. Modality vendors use private elements to encode acquisition parameters that are not yet defined by the DICOM Standard, or the vendor may not have updated an existing software product after DICOM defined new public elements. Because private elements are not standardized, a common de-identification practice is to delete all private elements, removing scientifically useful data as well as PHI. Researchers and publishers of imaging data can use the tools and process described in this article to de-identify DICOM images according to current best practices.
Subject(s)
Biomedical Research , Computer Security , Confidentiality , Radiology Information Systems , Humans , SoftwareABSTRACT
PURPOSE: The ongoing lack of data standardization severely undermines the potential for automated learning from the vast amount of information routinely archived in electronic health records (EHRs), radiation oncology information systems, treatment planning systems, and other cancer care and outcomes databases. We sought to create a standardized ontology for clinical data, social determinants of health, and other radiation oncology concepts and interrelationships. METHODS AND MATERIALS: The American Association of Physicists in Medicine's Big Data Science Committee was initiated in July 2019 to explore common ground from the stakeholders' collective experience of issues that typically compromise the formation of large inter- and intra-institutional databases from EHRs. The Big Data Science Committee adopted an iterative, cyclical approach to engaging stakeholders beyond its membership to optimize the integration of diverse perspectives from the community. RESULTS: We developed the Operational Ontology for Oncology (O3), which identified 42 key elements, 359 attributes, 144 value sets, and 155 relationships ranked in relative importance of clinical significance, likelihood of availability in EHRs, and the ability to modify routine clinical processes to permit aggregation. Recommendations are provided for best use and development of the O3 to 4 constituencies: device manufacturers, centers of clinical care, researchers, and professional societies. CONCLUSIONS: O3 is designed to extend and interoperate with existing global infrastructure and data science standards. The implementation of these recommendations will lower the barriers for aggregation of information that could be used to create large, representative, findable, accessible, interoperable, and reusable data sets to support the scientific objectives of grant programs. The construction of comprehensive "real-world" data sets and application of advanced analytical techniques, including artificial intelligence, holds the potential to revolutionize patient management and improve outcomes by leveraging increased access to information derived from larger, more representative data sets.