De-identification of Medical Images with Retention of Scientific Research Value.

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.

Collecting 48,000 CT exams for the lung screening study of the National Lung Screening Trial.

From 2002-2004, the Lung Screening Study (LSS) of the National Lung Screening Trial (NLST) enrolled 34,614 participants, aged 55-74 years, at increased risk for lung cancer due to heavy cigarette smoking. Participants, randomized to standard chest X-ray (CXR) or computed tomography (CT) arms at ten screening centers, received up to three imaging screens for lung cancer at annual intervals. Participant medical histories and radiologist-interpreted screening results were transmitted to the LSS coordinating center, while all images were retained at local screening centers. From 2005-2007, all CT exams were uniformly de-identified and delivered to a central repository, the CT Image Library (CTIL), on external hard drives (94%) or CD/DVD (5.9%), or over a secure Internet connection (0.1%). Of 48,723 CT screens performed, only 176 (0.3%) were unavailable (lost, corrupted, compressed) while 48,547 (99.7%) were delivered to the CTIL. Described here is the experience organizing, implementing, and adapting the clinical-trial workflow surrounding the image retrieval, de-identification, delivery, and archiving of available LSS-NLST CT exams for the CTIL, together with the quality assurance procedures associated with those collection tasks. This collection of CT exams, obtained in a specific, well-defined participant population under a common protocol at evenly spaced intervals, and its attending demographic and clinical information, are now available to lung-disease investigators and developers of computer-aided-diagnosis algorithms. The approach to large scale, multi-center trial CT image collection detailed here may serve as a useful model, while the experience reported should be valuable in the planning and execution of future equivalent endeavors.