The HIPAA privacy rule and protected health information: implications in research involving DICOM image databases.

摘要

Much of the medical imaging community now uses the Digital Imaging and Communication in Medicine (DICOM) format, developed by the American College of Radiology and the National Electrical Manufacturers Association as a standard system for viewing, archiving, retrieving, and transferring images (1). Benefits stem from the fact that a single standard provides physicians practicing within a variety of fields, for different institutions, and working with various technologies the ability to readily share images (2,3). As the DICOM image format was integrated into clinical practice, it was subsequently integrated into clinical research and teaching databases.The DICOM format is a multipart document that contains two layers: the header, typically hidden from view, and the viewable image. Most problematic from the standpoint of patient confidentiality is the identifying information saved in the DICOM header (4). Such information may include patient name, date and time of the exam, participating physicians (ordering, reading), and so on. Image dimensions, pixel spacing, slice thickness, scan time, and other scanning protocols are also saved in the header. Each variable is stored under a standardized data group and element number. An example would be 0010,0030, where the group number, in this case 0010, is the assigned location for much of the patient's personal information, and the element number, 0030, contains the patient's date of birth. Other examples are the group-elementnumbers 0010,0010 as the assigned location for the patient name, and 0018,0050 as the assigned location for the slice thickness.