Image Data Sharing for Biomedical Research—Meeting HIPAA Requirements for De-identification

Abstract

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.

What Drives Academic Data Sharing?

“…The sharing of data is restricted by the national privacy acts. In this regard, Freyman et al [91] and Pitt and Tang [30] emphasize the necessity for de-identification as a pre-condition for sharing individual-related data. Pearce and Smith [27] on the other hand state that getting rid of identifiers is often not enough and pleads for restricted access.…”

Personalizing Medicine Through Hybrid Imaging and Medical Big Data Analysis

“…Nevertheless, not all images which can be retrieved using open-i are free to use. Another major source for in vivo medical images is the National Biomedical Imaging Archive (NBIA) which includes clinical and genetic data associated to the images [136].…”

Risks of picture archiving and communication systems

“…Publicly shared archives of image data are an increasingly critical element of cross-disciplinary research, especially for clinical biomedical research where diagnostic images of the spectrum of human disease and its response to therapy are in limited supply, and need to be accessed by multiple different research groups often in varying scientific contexts. Large open-access DICOM image archives for research purposes that can be queried to correlate with specific scientific questions, (such as genetics), will only achieve their valuable scientific potential if there is international confidence in a robust, risk-free framework for de-identification meeting the privacy regulations, as described by Freymann et al 10 When imaging was provided by film and paper reports, the report formed the legal record in the UK and it was recommended that the films also be kept for seven years (except in special categories of patients such as the paediatric and mentally compromised populations where records are held for longer periods). Now that digital image archives can be easily and cheaply stored for long periods of time, questions have been raised as to the necessity, desirability and legality of long-term storage of patient imaging data.…”