Whitepapers on Imaging Infrastructure for Research Part Three: Security and Privacy

This is the third part of three describing an extension of the process for developing a clinical research project including the use of in vivo imaging data. The high-level process diagram for development of a research project including images is shown in Fig. 1. In part two of this series, data management requirements and practices for including images were described. This part describes the security and privacy requirements for supporting images used in research. Fig. 1 Process diagram including the workflow steps required for imaging infrastructure for research An important point that the authors wish to make is that imaging information is nearly always not simply an additional data point. The inclusion of imaging data results in many additional complexities that can lead to unintended or unrecognized biases and errors. For that reason, it is critical that imaging experts be involved in studies that rely on imaging data. That involvement is required during the conception and design of the experiment, the data collection phase, and the data analysis phase. Some of those challenges that are present when imaging data is used in research will be further defined in this paper. The proper collection of imaging data for research use demands monitoring that can be made better and more efficient than current manual methods. How measurements are extracted from the raw images and represented is a critical step that entails its own set of challenges. Finally, there are some unique and common security issues when images are used for research. Security and Privacy Issues Research consortiums and multi-site trials are increasingly a reality in the healthcare and research enterprise. In addition, there is increasing incentive and/or requirement for federally funded research projects to share the data collected and generated as part of the research plan. As the amount of data being collected increases in volume and complexity, the necessity of data-sharing infrastructure becomes obvious. With the implementation of formal data-sharing mechanisms comes the requirement of secure data sharing, both to protect subject privacy, as well as to provide investigator interests. Research image sharing scenarios face the same challenges as those for the generic data-sharing scenario. At the current time, however, there exists a gap in a researcher, an institution, or a research project’s ability to provide common infrastructure to support secure image sharing in a research scenario. In this part, the authors investigate the security requirements of the research imaging workflow outlined in part 1. While a significant emphasis will be placed on the security requirements of image sharing, it should be noted that data acquisition as well as analysis and result management also have significant security requirements and implications. The objective of summarizing these security requirements is to provide general guidance in the design and implementation of a secure image sharing system and to motivate research organizations and funding agencies in their consideration of data security issues in collaborative research. The paper is organized as follows. The first section reviews the research workflow outlined in part 1 and identifies the specific component of the research workflow whose security concerns this paper focuses on. The next section outlines relevant regulations and policies that impacts secure image data sharing. Next, a high-level overview of the specific capabilities required to support secure data sharing is presented. The next section discusses the security requirements of different general data-sharing scenarios. The final section lists the current available standards and technologies and gaps that might be applied to address some of the requirements we outline.