Consumer-mediated data exchange for research: Current state of US Law, technology, and trust

Abstract

A compendium of US laws and regulations offers increasingly strong support for the concept that researchers can acquire the electronic health record data that their studies need directly from the study participants using technologies and processes called consumer-mediated data exchange. This data acquisition method is particularly valuable for studies that need complete longitudinal electronic records for all their study participants who individually and collectively receive care from multiple providers in the United States. In such studies, it is logistically infeasible for the researcher to receive necessary data directly from each provider, including providers who may not have the capability, capacity, or interest in supporting research. This paper is a tutorial to inform the researcher who faces these data acquisition challenges about the opportunities offered by consumer-mediated data exchange. It outlines 2 approaches and reviews the current state of provider- and consumer-facing technologies that are necessary to support each approach. For one approach, the technology is developed and estimated to be widely available but could raise trust concerns among research organizations or their institutional review boards because of the current state of US law applicable to consumer-facing technologies. For the other approach, which does not elicit the same trust concerns, the necessary technology is emerging and a pilot is underway. After reading this paper, the researcher who has not been following these developments should have a good understanding of the legal, regulatory, technology, and trust issues surrounding consumer-mediated data exchange for research, with an awareness of what is potentially possible now, what is not possible now, and what could change in the future. The researcher interested in trying consumer-mediated data exchange will also be able to anticipate and respond to an anticipated barrier: the trust concerns that their own organizations could raise.