Research is evolving from considering patients as subjects to be studied to partners who are actively engaged in many aspects of the research. That engagement can be increased when people are in a position to choose to participate actively in research and donate their data. The NIH Precision Medicine Initiative is setting the pace for this new era of relationships between scientists and study participants. The challenge is that people have not been in a position to donate their data because they have had limited access to the data. Moreover, when data have been available, they have been in formats that often require manual entry.
A new initiative led by Harlan Krumholz, MD, SM, the Harold H. Hines, Jr. Professor of Medicine and director of the Yale Center for Outcomes Research and Evaluation (CORE), is developing HUGO PHR, a personal health platform that will empower people with their own data and put them in a position to leverage the data for their clinical care as well as participate actively with researchers. Developed in partnership with Yale New Haven Health System, HUGO is a cloud-based highly secure personal health platform that can be autopopulated and updated with data and images from the EHR, as well as receive data from wearable devices and other sources. When available to Yale patients in 2016, HUGO will be free of charge, and easily accessible via the Internet and on mobile devices. It conforms to new standards and can be easily applied regardless of the electronic health record vendor.
HUGO offers an efficient way to:
•Match individuals to clinical studies.
•Move data to researchers with participants’ authorization.
•Ensure that patients are vital components of the research process.
•Enable researchers to communicate easily with participants and share study data and results.
•Provide a conduit for patient-generated data from patient-reported outcome measures and wearable devices.
YCCI is helping Krumholz and his team assess the suitability of integrating HUGO in clinical research studies as well as evaluate the system with feedback from the IRB, the Yale New Haven Health System, the informatics team, community organizations, and patient representatives. If successful, HUGO has the potential to be adopted readily by other CTSA sites and academic medical centers.
HUGO could mark the end of an era in which patients are simply research subjects who never learn about study results or how their data were used, said Krumholz. “They will be the ones who make the decision to partner with us; to share their data; and to help us work together to generate the knowledge that will help them and the people that will follow them.”