One of the key goals of the National Institutes of Health’s Precision Medicine Initiative (PMI) is to collect longitudinal health data on 1 million people, much of it through health center networks, but some directly from research participants themselves. To allow individuals to gather and send their health data to PMI, its Working Group envisions the creation of a “Sync for Science” (S4S) application and protocol that would enable participants to acquire and review their EHR data.
Last week Josh Denny, M.D., a member of the PMI Working Group, gave a presentation at Johns Hopkins University’s Division of Health Science Informatics. Denny, who also is an associate professor in the departments of biomedical informatics and medicine at Vanderbilt University Medical Center, detailed the goals and required infrastructure of the PMI.
He said it is relatively easy to imagine how the PMI would get the desired patient data elements from provider organizations. “But it is less easy to figure out how we get them from individual participants.
The components of the EHR that are valuable for phenotyping informs what kind of data we want from participants,” he said. “We can get healthcare claims data from a lot of insurers, but medication data is important, some of which is in claims data, but some may not be, so we need to think about how we get that data.”
He said meaningful use, Stage 2, contains a standard that allows an individual to get access their data and view, download and transmit that data somewhere else. A commonly implemented version of this is the Blue Button technology, which he noted is really more of a download than a transmittal protocol. “Usually this is from a defined point in time, such as the visit you just had,” he explained, but some institutions, namely the VA hospitals, have instituted it as a broad-based download of the EHR data. “We envision Sync for Science as a broader ‘view, download and transmit’ tool that would allow a patient to have their EHR data from a given provider link to another resource, which could be PMI, and as new data accrues in that health system, that data could be synced up to PMI,” Denny said. “Participants would be in control of what those links are, and of course have the ability to cancel the links over time.”
Elements of metadata would be required to support that transmittal process, and a common standard, he said. He pointed to promising efforts such as the Argonaut Project, which uses the HL7 FHIR standard and APIs (application programming interfaces) to share data across institutions in a more robust way than many are doing currently with the standards around Blue Button.
As the PMI Working Group final report states: “Since it will be important to detect and forward clinical data as new medical events occur, a full implementation of the S4S concept will require coordinated action by federal agencies to design and incentivize adoption of EHR technologies that enable individuals to transmit and store their preference for automated data updates to be sent by their providers to the [PMI] Coordinating Center.” The report adds that “there is a need for development of a simple ‘complete medical record ‘electronic format for extraction of the entire collection of structured and unstructured information in an individual’s EHR.” It points to the White House Office of Science and Technology Policy and ONC as positioned to positively encourage the evolution of individually mediated clinical data exchange on a national scale.
“I think a really important part of what we thought about with PMI is how we could empower participants, and this Sync for Science protocol could be something that really empowers patients to get access to their data,” Denny said. “There is a lot to be worked out, but that is part of the role of the Office of the National Coordinator and other federal agencies working together on this project, he explained. “And there was ongoing communication amongst us throughout the project as we thought about what would be needed to allow individuals to meaningfully participate and provide healthcare data to the cohort, but also meaningfully take their clinical data and transport it to other health systems or to have it themselves.”
When the view, download and transmit protocol idea was first introduced, there was lots of grumbling about how difficult it would be to implement. Will health system CIOs who have struggled with view, download and transmit see it as good news that there may be further standards work to enable patients to share their data? Or will they see it as more trouble on the horizon?