This week, the National Institutes of Health (NIH) and the Office of the National Coordinator for Health IT (ONC) announced the launch of Sync for Science (S4S) to pilot the use of open, standardized applications to enable individuals the ability to contribute their data to research.
The pilot, announced Feb. 25 by NIH, will allow individuals to access their health data and send it to researchers in support of the goals of the Precision Medicine Initiative (PMI). Individual data donation will be a key component of the PMI Cohort Program, which aims to enroll more than one million U.S. participants who will volunteer to donate health data about themselves for precision medicine research.
The details of the S4S pilot were highlighted in a blog post written by Jon White, M.D., ONC’s deputy national coordinator, Josephine Briggs, M.D., interim director, Precision Medicine Initiative Cohort Program and Josh Mandel, M.D., research scientist, Harvard Medical School Department of Biomedical Informatics. ONC, NIH, and the Harvard Medical School Department of Biomedical Informatics will coordinate the implementation of the S4S pilot in collaboration with EHR developers who have committed to participate—Allscripts, athenahealth, Cerner, drchrono, Epic, and McKesson, according to the blog post.
S4S pilot developers will implement a consistent, standards-based workflow, building on open specifications including Health Level 7’s Fast Healthcare Interoperability Resources (FHIR) and OAuth.
“Once developed and implemented, this functionality will allow individuals to connect a research app to their electronic health data, facilitating individual data donation for research and leveraging patients’ access rights under the Health Insurance Portability and Accountability Act (HIPAA). The pilots will also collect information on individual participant preferences on alternative approaches for data donation,” the blog post stated.
White, Briggs and Mandel write that the pilot will not define new standards and specifications but will build on existing open community efforts to support interoperability.
“S4S will build on existing community standards and specification efforts (e.g., FHIR, SMART Health IT, Argonaut, CMS EHR Incentive Program) to support a key use case: giving patients an easy way to share their health data with researchers,” they wrote.
And, White, Briggs and Mandel also note that this work will align with ONC’s strategy to connect and accelerate a FHIR ecosystem.
“Under the hood, the S4S Pilot will use HL7’s FHIR specifications for data models and a REST API and SMART Health IT OAuth profiles for security. Our initial scope of data access and the vocabularies we use are aligned with the Common Clinical Data Set. Many S4S vendors and providers are also participating in the Argonaut Project, which is an ecosystem-wide effort to support the implementation of these same open specifications. S4S will leverage the work conducted by Argonaut, so participating vendors will be able to leverage those efforts for S4S.”
White, Briggs and Mandel write that the pilot has two goals:
- Develop methods to facilitate individually-controlled clinical data donations to the PMI Cohort. “It is important that anyone in the U.S. be able to enroll in the PMI Cohort. This includes the ability to easily share clinical data in a structured electronic format that could eventually enable automated data updates over time.”
- Accelerate and guide the national ecosystem for patient-mediated data access through APIs. Stage 3 of the Medicare and Medicaid EHR Incentive Program requires providers to offer application programming interfaces (APIs) allowing patients to access data via the application of their choice. “The S4S pilot will provide valuable insight into how this requirement can ultimately be implemented across the market.”
When S4S was announced back in February, Francis Collins, M.D., NIH director, said the S4S pilots will demonstrate a “new model of research that enables participants to access their electronic health records (EHRs), control and manage their data, and coordinate their care among their health care providers.”
As previously reported by Healthcare Informatics’ Contributing Editor David Raths, Josh Denny, M.D., a member of the PMI Working Group, detailed the required infrastructure of the PMI in order for individual participants to gather and send their health data to the PMI.
“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.”
The initial focus of the S4S pilot will be a core data set that includes medications, problem lists, and demographics as defined in ONC’s Common Clinical Data Set definition. ONC and NIH expect that future phases of S4S will support methods for sharing other data elements.
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