Sync for Science, a Pilot Program of the Precision Medicine Initiative, Will Pave Way for Participants to Access and Share Their Health Records
The Precision Medicine Initiative (PMI) Cohort Program aims to enroll more than one million U.S. participants, who will donate health data about themselves for precision medicine research. Of the million participants, 700,000 will be enrolled through through their health providers, but 300,000 are expected to be "Direct Volunteers" who enroll independently.
How will the disparate health records of these Direct Volunteers be obtained, let alone submitted electronically to a single research project?
One approach to answering this question will be Sync for Science, a pilot project being led by DBMI research scientist Joshua Mandel in collaboration with the National Institutes of Health (NIH) and the Office of the National Coordinator for Health IT (ONC). Mandel's co-leads are Jon White M.D., Deputy National Coordinator, ONC; and Josephine Briggs M.D., Interim Director, PMI Cohort Program, NIH.
Working with EHR developers who have committed to participate—Allscripts, athenahealth, Cerner, drchrono, Epic, and McKesson—S4S pilot developers will implement a consistent, standards-based workflow, building on open data specifications such as 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 S4S 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. In Stage 3 of the Medicare and Medicaid EHR Incentive Programs, the Centers for Medicare and Medicaid Services (CMS) requires providers to offer application programming interfaces (APIs) allowing patients to access data via the application of their choice – giving patients more options to view, aggregate, and understand their health data. The S4S pilot will provide valuable insight into how this requirement can ultimately be implemented across the market.
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.
Future impact of the S4S pilot
The potential value proposition for the APIs to be developed and lessons learned from the S4S Pilot could include:
Research Participants: An easier way of contributing to scientific progress and sharing medical records with researchers that doesn’t require faxed forms, delays, or in-person visits.
Researchers: A simple path to receive research participants’ basic clinical data, including essential details like lab results, vital signs, problem lists, medications, and immunizations, potentially increasing participation in studies. Data delivered in a structured format with standard vocabularies may also need less “cleanup” than typical EHR data.
Providers: A way to give patients access to the potential benefit from participating in research studies and a reduction in staff time to support data requests, as they flow automatically through our vendor-supplied patient portal.
EHR Vendors: A method to empower their health care provider customers, to facilitate research, to participate in the development of stronger health care systems, and to meet EHR Incentive Program requirements for API-based patient access.
How is the S4S pilot related to other Federal and community-driven 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. This requires standards and specifications to support this use case, but the pilots aim not to define new standards and specifications. For this reason, the pilots will build on existing open community efforts.
This work will align with ONC’s strategy to connect and accelerate a FHIR ecosystem, leveraging the growing interest in an industry-wide approach to open, standardized APIs in health care.
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.
How can I get involved?
EHR vendors: The easiest way to get up to speed is by joining Argonaut’s free, open Implementation Program. This program will guide you through the basics of supporting FHIR with SMART’s OAuth profiles. As the S4S pilot progresses, we’ll plan to openly publish our UX guidelines, sample code, and documentation for you to build on.
Health care providers: Check with your vendor to see whether they’re involved in S4S. If so, offer to be a pilot site. If not, encourage them to get involved!