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Sync for Genes Phase 2 Pilot Sites Picked to Test Real-World Implementations

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LAS VEGAS (GenomeWeb) – After demonstrating the usefulness of a standard for interchanging genomic data, a federal agency has identified four sites for a second round of pilots in the Sync for Genes program.

The Lehigh Valley Health Network in Pennsylvania, the National Marrow Donor Program, the Utah Newborn Screening Program, and Weill Cornell Medicine will test real-world data transfer between genomic laboratories healthcare providers, researchers, and patients.

The Office of the National Coordinator for Health Information Technology (ONC), the agency within the US Department of Health and Human Services tasked with promoting, planning, coordinating, and setting strategy for health IT and the exchange of health data, announced the pilot sites yesterday at the annual Healthcare Information and Management Systems Society conference, held here this week.

ONC also announced that Mayo Clinic bioinformatician Robert Freimuth, co-chair of clinical genomics for standards developer Health Level Seven International, will serve as technical director of Sync for Genes going forward.

"Phase 1 was really more about furthering the standard," ONC Chief Scientist Teresa Zayas Cabán told GenomeWeb at HIMSS. She said that the work contributed to the current, third version of FHIR Genomics, an add-on component to the HL7 Fast Healthcare Interoperability Resources (FHIR) standard.

"Phase 2 will be more on-the-ground implementation to see how this works," Zayas Cabán said. "We're really interested in making it easier to share genomic results at the point of care."

Sync for Genes is an extension of a data standardization effort called Sync for Science, which itself is part of the US National Institute of Health's All of Us research program. 

In a November report, a Sync for Genes task force recommended that precision medicine be added to the ONC "Interoperability Roadmap," an evolving document first published in 2015 that outlines a path to achieving secure, nationwide health IT data sharing. "Sync for Genes seeks to fulfill another recommendation — to '[i]dentify opportunities for ONC to collaborate with industry and pilot the use of standards to enable data donation and patient access through application programming interfaces (APIs) using standards'" including FHIR, the report said.

For phase 2, the National Marrow Donor Program, which took part in phase 1 in the area of tissue matching, will be working with the Stanford Blood Center in Palo Alto, California. "They are going to try and see if they share human leukocyte antigen and killer-cell immunoglobin receptor next-generation sequencing with Stanford, and then integrate either to a patient portal or an EHR," Zayas Cabán said.

Phase 1 did not include any integration with electronic health records or patient portals.

The Utah Newborn Screening Program will focus on calling data related to newborn genetic screening following the FHIR standard from the Utah Health Information Network to see what data the statewide health information exchange is and is not able to return, according to Zayas Cabán. The program will share data with both patients and integrators, she added.

Lehigh Valley will test FHIR Genomics with data from colorectal cancer screening. "They are really focused on integrating into EHRs, seeing how that works, measuring how that works, and then maybe having that be a use case for other conditions," Zayas Cabán explained.

"Weill Cornell is very much interested in integrating genomic results as part of decision support for a host of conditions," Zayas Cabán continued. ONC right now is helping the New York-based institution narrow the scope of its pilot. "They're also interested in possibly using some of that information to help enroll people in clinical trials as well, so [it's] kind of a research use case," she said.

A year from now, Zayas Cabán hopes to be able to report what ONC and the partners learned about implementation of the FHIR Genomics standard, challenges related to integration and sharing of data, whether the standard might need to be modified, and lessons to share with other organizations looking to share genomic data.

ONC has not decided whether there will be a third phase, however. "We will see where the needs are, particularly for NIH and the All of Us research program," Zayas Cabán said. "They're very interested in not only getting the data into the cohort and the database, but also figuring out how to share that it back with patients, so that will an area to explore."

A kickoff meeting among pilot participants is scheduled for later this month, Zayas Cabán said. It's likely the partners will participate in a connectathon in the fall. Expect the phase 2 tests to run through spring 2019.