Much of the focus on FHIR is on its potential to relieve interoperability woes in clinical care settings. But healthcare researchers also are working on ways to adopt the new data standard. In July, the National Institutes of Health (NIH) issued a notice encouraging NIH-funded researchers to use FHIR-compatible data formats to help accelerate the interoperability of data and its use for clinical research purposes.
In September the NIH also awarded two contracts related to the use of FHIR in biomedical research. Stating that NIH would like to develop and test FHIR tools for researchers and advance the sharing of phenotypic information using the FHIR standard, it announced these two grants:
Vanderbilt University Medical Center (VUMC) in Nashville, Tenn., will develop and test FHIR tools for researchers to increase the availability of high-quality, standardized research data sets. VUMC will focus on tools that can extract data from electronic health records to be used for research and that can map research data to the FHIR format. The Broad Institute, a host of the Global Alliance for Genomics and Health (GA4GH), in Boston, will develop and test a FHIR profile to increase the availability of high-quality, standardized phenotypic information for genomic research and genomic medicine. Applying the FHIR standard to phenotypic information can accelerate the use of this type of data for research.
During an Oct. 8 webinar, Clem J. McDonald, M.D., chief health data standards officer at the NIH’s National Library of Medicine, and Teresa Zayas-Caban, Ph.D., chief scientist for the Office of the National Coordinator for Health Information Technology, discussed some of the ways researchers are starting to take advantage of FHIR.
Research opportunities for FHIR
McDonald outlined some of the research opportunities FHIR might allow. Researchers could gather study patient data by using FHIR to pull that data out of the medical record. “You can query individual patient’s medical record for study data one at a time using FHIR queries, and there is a bulk download will allow pulling a whole cohort at regular intervals to follow consented patients,” he said, adding that there may be complexities and obstacles related to patient matching, consents and other built-in system permissions.
Also, FHIR could help standardizing study data for sharing. “NIH has pushed to get more sharing of existing research data,” he said. “If everyone used the FHIR observation structure to store data, that will go a long way.”
McDonald noted several developments going on involving FHIR and genomics:
● FHIR Clinical Genomics Working Group is getting ready to publish a specification for defining detailed, structured genetics reports in FHIR.
● FHIR Phenopacket, which he described as a “clever way to summarize the genetic data implying a phenotype.
● FHIR and eMerge is another version of the genomics work, but it is not quite done yet, he said.
● M-Code is a FHIR specification specialized for cancer.
McDonald also pointed to some policy changes requiring FHIR’s use that could benefit researchers. CMS has said payers must use a FHIR-based API to provide patients and their providers access to the claims data and any clinical data they carry. (Some payers carry all outpatient lab results, and payer data is linked.) “That is nice from the perspective of research because that data is already linked across many institutions,” McDonald said, adding that the TEFCA network of networks, although in its early stages, could have special potential benefit to researchers. “For consented patients, you could reach out to all systems and pull data in, and and in theory, you could also follow a patient even after a study has ended.”
He pointed to several groups already active with FHIR, including:
● General Biomedical Research and Regulation (BR&R), a workgroup focused on regulated research.
● Pfizer-Ochsner collaboration to connect EHRs and clinical trial systems.
● TransCelerate Biopharma (20 Big Pharma companies active in FHIR).
● CTSA, a big consortium of NIH-funded translational researchers.
ONC’s Teresa Zayas-Caban spoke about why NIH is so interested in FHIR. NIH sees data standards as key to interoperability and reusability of data, she said. “This is all taking place in the context of NIH’s broader interest in data science. NIH published a strategic plan for data science last year and outlined goals for connecting data systems, enabling robust storage and data sharing, increasing data management and analytics capabilities, and implementing good stewardship of policies regarding data and data use,” Zayas-Caban added. “They also espouse fair data principles, which include good interoperability and reusability. They really see the use of data standards in research as helping NIH advance its goals of data science and open science.”
Both ONC and CMS have proposed to use FHIR as the standard for application programming interfaces to enable electronic exchange of health information. The standard is already being broadly developed, Zayas-Caban noted. There also is interest by pharma and other parts of the healthcare sector. “NIH really saw an opportunity to use FHIR not only to pull data from EHRs for research but to share research data,” she stressed.
At the end of July NIH published two notices: the first was meant to encourage NIH investigators to explore the use of FHIR to capture and exchange data for clinical research purposes, as well as to enhance capabilities to share research data sets in standardized form. The second was a notice of special interest to inform the small-business community of its interest in supporting applications that use FHIR in health IT applications for a variety of purposes. “This is really a unique opportunity to bring together the development community and the research community to capitalize on this standard for research purposes,” she said, “and develop applications that support functionalities of interest to researchers.”
