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  • Washington Highlights

    AAMC Responds to NIH RFI about Using the FHIR Standard for Research

    Anne Berry, Lead Specialist, Implementation Research & Policy

    The AAMC Nov. 22 submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI) about the Use of the Health Level Seven International (HL7®) Fast Healthcare Interoperability Resources (FHIR®) for Capturing and Sharing Clinical Data for Research Purposes.

    In its comments, the AAMC praised the NIH for its efforts to ensure that health information technology (IT) is interoperable and for identifying ways to accelerate the use of clinical data in research. The AAMC noted that the FHIR standard is currently used primarily for clinical care and that its application in research is still relatively new. The comments note that there is a need to study FHIR’s use in research and to identify best practices, “Many are interested in its potential and are aware of FHIR’s use as a solution to interoperability challenges, but additional education and training are needed around what is possible for research.”

    The AAMC also emphasized that simply adopting FHIR will not solve existing data challenges and encouraged the NIH to help advance efforts to ensure there is a standard format for collecting clinical data for research. The comment letter states, “It is critical that the research community develop common data models and standards for using clinical data for research, and that the EHRs capture clinical data according to established standards.”

    In terms of privacy and security considerations related to FHIR, the AAMC noted that safeguards are required to restrict access to patient data and promote the security of patient health information. The AAMC recommends that the NIH “address this security concern by collaborating with other federal health agencies to closely study FHIR’s ability to grant access to only certain specified data, not all data available for the patient.”

    The AAMC also identified several limitations to FHIR’s use in research, including: challenges related to electronic health records (EHR) vendor-level differences in how FHIR is implemented; the additional step required to transform clinical data for research purposes after it is pulled; and that the most common implementation of FHIR enables data pulls only from an EHR for an individual, not for a population.  In addition, as FHIR becomes more widely adopted, the AAMC recommends that the NIH establish a mechanism for researchers to submit feedback about issues they encounter related to FHIR’s use and suggestions for research enhancements.

    The AAMC also recommends that the NIH collaborate with other federal health agencies to ensure that ongoing efforts to promote interoperability are aligned and encourages the NIH to continue to engage the clinical and research communities in discussions around data needs, development of FHIR implementation guides, EHR design, and how FHIR can be used to advance research.