FOA Title: 
Request for Information (RFI): Use of the Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR) for Capturing and Sharing Clinical Data for Research Purposes
Grant Type: 
NOT-OD-19-150
Primary IC: 
NIH
Release Date: 
Sep 24 2019
Expiration Date: 
N/A
AC Source: 
N/A
Purpose: 
Request Information RFI): of Health Level Seven International HL7®) Fast Healthcare Interoperability Resources FHIR®) Capturing Sharing Clinical Data Research Purposes Notice Number: NOT-OD-19-150 Key Dates Release Date: September 24, 2019 Response Date: November 23, 2019 Related Announcements NOT-OD-19-122NOT-OD-19-127 NOT-OD-19-014 NOT-OD-18-134 Issued National Institutes Health NIH) Purpose Request Information RFI) to solicit public input how Health Level Seven International HL7®) Fast Healthcare Interoperability Resources FHIR®) standard1 could used capture, integrate, exchange clinical data research purposes to enhance capabilities share research data. Background Once research approved compliant human subjects protections, of FHIR accelerate use clinical data research. FHIR a standardized of transmitting health data one health information system another through application programming interface API). of standard such FHIR accelerate use clinical data research. addition, FHIR provides way structure data generated research a manner fosters interoperability interchange both research clinical data. FHIR benefits relative ease implementation, availability open source implementation tools, considerable industry support, an American National Standards Institute ANSI) consensus development process. is also compatible analytic resources used biomedical research, such R Python. Several Federal health agencies promoting use FHIR electronic health record EHR) systems. 21st Century Cures Act requires a health information technology IT) developer entity allow health information… be accessed, exchanged, used without special effort through use application programming interfaces APIs)… including providing access all data elements a patient's electronic health record." 2 implement provision, Department Health Human Services, Office the National Coordinator Health Information Technology ONC) proposed new rule support seamless secure access, exchange, use electronic health information. 3 Specifically, proposed rule calls the health care industry adopt standardized APIs using FHIR standard share patient data. Concurrently, Centers Medicare amp; Medicaid Services CMS) released proposed rule requirements Medicaid, Children’s Health Insurance Program, Medicare Advantage plans, Qualified Health Plans the federally-facilitated Exchanges provide enrollees immediate electronic access medical claims other health information electronically 2020 adopting implementing openly published APIs. 4 CMS also require health care providers plans implement open data sharing technologies are consistent the FHIR standard ONC’s notice proposed rulemaking NPRM). Both ONC CMS NPRMs also support use specific content vocabulary standards achieve interoperability. FHIR already broadly used health care. of mid-April 2019, approximately third health developers certified under 2015 Edition 5 ONC’s Health Certification Program published they using FHIR API 6 . is estimated approximately 96% hospitals 74% clinicians EHR systems some FHIR API capabilities. addition, federal agencies using FHIR exchange data. example, CMS developed BlueButton 2.0 FHIR API enable exchange claims data software applications 7 . Payors, including CMS, providers working together automate data sharing using FHIR under Da Vinci Project 8 . broader sector also begun adopting FHIR, example, enable individuals import health records providers’ EHR systems to support uploading data cloud-based services. Pharmaceutical companies active FHIR development efforts 9 , including use FHIR integrate clinical trial management EHRs 10 . respective interoperability goals the NPRMs issued ONC CMS align and facilitate of objectives asserted the NIH Strategic Plan Data Science 11 , well NIH’s long-term policy goals data management sharing 12 . Additionally, its 2017-2027 Strategic Plan, 13  NLM proposes technical scientific advances ensure research data Findable, Accessible, Interoperable Re-usable FAIR). 14 with NIH-funded supported research involving human participants, as currently expectation using FHIR, investigators must obtain participant consent following applicable national, tribal, state laws regulations, well relevant institutional policies, the protection human subjects. July 30, 2019, NIH issued notice NOT-OD-19-122) encourage NIH-funded investigators explore use FHIR capture, integrate, exchange clinical data research purposes to enhance capabilities share research data. addition, NIH issued notice NOT-OD-19-127) small business communities announces NIH’s special interest supporting applications use FHIR the development health products services. Information Requested NIH requesting input how FHIR standard be used NIH funded researchers capture integrate patient- population-level data clinical information systems research purposes to it common structure sharing research data. particular, NIH like better understand researchers’ experiences using FHIR, extent which researchers plan do plan use FHIR, tools be needed effectively FHIR, need research regarding standards development, opportunities challenges using FHIR. NIH seeks comments any all the following topics: application the FHIR standard research data, considering: Anticipated challenges Anticipated opportunities Current experiences researchers using FHIR, including where researchers depositing data once FHIR-enabled, extent which researchers plan do plan use FHIR Current experiences researchers using FHIR reasons not using Additional routes which NIH encourage development use FHIR research purposes Ethical, privacy, security considerations using FHIR share research data Tools would assist NIH funded researchers advancing identified opportunities using FHIR Ways NIH stimulate research FHIR-related standards development Any topic may relevant NIH consider encouraging use the FHIR standard research to facilitate interoperability research data Submitting Response Comments should submitted electronically the following webpage: https://datascience.nih.gov/fhir-rfi-submission RFI for planning purposes only should be construed a policy, solicitation applications, as obligation the part the Government provide support any ideas identified response it. Please note the Government not pay the preparation any information submitted for use that information. Responses be compiled shared publicly an unedited version after close the comment period. Please not include any proprietary, classified, confidential, sensitive information your response. Government reserves right use any non-proprietary technical information summaries the state the science, any resultant solicitation(s). NIH use information gathered this RFI inform development future guidance policy directions. look forward your input hope will share RFI your colleagues. Inquiries Please direct inquiries to: Belinda Seto, PhD Office Data Science Strategy National Institutes Health Email: FHIRRFI@nih.gov nbsp; References 1  https://www.hl7.org/fhir/overview.html 2  Section 4002(D)(iv) the 21st Century Cures Act (P.L. 114 – 255) 3  https://www.federalregister.gov/documents/2019/03/04/2019-02224/21st-cen... 4   https://www.federalregister.gov/documents/2019/03/04/2019-02200/medicare... 5   https://www.healthit.gov/topic/certification-ehrs/2015-edition 6   https://chpl.healthit.gov/#/search 7   https://bluebutton.cms.gov/ 8 http://www.hl7.org/about/davinci/ 9    https://transceleratebiopharmainc.com/esource-connectathon-challenge-recap/ 10   https://www.healthleadersmedia.com/innovation/ochsner-and-pfizer-constru... 11   https://datascience.nih.gov/news/nih-releases-strategic-plan-data-science 12   https://osp.od.nih.gov/scientific-sharing/nih-data-management-and-sharin... 13    https://www.nlm.nih.gov/pubs/plan/lrp17/NLM_StrategicReport2017_2027.html 14   https://www.force11.org/group/fairgroup/fairprinciples nbsp; nbsp;