FOA Title: 
Fast Healthcare Interoperability Resources (FHIR) Standard
Grant Type: 
NOT-OD-19-122
Primary IC: 
NIH
Release Date: 
Jul 30 2019
Expiration Date: 
N/A
AC Source: 
N/A
Purpose: 
Fast Healthcare Interoperability Resources FHIR®) Standard Notice Number: NOT-OD-19-122 Key Dates Release Date: July 30, 2019 Related Announcements NOT-OD-19-014 NOT-OD-18-134 NOT-OD-19-150 Issued OFFICE THE DIRECTOR, NATIONAL INSTITUTES HEALTH OD) Purpose purpose this notice to encourage NIH researchers explore use the Fast Healthcare Interoperability Resources FHIR®) standard capture, integrate, exchange clinical data research purposes to enhance capabilities share research data. Background Once research approved compliant human subjects protections, FHIR format accelerate use clinical data research. FHIR a standardized of transmitting health data one health information system another through application programming interface API). is being widely promoted adopted use clinical care. addition, FHIR provides way structure data generated research a manner protects patient privacy 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 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 developer entity allow health information…to accessed, exchanged, used without special effort through use application programming interfaces APIs)… including providing access all data elements a patient's electronic health record.”[1] To 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.[2]Specifically, proposed rule calls the health care industry adopt standardized APIs using FHIR standard share patient data. Concurrently, Centers Medicare & 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.[3] CMS also require health care providers plans implement open data sharing technologies are consistent the FHIR standard ONC’s notice proposed rulemaking NPRM). Both NPRMs also support use specific content vocabulary standards achieve interoperability. FHIR broadly used health care. of mid-April 2019, approximately third developers certified under 2015 Edition[4] of ONC’s Health Information Technology IT) Certification Program published they using FHIR API.[5] It estimated approximately 96% hospitals 74% clinicians EHR systems some FHIR API capabilities. addition, federal agencies using FHIR exchange data. example, CMS developed Blue Button 2.0 FHIR API enable exchange claims data software applications.[6] Payors, including CMS, providers working together automate data sharing using FHIR under Da Vinci Project.[7] The broader sector also begun adopting FHIR, example, enable individuals import health records providers’ EHR systems to support uploading data cloud-based services. Pharmaceutical companies also active FHIR development efforts,[8] including use FHIR integrate clinical trial management EHRs.[9] FHIR framework accelerate research uses data collected the course clinical care. example, while monitoring cardiovascular, renal, kidney function during experimental evaluation a new therapeutic, query process be established using FHIR framework provide instructions access authorized participant’s electronic health record, extract medication list, vital signs laboratory observations, then transmit information directly a clinical trial management systems other research data repository. respective interoperability goals the NPRMs issued ONC CMS align and facilitate of objectives asserted the NIH Strategic Plan Data Science,[10] as well NIH’s long-term policy goals data management sharing.[11] Additionally, National Library Medicine, its Strategic Plan, 2017-2027,[12] proposes technical scientific advances ensure research data Findable, Accessible, Interoperable Re-usable FAIR) while protecting patient privacy security.[13] number tools technical resources supporting use FHIR clinical care administrative purposes already exist. addition, NIH considering approaches foster development FHIR tools support research uses clinical administrative data. NIH plans issue Request Information solicit input the scientific community other stakeholders the types tools might needed support of FHIR biomedical research, well implementation challenges opportunities foresee using FHIR, including privacy, security, protection patient data. Through notice, NIH encourages funded researchers explore use the FHIR standard capture integrate patient- population-level data clinical information systems research purposes to it common structure sharing research data. with NIH-funded supported research involving human participants, as currently expectation using FHIR, investigators must obtain participant consents follow applicable national, tribal, state laws regulations, well relevant institutional policies, the protection human subjects. about FHIR Health Level Seven International HL7®) FHIR a standardized of transmitting health data one health information system another through API. API a specified set protocols data standards establish ground rules which information system directly communicates another. Software developers seamlessly connect program another computer through FHIR API transmit electronic health data. FHIR enables exchange many different health data types such clinical information, demographics, billing claims data. special relevance, complementary specification, Substitutable Medical Applications, Reusable Technologies SMART) FHIR, enables third party applications apps) access data EHR systems approved purposes, including research. FHIR also specifies of specific coding systems required interoperability health data. 1] Section 4002(D)(iv) the 21st Century Cures Act (P.L. 114 – 255) 2] https://www.federalregister.gov/documents/2019/03/04/2019-02224/21st-cen... 3] https://www.federalregister.gov/documents/2019/03/04/2019-02200/medicare... 4] https://www.healthit.gov/topic/certification-ehrs/2015-edition 5] https://chpl.healthit.gov/#/search 6] https://bluebutton.cms.gov/ 7] http://www.hl7.org/about/davinci/ 8] https://transceleratebiopharmainc.com/esource-connectathon-challenge-recap/ 9] https://www.healthleadersmedia.com/innovation/ochsner-and-pfizer-constru... 10] https://datascience.nih.gov/news/nih-releases-strategic-plan-data-science 11] https://osp.od.nih.gov/scientific-sharing/nih-data-management-and-sharin... 12] https://www.nlm.nih.gov/pubs/plan/lrp17/NLM_StrategicReport2017_2027.html 13] https://www.force11.org/group/fairgroup/fairprinciples Inquiries Please direct inquiries to: Belinda Seto, PhD Office Data Science Strategy Email: setob@mail.nih.gov