Notice Number: NOT-OD-19-122
Key Dates
Release Date: July 30, 2019
NOT-HL-20-815
NOT-OD-19-014
NOT-OD-18-134
NOT-OD-19-150
NOT-OD-20-146
NOT-HL-21-010
Issued by
OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH (OD)
Purpose
The purpose of this notice is to encourage NIH researchers to explore the use of the Fast Healthcare Interoperability Resources (FHIR ) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data.
Background
Once research is approved and compliant with human subjects protections, the FHIR format can accelerate the use of clinical data for research. FHIR is a standardized way of transmitting health data from one health information system to another through an application programming interface (API). It is being widely promoted and adopted for use in clinical care. In addition, FHIR provides a way to structure data generated from research in a manner that protects patient privacy and fosters interoperability and interchange of both research and clinical data. FHIR benefits from relative ease of implementation, availability of open source implementation tools, considerable industry support, and an American National Standards Institute consensus development process. It is also compatible with analytic resources used in biomedical research, such as R and Python.
Several Federal health agencies are promoting the use of FHIR in electronic health record (EHR) systems. The 21st Century Cures Act requires that a health information technology developer or entity allow health information to be accessed, exchanged, and used without special effort through the use of application programming interfaces (APIs) including providing access to all data elements of a patient's electronic health record. [1] To implement this provision, the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology (ONC) has proposed a new rule to support seamless and secure access, exchange, and use of electronic health information.[2]Specifically, the proposed rule calls on the health care industry to adopt standardized APIs by using the FHIR standard to share patient data.
Concurrently, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule with requirements for Medicaid, the Children’s Health Insurance Program, Medicare Advantage plans, and Qualified Health Plans in the federally facilitated exchanges to provide enrollees with immediate electronic access to medical claims and other health information electronically by 2020 by adopting and implementing openly published APIs.[3] CMS would also require these health care providers and plans to implement open data sharing technologies that are consistent with the FHIR standard in ONC’s notice of proposed rulemaking (NPRM). Both NPRMs also support the use of specific content and vocabulary standards to achieve interoperability.
FHIR is broadly used in health care. As of mid-April 2019, approximately one third of developers certified under the 2015 Edition[4] of ONC’s Health Information Technology (IT) Certification Program published that they are using a FHIR API.[5] It is estimated that approximately 96% of hospitals and 74% of clinicians have EHR systems with some FHIR API capabilities. In addition, federal agencies are using FHIR to exchange data. For example, CMS developed the Blue Button 2.0 FHIR API to enable exchange of claims data with software applications.[6] Payors, including CMS, and providers are working together to automate data sharing using FHIR under the Da Vinci Project.[7] The broader IT sector has also begun adopting FHIR, for example, to enable individuals to import their health records from providers EHR systems or to support the uploading of data to cloud-based services. Pharmaceutical companies are also active in FHIR development efforts,[8] including to use FHIR to integrate clinical trial management with EHRs.[9]
The FHIR framework could accelerate the research uses of data collected in the course of clinical care. For example, while monitoring cardiovascular, renal, and kidney function during the experimental evaluation of a new therapeutic, a query process could be established using the FHIR framework to provide instructions to access an authorized participant’s electronic health record, extract the medication list, vital signs and laboratory observations, and then transmit this information directly into a clinical trial management systems or other research data repository.
The respective interoperability goals of the NPRMs issued by ONC and CMS align with and facilitate many of the objectives asserted in the NIH Strategic Plan for Data Science,[10] as well as NIH’s long-term policy goals for data management and sharing.[11] Additionally, the National Library of Medicine, in its Strategic Plan, 2017-2027,[12] proposes technical and scientific advances to ensure that research data are Findable, Accessible, Interoperable and Re-usable (FAIR) while protecting patient privacy and security.[13]
A number of tools and technical resources supporting the use of FHIR for clinical care and administrative purposes already exist. In addition, NIH is considering approaches to foster development of FHIR tools to support research uses of clinical and administrative data. NIH plans to issue a Request for Information to solicit input from the scientific community and other stakeholders about the types of tools that might be needed to support use of FHIR in biomedical research, as well as implementation challenges and opportunities they foresee in using FHIR, including privacy, security, and protection of patient data.
Through this notice, NIH encourages funded researchers to explore the use of the FHIR standard to capture and integrate patient- and population-level data from clinical information systems for research purposes and to use it as common structure for sharing research data. As with all NIH-funded or supported research involving human participants, and as is currently the expectation using FHIR, investigators must obtain participant consents and follow applicable national, tribal, and state laws and regulations, as well as relevant institutional policies, for the protection of human subjects.
More about FHIR
The Health Level Seven International (HL7 ) FHIR is a standardized way of transmitting health data from one health information system to another through an API. An API is a specified set of protocols and data standards that establish the ground rules by which one information system directly communicates with another. Software developers can seamlessly connect their program to another computer through a FHIR API to transmit electronic health data. FHIR enables the exchange of many different health data types such as clinical information, demographics, and billing and claims data. Of special relevance, a complementary specification, Substitutable Medical Applications, Reusable Technologies (SMART) on FHIR, enables third party applications (or apps) to access the data in EHR systems for approved purposes, including research. FHIR also specifies many of the specific coding systems required for interoperability of health data.
[1] Section 4002(D)(iv) of the 21st Century Cures Act (P.L. 114 255)
[2] https://www.federalregister.gov/documents/2019/03/04/2019-02224/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification
[3] https://www.federalregister.gov/documents/2019/03/04/2019-02200/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-and
[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-constructing-digital-superhighway-clinical-trials
[10] https://datascience.nih.gov/news/nih-releases-strategic-plan-data-science
[11] https://osp.od.nih.gov/scientific-sharing/nih-data-management-and-sharing-activities-related-to-public-access-and-open-science/
[12] https://www.nlm.nih.gov/pubs/plan/lrp17/NLM_StrategicReport2017_2027.html
[13] https://www.force11.org/group/fairgroup/fairprinciples
Inquiries
Please direct all inquiries to:
Belinda Seto, PhD
Office of Data Science Strategy
Email: [email protected]
and Human Services (HHS)
