Notice Number: NOT-HS-19-020
Key Dates
Release Date: September 9, 2019
None
Issued by
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
Purpose
The purpose of this notice is to encourage the Agency for Healthcare Research and Quality (AHRQ)-funded researchers to explore the use of the Fast Healthcare Interoperability Resources (FHIR ) standard to capture, integrate, and exchange healthcare data for research purposes and to enhance capabilities to share research data.
Background
The Health Level Seven International (HL7®) FHIR is a standard for exchanging health information electronically. FHIR specifies the content of the data exchanged between healthcare applications, and how the exchange is implemented and managed, typically through an application programming interface (API). Software developers can seamlessly connect their application to another through a FHIR API to transmit electronic healthcare data. FHIR enables the exchange of many different healthcare data types such as clinical information, demographics, and billing and claims data.
FHIR is broadly used in healthcare. As of mid-April 2019, approximately one third of developers certified under the 2015 Edition [1] of the Office of the National Coordinator for Health Information Technology's (ONC’s) Health Information Technology (IT) Certification Program published that they are using a FHIR API. [2] It is estimated that approximately 96% of hospitals and 74% of clinicians have electronic health record (EHR) systems with some FHIR API capabilities. In addition, federal agencies are using FHIR to exchange data. For example, the Centers for Medicare & Medicaid Services (CMS) developed the Blue Button 2.0 FHIR API to enable exchange of claims data with software applications.[3] Payors, including CMS, and providers are working together to automate data sharing using FHIR under the Da Vinci Project.[4] 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, [5] including to use FHIR to integrate clinical trial management with EHRs. [6]
AHRQ believes that the use of FHIR in healthcare has gained sufficient momentum to warrant the encouragement of its use for health services research. The FHIR standard could, for example, accelerate the research uses of data collected in the course of clinical care. Toward that end, AHRQ recently partnered with ONC to support and test the development of FHIR specifications for patient-reported outcomes (PROs). The mechanisms to exchange PROs for research purposes using FHIR are now available. Also, AHRQ’s clinical decision support (CDS) initiative has been leveraging FHIR to increase the interoperability of CDS knowledge resources and using FHIR in demonstration projects.[7] The CDS Connect project has developed open source, FHIR-based software packages in clinical domains such as cholesterol management, chronic pain, and preventive care.[8] An open source CDS Authoring Tool is also available that allows researchers and developers to build interoperable CDS logic using FHIR data models.[9]
Through this Notice, AHRQ 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 AHRQ-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.
The National Institutes of Health also released a Notice [10] encouraging its funded researchers to use the FHIR standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data.
[1] https://www.healthit.gov/topic/certification-ehrs/2015-edition
[2] https://chpl.healthit.gov/#/search
[3] https://bluebutton.cms.gov/
[4] http://www.hl7.org/about/davinci/
[5] https://transceleratebiopharmainc.com/esource-connectathon-challenge-recap/
[6] https://www.healthleadersmedia.com/innovation/ochsner-and-pfizer-constructing-digital-superhighway-clinical-trials
[8] https://cds.ahrq.gov/cdsconnect
[9] https://cds.ahrq.gov/cdsconnect/authoring
[10] https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html
Inquiries
Please direct all inquiries to:
Lisa Scott-Morring, MS, MSHS, CRA
Director, Division for Policy, Coordination and Analysis
Agency for Healthcare Research and Quality, HHS
Office of Extramural Research, Education, and Priority Populations
Email: Lisa.Scott-Morring@ahrq.hhs.gov
and Human Services (HHS)
