Data & Quality
FHIR (Fast Healthcare Interoperability Resources)
FHIR is the HL7-published standard, expressed as a RESTful API and resource-based data model, that enables interoperable exchange of structured healthcare data between EHRs, payers, registries, research systems, and patient applications.
FHIR is the foundation of modern EHR-to-research integration. Patient pre-screening, real-world evidence generation, and decentralized trial workflows all rely on FHIR APIs to extract demographics, diagnoses, medications, labs, observations, and clinical notes from EHRs at scale.
Major US EHRs (Epic, Cerner/Oracle, athenahealth, NextGen, eClinicalWorks, ModMed) expose FHIR endpoints under the SMART on FHIR security model. The 21st Century Cures Act and ONC's USCDI v3 mandate make FHIR-based data exchange a regulatory requirement, not just a best practice.
Kitsa's patient pre-screening platform integrates with EHRs over FHIR to apply trial eligibility criteria against real, de-identified patient data within the practice's own security perimeter.
Related terms
EHR Integration (for Clinical Trials)
EHR integration in clinical research is the secure, standards-based connection between an electronic health record system and a clinical-trial application that enables eligibility screening, data abstraction, and source-data verification without manual transcription.
Patient Pre-screening
Patient pre-screening is the process of evaluating individuals against a clinical trial's inclusion and exclusion criteria, before formal screening visits, to identify likely-eligible candidates and reduce screen failure rates.
Real-World Data (RWD) and Real-World Evidence (RWE)
Real-world data (RWD) is healthcare data collected outside the context of a controlled clinical trial; real-world evidence (RWE) is the clinical evidence about an intervention derived from analyzing RWD.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
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