# Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol

> **NIH FDA U01** · RESEARCH TRIANGLE INSTITUTE · 2021 · $99,864

## Abstract

PROJECT SUMMARY/ABSTRACT
Clinical registries play a vital role in aggregating data to monitor diseases, measure and improve healthcare
quality, and assess health outcomes. Despite the value of registries and laboratory data, laboratory results
are typically (and inefficiently) abstracted manually from clinical sites to registries. Even when these data are
electronically exchanged with registries, the process is often cumbersome and not standardized. Without
adequate semantic interoperability, the burden of managing these variations limits the potential for registries
to advance clinical practice, research, and policy-making.
The U.S. Food and Drug Administration (FDA) recognizes the role of registries and the importance of
interoperable laboratory data. The main goal of this cooperative agreement is to advance the semantic
interoperability of laboratory test data exchange between health institutions and registries. Oncology will be
the primary clinical domain for this work. To achieve FDA's objectives, RTI International, Intermountain
Healthcare (IHC), and CancerLinQ (CLQ) (the RTI Team) have the following specific aims:
AIM 1: Evaluate the technical requirements and readiness for electronic health record (EHR) to registry
exchange of laboratory data using Fast Healthcare Interoperability Resources (FHIR). We will take a user-
centered design approach to gather requirements and assess readiness. We will specify the structured
metadata and controlled terminologies, specifically Logical Observation Identifiers Names and Codes
(LOINC), needed in the data exchange. AIM 2: Develop and test the exchange of laboratory data from EHRs
to a registry using FHIR. We will develop a FHIR Implementation Guide (IG) for EHR to registry exchange of
laboratory data, which we will use to deploy software capabilities and conduct pilot tests of FHIR-based
laboratory data exchange between IHC's commercial EHR and the CLQ registry. AIM 3: Test and evaluate
the FHIR IG and system exchange of laboratory data from the EHR to registry using FHIR. We will further
test and evaluate the FHIR IG and system exchange of laboratory data from the EHR to registries in an HL7
Connectathon. We will summarize test findings, recommendations, and the benefits of FHIR-based
laboratory data exchange in a report to FDA.
This project is significant because it addresses the central challenge of laboratory data interoperability by
evaluating key national data standards for exchanging data between clinical systems and registries. The key
innovation is to develop and evaluate the novel, standards-based exchange of laboratory data to registries
using FHIR with pre-harmonized LOINC-coded tests. This project will advance the use of LOINC and FHIR
in laboratory data exchange and inform current FDA and industry laboratory data initiatives, including the
Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) collaborative.

## Key facts

- **NIH application ID:** 10165702
- **Project number:** 5U01FD006933-02
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Daniel Vreeman
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $99,864
- **Award type:** 5
- **Project period:** 2020-06-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10165702

## Citation

> US National Institutes of Health, RePORTER application 10165702, Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (5U01FD006933-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10165702. Licensed CC0.

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