# Multi-Stakeholder Consensus Approach to Problem Consolidation and Strategic Use of Electronic Health Record (EHR) Data Standards for Clinical Research and Regulatory Reporting

> **NIH FDA U01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $249,856

## Abstract

Project Summary/Abstract
The use of electronic health record (EHR) systems as a source of “real-world data” (RWD) has great potential
to transform and improve research. Despite the potential value and public health need for RWD, the ability to
extract and use data from EHR systems for research is limited due to the absence of clearly defined and
uniformly implemented standards that represent the semantic meaning of clinical data, including the context
and specificity of coding. A particular challenge is that clinical coding systems used for EHR data often have
very granular codes to support documentation of detailed diagnoses and highly specific tests and packaged
medications. These granular codes must be grouped into broad concepts for research analyses and
submissions, but consistent and reproducible data aggregation methods that preserve important semantic
meaning and context of clinical RWD for research purposes are lacking. We propose to use a well-informed
environmental scan, targeted literature review, and a multi-stakeholder group of standards experts to identify
unresolved methodological issues and critical challenges – and delineate alternative approaches for
standardization or harmonization - that can support strategic action for leveraging RWD in the short term and
enable a more robust clinical research infrastructure to support future research needs. The multi-stakeholder
group will include data and standards experts from both clinical informatics and research data standards
communities.

## Key facts

- **NIH application ID:** 10598730
- **Project number:** 1U01FD007673-01
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** RACHEL L RICHESSON
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $249,856
- **Award type:** 1
- **Project period:** 2022-07-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10598730

## Citation

> US National Institutes of Health, RePORTER application 10598730, Multi-Stakeholder Consensus Approach to Problem Consolidation and Strategic Use of Electronic Health Record (EHR) Data Standards for Clinical Research and Regulatory Reporting (1U01FD007673-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10598730. Licensed CC0.

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