CODE-EHR best-practice framework
The CODE-EHR framework provides guidelines for using structured electronic health records in clinical research. It helps researchers and clinicians design better studies by improving data quality, transparency, and public trust, especially when using routine healthcare data.
At a glance
Use when
Conducting clinical research using routine electronic health records, especially in large-scale or multi-center studies requiring high transparency and methodological rigor
Avoid when
Working with unstructured or highly incomplete EHR data; in settings where stakeholder engagement or data governance frameworks are not feasible
Inputs
Structured electronic health-care records, research study protocols, stakeholder input (patients, clinicians, regulators)
Outputs
Standardized, transparent, and methodologically sound clinical research using EHR data
How it works
The CODE-EHR framework establishes minimum standards for the use of structured electronic health-care records (EHRs) in clinical research. Developed by the European Society of Cardiology and the BigData@Heart consortium with input from international stakeholders—including patients, clinicians, regulators, and industry—it addresses challenges such as data verification, validation, privacy, and public mandate. The framework supports robust study design and methodological transparency in big data-driven clinical research.
- HTA domains
- Clinical Effectiveness, Safety, Organisational aspects
- Assumptions
- Structured EHR data are available and of sufficient quality; stakeholders are engaged in research design; public supports use of health data for research with appropriate safeguards
- Strengths
- Enhances study validity and transparency; incorporates multi-stakeholder perspectives; addresses key ethical and methodological challenges in real-world data use
- Limitations
- Dependent on availability and quality of structured EHR data; may be challenging to implement in healthcare systems with limited digital infrastructure
- Also known as
- CODE-EHR, CODE-EHR framework, CODE-EHR minimum standards framework
Questions this answers
- › How can structured electronic health records be used reliably in clinical research?
- › What standards ensure transparency and validity in EHR-based studies?
- › How can data privacy and public trust be maintained when using routine healthcare data?
- › What are the key methodological pitfalls in using EHR data for research?
- › How can researchers improve the credibility of findings from real-world data?
- › What stakeholder perspectives should be integrated into EHR-based research design?
References & sources
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