The approach was compiled by a wide range of global stakeholders, coordinated by the BigData@Heart consortium and the European Society of Cardiology.  This included patients and patient advocacy groups, regulators, government agencies and leading medical journals, plus representatives from professional societies, academic institutions, the pharmaceutical industry and payers. Participants convened to review opportunities and challenges and develop pragmatic advice on how healthcare data can be applied to research across the spectrum of disease.

The CODE-EHR framework was iteratively developed to provide researchers with step-by-step guidance on how to achieve appropriate governance and transparency, and for stakeholders to have confidence in the reported findings. Minimum standards are outlined for five key areas, with preferred standards providing the direction for future research:

• Dataset construction and linkage; clarifying the source, completeness and linkage of any healthcare data used in the study.
• Data fit for purpose; providing detail on the coding systems used, any data manipulation, and assessment of data quality.
• Disease outcome and definitions; allowing other researchers to re-use and improve by clearly stating all codes and algorithms used, including those for patient identification, therapy, procedures, comorbidities, and outcomes.
• Analysis; describing how outcome events were analysed to allow for validation and replication.
• Ethics and governance; communicating processes for consent, data privacy, and patient and public involvement.