Table 1.
Healthcare Data Standards and Models for Clinical Research and Regulatory Frameworks
| Organization/Collaborative Groups | Standards/Models | Description | Example |
|---|---|---|---|
| Observational Health Data Sciences and Informatics | OMOP | A common data model that standardizes diverse health data (e.g., claims, health records, etc.) for large-scale research analytics | Using OMOP to integrate data from multiple hospitals to analyze risk of kidney failure with anti-VEGF exposure24 |
| CDISC (Clinical Data Interchange Standards Consortium) | CDISC Standards | Develops global data standards to streamline clinical trial data and ensure data interoperability and FDA preferred submission format | Conducting a multi-center clinical trial for a new diabetic retinopathy drug, ensuring data consistency across sites using CDISC standards |
| HL7 (Health Level Seven International) | FHIR (Fast Healthcare Interoperability Resources) | A standard for electronic health information exchange and analytics using EHR data | Seamlessly transferring a patient's detailed DRD treatment history from a primary care physician to a specialist using FHIR |
| DICOM (Digital Imaging and Communications in Medicine) | DICOM (Digital Imaging and Communications in Medicine) | A standard for handling, storing, transmitting, and viewing medical imaging information | Using DICOM standards to store, retrieve, and share OCT scans from multiple machines in a vendor neutral imaging platform |
| LOINC (Logical Observation Identifiers Names and Codes) Regenstrief Institute | LOINC (Logical Observation Identifiers Names and Codes) | A clinical terminology and international standard for coding and describing clinical and laboratory observations | Recording and sharing standardized lab results, such as HbA1c levels, across different healthcare systems using LOINC codes |
| SNOMED International (Systematized Nomenclature of Medicine) | SNOMED CT (Systematized Nomenclature of Medicine Clinical Terms) | A comprehensive clinical healthcare terminology including diseases, symptoms, procedures, and other medical concepts | Documenting patient records with standardized terms for various stages of DRD and macular edema, using SNOMED CT |
| WHO (World Health Organization) | ICD (International Classification of Diseases) | A diagnostic tool for classification of diseases. Primarily used for insurance reimbursement and for public health tracking | Healthcare providers use ICD codes to classify and report cases of diabetic retinopathy; e.g. ICD-10-CM Diagnosis Code E11. 329: Type 2 diabetes mellitus with mild non proliferative diabetic retinopathy without macular edema |
| AMA (American Medical Association) | CPT (Current Procedural Terminology) Codes | Provides codes for medical procedures and services. Primarily used for insurance reimbursement | Coding procedures like retinal laser therapy or intravitreal injections for diabetic retinopathy treatment using CPT codes |