Big Data Clinical Research: Validity, Ethics, and Regulation

摘要: Electronic Health Records (EHR) promise improvement for patient care and also offer great value biomedical research including clinical, public health, health services research. Unfortunately, the full potential of EHR big data has remained largely unrealized. The purpose this study was to identify rate limiting factors, develop recommendations better balance unrestricted extramural access with legitimate safeguarding in retrospective By exploring primary, secondary, tertiary sources, review identifies external constraints provides a comparative analysis social influencers EHR-based Results indicate that EHRs have advantage reflecting reality but show frequency between 4.3-86% incomplete inaccurate various fields. rapid spread alternative analytics challenges traditional interpretations confidentiality protections. A confusing multiplicity controls creates barriers More on use is likely improve accuracy validity. Information governance approval processes should be simplified. Comprehensive regulatory policies do not exclusively cover entities, are needed. Finally, new computing safeguards needed address concerns, like only aggregate individually identifiable information.