Comparative effectiveness research and big data: balancing potential with legal and ethical considerations

Big data holds big potential for comparative effectiveness research. The ability to quickly synthesize and use vast amounts of health data to compare medical interventions across settings of care, patient populations, payers and time will greatly inform efforts to improve quality, reduce costs and deliver more patient-centered care. However, the use of big data raises significant legal and ethical issues that may present barriers or limitations to the full potential of big data. This paper addresses the scope of some of these legal and ethical issues and how they may be managed effectively to fully realize the potential of big data.