Abstract: ObjectiveTo introduce the concept of big data, the characteristic and the effect of medical big data, describe the necessity and feasibility of drug safety monitoring and evaluation by using medical big data, give suggestions on the secondary use of observational data for maximizing the benefit and minimizing the risk of pharmaceutical, and provide thought and references for the promotion of risk management. MethodsSubject study on linking of hospital information system and the national adverse drug reaction monitoring system was conducted, studing the current status and the practical application by using electronic healthcare data for pharmacovigilance in US and EU, compariing and analysing the gap between developed countries and China. The limitations of spontaneous reporting system were summarized, and the opportunities and challenges in medical big data application were analysed. Resultsand ConclusionThe healthcare data is important data resource with the features and the potential value of big data. Spontaneous reporting has inherent limitation, it will be a new way to rational use of medical big data for improving drug safety monitoring and evaluation. We should draw lessons from foreign advanced experience, and further strengthen in ideology, regulations and technology level.

Key words: medical big data, hospital information system, pharmacovigilance, risk management