The healthcare sector is currently facing a new paradigm, the explosion of “big data”. Coupled with advances in computer technology, the field of “big data” appears promising, allowing us to better understand the natural history of diseases, to follow-up new technologies (devices, drugs) implementation and to participate in precision medicine, etc. Data sources are multiple (medical and administrative data, electronic medical records, data from rapidly developing technologies such as DNA sequencing, connected devices, etc.) and heterogeneous while their use requires complex methods for accurate analysis. Moreover, faced with this new paradigm, we must determine who could (or should) have access to which data, how to combine collective interest and protection of personal data and how to finance in the long-term both operating costs and databases interrogation. This article analyses the opportunities and challenges related to the use of open and/or “big data”, from the viewpoint of pharmacologists and representatives of the pharmaceutical and medical device industry.