The intense competition that accompanied the growth of internet-based companies ushered in the era of 'big data' characterized by major innovations in processing of very large amounts of data and the application of advanced analytics including data mining and machine learning. Healthcare is on the cusp of its own era of big data, catalyzed by the changing regulatory and competitive environments, fueled by growing adoption of electronic health records, as well as efforts to integrate medical claims, electronic health records and other novel data sources. Applying the lessons from big data pioneers will require healthcare and life science organizations to make investments in new hardware and software, as well as in individuals with different skills. For life science companies, this will impact the entire pharmaceutical value chain from early research to postcommercialization support. More generally, this will revolutionize comparative effectiveness research.