At DIA2016, a panel discussion with experts from regulatory, academic research, industry and information technology explored the health care industry’s next beachhead: Europe and the US: Making Outcomes-Based Health Care Possible. Panelists focused on the topics of clinical data, real-world data, and their relationships to evidence that more adequately address questions of value to support this value-based wave of change. “I would argue that randomized clinical trials, our so-called ‘gold standard,’ will only show you the tip of the iceberg,” said DIA 2016 Co- Chair Dr. Hans-Georg Eichler. Moderator:  Duane Schulthess, Managing Director, VitalTransformation. Featured Speakers:  Dr. Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU; Dr. Gigi Hirsch, Executive Director, MIT Center For Biomedical Innovation; Richard Bergström, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA); and Steve Rosenberg, Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle Health Sciences.