This document discusses data-driven business models and their legal and regulatory limits. It begins with an overview of big data in healthcare, including definitions and characteristics of big data. It then discusses how companies leverage big data for decision making, operations, and monetization. Common challenges with big data in healthcare are also outlined. The document defines business models and strategies, and describes various data-driven business models like data brokerage and analytics as a service. Finally, it discusses the regulation of data-driven businesses, including GDPR, intellectual property rights, and contracting issues that present legal limits.