The purpose of this ACC guide (InfoPAK) is to provide an overview of opportunities available as a result of Big Data — the ability to collect, process, and interpret massive amounts of information — in healthcare, and the U.S. regulatory regime that is in part driving such industry change. It provides an overview of the key US federal and state laws pertaining to the collection and secondary use of health data, and suggests strategies and best practices for addressing health privacy and data ownership concerns.