This report from the U.S. Department of Health and Human Services 1) analyzes the scope of privacy and security protections of an individual’s health information for these new and emerging technology products that are not regulated by HIPAA; 2) identifies key gaps that exist between HIPAA regulated entities and those not regulated by HIPAA; and 3) recommends addressing those gaps in a way that protects consumers while leveling the playing field for innovators inside and outside of HIPAA. (June 2016)