A 122-page report was published this week by American University and the Center for Digital Democracy that examines features, key players and trends that are emerging in consumer-wearable and connected-health devices–this includes watches, fitness bands, clothing and other products that are linked to app through mobile devices for management of heart rate, sleep patterns and other health concerns. While these devices can certainly be beneficial to consumers, the report warns that the healthcare system is not ready for these devices and harms such as discriminatory profiling, manipulative marketing and security breaches linger. Professor at American University, Kathryn C. Montgomery, Ph.D., said, “There is an urgent need to build meaningful, effective and enforceable safeguards into [the connected healthcare systems’] foundation.” The report calls for the development of a “21^st century” approach to health privacy and consumer protection (i.e., guidelines for the collection and use of data), formal processes for assessing the benefits and risks of using the data collected from these devices, and stronger regulation of pharmaceutical companies marketing to consumer using data from these devices. The report explains that in order to appropriately regulate this area of the healthcare system, the effort will need to move beyond the traditional focus of protecting consumer privacy and address larger societal goals like ensuring fairness, preventing discrimination and promoting equity. Because of the highly sensitive nature of the data collection through these wearable devices, privacy, security and consumer-protection policies “should be held to a much higher standard,” says the report. Jeff Chester, Executive Director of the Center for Digital Democracy, said, “Americans now face a growing loss of their most sensitive information, as their health data are collected and analyzed on a continuous basis, combined with the information about their finances, ethnicity, location and online and off-line behaviors. Policymakers must act decisively to protect consumers in today’s Big Data era.” To read the full report click here.