This panel will focus on a multijurisdictional study commissioned by the CNIL in 2014 to examine the regulation of the ‘quantified self’, including wearable health devices. The panel will discuss the approaches of various jurisdictions to the definition of ‘health data’, and whether all health data are or should be considered sensitive. The panel will discuss the interface between the regulation of medical devices and data protection regulation, highlighting enforcement action in the U.S., the role of app stores and self-regulatory initiatives. The panel will examine possible alternative approaches to regulating connected health devices, including self-regulatory initiatives and risk-based approaches. What you’ll take away: · Understand the different definitions of ‘health data’ in European jurisdictions · Understand the relationship between medical device regulation and data protection regulation · Learn about enforcement actions and self-regulatory initiatives involving connected health devices · Hear from the regulators their ideas for reform