Legislation Introduced to Protect Personal Health Data Stored on “Consumer Devices” May Also Extend to FDA “Devices”—Including Hearing Aids

Senators Bill Cassidy (R-LA) and Jacky Rosen (D-NV) introduced The Stop Marketing and Revealing the Wearables and Trackers Consumer Health Data Act on November 14^th to prevent the data mining of personal health data stored on wearable personal devices, such as smartwatches.  However, the language of the bill also indicates that the provisions of the bill may also extend to “a device as defined in section 201 (h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)).  Hearing aids are considered a “device” under this code section.  This is significant because hearing aid technology is expanding to include integrated sensors to trace cognitive health and physical activity.