information from a device to a recipient, such as a caregiver or healthcare
provider, but often do not deliver any physiological change to the body ( i.e.
cause cardiac muscle to contract). 26 Wearables include devices like the Fitbit,
which measures heartrate, exercise, and sleep data, combining information
an individual enters and information gathered simply by being worn. 27
Wearables usually connect to an external mobile device via a wireless
network or other communication protocol like Bluetooth to transmit data to
a mobile application, an “app.” 28 Mobile apps can receive data from an
implanted device, non-implanted device, or wearable, and can store data
either on the device (thick client) or immediately send data to another
location (thin client). 29 Similar to mobile devices, organizations often design
Web applications to facilitate medical consultations (telehealth or remote
doctor visits), gather personal information, or provide treatment
recommendations based on information gathered from an online Web form. 30
Finally, general administrative IT software or Web applications provide
support to health-related operations. 31 This might include scheduling
software, time reporting and HR management, patient intake, or overall
storage of medical records. 32
Although all devices could pose some risk to patients or consumers,
devices with the highest inherent risk of harm include implanted or affixed
devices. 33 These devices may directly deliver medication or other stimulus to
the human body or gather biological health information directly. 34 When
combined with wearables, mobile apps, or Web applications that are exposed
26. Tyler Hayes, What’s Inside a Fitness Tracker, Anyway?, DIGITAL TRENDS (Nov.
29, 2014, 1:00 PM), http://www.digitaltrends.com/wearables/whats-inside-fitness-trackeany
27. Heather Landi, Health Systems Collaborating with Fitbit to Use Connected Health
Technologies for Research and Patient Engagement, HEALTHCARE INFORMATICS (July 29,
28. See generally FTC, supra note 7.
29. Id.; see Vangie Beal, The Differences Between Thick, Thin & Smart Clients,
WEBOPEDIA (July 14, 2006), http://www.webopedia.com/Did YouKnow/Hardware_Software/
thin_client_applications.asp (distinguishing between thick and thin client applications and
30. See NAT’L RESEARCH COUNCIL, U.S. COMM. ON ENHANCING THE INTERNET FOR
HEALTH APPLICATIONS, NETWORKING HEALTH: PRESCRIPTIONS FOR THE INTERNET 194–95
31. The 20 Most Popular EMR Software Solutions, CAPTERRA, http://www.capterra.com/
infographics/top-emr-software (last visited Oct. 13, 2016).
32.To p Electronic Medical Records (EMR) Software Products, CAPTERRA, http://www.
capterra.com/electronic-medical-records-software/ (last visited Oct. 13, 2016).
33. Food and Drug Administration Safety and Innovation Act § 618, infra 124; GENERAL
WELLNESS, infra 144.
34. Implants and Prosthetics, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/Medical
Devices/ProductsandMedicalProcedures/ImplantsandProsthetics/ (last visited Oct. 13, 2016).