discretion (such as fitness trackers). 39 The FDA approach remains useful for our current task because the agency’s risk-based approach to regulation or the exercise of its regulatory discretion should be loosely predictive of harm and liability exposure. 40 Mobile apps and wearables can be roughly divided into two categories: those that are essentially healthcare provider-facing, a greater part of the “digital health” domain, and those that are patient or consumer-facing. 41 The former includes: ( 1) apps providing remote control of medical device or enabling remote display or analysis of data from medical device (connectors); 42 ( 2) apps, wearables, sensors, or attachments providing functions similar to those of currently regulated medical devices (replicators); 43 and ( 3) apps, wearables, or sensors performing patient-specific analysis, diagnosis, or treatment recommendations (automators and customizers). 44 In contrast, consumer apps include: ( 1) apps providing access to health records, 45 ( 2) consumer versions of existing medical devices, 46 ( 3) condition monitoring and management apps, 47 ( 4) fitness trackers and wellness coaches, 48 and ( 5) diagnosis or treatment apps. 49 Obviously, there will be overlaps between the categories. Both patients
39. Id. at 23–26. 40. See id. at 13 (noting the FDA’s intent to “apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.”). 41. See generally U.S. FOOD & DRUG ADMIN., MOBILE MEDICAL APPLICATIONS, http://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/default.htm (discussing the FDA regulations for mobile medical apps and how these apps assist providers and consumers, and also discussing that consumers can use both mobile medical apps and mobile apps so manage their own health and wellness) [hereinafter FDA MEDICAL APPS]. 42. Cortez, supra note 13, at 1182. 43. Id. at 1184. 44. Id. at 1186. 45. See generally Medfusion Launches First Consumer Mobile App to Simplify Healthcare Records, MEDFUSION (Sept. 16, 2015), http://www.medfusion.com/press- releases/medfusion-launches-first-consumer-mobile-app-to-simplify-healthcare-records/. 46. See generally FDA MEDICAL APPS, supra note 41 (stating that, “Mobile medical apps are medical devices that are medical apps, meet the definition of a medical device, and are in accessory to a regulated medical device or transform a mobile platform into a regulated medical device.”). 47. See generally Julie Bird, 7 Mobile Apps for Chronic Condition Management, FIERCE MOBILE HEALTHCARE, (Sept. 25, 2012), http://www.fiercemobilehealthcare.com/slideshows/ 7-mobile-apps-chronic-condition-management (discussing the top consumer mobile apps for chronic condition management). 48. See generally FDA, MEDICAL APPS, supra note 41 (stating that, “Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance.”). 49. See id. (discussing how some apps are used for diagnostic purposes for diagnosing and treating different patient conditions).
