enabling clinicians to view scans and other biometric readings, and/or act as wireless remote controls for medical devices, raising the possibility of patient injuries. 29 “Replicators” turn “the smartphone or tablet itself into a medical device” using “attachments or sensors to send data directly to the smartphone, which then processes and displays the results,” and in some cases recommends, diagnoses or provides treatment options. 30 “Automators” and “customizers” use surveys, algorithms, and the like to aid clinical decision- making but could lead to faulty diagnosis or treatment decisions. 31 “Informers” and “educators,” which make up a significant portion of the hundreds of mobile health apps now on the market, are digital versions of resources that are also available in print or would have been in the past. 32 “Administrators” are the mobile health equivalent of practice management software—to the extent that they are confined to scheduling patient appointments and performing billing functions; there would not appear to be any significant liability concerns regarding administrator apps. 33 Yet, as they start to incorporate automator and customizer functions to triage patients for appointments, 34 they could expose healthcare providers to liability. 35 “Loggers” and “trackers” allow users to record and analyze information about their diet, physical activity, sleep patterns, and so on. 36 The FDA has its own, somewhat less transparent mobile health app typology, suggesting ten types of apps in recently-published guidance for the medical application industry and FDA. 37 That guidance identified mobile apps that could be regulated under section 201(h) of the Federal Food, Drug, and Cosmetic Act either “as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.” 38 The guidance then identified classes of apps over which the FDA would exercise regulatory
29. Id. at 1182. 30. Id. at 1184. 31. Id. at 1186. 32. Id. at 1188. 33. Id. at 1189. 34. Id. 35. Ken Terry, A Physician’s Guide to Prescribing Mobile Health Apps, MED. ECON. (Oct. 8, 2014), http://medicaleconomics.modernmedicine.com/medical-economics/content/ tags/2014-ehr-scorecard/physicians-guide-prescribing-mobile-health-apps?page=full (discussing the fear physicians have when dealing with medical mobile apps causing them to be very general when recommending apps to patients). 36. Cortez, supra note 13, at 1189. 37. See generally U.S. DEP’T OF HEALTH & HUMAN SERVS., MOBILE MEDICAL APPLICATIONS: GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF 13–18 (2015) [hereinafter FDA 2015 GUIDANCE], http://www.fda.gov/downloads/Medical Devices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf (superseding the original Guidance issued in September 2013, but the 2015 Guidance is primarily consistent with the original Guidance). 38. Id. at 12.