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clothing188 or have sensors or other mechanisms that more directly contact the skin, arguably increasing risk. For example, in 2014, Fitbit recalled its Fitbit Force wearable after more than 10,000 purchasers complained of skin blisters and rashes.189 The company only avoided a recall of its Flex product by agreeing to warn of allergens such as nickel.190 In an emerging field, courts likely will look to a broad array of expert evidence and other normative sources to flesh out the meaning of defectiveness in app and wearable cases. For example, the FDA, while exercising its discretion and not applying device regulation to most apps, nevertheless,
[S]trongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.191
Similarly, platform owners may help courts understand safe practices. For example, Apple’s App Store Developer Guidelines already set a reasonably high bar for app privacy and security standards.192 The same company also publishes developer guidelines on designing interfaces and optimizing usability,193 and has published detailed rules as to how the third party
188. See Zach Miners, Under Armour Snaps Up MyFitnessPal to Become Largest Health Tracker, PCWORLD (Feb 5, 2015, 7: 32 AM), http://www.pcworld.com/article/2880312/under- armour-buys-two-fitness-apps-builds-trove-of-health-data.html (referencing popular devices like Fitbit and Jawbone). 189. Fitbit Recalls Force Activity-Tracking Wristband Due to Risk of Skin Irritation, U.S. CONSUMER PROD. SAFETY COMM’N (Mar. 12, 2014), http://www.cpsc.gov/en/Recalls/ 2014/Fitbit-Recalls-Force-Activity-Tracking-Wristband/. 190. See Rachel Abrams, After One Product Recall, Fitbit Faces a New Safety Inquiry, N. Y. TIMES (Sept. 26, 2014) http://www.nytimes.com/2014/09/27/business/after-product- recall-fitbit-faces-a-new-safety-inquiry.html?_r=0 (explaining United States requirements to warn consumers about the risks of nickel exposure from Fitbits and of wearing the device too tightly). 191. U.S. FOOD & DRUG ADMIN., MOBILE MEDICAL APPLICATIONS: GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF 13 (2015) (referring to 21 C.F.R. § 820 (2011)). 192. See App Store Review Guidelines, HealthKit and Human Subject Research, APPLE, https://developer.apple.com/app-store/review/guidelines/#healthkit (last visited Feb. 16, 2016) (outlining privacy guidelines in Section 17) (“Apps cannot transmit data about a user without obtaining the user’s prior permission and providing the user with access to information about how and where the data will be used.”); see Terry, supra note 13, at 1431. 193. iOS Human Interface Guidelines: HealthKit, APPLE, https://developer.apple. com/library/ios/documentation/UserExperience/Conceptual/MobileHIG/ HealthKit.html (last visited March 18, 2016) (explaining that “apps built with HealthKit can use data from the Health app to provide health and fitness services that are more powerful and integrated”).