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A woman living in a remote part of Kenya cannot see vision is clouded and dark, and she is miles away from a hospital. Fortunately, a doctor visiting her community lifts up a smartphone and takes a picture of her eye. The Portable Eye Examination Kit ("PEEK") mobile application ("app") on the smartphone then conducts a vision test and reports her diagnosis of cataracts. 1
With the proliferation of mobile health apps like Dr. Andrew Bastawrous's PEEK app, more people around the world, including those living in remote areas, can access healthcare.2 Approximately 85% of adults in the United States have a cell phone, and 53% of those phones are smartphones.3
As of 2012, one in five smartphone users in the United States had downloaded a health app.4 Today, studies suggest users, physicians, app developers, and technology companies have developed over 97,000 mobile health apps.5 From fertility scheduling apps like Glow6 to MedXSafe7-an app that syncs sexually transmitted disease test results onto the user's personal mobile page -health-related applications for smartphones are becoming an increasingly prominent part of the healthcare market.8
These health apps, which often prompt users to input intimate personal information, pose a number of privacy concerns. 9 Health apps stand to improve doctor-patient communications,10 increase access to healthcare,11 reduce hospital readmissions,12 and decrease healthcare costs.13 However, many commercially available health apps also transmit unencrypted information to advertising and data analysis sites without the user's knowledge. 14 In a study by Privacy Rights Clearinghouse, approximately 39% of free apps and 30% of paid -for apps sent smartphone app user data to a third party; this data sharing was not disclosed by the developer in the app or in its privacy policy. 15 Due to these transmissions, the extent to which health apps are subject to Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance and U.S. Food and Drug Administration (FDA) regulation has become a topical issue.16 On September 23, 2013, the FDA released its final mobile health app guidance, which revealed that the FDA would regulate only those apps that constitute medical devices and/or pose significant risks to patients.17 This guidance has left some questions unanswered, particularly regarding which types of apps "pose significant risks." In addition to following FDA regulation,...