Health Apps and Health Policy : What Is Needed?

To measure the performance of smartphone applications that evaluate photographs of skin lesions and provide the user with feedback about the likelihood of malignancy. Case-control diagnostic accuracy study. Academic dermatology department. PARTICIPANTS AND MATERIALS: Digital clinical images of pigmented cutaneous lesions (60 melanoma and 128 benign control lesions) with a histologic diagnosis rendered by a board-certified dermatopathologist, obtained before biopsy from patients undergoing lesion removal as a part of routine care. Sensitivity, specificity, and positive and negative predictive values of 4 smartphone applications designed to aid nonclinician users in determining whether their skin lesion is benign or malignant. Sensitivity of the 4 tested applications ranged from 6.8% to 98.1%; specificity, 30.4% to 93.7%; positive predictive value, 33.3% to 42.1%; and negative predictive value, 65.4% to 97.0%. The highest sensitivity for melanoma diagnosis was observed for an application that sends the image directly to a board-certified dermatologist for analysis; the lowest, for applications that use automated algorithms to analyze images. The performance of smartphone applications in assessing melanoma risk is highly variable, and 3 of 4 smartphone applications incorrectly classified 30% or more of melanomas as unconcerning. Reliance on these applications, which are not subject to regulatory oversight, in lieu of medical consultation can delay the diagnosis of melanoma and harm users. Show more

Mobile health (mHealth) technology has facilitated the transition of care beyond the traditional hospital setting to the homes of patients. Yet few studies have evaluated the legal implications of the expansion of mHealth applications, or "apps." Such apps are affected by a patchwork of policies related to medical licensure, privacy and security protection, and malpractice liability. For example, the privacy protections of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 may apply to only some uses of the apps. Similarly, it is not clear what a doctor's malpractice liability would be if he or she injured a patient as the result of inaccurate information supplied by the patient's self-monitoring health app. This article examines the legal issues related to the oversight of health apps, discusses current federal regulations, and suggests strategies to improve the oversight of these apps. Show more