The number and use of mobile health applications (mHealth apps) continues to increase rapidly. These apps are part of the overall digital health ecosystem, which includes wearable devices (e.g., Apple Watch), telemedicine, personalized medicine and more. The app development of mHealth has become easier partly due to the investment in resources by mobile platform providers (e.g., Apple’s ResearchKit, CareKit and HealthKit). However, with this growth has come additional regulatory scrutiny and enforcement. In addition to the traditional health issues, many of these apps use contests, gamification and user-generated content to incentivize users to take certain actions that raise other legal issues.
The following federal agencies have asserted jurisdiction over certain aspects of mHealth app regulation:
• the Food and Drug Administration (FDA) regarding safety and efficacy
• the Federal Trade Commission (FTC) regarding deceptive advertising, privacy and paid endorsements
• the Federal Communications Commission (FCC) regarding wireless/communications, particularly with wearables
• the U.S. Department of Health and Human Services (HHS) regarding HIPPA
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