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Given the uncertainty in reimbursement from private insurance and government programs such as Medicare and Medicaid, it is important early on to consider how best to land and leverage relationships with key customers and strategic partners.
Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps. These data troves can trigger significant compliance responsibilities for the app developer, along with significant legal and contractual risk.
As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties.
The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow.  Last week, the U.S. Food and Drug Administration (“FDA”)  approved a new smartphone-based "carbon monoxide breath sensor system" that measures carbon monoxide levels on a user's breath.
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration ("FDA") refers to as "mobile apps." The goal of this post is to provide you with a basic understanding of FDA's evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app's functionality.
This post is the second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful launch.
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. 

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