mHealth Apps: Risky Business?
Mobile technology has revolutionized the digital health landscape. Nowhere is that more evident than within the smartphone app world. Apps have become a multi-billion dollar industry, potentially shaping and assisting with every aspect of life for their users. With the debut of the Apple watch, apps will grow even more personalized, aiming to monitor and optimize, organize and entertain as never before. Research2guidance, a mobile market research firm, estimates that by 2017 the market for Mobile Health apps alone will be $26 billion.
Within the health-related mobile and app realm (referred to as “mHealth”), there is tremendous potential for growth and positive outcomes, but users and businesses alike must exercise caution, especially when the device itself becomes an instrument for monitoring or treatment. A hastily produced health app could draw the ire of the FDA or end up being removed by Apple/Google from the app market. By the same token, users who rely on apps for health information, testing, or guidance could find that they have wasted their money, or worse, have their health or well-being negatively impacted.
A recent article in the New York Times outlines some recent cases:
In 2011, the Federal Trade Commission fined a developer who claimed that his program, AcneApp, could treat acne with the light from an iPhone screen. Before it was removed from the iTunes store, almost 12,000 people had downloaded it. Last year, the F.D.A., which regulates medical devices, sent a letter to Biosense Technologies inquiring about its uChek app, which is designed to use the iPhone’s camera to interpret urinalysis strips. The app is no longer sold in the iTunes store for the United States.
As the app market continues to grow, companies would be wise to think strategically about not just the revenue generating impact an app can have, but of legal and medical implications as well.