With the massive increase in health apps over recent years, the Federal Trade Commission (“FTC”), the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (“ONC”), the Office for Civil Rights (“OCR”), and the Food and Drug Administration (“FDA”) have coordinated and together, have created a tool to help developers of health-related apps navigate federal laws and regulations.
The tool will ask developers a series of questions regarding the nature of the app. These questions will cover how the app is designed to function, what data it will collect from users, and what services it’s designed to provide. Based on the answers provided, the tool will point to detailed information regarding federal laws that could apply to the app. These laws can include the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA) and the Federal Food, Drug and Cosmetics Act (FD&C Act).
A major goal of the FTC is consumer protection. (For more posts we’ve written on the FTC, click here). The creation of this tool is one way the FTC can ensure app developers get the right information about the laws at play, while furthering their goal of protecting the consumer base.
The FTC has no interest in shutting down or doing away with health apps, as they recognize this is the direction the world is heading in and encourage competition. Through the use of their tool, app developers can build with confidence and recognize potential legal problems before any issues arise by understanding laws they need to be taking into account.
While the tool is only designed to address federal laws at this point, there is hope that similar tools will be designed for the State level. This will add another layer of protection to both the companies producing the apps and the consumers relying on them.
While we can’t yet guarantee that the information and advice in health apps will be any better than the slippery slope of asking Google, we now know that app developers can be aware of the laws associated with building such apps. This may not do away with the slippery slope, but it is one step closer to the apps truly being built to the benefit of the consumer.
For more information regarding the FTC’s health app tool and how it can be used to your benefit, contact Revision Legal’s Corporate attorneys by filling out our contact form or by calling 855-473-8474.
Image courtesy of Flickr user Jason Howie.
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