The emerging health app market holds promise for consumers, but only if — and this is a big assumption — app developers understand their legal obligations and meet them. The FTC has just released an updated interactive tool for mobile health apps to help industry members determine which federal laws and regulations may apply to their apps. If you are involved in the health app market, you should check out this new compliance resource for your company and your current and future clients.
The FTC first released the online tool in 2016, created in partnership with HHS’s Office for Civil Rights (OCR), the Office of the National Coordinator for Health Information Technology (ONC), and the FDA. But as any app developer knows, this is the technological equivalent of a century. Therefore, the FTC, working with these three offices, has just issued a revised version that reflects the regulatory changes that have occurred since then.
A quick look at the updated interactive tool shows how easy the process is. Just answer a few high-level questions about the nature of your app, its functionality, the data it collects, and the services it provides to its users. After a few clicks, you’ll see some of the federal laws and regulations that may apply to your product. For example, is your app subject to the FTC Health Breach Notification Rule, the Children’s Online Privacy Protection Act (COPPA), the Health Insurance Portability and Accountability Act (HIPAA), the 21st Century Cures Act, and the ONC Information Blocking Regulations, or the federal Food, Drug and Cosmetic laws? To be clear, an interactive tool cannot replace personalized legal advice, but it can give you a head start on compliance.
Also on your must-read list: Mobile Health App Developers: FTC Best Practices , which presents a series of issues for health app developers to consider.
