The burgeoning market for health apps holds promise for consumers, but only if – and this is a big if – app developers understand their legal obligations and honor those responsibilities. The FTC just released an updated Mobile Health App Interactive Tool to help industry members determine what federal laws and regulations might apply to their apps. If you’re involved at all in the health apps marketplace, you owe it to your company – and to your present and future customers – to check out this new compliance resource.
Created in conjunction with HHS’ Office for Civil Rights (OCR), the Office of the National Coordinator for Health Information Technology (ONC), and the FDA, the FTC first released the online tool in 2016. But as any app developer knows, that’s the equivalent of a century in tech years. So working with the three offices, the FTC just issued a revised version that reflects regulatory changes that have occurred since then.
A quick look at the updated interactive tool demonstrates how easy the process is. Just answer a few high-level questions about the nature of your app, how it functions, the data it collects, and the services it provides to users. A few clicks later and you’ll be pointed to certain federal laws and regulations that might apply to your product. For example, is your app covered by the FTC’s 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 ONC Information Blocking Regulations, or the Federal Food, Drug, and Cosmetic Act? To be clear, the interactive tool can’t substitute for 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.
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