On December 7, 2022, the Federal Trade Commission (“FTC”), along with the U.S. Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA”), announced updates to the Mobile Health App Interactive Tool—a questionnaire designed to help mobile health app developers identify federal laws and regulations that may apply to their products.
The tool is designed for mobile apps that access, collect, share, use, or maintain information related to a consumer’s health through features such as fitness tracking, medical record sharing, sleep monitoring, disease diagnostics, and more.
The tool guides developers through fifteen questions, including:
- Does/will your app collect, share, use, or maintain health information?
- Is your app for use by consumers?
- Does your app include a device software function that is the focus of FDA’s oversight?
Based on the answer to each question, the tool directs the user to other relevant questions and highlights at each step the laws and regulations that may apply to the mobile app. The tool covers, among other laws and regulations, the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”), the Food, Drug, and Cosmetic Act (“FD&C Act”), the FTC Act, and the 21st Century Cures Act.
The tool was first released in 2016 and included ten questions to help developers determine whether their apps would be subject to HIPAA, the FD&C Act, the FTC Act, and/or the FTC’s Health Breach Notification Rule. The latest update to the tool adds new questions to help mobile developers understand legal requirements for their apps under the Children’s Online Privacy Protection Rule (“COPPA Rule”) and the 21st Century Cures Act but does not refine the analysis for the laws covered in the original version. The tool is not intended to offer legal advice and is provided for informational purposes only.