Health-related mobile apps, particularly those that collect, create, or share consumer information, are regulated under a variety of federal laws, including the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA), the Federal Food, Drug and Cosmetics Act (FD&C Act), and the FTC’s Health Breach Notification Rule. This regulatory landscape is changing as the result of new laws (for example, the 21stCentury Cures Act of 2016) and guidance (such as FTC Best Practices and FDA Guidance on Mobile Medical Applications), and this can make effective project planning difficult. To ease the regulatory burden, the FTC maintains a web-based tool to guide developers to the applicable legal framework(s) using a series of 10 natural language questions about the function of the app, the data it collects, and the services it provides. Based on your answers, the tool indicates which of the four laws applies, and provides links to additional information. The app was developed with input from the FDA, the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), and the Office for Civil Rights (OCR). You can find the interactive tool here.

Text Copyright © 2018 Katrina Rogers