FTC Releases New Guidance for Developers of Mobile Health Apps
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FTC Releases New Guidance for Developers of Mobile Health Apps

April 6, 2016

The Federal Trade Commission (FTC) has created a new web-based guidance tool for developers of health-related mobile apps, which is designed to help the developers understand what federal laws and regulations might apply to their apps.

The FTC developed the tool in conjunction with the Department of Health and Human Services' Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA).

To help ensure that a new app is in compliance with all applicable laws and regulations, the guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users.

Based on the developer's answers to those questions, the guidance tool will point the app developer toward detailed information about certain federal laws that might apply to the app. These 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).

"Mobile app developers need clear information about the laws that apply to their health-related products," said Jessica Rich, director of the FTC's Bureau of Consumer Protection. "By working with our partner agencies, we're helping these businesses build apps that comply with the law and provide more protection for consumers."

"As the number of mobile health products available today continues to rise, it's important to clarify for developers how FDA and other agencies' regulations would apply to their app," said Bakul Patel, associate director for digital health in the FDA's Center for Devices and Radiological Health. "This effort is part of the FDA's continued commitment to protecting patient safety while encouraging innovation in digital health."

The guidance tool, which is maintained on the FTC's website, links directly to each agency's information about applicable laws. Additionally, the FTC has also released its own business guidance aimed at helping health app developers comply with the FTC Act by building privacy and security into their apps.