FTC launches tool to help mobile health app developers determine applicable regulations

pharmafile | April 8, 2016 | News story | Medical Communications, Sales and Marketing FDA, FTC, apps, health, health apps, regulation 

The US Federal Trade Commission has created a new web-based tool for developers of health-related mobile apps to help them understand what federal laws and regulations may apply to their apps.

Developed in conjunction with the Office of National Coordinator for Health Information Technology, Office for Civil Rights and the Food and Drug Administration, the guidance tool asks developers a series of high-level questions about the nature of their app.

Based on its function, the data it collects, and the services it provides to users, the guidance will point the app developer toward detailed information about certain federal laws that may apply to the app.

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

Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, says: “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.”

Sean Murray

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