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Smartphone apps or mobile apps in research is rapidly growing and evolving. The FDA has developed a policy document and guidance entitled Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.

There are four government agencies that may have a hand in regulating mobile apps

• U.S. Food and Drug Administration (FDA)
• Office of the National Coordinator for Health Information Technology (ONC)
• Office for Civil Rights (OCR)
• Federal Trade Commission (FTC)

It is important to follow the applicable regulations, as agencies do investigate and enforce non-compliance

Visit this resource to find a tool to determine applicable FTC or FDA regulations.