The Federal Trade Commission (FTC), the HHS Office for Civil Rights (OCR), the HHS Office of the National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA) created an interactive tool to help app developers navigate applicable U.S. laws and regulations that may apply to the design, marketing, and distribution of mobile health apps.
After guiding the developer through a series of questions about a potential app, the tool points the developer to detailed information about relevant laws, including:
- Health Insurance Portability and Accountability Act (HIPAA) Rules
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- 21st Century Cures Act & ONC Information Blocking Regulations
- Federal Trade Commission Act (FTC Act)
- FTC’s Health Breach Notification Rule
- Children’s Online Privacy Protection Act (COPPA)
Visit the FTC’s Mobile Health App Interactive Tool page for more information and to start responsibly developing your mobile health apps.
Mobile Health App Interactive Tool
Access Now
