Mobile Medical Device – Interactive Tool

OMEDtechNews & Events, Uncategorized

health appThere are more and more mobile health apps created every day.  Mobile medical devices and health apps must follow federal laws that apply to their product. The FTC has worked with the FDA, ONC, and OCR to release an interactive tool which will help mobile app developers understand which federal laws apply to their products. The user is able to go through a list of questions that will help to determine which laws apply to their mobile medical device or app. This interactive tool can point developers towards some of the federal regulations and laws they may need to follow.

The various groups and laws the interactive tool covers includes:

– OCR; HIPAA rules: protecting the privacy and security of applicable health information
– FDA; FD&C Act: regulates the safety and effectiveness of medical devices
– FTC; FTC Act: prohibits deceptive practices, privacy and data security, false claims about safety
– FTC; Health Breach Notification Rule: applicable businesses must provide notification of breaches of personal health record information

For more information on mobile medical devices:

Mobile Medical Applications Guidance
Mobile Medical Applications Website