US regulators launch online tool for mobile medical app developers

By Stewart Eisenhart, Emergo Group

The US Federal Trade Commission (FTC) has published an online tool designed to help developers of mobile medical and telehealth apps determine which laws and regulations pertain to their products.

Designed with input from the Food and Drug Administration and other agencies, the Mobile Health Apps Interactive Tool presents a series of questions for developers to see whether they must comply with one or more of the following US laws:

• Health Insurance Portability and Accountability Act (HIPAA), enforced by the US Department of Health & Human Services
• Food, Drug & Cosmetic Act, enforced by the FDA
• Federal Trade Commission Act, enforced by the FTC
• Health Breach Notification Rule, enforced by the FTC

Developers whose apps collect or create user data, or that diagnose or treat diseases, should explore the tool if they are unsure which (if any) laws apply to them.

Determining whether a mobile medical app qualifies as a medical device can be a significant challenge for developers unfamiliar with the concepts of FDA registration, Quality System Regulation compliance and related requirements. Additional information on telehealth apps and FDA clearance is available in our article on the topic; for developers seeking to consult with the FDA on whether their apps qualify as medical devices, our whitepaper on early communication with the agency may be useful as well.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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