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.