The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced that the Federal Trade Commission (FTC) developed a web-based tool to help developers of health-related mobile apps understand what regulations may apply to them. The tool was developed in conjunction with the OCR, the HHS Office of National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA).
The guidance asks developers of health-related mobile apps a series of questions about the nature of their app, including about its function, the data it collects, and the services it provides to users to help them understand what Federal laws may apply. These Federal laws include Health Insurance Portability and Accountability Act (HIPAA), Federal Food, Drug, and Cosmetic Act (FD&C Act), and others.
Click on Mobile Health Apps Interactive Tool for more information or to access the guidance.