The Federal Trade Commission (FTC or the Commission) announced yesterday that it has created a web-based guidance tool for developers of health-related mobile applications (health apps).  FTC did not take this action alone, but rather developed the tool in conjunction with the Department of Health and Human Services’s (HHS) Office of the National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR), and the U.S. Food and Drug Administration (FDA).  As some readers will recall, FDA is not new to this space, having released a seminal guidance document on mobile medical apps early last year.  In its guidance document, FDA addresses, among other things, those apps that FDA intends to regulate as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and those for which the agency intends to exercise its enforcement discretion.  OCR has also recently issued guidance in this area, providing examples of scenarios where the Health Insurance Portability and Accountability Act (HIPAA) regulations might apply to health information created, managed, or organized through the use of health apps.

The FTC’s new health apps tool asks developers a series of high-level questions about the nature of the app, including questions about its function, the data it collects, and the services it provides to users.  These questions include the following: 
Continue Reading FTC Creates Compliance Tool for Mobile Health App Developers; Simultaneously Releases Business Guidance