Dive Brief:
- Several federal agencies have developed an interactive tool available on the Federal Trade Commission (FTC) website that enables health app developers to determine if their app is subject to certain regulations.
- The tool asks developers up to 10 questions, and the responses determine whether federal laws are relevant to them, including the FTC Act, the FTC's Health Breach Notification Rule, HIPAA, and the Federal Food, Drug, and Cosmetics Act.
- The FTC has filed charges against several health-related apps over the past several years, but its Director of Bureau of Consumer Protection Jessica Rich said the new tool will help "businesses build apps that comply with the law and provide more protection for consumers."
Dive Insight:
The agencies that assisted with the development of the interactive tool include the Office of the National Coordinator for Health Information Technology (ONC), the Office for Civil Rights (OCD) and the FDA.
Bakul Patel, associate director for digital health at the FDA's Center for Devices and Radiological Health, said in a statement that as the number of mobile health products increase, it is important that developers understand how the agency's regulations would apply to their app.
The FTC has charged some health apps with deceptive claims including a vision improvement app called UtlimEyes, which was required by the agency to stop making such claims. The FTC made similar charges against two skin cancer apps last year, and two acne apps in 2011.
In February, HHS' Office for Civil Rights published its own reference guidance for HIPAA regulations.