The FTC has developed a web-based guidance tool for mobile health app developers, which links directly to information on federal regulations that may affect their apps.
The tool — which the FDA says could help make medicine more personalized for patients — asks developers questions regarding an app’s purpose, data and services. After answers are received, the tool then directs the developer to more information intended to help them better understand the federal regulations that apply their apps.
Laws may include the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act and the Federal Food, Drug and Cosmetics Act.
“As the number of mobile health products available today continues to rise, it’s important to clarify for developers how FDA and other agencies’ regulations would apply to their app,” says Bakul Patel, CDRH’s associate director for digital health.
The tool was created under a partnership between the FTC and the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology, Office for Civil Rights and the FDA.