FTC’s new tool helps developers determine whether regulations apply to their apps

FDA - FTC mobile health guidance

The Federal Trade Commission (FTC) has released a web-based tool to help health app developers to determine whether certain regulations apply to their app. Developed with help from the Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA) – the tool presents developers with as many as 10 questions about their app and themselves. Based on these answers, the service determines whether federal laws and regulations are relevant to them; those include the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA) and the Federal Food, Drug and Cosmetics Act (FD&C Act). Also included in the tool are definitions for all the terms used.

“Mobile app developers need clear information about the laws that apply to their health-related products,” Jessica Rich, director of the FTC’s Bureau of Consumer Protection, said in a statement. “By working with our partner agencies, we’re helping these businesses build apps that comply with the law and provide more protection for consumers.”

In the past few years, the FTC has filed charges of deceptive claims against a few health-related apps. Notable examples include the vision improvement app UltimEyes, two skin cancer-related apps – Mole Detective and MelApp, and two acne apps – AcneApp and Acne Pwner.

“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,” Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, said in a statement. “This effort is part of the FDA’s continued commitment to protecting patient safety while encouraging innovation in digital health.”

Meanwhile, the HHS Office for Civil Rights recently released additional guidance on its mHealth Developer Portal that provides developers with different scenarios in which HIPAA might apply to the data their app collects.

[Via: mobihealthnews]