FTC releases tool to help health app developers determine whether regulations apply

By Aditi Pai
11:00 am

The Federal Trade Commission (FTC) has released a new interactive tool on its website, 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), to help health app developers to determine whether certain regulations apply to their app.

“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.”

The tool asks developers as many as 10 questions about their app and themselves. It uses the answers to determine 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).

FTC’s web tool also includes definitions for all the laws and a glossary of terms used, including simpler terms like "health plans", as well as more jargony ones, like "HIPAA business associate" and "protected health information (PHI)".

“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.”

In the past few years, the FTC has filed charges of deceptive claims against a number of health-related apps.

In March, about five months after the Federal Trade Commission (FTC) first charged the marketers of a vision improvement app, called UltimEyes, with deceptively claiming their program was scientifically proven to improve the user's eye sight, the FTC approved a final consent order that requires the company to stop making these claims.

UltimEyes was the fifth health-related app to have the FTC file charges of deceptive claims against it, but it was the only one not to shut down as a result. In February 2015, the FTC made similar moves against the owners and marketers of two skin cancer-related apps -- Mole Detective and MelApp. Back in 2011 it went after two acne apps, AcneApp and Acne Pwner.

A couple months ago, The HHS Office for Civil Rights, which collaborated on the FTC’s new tool, published its own additional guidance on its mHealth Developer Portal that provides developers with different scenarios in which HIPAA might apply to the data their app collects.


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