FTC: Web-Based Tool Clarifies Law For Mobile App Developers
The Federal Trade Commission (FTC) — in collaboration with FDA, the Office of National Coordinator for Health Information Technology (ONC), and the Office for Civil Rights (OCR) — has launched a new interactive tool that mobile app developers can use to clarify what regulations and laws apply to their health and wellness products. The initiative aims to better protect consumer safety and privacy while encouraging the development of innovative digital health technology.
In a guidance issued last year, the FDA said it would limit its regulatory oversight to mobile apps designed to influence or control medical devices currently regulated by the agency, or mobile apps that could pose a health risk to the user if they malfunctioned. Furthermore, the agency noted it would exercise “enforcement discretion” with apps that technically qualified as medical devices but posed little danger to the public.
Per the FDA, “Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the Federal Food, Drug and Cosmetic (FD&C) Act), and FDA does not regulate them.”
Though the FDA has limited its oversight to a specific subset of mobile apps, products still may be subject to federal laws, as governed by the FTC, ONC or OCR. Failure to comply could incur a hefty fine, such as the $2 million paid by Lumosity to settle FTC allegations of deceptive advertising of its “brain training” app.
“Mobile app developers need clear information about the laws that apply to their health-related products,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection, in a press release. “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, which is available online, guides developers through a series of questions about who they are, what kind of app they are developing, and how much data their app will collect. The tool then uses these answers to provide information about various relevant laws, including the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPPA), and the FD&C Act.
In addition to the online questionnaire, the FTC has also released a guidance to establish “best practices” for mobile health app development, which helps developers comply with the FTC Act’s regulations for app security and privacy standards.
“As Americans become increasingly engaged in managing their health through diverse health IT products, this tool will provide product developers with access to the critical information and consistent guidance they need in order to innovate,” said Lucia Savage, chief privacy officer, ONC, who added that the tool was the result of a year-long collaboration between regulators.
FDA estimates that by 2018, 50 percent of 3.4 billion smartphone and tablet users will have downloaded a mobile health application, and mobile health apps are “being adopted as quickly as they can be developed.”
According to Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, the regulators’ goal is to speed innovation while still protecting the safety and privacy of consumers.