The Federal Trade Commission, in partnership with the Office of National Coordinator for Health IT, the HHS Office for Civil Rights and the U.S. Food and Drug Administration, released an online tool this past week to give mobile app developers legal guidance for the development of their health products.
The agencies aim to help app developers stay aware of consumer privacy and safety protections, while still enabling innovation, officials say.
"Mobile app developers need clear information about the laws that apply to their health-related products,” Jessica Rich, director of FTC's Bureau of Consumer Protection, 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 new tool asks developers a series of questions about their app, such as information on its function, the type of data collected and services provided. Answers to these questions will prompt guidance toward the applicable laws and regulations such as the Federal Trade Commission Act, FTC’s Health Breach Notification Rule, the Federal Food, Drug and Cosmetics Act and HIPAA.
The FDA released regulations for mobile apps this past year, stating it would limit regulatory oversight since "many mobile apps aren't medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the FD&C Act), and FDA does not regulate them.”
But while oversight of these products is limited, apps may be subjected to federal laws governed by the OCR, ONC and FTC. A failure of compliance could result in a hefty fine.
"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,” said Bakul Patel, associate director for digital health in the FDA Center for Devices and Radiological Health, in a statement.
"This tool will provide product developers with access to critical information and consistent guidance they need in order to innovate," added ONC Chief Privacy Officer Lucia C. Savage. "We hope that as a result, consumers are presented with effective, private, and secure products to support better health, smarter spending and a healthier population."
Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com