US government tool aims to helps mhealth app developers
April 19, 2016
The US Federal Trade Commission has created a web-based tool for developers of health-related mobile apps. It is designed to help developers understand what federal laws and regulations might apply to their apps.
The FTC developed the tool with the Department of Health & Human Services’ Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food & Drug Administration (FDA).
“As the number of mobile health products available today continues to rise, it’s important to clarify for developers how the FDA and other agencies’ regulations would apply to their app,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices & Radiological Health. “This effort is part of the FDA’s continued commitment to protecting patient safety while encouraging innovation in digital health.”
The guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers, the guidance will point the app developer towards detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability & Accountability Act (HIPAA) and the Federal Food, Drug & Cosmetics Act (FD&C Act).
“We are committed to helping technology developers understand when and how they must comply with HIPAA, and to that end recently issued guidance illustrating scenarios that trigger HIPAA coverage,” said Jocelyn Samuels, OCR director. “This valuable new tool will help developers gain a greater understanding of their responsibilities under federal law.”
Lucia Savage, chief privacy officer at the ONC, added: “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. The ONC is proud to have collaborated with the FTC over the past year on this effort and 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.”
The guidance, which is maintained on the FTC’s web site, links directly to each agency’s information about applicable laws. In addition, the FTC simultaneously released its own business guidance aimed at helping health app developers comply with the FTC Act, by building privacy and security into their apps.
“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. “By working with our partner agencies, we’re helping these businesses build apps that comply with the law and provide more protection for consumers.”