In prior blogs, we’ve discussed the “team” approach being used by federal agencies to regulate consumer products. Last week, the FTC provided further evidence of the government’s collaborative spirit, through the release of a web-based tool designed to help developers of health-related mobile apps understand what federal laws and regulations might apply to their apps.
According to its press release, the FTC developed this guidance tool in conjunction with the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology, Office for Civil Rights, and the Food and Drug Administration, with consideration of the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act and the Federal Food, Drug and Cosmetics Act.
The guidance tool asks developers a series of high-level Yes/No questions about the nature of their app, including about its function, the data it collects, and the services it provides to users and then, based on the developer’s answers to those questions, provides the app developer with information about certain federal laws that might apply to the app. Because the jurisdictional reach of those laws may be difficult to navigate, the tool can serve as a helpful first step in the compliance efforts of mobile app developers. To take the next step, developers need to follow the rapidly evolving regulations that apply to such technologies. (For example, the FTC released, along with the jurisdiction-focused tool, guidance aimed at helping health app developers comply with the FTC Act, by building privacy and security into their apps. That guidance supplements the FTC Staff Report issued in 2013, “Mobile Privacy Disclosures: Building Trust Through Transparency.”)
Developing an app, but unsure of which rules may apply to it and how to find and interpret those that do apply? Or have you already issued an app and are unsure whether it complies with all applicable rules? You may want to attend our April 19 webinar on advertising, data privacy, and data security issues raised by consumer-directed health-related mobile apps or Health IT solutions. During the webinar, Nancy Perkins and Matt Shultz will work through advertising- and privacy-related legal issues that must be considered when developing a mobile app intended for use by consumers. For more information, click here.