FTC Announces Guidance Tool for Health-Related Mobile App Developers | Practical Law
The FTC has created a new web-based tool to help developers of health-related mobile apps to understand what federal laws and regulations could apply to their apps.
The FTC has created a new web-based tool to help developers of health-related mobile apps to understand what federal laws and regulations could apply to their apps.
On April 5, 2016, the FTC announced that it had created a new web-based tool to help developers of health-related mobile apps to understand what federal laws and regulations could apply to their apps. The FTC developed this tool with the Department of Health and Human Services' Office of National Coordinator for Health Information Technology, Office for Civil Rights, and the FDA.
The tool provides guidance by:
Asking developers a series of high-level questions regarding the app, including:
the app's function;
the data it collects; and
the services it provides its users.
Based on the developer's answers, pointing out federal laws that might apply, including:
FTC Act;
FTC's Health Breach Notification Rule;
Health Insurance Portability and Accountability Act (HIPAA); and
Federal Food, Drug, and Cosmetics Act (FD&C Act).
Linking the app developer to relevant agency's information for the applicable laws, including newly released FTC Act compliance best practices tailored for health app developers.