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FTC Releases New Guidelines for Mobile Health Apps

The creation of a new web-based tool for developers of health-related mobile apps.

The FTC has created a new web-based tool for developers of health-related mobile apps, designed to help developers better understand what federal laws and regulations might apply to their apps. The FTC developed the tool in conjunction with the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA).

App developers are given access to clear information about the laws that apply to their products, thus helping the developers build apps that comply with applicable laws, and providing better protection of consumers intended by the applicable laws. The tool, which is maintained on the FTC’s website, links directly to the relevant agencies’ information regarding applicable laws.

The tool is designed to direct developers to detailed information about certain federal laws that may apply to their app. It asks developers a series of high-level questions, including questions regarding the app’s function, the data it collects, and the services it is designed to provide to users. Developers are pointed to applicable laws, such as the FTC Act, the FTC’s Health Breach Notification Rule, HIPAA and the Federal Food, Drug and Cosmetics Act (FD&C Act).

The ONC emphasized that, as Americans increasingly manage their health through IT products, it is important that those products have access to and guidance on the critical information needed in order to properly and safely develop these products. This tool helps developers gain a greater understanding of their responsibilities under applicable laws and regulations.

In addition to this guidance tool, the FTC released its own business guidance aimed at helping health app developers build privacy and security into their apps in order to comply with the FTC Act.

Takeaway: Mobile health app developers and marketers need to consider the released tool as well as other FTC guidance regarding privacy and health claims.  The agency’s release of tools such as this one usually portends future enforcement actions.

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