FTC Announces Guidance for Developers of Mobile Health Apps

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC.  The Guidance is a tool created in collaboration with the FTC, the U.S. Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) to assist app developers in determining what laws and regulations apply to their products.

The Guidance is a web-based tool that asks developers a series of questions in order to assist in determining regulatory scheme may apply to the developer’s app.  Laws that may apply in this area can vary and often overlap and developers are often confused as to what regulatory agency has authority over their mobile apps.  The FTC’s press release notes that the Guidance should assist in determining applicability of various laws including, but not limited to, “the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance and Accountability Act (HIPAA) and the Federal Food, Drug, and Cosmetics Act (FD&C Act).”

Chairwoman Ramirez stated in that with regard to privacy, the FTC wants mobile app developers to “be aware of the obligations with regard to the collection, use, and sharing of health information” and the FTC believes this Guidance will assist in that purpose.  In addition to releasing the Guidance, the FTC also announced today that it is releasing its own guidance to assist mobile app developers in complying with the FTC Act.

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Filed under FDA, Health Care, Health Information Privacy, Health IT, HIPAA, Medical Devices, Mobile Health, Privacy and Security

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