FTC's new health app tool: 4 things for mhealth app creators to know

The Federal Trade Commission launched a website geared toward mobile health app developers offering guidance on which federal laws apply to their apps.

Here are four things to know about the website.

1. Developers can click through a series of 10 questions about the app to help determine which laws may apply. Questions include "Do you create, receive, maintain, or transmit identifiable health information?" and "Do consumers need a prescription to access your app?"

2. Based on answers to these questions, the web-based tool indicates which of the following four laws apply to the app: HIPAA; the Federal Food, Drug, and Cosmetic App; Federal Trade Commission Act and FTC's Health Breach Notification Rule.

3. The web-based guidance tool was developed by the FTC in collaboration with HHS, ONC, Office for Civil Rights and the U.S. Food and Drug Administration. "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."

4. Additionally, attorneys at Venable indicate more laws regarding mobile health apps are still to come. "Given the proliferation of health apps, developers can expect increasing federal and state scrutiny over these products," according to a brief from the attorneys. "The veritable alphabet soup of potentially applicable laws require that developers maintain a sophisticated understanding of both existing requirements and new requirements that are sure to come online over the coming months and years."

More articles on mHealth apps:

Google, Kivney to launch HIPAA-compliant mobile service on Google Cloud
mHealth market to experience rapid growth through 2022
The rise of mHelath: 157M users by 2020

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.


Top 40 Articles from the Past 6 Months