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FTC Creates Tool to Help Developers Find mHealth Regulations

The FTC launched a guidance tool for mHealth developers that identifies mobile health regulations and laws that may apply to the app.

By Jacqueline LaPointe

- The Federal Trade Commission (FTC) recently announced the release of a web-based tool that will help mHealth developers to determine what mobile health regulations and laws might apply to their apps, according to a press release.

FTC tool helps developers find mobile health regulations

The FTC partnered with other regulatory agencies to design the tool, including the Office of National Coordinator for Health Information and Technology at the Department of Health and Human Services (ONC), Office of Civil Rights, and the Food and Drug Administration (FDA).

“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.”

To figure out what laws and regulations apply to a mHealth innovation, developers must answer a series of high-level questions about their app. The guidance tool asks about the app’s function, the data it collects, and the services it offers to users.

The guidance tool uses these answers to point out the specific federal laws that may apply to the app. Some federal laws that are included in the guidance tool are the Health Insurance Portability and Accountability Act (HIPAA), the FTC Act, the FTC’s Health Breach Notification Rule, and the Federal Food, Drug and Cosmetics Act.

“As the number of mobile health products available today continues to rise, it’s important to clarify for developers how FDA and other agencies’ regulations would apply to their app,” said Bakul Patel, Associate Director for Digital Health in the FDA’s Center for Devices and Radiological Health. “This effort is part of the FDA’s continued commitment to protecting patient safety while encouraging innovation in digital health.”

Organizations, like the FTC and the FDA, are rushing to develop more ways to regulate health apps for patient safety. At the same time, these organizations still want to encourage mHealth developers to design innovative methods for patients to engage with their health and EHR information.

“As Americans become increasingly engaged in managing their health through diverse health IT products, this tool will provide product developers with access to the critical information and consistent guidance they need in order to innovate,” said Lucia C. Savage, chief privacy officer, ONC. “ONC is proud to have collaborated with FTC over the past year on this effort and we hope that as a result, consumers are presented with effective, private, and secure products to support better health, smarter spending and a healthier population.”

In addition to the guidance tool, the FTC has simultaneously released a business guide for mHealth developers that helps them create apps that comply with the FTC Act. The business guide focuses on how developers can protect and secure consumer health information.

The new guidance tools from the FTC arrive just as some individuals speculate that the FTC is taking the lead from the FDA in regulating mHealth apps.

The FDA first took the initiative in governing the mHealth sphere, but the agency has recently taken a step back because it lacks the experience to heavily regulate this area of the healthcare industry.

To fill the void, the FTC has stepped up to continue the regulatory work of the FDA.

The FTC demonstrated its regulatory power in a recent case against Carrot Neurotechnology. In the case decision, the FTC fined the company $150,000 and ordered it to stop making certain claims on its Ultimeyes app. The FTC found that the company never proved that its app could improve vision in a randomized and blinded study. 


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