Joint tool aims to clarify understanding of regulatory landscape for mHealth app developers

A new online tool launched Tuesday by the Federal Trade Commission, the U.S. Food and Drug Administration and the Office of the National Coordinator for Health IT aims to help mobile health app developers navigate myriad looming applicable federal regulations for their prospective creations.

The tool, according to an FTC announcement, queries developers about the functionality of their apps and what information the tools will collect. It then funnels information based on relevant rules from the three agencies.

Bakul Patel, associate director for digital health at the FDA's Center for Devices and Radiological Health, called such clarification important, especially given the rising use of such tools by consumers and providers.

"This effort is part of the FDA's continued commitment to protecting patient safety while encouraging innovation in digital health," Patel said.

Lucia Savage, chief privacy officer at ONC, hopes the tool will help developers improve their innovation, in turn prompting "smarter spending" in healthcare and better care results. Jocelyn Samuels, director of the Health and Human Services Department's Office for Civil Rights, thinks the tool could help to boost HIPAA compliance.

In a letter to HHS Secretary Sylvia Mathews Burwell last month, eight House lawmakers said the agency's progress on long-promised updated HIPAA technical compliance guidance has been "sluggish" and "disappointing."

Legislators began pressing the issue in response to a letter to Reps. Tom Marino (R-Pa.) from ACT-The App Association, which represents more than 5,000 mobile app developers. FierceMobileHealthcare reported in January 2015 that HHS was working with ACT to provide clearer and more accessible regulatory guidance on the issue.

In addition, the FTC also published business guidance for health app developers to help them build privacy into their tools, a requirement of the FTC Act.

"Mobile app developers need clear information about the laws that apply to their health-related products," Jessica Rich, director of the FTC Bureau of Consumer Protection, said. "[W]e're helping these businesses build apps that comply with the law and provide more protection for consumers."

To learn more:
- here's the FTC announcement
- check out the tool
- read the FTC business guidance for health app developers

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