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| Bakul Patel |
Mobile health app developers have struggled to figure out whether their technology will pass muster with regulators. Now, feds want to take out some of the guesswork. The FTC and FDA are rolling out a new web-based tool for companies making mobile health apps that helps them understand which laws and regulations apply to their products, especially regarding security.
The new system, which the FTC and FDA created with the Department of Health and Human Services (HHS), asks developers questions about their app to get the best sense of whether the technology meets safety and privacy standards. Questions include how the app functions, what data it collects and what services it provides to consumers.
Based on those answers, the system then helps the developer find "detailed information" about federal laws governing apps. Some of those laws include the Health Insurance Portability and Accountability Act (HIPAA), which governs patient privacy.
"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," Bakul Patel, associate director for digital health in the FDA's Center for Devices and Radiological Health, said in a statement. "This effort is part of the FDA's continued commitment to protecting patient safety while encouraging innovation in digital health."
The tool is trying to make it easier for mobile app developers to stay in line with the law. Guidance offered through the system links to each agency's applicable laws. The FTC also released its own business guidance along with the new system, which further spells out how mobile health app developers can build "privacy and security into their apps," the agency said in a statement.
- read the statement