FDA Taking Closer Look at Regulation of Health-Related Mobile Apps
An FDA spokesperson recently said the agency intends to provide "greater regulatory clarity" on health-related mobile applications, as the technology becomes more popular and sophisticated, InformationWeek reports.
Health-related apps increasingly are offering more services to users. For example, some can send data to patients' electronic health records or assist clinicians in diagnosing or treating patients.
Based on this evolution, experts have raised concerns with the apps' reliability, safety and security standards.
According to a recent agency email, "The rapid development and use of mobile apps for medical purposes has signaled the need for greater regulatory clarity." The email added that FDA plans "to provide draft guidance for public comment prior to finalizing, which will provide clarity for manufacturers as they continue to develop innovative, health-related mobile apps."
InformationWeek reports that FDA could consider apps as medical device data systems and regulate them under agency 501(k) rules for medical devices.
FDA defines MDDS products as hardware or software items that convert, display, store or transfer medical data. MDDS products do not modify data or control the functions or parameters of other medical devices.
Monique Levy, vice president of research at Manhattan Research, said FDA's plans come "at an interesting time" when mobile health apps are shifting from consumer-directed products to products that help link patients and clinicians.
App developers are concerned about how intensive new FDA regulations could be and whether they could hinder innovation, especially among startups and other smaller companies (McGee, InformationWeek, 6/7).
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