6 points with regard to regulatory threats and mobile health IT

The American Enterprise Institute (AEI) hosted an event discussing the FDA’s regulatory threats to mobile health information technologies. The FDA’s Draft Guidance on mobile medical applications makes it so apps fall under FDA regulatory authority as medical devices. Issues arise in the regulatory process, as the FDA’s 510(k) process is known to be slow. The IOM has identified serious risk factors associated with mobile apps, including errors with IT operation and lack of coordination across agencies.