As the plethora of mobile health applications grows, regulatory agencies are trying to get a handle on how technology can make its way to consumers safely. For example, the Federal Trade Commission (F.T.C.) recently created a new interactive tool for mobile health application developers that helps them determine which federal laws and regulations might apply to them. Announced on April 5 by F.T.C. Chairwoman Edith Ramirez, the web-based tool is now making its way to app developers to help them stay compliant and understand the many laws that could apply to their technology.
The National Law Review reports that together with the Office of Civil Rights, the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, the F.T.C.’s tool takes mobile health application developers through a series of questions about the nature of their applications, “including the function, the data collected, and the services provided to users.” It then helps developers determine whether or not certain federal statutes and regulations might apply to them, including the Health Insurance Portability and Accountability Act Rules, the Federal Food, Drug, and Cosmetic Act, the Federal Trade Commission Act, and/or the Federal Trade Commission’s Health Breach Notification Rule.
Tools such as this one are going to be vital for the building out of the mobile health industry — it has been slower to take off than other technological markets because of the regulatory paranoia that so often comes with anything health-related. Security, confidentiality, and safety are all concerns when it comes to digitizing anything in health, but mobile health is well on its way to integrating with legacy services. And types of tools from regulatory bodies, such as this one, can try to help assuage the fears developers might have about red tape in such a highly regulated industry.