FDA Moving Forward with Regulating Mobile Health Apps
This post is prepared by Christopher Dodson.
Mobile medical apps designed for use on phones and tablets are generally unregulated. In July 2011, the FDA published guidance indicating its intention to use the existing regulatory
framework for a small subset of apps. It planned to scrutinize apps used as accessories to already-regulated medical devices and apps that use attachments to turn mobile devices into regulated medical devices.
Even as the FDA finalizes its guidelines, President Obama has signed the “Food and Drug Administration Safety and Innovation Act” which includes a provision laying the groundwork for broader regulation of mobile medical apps. Section 618 gives the HHS Secretary until January 2014 to issue a report with a proposed strategy for a risk-based regulatory framework for HIT, including mobile medical apps. The new law requires that the framework promote innovation, protect patient safety and avoid regulatory duplication.
In developing the framework, the Secretary has the option of assembling a working group of stakeholders to provide guidance. If the Secretary does form the group, it is required to have representatives from a variety of groups including patients, providers, health plans, startup companies, venture capitalists, technology vendors and small businesses.
This puts mobile medical app developers in a difficult position.
The FDA is still finalizing a narrow set of guidelines. But in 18 months the Secretary’s report will likely open the door to broader regulations sometime in the future. For now app developers are stuck with the reality that at an unknown point in the future there will probably be more regulations of an unpredictable nature.
Christopher is a former software developer and current J.D. candidate at the Earle Mack School of Law of Drexel University. He is working with the Attorneys at Oscislawski LLC as a summer intern.
