FDA to Move Forward with Medical Mobile Apps Regulation

by Holly Shoemaker

After weeks of debating the scope of how and what the Food and Drug Administration (FDA) should regulate when it comes to medical mobile apps, Congress has finally reached a decision – well somewhat of one. The FDA may move forward with defining regulations regarding medical mobile apps used as devices, but other agencies are now required to provide their input.

Overview of Action Taken and Next Steps

The FDA published its drafted guidelines in July 2011. Now, Congress modified a section of the FDA Safety and Innovation Act that will allow the FDA to progress on its planned regulation. However, Congress has asked for additional input. The Department of Health and Human Services (HHS) must draft a report using input from the FDA, the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health IT (ONC), which is part of HHS.

The FDA has until the end of year to publish its findings. By the fall of 2013, the FDA must finalize regulations and implement a program within two years of the published date. The FDA and other agencies have 18 months to recommend a regulatory framework for mobile apps and IT-related software.

Concluding Thoughts

The action taken by the House and Senate allows stakeholders, including developers, to know where the issue stands. However, it still draws the process out and comes almost a year after the FDA published its drafted guidelines. The enhanced gathering process could go either way. It will either result in clarity for developers, users and agencies or even more questions and confusion.