FDA regulation may hinder mHealth innovation

Mobile health apps are promising, but the upcoming Food and Drug Administration (FDA) guidelines regulating them may impose an undue burden and stifle innovation, according to the keynote panel discussion at the Fourth Annual health World Congress in Boston this week, HealthImaging.com reports.

The FDA's focus on mobile health apps is on patient safety, according to panelist Bakul Patel, with the FDA's Center for Devices and Radiological Devices. The FDA published draft guidance for mobile apps in July 2011 and is expected to issue final guidance in the form of regulations later this year.  

However, the draft guidance needs to be clarified, and the FDA should weigh the benefits of mHealth apps against the costs should they need FDA approval, said Brad Merrill Thompson, General Counsel to the mHealth Regulatory Commission.  

The FDA's focus and oversight is of mobile apps that perform a medical function and present the greatest risks to patients when they don't work as intended. The agency's draft guidance applies in most cases only to mobile apps that either transform the mobile platform into a medical device or controls an existing one's use, function, modes or energy source.

The prospect of new regulations arren't stifling all innovation, according to another panel discussion held at the Congress, CMIO reports. For instance, Children's Hospital Boston's Chief Innovation Officer Naomi Fried noted that her hospital has an in-house health IT development team and is creating its own mHealth app that patients can use to see their providers, access their personal health information and ask questions of hospital staff.   

To learn more:
- read this article about the FDA panel discussion
- here's the one about Children's Hospital Boston
- learn about the mHealth Congress
- check out the FDA's guidance