On day three of the Health Information Technologies: Harnessing Wireless Innovation hearing, it was the FDA's turn to issue their perspective on the regulation of innovative medical applications.
Christy Foreman, the Director of the Office of Device Evaluation in the Center for Devices and Radiological Health had a balanced response noting that the FDA doesn't want to stifle innovation, yet there are some apps that, if used incorrectly, can have detrimental effects on the user. She also clarified the FDA's stance on regulation stating that "the focus of the FDA's oversight will be the small subset of mobile apps, referred to as mobile medical apps, that meet the definition of device."
This focus will be further explained in a report due January of 2014 where the Secretary of Health and Human Services needs to propose "a strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."
Read the full testimony on the FDA's website - www.fda.gov.
Overall, the Health Information Technologies: Harnessing Wireless Innovation hearing seemed to be a success. All parties involved understand that mobile technology, especially in the world of healthcare where it can have such a meaningful impact, is still very much the wild west. As a result, there has to be balanced regulation that ensures the apps are safe in users' hands while not curbing innovation via costly FDA processes.
An important takeaway is that everyone needs to be on the same page when it comes to knowing which types of applications are subject to regulation and a clear vision on the process. Transparency was a word repeated by the Director of the Office of Device Evaluation in the Center for Devices and Radiological Health. Hopefully this will be on full display when the Secretary of Health and Human Services issues their report in January.