Industry experts are growing restless at the Food and Drug Administration’s (FDA) failure to issue its final guidance on mHealth app regulation as promised in a hearing earlier this year. Two years after releasing a draft of the guidelines, taking the pulse of developers, and debating how mHealth devices and apps will be taxed, the FDA has still not made a decision that will affect the course of one of the hottest and fastest growing areas of healthcare technology.
In a letter and position paper sent to HHS Secretary Kathleen Sebelius last week, the mHealth Regulatory Coalition (MRC) urged HHS and the FDA to publish final guidance as soon as possible, expressing their mounting impatience with the delay. The draft guidance is deregulatory in nature, focusing on the fact that the FDA has little intention to regulate low-risk apps like weight loss trackers or diabetic management programs. Instead, the intention is to monitor mobile apps that can be used in conjunction with critical lifesaving equipment, such as apps to operate infusion pumps or CT scanners. But the line has not been clearly drawn, and many developers are anxious to see which side their products will fall on.
“It is incredibly important for companies to understand if their app will not be regulated,” states the MRC paper. “Right now, many companies are sitting on the sidelines and not developing higher risk apps because the rules are unclear. They do not want to invest in developing a quality system, taking the time to develop evidence, and submitting that evidence to FDA as needed, if their competition is going to be able to undercut them by not investing in FDA compliance. The final guidance will clarify those higher risk apps that are subject to FDA regulation and help level the playing field for companies in that segment.”
MRC is particularly concerned that the FDA might delay the final rules until after HHS issues its broader recommendations on health IT regulations as required by The Food and Drug Administration Safety and Innovation Act (FDASIA) of July 9, 2012. That would push back the FDA’s mHealth guidance until after a 32-member ONC workgroup submits a report on regulation by January, 2014. That would be unacceptable to the mHealth community, MRC says. “To delay the release until after the comprehensive health IT strategy is finalized would only perpetuate the confusion that plagues the mHealth industry today without providing the clarity and direction to enable and accelerate mHealth innovation.”
mHealth is becoming wildly popular with physicians and patients alike, and represents a huge market for new products to fill niches created by patient engagement requirements and an increasing reliance on the internet to provide services and increase the coordination of care. The FDA has promised to release its final guidance by the end of fiscal year 2013, and has assured developers that the regulatory restrictions will be as limited as possible while still ensuring appropriate patient protections.