When federal agencies hold a three-day public meeting next month to get feedback from stakeholders on their health IT report, one technology area that will no doubt garner prominent discussion is mobile medical applications. Though the draft report developed by the Food and Drug Administration, in consultation with the Office of the National Coordinator for HIT and the Federal Communications Commission, contains a proposed strategy and recommendations for a risk-based regulatory framework for health IT, it says very little about mobile technology.
Section 618(a) of FDASIA explicitly directed that the agencies publish a report to Congress that includes mobile medical apps. However, the document simply summarizes in a single paragraph the essence of the FDA's 43-page September 2013 final guidance on mobile medical apps, reiterating the regulatory agency's "narrowly focused approach" to oversight of these products and its intention to concentrate on a "small subset" of the app market--only those apps that present the greatest risk to patients if they do not work as intended.
"As stated in the [2013 FDA] guidance, the agency does not regulate the sale or general consumer use of smartphones or tablets or consider entities that exclusively distribute mobile medical apps (e.g. the owners and operators of the iTunes App store or the Android market) to be medical device manufacturers," states the draft report. "Nor does the agency consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a product regulated by FDA."
According to agency officials, the FDA's regulation of mobile apps as a medical device is based on risk and function, regardless of the platform on which it is used.
"Platforms can change. Today, we have smartphones. Tomorrow, we can have something else. And, until now, we had laptops that evolved from desktops," said Bakul Patel, senior policy advisor for the Food and Drug Administration, during an April 10 eHealth Initiative webcast. "So, functionality really becomes the most important point in distinguishing patient safety risk."
Still, industry observers assert that the HIT report reaffirms the need for additional guidance from the FDA to help mobile app developers in a couple of important areas: the ability to discern the difference between FDA regulated disease claims and unregulated wellness claims; and the ability to draw the line between FDA regulated accessories to known medical devices, and those software and hardware products that are simply part of the communication network.
"That first area is probably the number one issue facing mobile app developers because a tremendous number of apps are really designed to help us live healthier lives, as opposed to managing a specific disease, says Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition. Knowing exactly where FDA draws that line will help companies develop their business plans and get funding.
To date, the FDA has cleared approximately 100 mobile medical apps covering remote blood pressure, heart rhythm and patient monitors, and smartphone-based ultrasounds, electrocardiographic machines and glucose monitors. However, Thompson says mobile health operates in a "gray zone" between FDA regulated medical devices like blood glucose meters and blood-pressure cuffs on the one hand, and general communications infrastructure like cell phones, tablets and Wi-Fi hubs that have multiple uses.
"We need to know exactly where FDA regulation ends," he contends. "The HIT report is very light on exactly how and when the agency plans to go about doing that. The general impression is that FDA will develop new guidance documents on each of those topics in the same way that they did the guidance on mobile medical apps."
Nevertheless, FDA officials argue that the FDASIA HIT report is a high-level report to Congress and the FDA's final guidance on mobile medical apps is a more detailed roadmap for FDA reviewers and industry. "If you put those two documents side by side, you can see that the FDASIA report tackles a much broader picture of health IT," said Patel.
Industry stakeholders will get a chance to provide feedback on the draft report now that the FDA, ONC and FCC have announced that they will hold a public workshop May 13-15 at the National Institute of Standards and Technology in Gaithersburg, Md.
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