“Should an EMR App be Regulated?” and Other mHealth Considerations

Expert Article by Matthew A. Kaminer

Before I provide some background—and recommendations—regarding the regulation of mobile health (mHealth) apps, be they drug lookups, electronic medical records (EMR) or otherwise, let me begin with one statement: The U.S. Food and Drug Administration (FDA) regulating and defining mobile medical reference apps is like an agency regulating calculators because long division exists. The FDA regulates an action that’s completed with greater accuracy and ease electronically vs. the traditional written format. Okay, now that I’ve got that off my chest, on to the topic at hand. Based on the FDA’s Draft Guidance for Mobile Medical Applications, it is clear that the agency intends to regulate any app that qualifies as a “device” under current FDA regulations, and is an “accessory” to medical devices, or transform a mobile platform into a medical device. Some clear examples: diagnostic imaging apps, blood glucose monitoring apps and apps that monitor a patient’s vital signs. It is also clear from the Guidance that electronic medical textbooks, apps that automate general office operations and EMR apps will not be regulated as mobile medical apps… yet. I say “yet” because the FDA has stated it may revise its position as it figures out this thing called “technology,” as it’s used in medical practice. Despite these examples, and two years of industry discussion following release of the Guidance, mHealth companies continue to have plenty of questions regarding the FDA’s regulation of certain mobile medical apps. Recent FDA hearings have provided some clarity regarding specific categories of apps that will or will not be regulated, but there are still some gray areas regarding regulating accessories to medical devices, an app’s intended use rather than its function, and clinical decision support tools. Based on the general language set forth in the Guidance, a staggering number of apps are likely to fall within the FDA’s purview. For example, if the FDA regulates those apps that serve as clinical-decision support tools (that essentially collect information and convert into a patient-specific result), the Epocrates mHealth application could ultimately become subject to FDA regulation. Why? Merely because the app automates a calculation that could be done by a physician with the use of pen, paper and medical reference materials. Without clarification by the FDA, we believe the Guidance could result in the regulation of mere information delivered via technology. At a recent event hosted by the American Conference Institute entitled “mHealth and Wireless Medical Technology,” I outlined recommendations for the FDA that would eliminate both confusion and delay, as they seek to regulate medical mobile applications:
  • Regulate the Function, Not the Category
Don’t determine which tools to regulate based on the name they’re given (such as a ‘clinical support tool’). Focus instead on regulating based on the functions that each app provides. This will avoid the regulation of apps that merely provide electronic access to a service that’s already available (and unregulated), such as the Epocrates core app.
  • Create a Flexible Framework Based on Risk Profiles
Regulate those apps that pose a high risk to patients, review apps that pose a moderate risk and do not regulate apps that pose a low risk. We believe our recommendations will create an approach that’s beneficial for mHealth developers, physicians and patients, one that will enable innovation to provide health care professionals the right information, at the right time, at the point of care.  

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