American Telemedicine Association, mHealth Initiative Weigh in on FDA’s Mobile Medical App Guidelines

Two more healthcare organizations are weighing in on guidelines proposed by the FDA to regulate mobile medical apps, joining other groups such as the mHealth Regulatory Coalition and HIMSS to offer comments and concerns on the future of mHealth regulation.

The American Telemedicine Association (ATA) and the mHealth Initiative have both come out with questions it’s asking the FDA to answer, following a public comment period on the 30-page draft document that ended on October 19th.

The ATA is calling on the FDA to better define mHealth devices and applications, saying it would be “misguided to treat them all the same.”  The organization, in an 11-page document submitted Oct. 18, urged the FDA to regulate mobile medical apps based on their intended use, likelihood of failure and the severity of the outcome should the app fail.  The ATA’s concerns mimic that of most organizations submitting comments to the FDA, which primarily surround the definition of “intended use” and other ambiguous concepts.

The ATA is asking the FDA to classify hardware into five categories: Medical information and measurement capture; data aggregators; communication technologies; network infrastructure; and healthcare provider graphic user interfaces.  In addition, it’s asking the FDA to establish whether software is “off the shelf” or has “a specific intended use,” with the latter devices being evaluated based on risk.  “The ATA recognizes the fundamental importance of government to regulate the practice of medicine and strongly supports a regulatory mechanism to assure patients, providers and payers that mobile health applications are safe,” wrote ATA CEO Jonathan D. Linkous.  “However, in developing such regulations it is critical that the regulations be clearly and carefully written in order to advance mHealth.”

Likewise, the mHealth Initiative — a Boston-based member of the mHealth Regulatory Coalition — issued a letter reaffirming the coalition’s initial comments submitted earlier this month.  The coalition has called the FDA’s approach to regulating mobile medical apps “too broad,” and said it “would result in unnecessary regulation of mHealth Technologies.”

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