Tag Archive | "mHealth Regulatory Coalition"

Extension, Inc. Extends Expertise to the mHealth Regulatory Coalition

Extension, Inc. Extends Expertise to the mHealth Regulatory CoalitionExtension, Inc. today announced its admission to the mHealth Regulatory Coalition (MRC).

The mHealth Regulatory Coalition (MRC), formed in 2010, has become “the voice of the mHealth technology stakeholders in Washington.”

The coalition’s purpose is to serve as a thought leader in the mHealth ecosystem to provide its expertise on what mHealth technologies should be regulated and how they should be regulated.

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mHealth Regulatory Coalition Asks FDA to Revamp and Republish 2nd Draft of mHealth App Guidelines

The mHealth Regulatory Coalition (MRC), who has been very vocal in terms of the guidelines being proposed for mobile medical apps, has asked the FDA to revamp and republish its proposed guidelines — but as a second draft instead of finalized regulation.

On January 20th, the MRC made its request to the FDA in a letter by founding member and attorney Bradley Thompson of Washington, D.C.-based law firm Epstein Becker Green, which has been published to its website.  In it, the MRC explains industry fears that the FDA will scale back its proposed guidelines after being overwhelmed with more than 500 pages of industry comments from more than 100 interested parties.

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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.

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mHealth Regulatory Coalition Says FDA’s Intended Use Approach for Mobile Medical Apps is Too Broad

The FDA has had plenty of input as it works to draft guidelines for regulating mobile medical apps, but the mHealth Regulatory Coalition (MRC) in particular has maintained a leading voice since the guidelines were introduced.

Following initial comments on the proposed guidelines submitted October 19th, the MRC just submitted additional comments related to the FDA’s definition of “intended use,” which has been surrounded in debate since it was introduced.  Among more specific comments to the FDA, the MRC said its approach for evaluating intended uses of mobile medical applications was “too broad and would result in unnecessary regulation of mHealth technologies.”

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mHealth Regulatory Coalition Wants to Help FDA Classify Healthcare Apps With New Assessment Tool

It seems as though the entire mobile healthcare industry is waiting on the FDA to finalize its classification of mobile medical apps, and now the mHealth Regulatory Coalition (MRC) has developed a tool to help the FDA speed up the process.

The MRC published a 55-page document last week that outlines its comments and thoughts on how the FDA should regulate mHealth apps, along with a detailed risk assessment tool that the MRC hopes the FDA will use to determine the true risk of mobile medical apps.  The tool is a simple color-coded matrix that compares the likelihood of a device’s failure — from “improbable” to “frequent” — against the severity of the health result from such a failure.

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