Health app users beware: Column - USA Today

Health app users beware: Column - USA Today:

"But how many are actually useful? An analysis by the IMS Institute for Healthcare Informatics found that only about 40% of those apps — 16,000 — are "truly related to health care" and oriented toward the consumer patient. Of those, two-thirds offered patients legitimate medical information."

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Mobile Medical Applications: Guidance Finalized - FDA Law Blog

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FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:

"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."

Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)

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mHealth to see big growth, barriers | Healthcare IT News

mHealth to see big growth, barriers | Healthcare IT News:

"A new mobile health trends report released Wednesday underscores the mid- to low sophistication of current mHealth application technology but also emphasizes the explosive growth and integration headed for the market .

The Research and Markets mHealth trends report shows the industry poised for a compound annual growth rate of 61 percent by 2017, to reach a value of $26 billion. This revenue, researchers project, will be derived predominantly from mHealth hardware sales and services."

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FDA Draft Guidance - Mobile Medical Apps - Practical Insights

A quick and insightful perspective on the much anticipated mobile medical app guidance . . .

Compliance Zen: Majority of Mobile Health Apps Class II Devices for FDA:

"FDA’s current draft guidance on mobile medical apps is woefully short of such practical specifics. And yet it’s these specifics that will get even the most forthright medical app developer in trouble with FDA-483s and Warning Letters. Warning Letters have been shown to reduce product sales by at least 8% the first year and for three years thereafter. For many of these developers, a Warning Letter might be the kiss of death and bring a painful chill to the innovation marketplace."

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FDA 101 Digital Health Guide - Free Rock Health Report

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Does your mobile health app need FDA clearance? Checklist gives guidance for digital health entrepreneurs | MedCity News:

In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance. Rock Reports - FDA 101 - A guide for digital health entrepreneurs

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FDA regulators face daunting task as health apps multiply

Jenny Gold reports that, "In fact, there are 40,000 medical applications available for download on smartphones and tablets — and the market is still in its infancy. But that growth is in the cross hairs of new regulatory efforts from the Food and Drug Administration."

FDA regulators face daunting task as health apps multiply – USATODAY.com:

"Franko's goal is to make sure doctors and patients know what they're getting as quickly as possible. "These apps already exist," he says, "and people are using them in hospitals to make medical decisions, but no one knows if they're actually doing what they claim to be doing.""

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This is all about mobile, tablet, digital technologies intersecting the FDA's QSR regulations applicable to medical device manufacturers (i.e., 21 CFR 820).

You might also be interested in:
Essentials for Medical Device Manufacturers - Recommended QSR Training - SkillsPlus Intl Inc.
21 CFR 820 Essential Elements - The Best Online QSR Training - SkillsPlus Intl Inc.

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