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."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

inShare

Mobile Medical Applications: Guidance Finalized - FDA Law Blog

• Respected FDA GMP online training programs and courses by SkillsPlus International Inc.

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"The final guidance is similar to the draft guidance – but with improved clarity.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)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

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."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

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."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA - Mobile Medical App Guidance - Will it be delayed?

Final days of waiting for FDA mobile medical app guidance? | mobihealthnews:

"Now, on the eve of the FDA’s publication of the final guidelines, the Bipartisan Policy Center and companies that include McKesson, Microsoft, Oracle, athenahealth, Epocrates, Siemens, UnitedHealth Group, Teladoc, the Silicon Valley Chapter of Health 2.0 and StartUp Health have asked HHS to delay the FDA’s final guidelines on mobile medical apps until the workgroup [FDASIA workgroup] finishes."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA 101 Digital Health Guide - Free Rock Health Report

• Recommended FDA GMP online training courses taught by SkillsPlus International Inc.

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

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Mobile Usage While Driving - Increasing In The US

My latest pet peeve, seeing people driving while on the phone or using their phone.

The Distracted American Driver - NYTimes.com:

"Despite increasing media attention and laws forbidding the practice, more Americans than ever are using their cellphones to talk and send text messages while driving, a new study shows.

According to the research, nearly 70 percent of Americans ages 18 to 64 said they had chatted on their phones while driving in the past 30 days, and about 30 percent said they had sent text messages while behind the wheel. Drivers in seven European countries were also included in the study, and the numbers showed that the practice appears to be far more common in the United States than overseas."

'via Blog this'

Read the findings of the study that's referenced above:
Mobile Device Use While Driving — United States and Seven European Countries, 2011 - MMWR March 15, 2013 / 62(10);177-182

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Asked About Mobile Apps and the FDA 510K Process

Congress asks FDA if “actual use” is factor in medical app regulation | mobihealthnews:

". . . The letter also asks whether the FDA will consider the “actual use” of a mobile medical app in addition to the “intended use” when making its determination about whether an app needs to go through the 510(K) process. Finally, the letter closes with a series of questions related to the final guidance document and the committee wants answers by March 15th."

'via Blog this'

Read the Letter Sent to FDA Commissioner Margaret Hamburg (pdf)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• FDA Free Tips - Don't Fall for Health Fraud Scams (video) (drughealth.blogspot.com)

A Regulatory App-ening - A mobile apps POV on FDA medical device regulations

Read this well-written point of view regarding the FDA's medical device regulations and how they impact mobile applications . . . are they or aren't they medical devices?!

Drugwonks | A Regulatory App-ening:

" . . . during the session on mobile apps as medical devices. At present, there are some 17,828 healthcare and fitness apps and 14,558 that can be deemed “medical.” As Vice President Biden said, “It’s a big f**kin’ deal.”

But when is an app a medical device and when is it not? Not surprisingly, it depends."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturer - Learn the basics of the FDA's QSR regulations

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

Related articles

• Medical device firms growing in South Florida (skillsplusinfo.blogspot.com)
• What to do after a hurricane if you use a home medical device (drughealth.blogspot.com)

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.""

'via Blog this'

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.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Should Mobile Medical Apps Require FDA Approval?

• Purchase now! FDA CGMP online training programs provided by SkillsPlus International Inc.

Updated June 10, 2021

The links in the original post broke.

You can read more about this topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

---  the original post follows below  ---

Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: 

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Issues Guidance For Mobile Medical Applications

Updated June 30, 2023

This topic has evolved over the years. Therefore, the original links broke.

You can still read about this same topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

---  the original post follows below  ---

The U.S. Food and Drug Administration (FDA) announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

Today, mobile medical applications or "mobile medical apps," include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device. According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015.

"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

A. are used as an accessory to medical device already regulated by the FDA

(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or

B. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices

(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

For more information:

FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications

FDA: Consumer Update - FDA Proposes Health 'App' Guidelines

FDA:  Mobile Medical Applications

FDA - 21 CFR 820 - Mobile Optimized

Need a quick way to reference the FDA's 21 CFR 820 (Medical Device regulations)?

Then checkout this mobile optimized collection of these regs, in one of two ways:

1. Go to this link:  http://breadcrumb.googleusercontent.com/view?id=ag5nbGFiczIwLXBhdmxvdnIOCxIFU3RvcnkYlZm7AQw
2. Follow the QR code, in this post.

Return Home: http://drughealth.blogspot.com/

Our Mobile Optimized Blog Re-Launched

I'm stoked!  I just finished refreshing the mobile optimized version of this blog.

Check it out in one of two ways:

1. Follow this url:  http://drughealth.prohost.mobi/
2. Follow the QR code provided in this post

Return Home: http://drughealth.blogspot.com/

Is FDA Watching Over Cell Phones as Medical Devices?

• People also need FDA CGMP Online Training - trusted GMP online training courses offered by SkillsPlus International Inc.

Updated March 24, 2021

People also search for the:

Digital Health Center of Excellence - FDA.gov

---  original post follows below  ---

Lately at work I've been noticing some buzz about mHealth, mobile health. The intersection of mHealth, cell phones, and FDA regulation of medical devices seems to be happening, reports this Bob on Medical Device Software post, When Cell Phones Become Medical Devices. According to the post:

Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data. The FDA will soon be forced to step in and take regulatory control. It’s going to happen eventually.

In a nutshell, it's time to start watching this, and paying attention to the possibility of having to follow FDA medical device regulations.  

Return Home: http://drughealth.blogspot.com/

Web Health Tools - Free

Use these cool tools to take care of your health. I just love the web! There are these free health tools and resources all over the place. Here's just a sample . . .

1. AARP Symptom Checker - just enter your symptoms to find out the possible causes
2. Kaiser Permanente Drugs and Natural Medicines - giant databases of information
3. AARP Illustrated Health Encyclopedia
4. AHA body mass index (BMI) calculator - a measure of body fat based on height and weight

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

This Blog Has Gone Mobile - The Health, Drug, Prescription, and GMP Supersite

Our posts are now available for mobile viewing too! So here's what will happen.

We'll maintain our original Blogger blog, here at: http://drughealth.blogspot.com/
I'll continue to post new content here.

Mobile phone readers can view our posts via this url: http://drughealth.mofuse.mobi/
Here's what happens. When I post to Blogger, an RSS feed gets sent to our mobile blog site hosted on MoFuse. You'll just be viewing our mobile optimized content with the help of the fine folks at MoFuse. What's cool is from our original Blogger site (look at the 'sidebar'), you can send yourself the mobile blog link to your phone. We also supply you with a link to the mobile site too.

Happy reading!

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/