Posts tagged ‘mhealth’

July 22, 2014

Could health apps save your life? That depends on the FDA

The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will soon have its hands full with consumer health apps and devices.

 

The vast majority of the health apps you’ll find in Apple’s or Google’s app stores are harmless, like step counters and heart beat monitors. They’re non-clinical, non-actionable, and informational or motivational in nature.

 

But the next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels. More clinical apps

The FDA is charged with keeping watch on the safety and efficacy of consumer health products. Lately, that includes more clinical apps as well as devices you might buy at the drugstore, like a home glucose testing kit.

 

“It’s these apps that the FDA says it will regulate,” David Bates of Brigham and Women’s Hospital and Physicians Organization told VentureBeat in June. These apps will have to go through the full 510(k) process,” he said.

 

Dr. Bates chaired a group to advise the FDA on how to review health apps for approval, and on how the FDA should advise developers.

“It was intended to help them think through the risk factors involved with these products and then give guidance on how to stay within the guidelines,” he said.

 

“The device makers were asking from some guidance from The FDA on what types of things would be accepted and what wouldn’t,” Bates said.

Bates believes the FDA wants to use a light regulatory touch when looking at new medical devices. “The FDA definitely wants innovation to continue in clinical devices,” he said. “In general the FDA knows that the vast majority of apps are just informational.”

 

The FDA’s final guidance focuses on a small subset of mobile apps that present a greater risk to patients if they do not work as intended.

 

Health apps go mainstream

The big software companies (Apple, Google, and Samsung) have brought attention to, and lent credibility to, apps and devices that do more than count steps. These companies are building large cloud platforms designed to collect health data from all sorts of health apps and devices.

 

more at http://venturebeat.com/2014/07/21/health-apps-are-changing-so-must-the-fda/

 

Source: venturebeat.com

July 22, 2014

Can Mobile Technologies and Big Data Improve Health?

After decades as a technological laggard, medicine has entered its data age. Mobile technologies, sensors, genome sequencing, and advances in analytic software now make it possible to capture vast amounts of information about our individual makeup and the environment around us. The sum of this information could transform medicine, turning a field aimed at treating the average patient into one that’s customized to each person while shifting more control and responsibility from doctors to patients.

 

The question is: can big data make health care better?

 

“There is a lot of data being gathered. That’s not enough,” says Ed Martin, interim director of the Information Services Unit at the University of California San Francisco School of Medicine. “It’s really about coming up with applications that make data actionable.”

 

The business opportunity in making sense of that data—potentially $300 billion to $450 billion a year, according to consultants McKinsey & Company—is driving well-established companies like Apple, Qualcomm, and IBM to invest in technologies from data-capturing smartphone apps to billion-dollar analytical systems. It’s feeding the rising enthusiasm for startups as well.

 

Venture capital firms like Greylock Partners and Kleiner Perkins Caufield & Byers, as well as the corporate venture funds of Google, Samsung, Merck, and others, have invested more than $3 billion in health-care information technology since the beginning of 2013—a rapid acceleration from previous years, according to data from Mercom Capital Group.   more at http://www.technologyreview.com/news/529011/can-technology-fix-medicine/ ;

Source: www.technologyreview.com

December 23, 2013

Is mHealth Data Moving Towards Big Data?

Nathan E. Wineinger, Ph.D., a research scientist at Scripps Genomic Medicine discusses how mhealth data is moving towards big data at a rapid pace at the recent BigData@UCSD workshop last month.

Mobile health (mHealth) technologies allow for the generation of intensive care unit medical information, literally, in the palm of your hand. A smart phone can be transformed into a mobile heart monitor to diagnose atrial fibrillation, and continuous glucose monitoring has revolutionized the way diabetics manage their blood sugar levels. The digitization of human health through noninvasive devices and sensors can provide meaningful measures of individual wellness outside of a clinical environment.

This information can then be used to guide health decisions — or personalize medicine. However, mHealth data presents a computational challenge as it can be both wide and long (i.e. big data). Furthermore, this challenge can be broken into two components that are both vital to the production of actionable health care: data storage and processing; and its interpretation. It is this latter component that is notoriously omitted in the conversation on big data. This talk lead by research scientist at Scripps Genomic Medicine, Nathan E. Wineinger, Ph.D. will focus on analytical methods designed to interpret information from big data sources. Particularly, this talk will address approaches to analyze data on numerous variables from multiple sources which are serially correlated over time. This investigation is motivated by a recent mHealth study conducted at the Scripps Translational Science Institute designed to assess the relationship between neurocognitive and cardiovascular/pulmonary measurements, and the overall health benefits of meditation.
See on www.hitconsultant.net

From Pharmaceutical Industry digital vision

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December 17, 2013

2013: A Remarkable Year for mHealth Apps

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From record venture capital funding, to unprecedented scientific research behind their creation, mHealth applications finally turned the corner in 2013 as they emphatically entered the mainstream for mobile device users around the world.

According to the recently published findings of Manhattan Research‘sCybercitizen Health U.S. 2013 Study, 95 million Americans now count on their mobile devices to access health information and services. In fact, the number of Americans using mHealth resources is up 27 percent from just one year ago.

In September, the U.S. Food and Drug Administration announced plans to begin regulating a small segment of the expanding universe of mobile health applications that, in light of their growing scientific grounding, are making bigger and bolder claims about what they can achieve for our general health and wellness.

Unlike the large assortment of ineffective gimmick apps and simple activity trackers that first arrived in the world’s leading app stores in the early days of their existence, today’s most popular mHealth apps are also the most critically acclaimed and clinically supported by physicians and health experts.

As 2013 rapidly winds to a close, a compelling case can now be made that this year brought with it the most impressive and consequential mHealth apps we’ve seen to date.

“mHealth apps have come a long way from their humble and ‘too cute to be taken seriously’ beginnings,” says Mario Westbury, a Boston-based business analyst and nationally published tech news columnist.

See on mhealthwatch.com

From Pharmaceutical Industry digital vision

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December 17, 2013

mHealth Company Pushing Dario Diabetes Management Platform Globally

LabStyle Innovations Corp., the developer of Dario – a cloud-based, mobile health platform for diabetes – announced that the global launcg of its diabetes management platform is now in progress.

In a statement issued to the press, customers in the United Kingdom, New Zealand and Australia are being encourahed to download the complimentary app from the Apple App Store.

The app works with all blood glucose monitoring devices. By simply manually inputting blood glucose information, customers will be able to experience the novel functionality and benefits of Dario’s iOS app.

“With the introduction of the Dario iOS app, we officially begin the world roll-out of the complete Dario diabetes management platform.  Customers can now easily and instantly check blood sugar levels using their smartphone and gain useful insights and views regarding the management of their condition.  Starting today, diabetes management just got easier, social and much more enjoyable,” said LabStyle’s CEO Erez Raphael.

See on mhealthwatch.com

from Pharmaceutical Industry digital vision

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December 15, 2013

mHealthWatch Reporting Live from mHealth Summit 2013

mHealthWatch is at the 5th annual mHealth Summit this week in Washington, D.C.

The annual event brings together a wide array of healthcare and technology leaders from  across the mobile health continuum to discuss, debate, and ultimately “advance collaboration in the use of wireless technology to improve health outcomes.”

Throughout the week, we’ll be reporting directly from the floor of the largest mobile health event in the world. So be sure to stay with mHealthWatch for news and announcements as they emerge from the Summit.

To stay connected on Twitter, the official hashtag for the Summit is #mHealth13.

See on mhealthwatch.com

From Pharmaceutical Industry digital vision

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December 10, 2013

Is mHealth Data Moving Towards Big Data?

Nathan E. Wineinger, Ph.D., a research scientist at Scripps Genomic Medicine discusses how mhealth data is moving towards big data at a rapid pace.

Mobile health (mHealth) technologies allow for the generation of intensive care unit medical information, literally, in the palm of your hand. A smart phone can be transformed into a mobile heart monitor to diagnose atrial fibrillation, and continuous glucose monitoring has revolutionized the way diabetics manage their blood sugar levels. The digitization of human health through noninvasive devices and sensors can provide meaningful measures of individual wellness outside of a clinical environment.

This information can then be used to guide health decisions — or personalize medicine. However, mHealth data presents a computational challenge as it can be both wide and long (i.e. big data). Furthermore, this challenge can be broken into two components that are both vital to the production of actionable health care: data storage and processing; and its interpretation. It is this latter component that is notoriously omitted in the conversation on big data. This talk lead by research scientist at Scripps Genomic Medicine, Nathan E. Wineinger, Ph.D. will focus on analytical methods designed to interpret information from big data sources. Particularly, this talk will address approaches to analyze data on numerous variables from multiple sources which are serially correlated over time. This investigation is motivated by a recent mHealth study conducted at the Scripps Translational Science Institute designed to assess the relationship between neurocognitive and cardiovascular/pulmonary measurements, and the overall health benefits of meditation.

See on www.hitconsultant.net

From Pharmaceutical Industry digital vision

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December 10, 2013

Time to nail down an mHealth definition | Government Health IT

Deep in the back offices of Silicon Valley startups and stalwarts, you won’t commonly encounter phrases like “automotive IT” or “plastic injection molding IT” – yet all through the healthcare industry, such vague-almost-to-the-point-of-confusing terms pepper the conversation.

The most egregious example, indeed, is “health IT”. Is health IT just an EHR or even the market brimming with so many electronic health records systems and modules? No. Realistically, health IT comprises any number of the technologies, whether it’s low-cost practice management services in the cloud or big, iron-bound database management systems that huge health networks plunk down tens of millions of dollars to acquire and run themselves.

Every day we talk about health IT almost as if it is one single simple solution, rather than all the technologies taken together that a hospital needs to survive, if not thrive.

Is mHealth destined for the same ambiguous fate?

As of today three main terms reign: mHealth (of course), mobile health and mobile medical apps, the latter being not so much an entire marketscape but the phrase our Food and Drug Administration (FDA) uses to determine which, well, mHealth apps and devices to regulate and those to leave alone.

Whether the FDA’s mobile medical apps phrase survives hardly matters to the larger conversation about mobile and mHealth. Are we talking about smartphone apps? Tablet hardware? Does telehealth fit under the mHealth umbrella, or vice versa? When will it all just be healthcare, anyway? And what of the rapidly expanding realm of borderline medical devices – products like glucometers that plug into smartphones?

See on www.govhealthit.com

From Pharmaceutical Industry digital vision

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December 2, 2013

Visual Wednesdays: mHealth – A checkup on consumer use –

See the full infographic here

See on rockhealth.com

From Pharmaceutical Industry digital vision

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November 26, 2013

Visual Wednesdays: mHealth – A checkup on consumer use –

See on rockhealth.com

From Pharmaceutical Industry digital vision