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Rescooped by Giuseppe Fattori from Pharma Industry Regulation
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FDA declines to scrutinize claims by “low risk” mhealth apps, devices. What’s the takeaway?

FDA declines to scrutinize claims by “low risk” mhealth apps, devices. What’s the takeaway? | #eHealthPromotion, #SaluteSocial | Scoop.it

FDA said it will ease up vetting general health and wellness apps, but it will scrutinize clinical applications and devices. Does this mean the FTC will step up?

 

The U.S. Food and Drug Administration has issued final guidance on “low-risk” digital health apps and devices for general health management 18 months after it  came out with draft guidance.

The document offers information on the kinds of apps and devices for which it will and won’t take action. Apps promoting or maintaining a healthy weight or to assist with weight loss goals and healthy eating are OK.  The guidance says that companies can make claims that their apps and devices can help with healthy lifestyle choices to reduce the risk of chronic conditions such as Type 2 diabetes, high blood pressure and heart disease or improve their management. But those lifestyle choices have to be advocated by the likes of the American Heart Association or American Association of Clinical Endocrinologist or peer-reviewed medical journals.

So what are some examples of what’s not OK? Claims that a product will treat or diagnose obesity, an eating disorder, such as bullimia or anorexia, or an anxiety disorder. Digital health entrepreneurs are also encouraged to ask themselves the following questions:

Is the product invasive?
Is the product implanted?
Does the product involve an intervention or technology that may pose a risk to
the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?

If the answer is yes to any of the above, they need to assume their products are considered clinical applications, will be scrutinized and should act accordingly.

My takeaway from the guidance is twofold. It’s a question of resources. Although there are thousands of general wellness apps, more and more medical device and pharma companies are developing digital health devices and apps of their own.  Second, the Federal Trade Commission has shown it is willing to take action against companies that it deems to be making false health claims about their apps and devices.

 


Via rob halkes, Pharma Guy
rob halkes's curator insight, August 1, 2016 4:50 AM

Health apps should do what they promise! At the moment they need to take a diagnostic feature and use personal physics to arrive at advice or conclusions about the health status of the person who uses the app, they are considered not to be 'just' an "app" but a medical device. At that condition they need to adhere to and be certified by several criteria attached to 'medical devices". Developers should know about this, which the more professional ones will. Rightly so!

PatientView has developed a website MyHealthApps that presents an inventory of the better Health Apps.

Pharma Guy's curator insight, August 1, 2016 8:38 AM

Also read “FDA Won't Regulate ‘Low-Risk’ mHealth Apps as Medical Devices. But Battle Looms Over Defining ‘Low Risk’"; http://sco.lt/5kkDyr

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Can Mobile Technologies and Big Data Improve Health?

Can Mobile Technologies and Big Data Improve Health? | #eHealthPromotion, #SaluteSocial | Scoop.it

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. 


Via nrip
Paul's curator insight, July 24, 2014 12:06 PM

Yes - but bad data/analysis can harm it

Pedro Yiakoumi's curator insight, July 24, 2014 1:48 PM

http://theinnovationenterprise.com/summits/big-data-boston-2014

Vigisys's curator insight, July 27, 2014 4:34 AM

La collecte de données de santé tout azimut, même à l'échelle de big data, et l'analyse de grands sets de données est certainement utile pour formuler des hypothèses de départ qui guideront la recherche. Ou permettront d'optimiser certains processus pour une meilleure efficacité. Mais entre deux, une recherche raisonnée et humaine reste indispensable pour réaliser les "vraies" découvertes. De nombreuses études du passé (bien avant le big data) l'ont démontré...

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Where Will mHealth Be in 2024?

Where Will mHealth Be in 2024? | #eHealthPromotion, #SaluteSocial | Scoop.it
Ten years ago, mHealth as we presently know it didn't exist. But ten years from now, its sophistication and utility may be far greater than anything we can


more at http://mhealthwatch.com/infographic-where-will-mhealth-be-in-2024-22556/



Via nrip
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Interactive Infographic: How Physicians Use Mobile Technology

Interactive Infographic: How Physicians Use Mobile Technology | #eHealthPromotion, #SaluteSocial | Scoop.it
Explore the rise of mobile in the clinical setting and better understand how physicians are using mobile technology and social media to improve healthcare.

Via ET Russell, Texas Medical Association
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How mHealth tech is changing diabetes treatment

How mHealth tech is changing diabetes treatment | #eHealthPromotion, #SaluteSocial | Scoop.it

Today's mobile apps are helping diabetics aggregate blood sugar and nutritional data from multiple platforms and devices and logging data into central portals accessible anywhere, according to Steve Robinson, general manager of the Cloud Platform Services Division for IBM.

The apps and snap-on smartphone monitoring devices are letting physicians integrate biometric data from wearables into patient data and analyze patient data at fast speed, Robinson writes at InformationWeek. The benefits are just as extensive as the functionality being developed, he says

The gains include everything from simplifying records and improving doctor-patient conversations to gaining a holistic view of a diabetic's health. Doctors can "crunch and analyze patient data at rapid speeds to help identify patterns and predict future health and treatment needs," he writes.

"Mobile apps can help diabetes sufferers get ahead of their symptoms and live healthier, more carefree lives," Robinson says. 

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Diabetes tools have ranged from providing smartphone coaching that is helping diabetics living in low to modest socioeconomic communities manage their disease and improving their health, to a wearable, automated bionic pancreas for continuous glucose monitor and a software algorithm, according to a study at the New England Journal of Medicine.

In addition, mobile monitoring of diabetic employees can save more than $3,000 a year in healthcare costs, half of the average annual medical insurance cost for workers diagnosed with diabetes. 

Today's tools and cloud-based capabilities are reducing those costs while also driving innovation for disease management, Robinson says.

"Using cloud services, combined with the ease and convenience of mobile, new methods of managing this disease are being brought to patients around the world," he writes.

For more information:
- read the article

Related Articles:
Mobile monitoring tools can cut diabetes management costs in half
Smartphone-powered bionic pancreas outperforms traditional diabetes pump
Smartphone coaching can boost diabetic management, help reduce disease risks
Smartphone app aims for faster, more accurate, body fluid testing
Smartphones may be the next-gen blood test laboratory
Montefiore explores texting for diabetic teens, pre-op care


Via Celine Sportisse, DIRECT MEDICA by Webhelp, dbtmobile
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Could health apps save your life? That depends on the FDA

Could health apps save your life? That depends on the FDA | #eHealthPromotion, #SaluteSocial | Scoop.it

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/



Via nrip
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Rumor: Apple developing Healthbook app for iOS8 | mobihealthnews

Rumor: Apple developing Healthbook app for iOS8 | mobihealthnews | #eHealthPromotion, #SaluteSocial | Scoop.it

According to a report over at 9to5Mac, Apple is developing a health app called Healthbook that will track steps taken, calories burned, and miles walked. The app will also helps users track blood pressure, hydration levels, heart rate, and other blood-related biometrics, including — possible — glucose levels. In addition to the tracking features, Healthbook will also reportedly help users remember to take their medications and may even integrate with the iPhone’s existing, built-in Reminders app.

The report cites sources who describe the app as being modeled after Apple’s Passbook app, which is an app for storing loyalty cards and coupons. Like Passbook, Healthbook would be designed with an interface that resembles a stack of cards — each card representing a different health or fitness data point.

9to5Mac points out that many features and apps are developed for an upcoming iOS launch than the number that actually makes it into the final cut. While Healthbook may be under development at Apple, it still may never find its way to market.

Rumors aside, Apple has been poaching engineering talent and senior employees from digital health companies over the course of the past year. So, it certainly has more than a passing interest in digital health. Most recently, MobiHealthNews broke the news that Apple had hired Michael O’Reilly, the former chief medical officer of Masimo Corporation, which specializes in pulse oximeters. At the very end of 2012 Masimo commercially launched an iPhone-enabled pulse oximeter called the iSpO2.

Over the weekend The New York Times reported a few new scoops on Apple’s mobile health plans and its rumored iWatch project. Apple’s meeting in December with the FDA was focused on the subject of “mobile medical apps”, which is the term the FDA uses for those apps that need to be regulated as medical devices.

“They are either trying to get the lay of the land for regulatory pathways with medical devices and apps and this was an initial meeting, or Apple has been trying to push something through the FDA for a while and they’ve had hangups,” Mark A. McAndrew, a partner with the law firm Taft Stettinius & Hollister, who first noticed the public notice about the Apple-FDA meeting, speculated in an interview with The New York Times.... [read on ]


Via rob halkes
rob halkes's curator insight, February 3, 2014 2:06 PM

Curious where this will bring us..

Richard Baxter's curator insight, February 5, 2014 4:44 AM

Only a matter of time before Apple saw the potentail of health and big data combinations

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Health Devices at a Glance

Health Devices at a Glance | #eHealthPromotion, #SaluteSocial | Scoop.it

The infographic presents different heath devices.
88% of physicians want their patients to monitor health parametrers at home inclusding weight, blood pressure, blood sugar, exercise, calories, pain and sleep.
==================
Infographic from Misfit Wearables developers of highly wearable sensor products and services for wellness and medical applications Check out the other infographic pages in the series (the large left and right arrows on each side of the page), there’s a lot of interesting info.


Via Seth Bilazarian, MD
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