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The FDA Wants 23andMe To Stop Selling Its Genetic Testing Kits

The FDA Wants 23andMe To Stop Selling Its Genetic Testing Kits | Digital Health | Scoop.it

The Food and Drug Administration is ordering 23andMe to stop selling its saliva collection kits for its personal genome service.

 

23andMe is a health and ancestry DNA startup, founded by Anne Wojcicki in 2006. For $99, you receive a spit kit, provide 23andMe with a saliva sample, and send in your results.

Within a few weeks, you receive a bunch of information about what your DNA says about you.

But now the FDA is accusing 23andMe of violating the Federal Food, Drug, and Cosmetic Act, it recently stated in a warning letter addressed to 23andMe CEO Anne Wojcicki. In the letter, the FDA claims that 23andMe marketed its saliva collection kit and personal genome service without clearance or approval.

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The intersection between health and digital technology will herald a revolution for patients, healthcare professionals and pharmaceutical companies
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"The Healthcare revolution will not be televised"

My Presentation from Athens looking at 5 things digital can do to revolutionise pharmaceuticals (with a bit of Gil Scott Heron thrown in for good measure)

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Alex Butler's comment, August 13, 2013 4:31 AM
Thanks for watching Dan, appreciated :-)
Sophie Undreiner's curator insight, March 15, 2014 5:23 AM

@TedMed par Alex Butler

Vigisys's curator insight, November 2, 2014 5:10 AM

Une intéressante présentation (en anglais) qui aborde les principaux concepts qui seront fondateurs de l'e-santé à venir. Une belle inspiration pour le développement des futurs réseaux de santé numériques.

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Built By A Parkinson’s Sufferer, MyHealthPal Tracks Symptoms, Creates Research Data

Built By A Parkinson’s Sufferer, MyHealthPal Tracks Symptoms, Creates Research Data | Digital Health | Scoop.it

The development and availability of wearables is running hand in hand with the exploding interest in the digital health space. Managing our health via apps and devices is slowly becoming the norm. And patients that need to monitor their condition day-to-day have even more to benefit from this powerful combination. Startups are of course entering this space in droves.


The latest is a startup which launches out of stealth today: MyHealthPal, an iOS app and analytics platform that enables people with long-term health conditions to manage their condition, is initially focusing on Parkinson’s Disease, but could be applied similar diseases.


It’s now secured an initial seed funding of £500,000, and launched a trial with the highly respected Mount Sinai Hospital in New York.

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Sarah Palmer's curator insight, March 27, 12:40 PM

#innovate #healthcare

Courtney Bonner's curator insight, March 28, 8:01 PM

This is a great idea for those patients who are forgetful about taking their medications

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23AndMe Wants to Turn Its DNA Data into New Drugs

23AndMe Wants to Turn Its DNA Data into New Drugs | Digital Health | Scoop.it
DNA testing startup 23andMe has been doing brisk business collecting genetic samples from over 800,000 customers. But the company just announced a new plan that'll launch it into the big pharma world: 23andMe is going to invent its own pharmaceutical drugs using the data it collects from customer DNA.
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Courtney Bonner's curator insight, March 25, 1:05 PM

This has the potential to be big. If drugs are made from samples from 800,000 customers, it could prevent big epidemics and other super-infections from even happening.

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Apple ResearchKit: Three Reasons For Pharma To Be Optimistic

Apple ResearchKit: Three Reasons For Pharma To Be Optimistic | Digital Health | Scoop.it
At Apple’s much-anticipated Watch launch event in San Francisco yesterday they delivered what was largely a surprise announcement. For months there has been speculation about the Watch and its possible implications and applications for health. Recently these expectations had been diminished by leaked reports of greatly scaled back integrated sensor technology..
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The FDA is finally embracing health tech -- that's both good and bad news

The FDA is finally embracing health tech -- that's both good and bad news | Digital Health | Scoop.it
23andMe was built on the idea that consumers are smart enough to handle their own health-care information and guide their own care. Now, apparently, the FDA is starting to agree.
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Facebook rolls out new tools to help prevent suicides

Facebook rolls out new tools to help prevent suicides | Digital Health | Scoop.it
With over a billion users, Facebook plays an important role in keeping people connected. It serves as a place to share good news, but also provides a platform for users to request support from their digital peers.


The company is keenly aware that it can assist users when there is a cry for help, which is why it rolled out an (lengthy) way to flag suicidal content back in 2011. Now, it's taking that one step further by introducing new tools to boost its suicide prevention efforts

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Microsoft Band Gets Major Features and SDK in Update

Microsoft Band Gets Major Features and SDK in Update | Digital Health | Scoop.it

Microsoft’s quirky amalgamation of fitness tracker and smartwatch, the simply namedBand, is about to get more powerful; the company is launching a series of updates for the tracker, as well as introducing an SDK for developers.


Users on a desktop can now check their fitness information more easily with a new Web dashboard for Microsoft Health, which expands on the features available on the mobile Health app. You can now see extended data views and more detailed charts on your health stats.



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5 imperatives of user experience design in mobile health technology

5 imperatives of user experience design in mobile health technology | Digital Health | Scoop.it
The Wiki definition of UX design is “the process of enhancing user satisfaction by improving the usability, ease of use and pleasure provided in the interaction between the user and the product.” UX design success in mobile health technologies depends upon the achievement of including the best in reliability, usability, privacy and safety, content and pleasurable experience. I will discuss what I think are five important issues in achieving the ideal mobile technology user experience, specifically for those technologies hoping to enter thehealthcare (vs. consumer) market.
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The latest Nike+ FuelBand is actually your iPhone

The latest Nike+ FuelBand is actually your iPhone | Digital Health | Scoop.it

No fitness tracker, no problem! Just use your iPhone and the newly updated Nike+ Fuel app.


The Nike+ Fuel app for iPhone now supports Apple's HealthKit. As a result, this means you don't actually need a FuelBand for the app to track your movements and earn points and trophies — the sensors on your iPhone do all that for you.


The update comes nearly a year after Nike jettisoned its FuelBand team, opting instead to focus on a larger software partnership with Apple,

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14 Major U.S. Hospitals Now Using HealthKit as Apple Adds Health Industry Advisors

14 Major U.S. Hospitals Now Using HealthKit as Apple Adds Health Industry Advisors | Digital Health | Scoop.it

Fourteen major U.S. hospitals have rolled out their own trials of Apple's HealthKit tool, with the pilot program earning praise among doctors for its ease of use and advanced tracking of various health metrics, reports Reuters

According to the news agency, eight hospitals trying out HealthKit are on the U.S. News & World Report's Honor Roll which ranks the best hospitals, with the program seeing more of a positive reaction versus health tracking programs by Google and Samsung.


Ochsner Medical Center in New Orleans has been working with Apple and Epic Systems, Ochsner's medical records vendor, to roll out a pilot program for high-risk patients. The team is already tracking several hundred patients who are struggling to control their blood pressure. The devices measure blood pressure and other statistics and send it to Apple phones and tablets. 

"If we had more data, like daily weights, we could give the patient a call before they need to be hospitalized," said Chief Clinical Transformation Officer Dr. Richard Milani.
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mHealth Tools Shown to Improve HIV Management

mHealth Tools Shown to Improve HIV Management | Digital Health | Scoop.it

This week, mscripts and Avella Specialty Pharmacy announced the findings of their recently completed research analyzing data demonstrating the effectiveness of mobile pharmacy apps in helping HIV patients better manage their disease (through improved medication adherence).


According to a report summary and news release shared with mHealthWatch this morning, results show that HIV patients using a mobile app (one that provides refill reminders, dosage reminders and other prescription management functionality) are 2.9 times more likely to be adherent.

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How iPhone health gadgets could change what 'see your doctor' means

How iPhone health gadgets could change what 'see your doctor' means | Digital Health | Scoop.it

Apple's Health app had a quiet rollout in late 2014, and months later many iOS users still aren't sure how the platform works on their new (or newly updated) iPhone.


Sure, we've already seen a series of apps like Nike+ Running, MyFitnessPal and the MayoClinic work with the iOS-based hub for tracking personal health data, but as of now, Health's forecasted impact on the medical industry has yet to be proven.

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Here's How Apple Could Keep You Out Of The Doctor's Office

Here's How Apple Could Keep You Out Of The Doctor's Office | Digital Health | Scoop.it

Apple announced its health monitoring app, HealthKit, last June.

Now we're getting a better idea about how Apple could be making its devices into a hub for your medical needs.


The iPhone and Apple Watch may upend how we take care of ourselves through do-it-yourself (DIY) diagnoses, according to a new report by UBS analyst Steven Milunovich.


UBS talked to Dr. Eric Topol, a cardiologist who has written about the intersection of technology and medicine.


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FDA 'Taking a Very Light Touch' on Regulating the Apple Watch

FDA 'Taking a Very Light Touch' on Regulating the Apple Watch | Digital Health | Scoop.it

With Apple Inc. and fellow Silicon Valley companies edging further into health care, the U.S. agency in charge of oversight says it will give the technology industry leeway to develop new products without aggressive regulation.


Bakul Patel, who oversees the new wave of consumer-focused health products at the Food and Drug Administration, said most wearable gadgets such as the soon-to-be-released Apple Watch and health-focused applications for smartphones have a way to go before warranting close scrutiny from the agency.

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Inside Apple's Top Secret Apple Watch Fitness Lab

Inside Apple's Top Secret Apple Watch Fitness Lab | Digital Health | Scoop.it

Apple, known for keeping its product developments under the strictest of lock-and-key, gave ABC News exclusive access into its top secret health and fitness lab, where only Apple employees became test subjects for the new Apple Watch.

Apple engineers, managers and developers have been secretly volunteering for the past year in this state-of-the-art lab to participate in rowing, running, yoga and many more fitness activities in order to collect data for the Apple Watch’s inner workings.

“[The employees] knew they were testing something, but they didn't know it was for the Apple Watch,” said Jeff Williams, Apple’s senior vice president of operations. “We hooked them up with all the masks and so forth, but we would put on an Apple Watch covered up.”

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UCanRow2's curator insight, March 25, 12:32 PM

So cool to see them using rowing as one of the exercises to test this new product!

Denise Silber's curator insight, March 25, 7:49 PM

All is top secret at Apple

 
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Tim Cook names health as the biggest frontier for Apple

Tim Cook names health as the biggest frontier for Apple | Digital Health | Scoop.it

Apple CEO Tim Cook phoned in to Jim Cramer, the star host of CNBC's "Mad Money," and shared what he thinks are the next big three frontiers for Apple.


When Cramer asked Cook if he sees the car and the home as the next big frontiers for Apple, Cook responded, "I think those are the two big ones."

Then he continued, "I think health may be the biggest one of all."

He continued, "Because for years — people have depended on strictly somebody else to determine their health. And now these devices in essence, empower people to manage and track their own health and fitness. And so I think that market is probably significantly underestimated."

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Jim Murphy's curator insight, March 13, 7:29 AM

Excited to say that we will soon have an announcement in this area. 

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The Five Foundations of Digital patient Support programmes

The Five Foundations of Digital patient Support programmes | Digital Health | Scoop.it

The term ‘digital’ in 2015 is a dangerous one. We all live in a complex mixed reality where the confines of digital and non-digital channels are blurred. The focus is rightly on integration with and augmentation of the human experience. That being said, when we look at health, people turn to digital channels first when seeking help and when looking for on going support, digital and especially mobile, are the future of interventional relationships between healthcare providers, pharmaceutical companies and patients. When designing patient support programmes with a digital element these are the 5 key foundations you need to bear in mind...

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How Google's using big data and machine-learning to aid drug discovery

How Google's using big data and machine-learning to aid drug discovery | Digital Health | Scoop.it

From answering heath-related questions in its search results to a fitness data platform for developers, Google is becoming increasingly ingrained in the fabric of our daily health-and-wellbeing habits. But behind the scenes, the Internet giant is also working to expedite the discovery of drugs that could prove vital to finding cures for many human ills.


Working with Stanford University’s Pande Lab, Google Research has introduced a paper called “Massively Multitask Networks for Drug Discovery,” [PDF] which looks at how using data from a myriad of different sources can better determine which chemical compounds will serve as “effective drug treatments for a variety of diseases.”


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Healthcare Providers warming up to mobile health

Healthcare Providers warming up to mobile health | Digital Health | Scoop.it

The use of electronic health records has come a long way since 2010, but EHRs cannot stand alone, warns a PwC report. The next challenge is integrating mobile health devices into the EHR and the provider–patient relationship.


The consulting company interviewed 1,000 physicians and physician extenders—nurse practitioners, physician assistants—to discover how they use digital technology and some of the concerns they have about incorporating it into clinical practice (http://tinyurl.com/digital-study).

The number of providers using smartphones and tablets is increasing. For example, in 2010, about 1 in 8 (12%) used mobile devices to check medical records. In 2014, the survey found that almost half (45%) do.

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Jenna Collins's comment, March 25, 11:28 AM

Using electronic records is so much more efficient than the old style of millions of folders and files. While it is much easier to search and find specific files electronically, there is also the possibility of losing records or being hacked.
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New App Store for Health Professionals Planned

New App Store for Health Professionals Planned | Digital Health | Scoop.it

Epic Systems Corp. recently divulged plans to launch its own app store for healthcare professionals.

Such a move could invite developers and companies to produce countless new apps compatible with Epic’s electronic health records systems.

According to published reports, the app store will launch in a few weeks.

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Jenna Collins's comment, March 25, 11:17 AM
An app store such as this would be greatly beneficial to the healthcare professionals, enabling better communication and ways of sending and receiving data on the go.
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Silicon Valley Turns Smartphones Into Mobile Health Clinics

Silicon Valley Turns Smartphones Into Mobile Health Clinics | Digital Health | Scoop.it

Silicon Valley companies are creating more mobile health apps and getting more financial backing than ever before. You can now use your phone to help diagnose an ear infection, and even monitor a diabetic child's blood sugar.

"It's the next big thing, no question about it,” Vital Connect CEO Nersi Nazari said of mobile health. Vital Connect in Campbell just launched the HealthPatch MD. It’s a patch that sticks onto the skin and provides constant heart monitoring and tracks pulse, respiratory rate, and other health metrics. It’s the first device of its kind and available for doctors or loved ones to track someone with a heart condition.

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Courtney Bonner's curator insight, March 25, 1:01 PM

This is a great idea because sometimes people can not find time in their busy schedules to go over to a clinic for care. 

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Test for HIV in just 15 minutes with this $34 smartphone dongle

Test for HIV in just 15 minutes with this $34 smartphone dongle | Digital Health | Scoop.it

A dongle created by Columbia University researchers can turn any smartphone (whether iPhones or Android devices) into an HIV and syphilis tester. Even better, it only takes 15 minutes and a tiny drop of blood to get a result -- the device doesn't even need a battery to work. According to the paper the researchers published in Science Translational Medicine, the dongle performs enzyme-linked immunosorbent assay (ELISA) to detect HIV antibody, treponemal-specific antibody for syphilis, and non-treponemal antibody for active syphilis infection. Labs don't currently offer the three tests needed to detect those in a single format. ELISA machines, by the way, cost around $18,000, but each of these dongles only cost around $34 to manufacture.

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Mobile Health Adoption Growing Among Doctors, for Apps and Content

Mobile Health Adoption Growing Among Doctors, for Apps and Content | Digital Health | Scoop.it

More than 80 percent of U.S. doctors surveyed use mobile apps or view professional content on mobile devices for work. That’s a significant increase over the numbers from around a year ago, according to a new survey.


The main reasons for adoption? Improved patient care and communication, and time efficiency, doctors say. The survey was conducted byMedData Group, a healthcare marketing company in Topsfield, MA, and involved polling 375 physicians around the country this month.


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Decide Consulting's curator insight, January 28, 11:11 AM

mHealth is growing whether physicians, hospitals, or offices are ready or not. Learn about Decide's impact on the mHealth market here: decidemobility.com

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Study: Complaining on Twitter correlates with heart disease risks

Study: Complaining on Twitter correlates with heart disease risks | Digital Health | Scoop.it

This week, a study was released by researchers at the University of Pennsylvania that found a surprising correlation when studying two kinds of maps: those that mapped the county-level frequency of cardiac disease, and those that mapped the emotional state of an area's Twitter posts.

In all, researchers sifted through over 826 million tweets, made available by Twitter's research-friendly "garden hose" server access, then narrowed those down to roughly 146 million tweets that had been posted with geolocation data from over 1,300 counties (each county needed to have at least 50,000 tweets to sift through to qualify). The team then measured an individual county's expected "health" level based on frequency of certain phrases, using dictionaries that had been put through scrutiny over their application to emotional states. Negative statements about health, jobs, and attractiveness—along with a bump in curse words—would put a county in the "risk" camp, while words like "opportunities," "overcome," and "weekend" added more points to a county's "protective" rating.

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How Mobile Tech is Revolutionizing Patient Health Management

How Mobile Tech is Revolutionizing Patient Health Management | Digital Health | Scoop.it

The term “revolution” is applied a little too abundantly to technological innovations, isn’t it? It is however, noteworthy to observe how certain tech advances in mobility have quite unapologetically revolutionized the way people access information.

These advances are quickly gaining momentum in the patient health management sector, as mobile devices continue to penetrate the consumer market. A 2013 Forbes article pointed out how over 80% US citizens use cell phones on a daily basis, out of which about 50% are smartphone users.

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Richard Platt's curator insight, January 14, 9:34 PM

Part of the large appeal and value apps hold for physicians is the way they easily integrate into their daily to-dos: info is delivered as and when needed, after a few taps. - Not to mention what the technology does for patients.  - Most well-known medical apps provide a level of flexibility which makes them an ideal choice no matter what smartphone device physicians are using. 

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HealthPatch MD alerts your doctor about heart problems in real time

HealthPatch MD alerts your doctor about heart problems in real time | Digital Health | Scoop.it

What's more important than your health? Not much, we think you'll agree. The team behind HealthPatch MD certainly knows our well-being is top of most of our lists -- so it made the aforementioned product to help monitor it.


HealthPatch isn't a fitness-tracking wristband or a home health accessory; it's aimed at hospitals, doctors and medical services. What is it? It's a small patch with a module that monitors heart activity (ECG), heart rate (and variability), respiratory rate, skin temperature, activity posture and even fall detection.


What makes it interesting is that it's also a connected device, so you no longer need to go to a medical facility to be monitored. You can just go about your normal life.

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Art Jones's curator insight, January 7, 9:05 AM

A small device with all the capabilities of an ECG plus more and it's connected so your state of wellness can be monitored remotely. #TheFutureofHealthcare

Richard Platt's curator insight, January 8, 9:01 PM

It's a small patch with a module that monitors heart activity (ECG), heart rate (and variability), respiratory rate, skin temperature, activity posture and even fall detection. What makes it interesting is that it's also a connected device, so you no longer need to go to a medical facility to be monitored. You can just go about your normal life.

Allen Taylor's curator insight, January 11, 5:35 PM

Heart monitoring is becoming less intrusive all the time.