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Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication | FDA.gov

HHS today released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication.

 

The Congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

 

The report was developed by the U.S. Food and Drug Administration (FDA) in consultation with two other federal agencies that oversee health IT: HHS’ Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC). The FDA seeks public comment on the draft document.

 

“The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.”

 

Innovative health IT products present tremendous potential benefits, including: greater prevention of medical errors; reductions in unnecessary tests; increased patient engagement; and faster identifications of and response to public health threats and emergencies.

 

However, if health IT products are not designed, implemented or maintained properly, they can pose varying degrees of risk to the patients who use them. The safety of health IT relies not only on how a product is designed and developed, but on how it is customized, implemented, integrated and used.

 

As proposed in the draft report, posted on the ONC, FDA and FCC websites, there would be three health IT categories, based on function and level of risk, that focus on what the product does, not on the platform on which it operates (mobile medical device, PC, or cloud-based, for example).

 

Click headline to read more--

 


Via Chuck Sherwood, Senior Associate, TeleDimensions, Inc
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Health Risk Assessments Are A Powerful Component of Population Health Management

Health Risk Assessments Are A Powerful Component of Population Health Management | Healthcare | Scoop.it
Health Risk Assessments (HRAs) are a powerful component of population health management strategies for healthcare organizations.

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Sherri Altman's curator insight, September 15, 2014 9:53 PM

Curious how these metrics compare to the HRA we have deployed to our consumers.  As an organization we have decided to target key chronic conditions to help reduce costs. What other prevention programs could or should we be considering to assist our members?

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5 Medical Technologies Revolutionizing Healthcare

5 Medical Technologies Revolutionizing Healthcare | Healthcare | Scoop.it

A deeper look at five technologies that are currently advancing exponentially and radically reshaping healthcare. In other words, for the long suffering, there is plenty of hope to go around.

 

3-D printing 

 

3D printing is already making its presence felt in medical device world. Ninety-five percent of all hearing aids are today 3D printed. This tech is also pushing into prosthetics. There are custom-made back braces for scoliosis patients and casts for broken bones (perforated with holes so people can finally scratch through their casts) and, in the latest development, 3D printed facial prosthetics (noses, ears, etc.).

 

 Artificial Intelligence
 

It started with IBM’s Watson. After besting humans on Jeopardy back in 2011, Big Blue sent their thinking machine to medical school. Now loaded up with everything from journal articles to medical textbooks to actual information culled from patient interviews, the supercomputer has remerged as an incredibly robust diagnostic aid that is already being used for everything from training medical students to managing the treatment of lung cancer.

 

 Brain- Computer Interfaces  

We’ve been hearing about BCIs for a little while now. The tech originated out of the desire to help paraplegics and quadriplegics control computer cursors with only their brains. Of course, these developments will continue apace, bringing far more liberation to the disabled then ever before possible, but the bigger news is in BCIs that can control robotic limbs or even restore function to paralyzed limbs.

 

Robotics:


The robots are coming, the robots are coming, the robots are, well, here. Whether we’re talking the da Vinci Surgical System—which has performed over 20,000 operations since its 2000 debut—or newer developments like the nanobots swimming through our bloodstream and scraping plaque from our arteries, robots are already deep into the healthcare space.

 

Point-of-Care Diagnostics


In medicine, one of the major promises of technology is patient empowerment—especially when it comes to diagnostics. Suddenly, patients no longer have to go to the doctor’s office or hospital. Instead, in the comfort of your home, a system called the  Tricorder will analyze data, diagnose the problem, and send that information to a doctor who, quite possibly, can treat you remotely. In the developed world, where doctors make diagnostic errors 10 percent of the time, this will make a significant difference in quality-of-care and significantly reduce the roughly $55 billion spent annually on the malpractice system) In the developing world, this will make healthcare far more accessible.

 

  for more check out the original at http://www.forbes.com/sites/stevenkotler/2013/12/19/5-medical-technologies-revolutionizing-healthcare/
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3-D printing is amazing! Just imagine 3-D printing bones with all the nerves...truly amazing 

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Ellie Kesselman Wells's comment, December 21, 2013 9:26 PM
Re Point of Care: in the developed world, machines will make diagnostic errors a lot more often than physicians. And in the developing world, yes, access to care would improve but that doesn't address the other issue, which is paying for required treatment, whether pharmaceutical or otherwise. I'll go complain in the comments for the original post at Forbes, not here, as it isn't your fault! Thank you for sharing with us; I don't intend to seem ungrateful.
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Apple vs. Google: An mHealth Face-Off

Apple vs. Google: An mHealth Face-Off | Healthcare | Scoop.it

Industry observers like myself have often painted the competitive mHealth landscape with a brush that wages computer manufacturer Dell and software behemoth Microsoft versus Apple--the reigning mobile healthcare champion. However, the real battle for the heart, mind and soul of the still-emerging mHealth market places Apple and search engine giant Google squarely in the commercial trenches.

 


Apple's iPhone and iPad have set the standard for other mobile devices in healthcare. Doctors, in particular, simply love their iPhones and iPads. But, now, the mHealth war between Apple and Google appears to be entering a new battlefield, namely wearable devices. 

At the center of Apple's efforts in this area is its long-awaited iWatch, a wristwatch-like computing device with smartphone/tablet and health/activity tracking capabilities. Reportedly, iWatch includes a pedometer for counting steps and sensors for monitoring health-related data such as heart rate.

 

Apple is growing its team of medical sensor specialists by hiring some of the world's premiere experts in mobile medical technologies. Presumably, this expertise will be heavily leveraged by Apple in their development of the iWatch or some other device.    

 

Simultaneously, Google has been working on its much-heralded Google Glass, high-tech glasses which contain a heads-up display, camera and a microphone, and can ostensibly support mobile health apps directly on the device. Google Glass, developed by the company's secretive Google X lab, has strong potential for healthcare, particularly in the ER where physicians could use the glasses to scroll through lab and radiology results and in the OR providing surgeons with hands-free access to critical clinical information.

 

In addition, earlier this month, Google unveiled its contact lenses, which use a tiny sensor and wireless transmitter, to monitor and measure glucose levels in tears, potentially replacing the self-administered blood tests from finger pricks that diabetics must endure on a daily basis. Not surprisingly, Google employees recently met with U.S. Food and Drug Administration officials at FDA headquarters who regulate eye devices. 


Who will be first to market with these wearable devices--Apple or Google--remains to be seen. What is certain, however, is that the two technology leaders with track records for building strong brands will no doubt dazzle the marketplace with innovative, leading-edge products that put sensor-based devices in the hands of consumers and medical professionals. That kind of competition in mHealth can only serve to benefit us all as this nascent industry moves forward

More at  http://www.fiercemobilehealthcare.com/story/apple-vs-google-mhealth-face/2014-01-27



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Competition is always great! 

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Ricardo Rocha's curator insight, February 16, 2014 7:53 PM

"wearable devices"  .... Estamos falando apenas do começo, as possibilidades e benefícios são incontáveis!!!! Imagine não ter que tomar uma agulhada por dia para medir a glicose?

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When analytics falls short | Healthcare IT News

When analytics falls short | Healthcare IT News | Healthcare | Scoop.it
The joys of unintended consequences never end. The Patient Protection and Affordable Care Act required hospitals to get paid based on how much they improved their patients' health rather than on how many tests and procedures were completed. The intent was to improve patient care.
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INFOGRAPHIC: The Future Of Big Data

INFOGRAPHIC: The Future Of Big Data | Healthcare | Scoop.it
Big Data is BIG business and will continue to be one of the more predominant areas of focus in the coming years from small startups to large scale corporations.

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Peter Azzopardi's curator insight, June 3, 2014 5:55 PM

Included is an infographic created by the non profit group TiE which shows us where the industry looks to be heading.

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Health 2.0 Presentation: Big Data Tools for Population Health Management

Lumeris' Jim Hansen, Vice President, Health Policy discusses the importance of virtualizing health care functions while demonstrating the Care Management Sol...
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Fitness Trackers Are Useless Without Real-Time, Personalized Analysis

Fitness Trackers Are Useless Without Real-Time, Personalized Analysis | Healthcare | Scoop.it

No one has arms long enough to wear all of the activity-tracking wristbands currently on sale or awaiting release. These devices count your steps, measure your sleep and some even monitor your heart rate.

 

But do you know how this information immediately applies to your lifestyle, or what you should do with it?

 

The services behind these trackers need to invest in immediacy by providing useful information, ideally in real time, so we can optimize our wealth of data into action.

 

Everyone wants to be better, but nobody has a baseline for understanding themselves.


what use is the data without knowing in real time what you, individually, can do to change it?


I’d like to know whether I need to slow down. Am I pushing myself too hard?


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A good example of how data is cool. But, in order to make it meaningful, it needs to be analysis!! 

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nrip's curator insight, January 27, 2014 1:54 AM

If I got a dollar for each time I said this to someone in the last year, I would have got a million plus by now :) ...  I am happy that others see this as a deal breaker for wearables too.


The mediXcel PHR is solving this very problem by trying to build a personalized analysis engine on top of the wearable databank it has which connects to 40 odd wearables at the moment.

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DNA Nanotechnology the Future of Modern Medicine?

DNA Nanotechnology the Future of Modern Medicine? | Healthcare | Scoop.it

One of the most significant achievements in the field of biomedical engineering is the creation of DNA nanobots. These molecular robots made of DNA are designed to deliver medicines to specific cells that require healing and to target harmful cells, killing them without harming the healthy ones.

 

Unlike commonly used drugs and supplements, nanobots have a measure of intelligence and can conveniently move through the body in smart ways.

 

How are these nanobots produced? Scientists use DNA, breaking up the components and rearranging them into shapes such as barrels to carry medicine. DNA naturally has a tendency to react in certain ways to outside stimuli, and its components assemble according to natural attraction and repulsion. These reactions are manipulated to make the nanobots and to program them.

 

Nanobots are free-floating structures that move through the bloodstream and remain neutral until they encounter a particular site that requires assistance. With the help of molecular cues programmed into them, they can identify a precise location and perform the necessary actions.

 

Treatment with nanobots could prove to be especially effective against cancer. With chemotherapy treatment, healthy cells are killed along with the cancerous cells. Nanobots can detect the cancerous cells, however, and only release medicine upon encountering them.

 

Read more: http://www.theepochtimes.com/n3/390772-dna-nanobots-the-future-of-modern-medicine/#ixzz2oWJdpY00


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So long as the little bugs damage my insides! 

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Sidney Williams-Goddess's curator insight, February 5, 2014 11:46 PM

This article is about the eventual use of nanotechnology in humans to work as little nurses, called nanobots, to deliver medicine directly to sick or cancerous cells with out harming the healthy cells. I am really fascinated by nanotechnology, it is crazy ad unknown to me, i would really like to learn more about it. This article is from The Epoch Times, which in their "about us" claims "unwavering commitment to objective reporting" . 

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Should companies in the healthcare sector use social media?

Should companies in the healthcare sector use social media? | Healthcare | Scoop.it

or some industries like travel, beauty and fashion, the advent of social media has been a marketing match made in heaven.

Brands have cashed in on the narcissistic post and boast culture we now live in, offering endless competitions to win 'money can’t buy' prizes in exchange for likes, shares or tweets on Facebook, Instagram or Twitter.

For others the relationship with social media has been less harmonious or practically non-existent.

Sectors such as finance and insurance have been slow to dip their toe into what they perceive to be piranha infested waters.

Thinking ‘dabbling’ in social media is equitable to customer service suicide. 

For the healthcare industry the debate about whether social media is ethical or relevant has been rumbling for some time. Should it be used by healthcare professionals? And if so, to what extent? 

The British NHS has embraced Twitter as a broadcasting channel under its @NHSChoicesaddress. It sticks to lifestyle and healthier living tips but strictly does not offer patients any diagnostic advice or help on this channel – instead referring them back to the 111 telephone number.

Research conducted by PwC’s Health Research Institute, back in 2012, revealed that patients are now seeking answers to their healthcare concerns on social media to self diagnose, get a second opinion on a recently diagnosed illness or to gain support from people suffering from the same conditions in the wider community.

Its survey also found that 80% of individuals between the ages of 18-24 would be likely to share health information through social media.  

The public is using social media. Should healthcare companies use it too?Yes:1. It’s a great way to broadcast a public health message to a wider audience

Earlier this summer Sanctuary Health used Twitter to raise awareness of #dieticiansweek as part of a wider campaign led by the British Diabetic Association.

The Trust a Dietician campaign was designed raise the profile of qualified health professionals that assess, diagnose and treat dietary and nutritional problems at an individual and wider public health level.

2. It can be used effectively to gain feedback from patients

Cancer Research UK works across three social media platforms, including its specially createdCancer Chat.

Cancer Research listens and monitors all its social media channels and with the information it gathers it informs and influences its policies and campaigns.

 

3. Allows for greater individual patient, carer and citizen involvement in services.

The Brighton & Hove Maternity Services Liaison Committee (a group run by parents for parents) set up a Facebook page to answer people’s questions and help them get the best from their local maternity services – putting them in touch with health specialists or passing their feedback on to healthcare professionals. 

No:1. It raises data protection issues and jeopardises patient confidentiality

The NHS has had to take legal action after some of its employees were found having inappropriate conversations about patients and colleagues on Facebook and even uploading photos from private patient records.

2. Could undermine the reputation of the healthcare professional

The BMA and the Nursing and Midwifery Council (NMC) have both issued guidance to doctors and nurses warning them not to accept friend requests from patients.

It said that medical professionals should be wary of who could access their personal material online, how widely it could be shared and how it could be perceived by their patients and colleagues.

3.There is an inequality of access to the internet

Reaching vulnerable people, such as the elderly or those who do not have access to the internet, raises concerns about equality of access to information. The Cabinet Office Minister, Francis Maude, said recently that people who are offline risk losing access to crucial government services.

As social media is becoming embedded in our daily lives it will be hard to ignore its presence. As with any new method of communication there are pros and cons to using it.

It’s a great way to signpost to related healthcare services, to provide information or community support for those unable to leave their homes. It is also less resource intensive than traditional engagement techniques.

But there are massive ethical concerns about use of personal data collected from those monitoring conversations being had online. Plus, there is room for abuse and those using social media may breach the patient confidentiality laws we enjoy.

 


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HIPPAA?? 

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100 Healthcare And Digital Health Influencers To Follow In 2014

A list of healthcare and digital health influencers to follow in 2014.


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A great look into the future!

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nrip's curator insight, December 29, 2013 4:14 PM

I would also add @JBBC to this list... 

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What Big Data Brings to Decision-Making Strategies

What Big Data Brings to Decision-Making Strategies | Healthcare | Scoop.it

big data only matters if an organization knows what to do with it. When considering the value of big data from a strategic perspective, it's usually more important to focus on the ends, not the means, of what big data can provide. Big data analytics can and should be part of executive-level efforts for building out overall corporate strategy, for uncovering new business opportunities and innovative direction, and for expanding decision-making processes.


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Apple Monitors for Health and Home - New York Times

Apple Monitors for Health and Home - New York Times | Healthcare | Scoop.it
Apple Monitors for Health and Home
New York Times
SAN FRANCISCO — Apple is unlikely to introduce new devices this week, the things that most excite customers and investors these days.
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