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I have been following closely the debate surrounding the FDA's call to regulate apps like you use on your smart phone as a device, like a heart monitor or diabetes test kit.
I am all for regulation of industries to ensure safety and make sure no one dies because a product was used. But this is a whole new era. Is an app a device? Is it a life-saving tool or is it the new shiny toy on your smart phone about which you know nothing about the reliability or specificity of how it works? This debate has been roiling the device/app/regulated industry market for a long time already, but is really heating up this week due to pending legislation currently being “worked up” in the U.S. House of Representatives.
There are many legitimate questions at stake. Capitalism and how it relates to government regulated industries in a rapidly changing world for one. Health and safety of any “tool” whether device, software, hardware, application or just a bandaid; when it comes to being used on humans? Should the government stifle innovation efforts by regulating apps for your smart phone exactly as a medical device? Are small companies who are the primary developers of most apps still – being shut out of a marketplace controlled by only the largest and most set in place corporations and being assisted through legislative and regulatory ruling? What happens when one of these apps is used in a “cloak operation” and is actually something like a private information/financial information thief?
Wait, what did I just say? The harsh reality is the FDA even admits that the “device approval” is one of the hardest processes they put any company through, outside of actual drug approval. Just ask any device manufacturer about their recent run-ins with the PMA (premarket approval). You will get an earful.
But translate this to medical smart phone apps and the FDA. Who builds apps? As stated above, mostly small companies with small numbers of employees (obviously there are clear exceptions.) If the apps are to be regulated exactly as devices then it subjects these companies to lengthy, even multi-year engagements just to get approval prior to selling anything. This flips the market dynamics of most app companies; that are used to making their money off short development/lead time cycles, and short sales cycles. How can most small companies survive this? They can’t; and back to the question of a stifling of innovation in small businesses through the FDA on behalf of the few companies with the bucks to last out this process.
I would suggest the FDA look at how software and hardware is approved under FIPS for example. (FIPS are requirements issued by the National Institute of Standards and Technology that apply to federal government computer systems.) Additionally I would suggest the FDA create a tiered regulatory system, one for devices; one for aps. Clearly this debate is not going away without a fight.
The iPad is quickly becoming a useful tools for speech language pathologists. Applications are often more affordable than paper materials, and they can be more engaging for children and adult patients. It can be difficult to choose which apps are best for your patients. Here are a few of our favorite new SLP apps and how they can be used.
Popular Bluetooth headset maker Jawbone announced two things today: $70 million in new funding and plans to launch a new fitness device, called UP, later this year.The wristband will monitor users movement and sleep patterns and pairs with a smartphone app that analyzes the data and provides users with challenges and social recommendations. Jawbone calls it “functional jewelry.”
While Jawbone’s UP has a number of competitors, including BodyMedia, FitBit, Nike+, and DirectLife, the Jawbone offering is most similar to the device coming out from Basis, which was previously known as PulseTracer. Basis is set to offer a wrist worn device called Basis Band that measures the wearer’s heart rate and other vital signs. Basis also plans to allow third party developers to build apps that work with the device. The startup secured $9 million in funding this past March and its team includes a former Google Health alum and a new CEO, Jef Holove, who was formerly CEO of Eye-Fi. While Basis Band is available for pre-order from the company’s website at $199, the company has yet to announce when the device will first ship.
Jawbone has yet to announce pricing or an official ship date for its UP device. The company’s CEO Hosain Rahman explained Jawbone’s move into health in an interview with TechCrunch today:
“It seems like a big departure, but once we start talking about the things it takes to make this whole category work, we get into things like making it tiny, having a long battery life, making it fashionable, making it waterproof, working with smart phones, having a rich, visual experience on your smart phone and making it social,” Hosain said. “This is all stuff we do anyway. It comes back around to the mission of your mobile lifestyle.”
More on Jawbone’s fitness device contender in the press release below:
Jawbone® Unveils Vision to Help People Live a Healthier Life
UP™ by Jawbone to Launch Later this Year
TEDGlobal, SCOTLAND – July 13, 2011 – Jawbone®, a leading innovator of products and services for the mobile lifestyle, today unveiled its vision to inspire people to live healthier with UP™ by Jawbone– a new product the company plans to launch later this year.
Lifestyle diseases such as heart disease, diabetes, and some forms of cancer cause more deaths than communicable diseases, according to the CDC. Research shows eating healthier, getting quality sleep, and moving more can prevent most of these lifestyle diseases.
“We are excited to share our vision at TEDGlobal because this epidemic will take an entire community to affect a global change,” said Jawbone CEO Hosain Rahman. “TED is a community of thought leaders that can help propel this idea into a global movement.”
UP leverages Jawbone’s expertise and partner ecosystem integrating robust computing and sophisticated sensor technology in the form of functional jewelry. UP by Jawbone is a new system that tracks your movement, sleep patterns, and nutrition so you can live a healthier life. This new end-to-end system consists of a small wristband that monitors your activity 24/7, a mobile app that analyzes the activity, and an open platform that motivates you with personal and social recommendations and challenges tailored to your goals.
“We’re passionate about creating products for the mobile lifestyle that people love to use everyday. And now, we’re harnessing that passion to approach a major global issue – health,” Rahman continues. “We are focused on a creating a highly accessible solution for this particular space that integrates seamlessly into a user’s daily life with the goal of making it absolutely easy for them to live better.”
UP by Jawbone will be available later this year. To be alerted to the release of UP, sign up for email updates at http://up.jawbone.com/.
For more information, images and product demos, please visit: www.Jawbone.com/Press or follow @Jawbone on Twitter.
For more than a decade, Jawbone has developed products and services for the mobile lifestyle unparalleled in their innovation, ease-of-use and sophistication of design. The company is the creator of the award-winning and best-selling premium ICON Bluetooth headset; the inventor of NoiseAssassin® technology, the world’s first and only military-grade noise-eliminating technology; JAMBOX, the first intelligent wireless speaker and speakerphone; as well as THOUGHTS, a free mobile service that allows users to utilize their voice in a new way. A 2010 IDSA Design of the Decade winner, Jawbone is committed to delivering innovative products that improve the mobile lifestyle through ever-changing software and wearability. Jawbone is privately-held and headquartered in San Francisco.
IBM has been awarded a patent for a game that will pay rewards to people who eat right.
Via Alex Butler
Brian S. McGowan (@CMEAdvocate) on:
* The value of social learning
Social media as 'the natural evolution of the social learning that takes place in hallways and lecture halls' for healthcare professionals
* How medical practices can utilize social media
- Provision and co-ordination of patient care
- Engaging the public in discussion of preventative health and disease management
- Education and staff development
* How patients can use social media
- For peer discovery
- To offer and receive support and counsel
- To share experiences
- Perhaps, in the right places and from the right people, to be directed to appropriate health information^
[AS: ^this is my add; I'm extrapolating from Brian's suggestion that users may encouter representatives of or links to high-quality resources like ACOR where they will also encounter 'in-depth conversations when Twitter character limits won't suffice' (although personally, I always challenge the 'can't say this in 140' idea. You can! Be concise. Then publish another tweet.]
Via Andrew Spong
As evidence by the 5,000-or-so attendees at last week’s American Telemedicine Association conference and exhibition, telemedicine is ready for the spotlight. So what can it do to assume a leading role in the nation’s healthcare?
That was the question put forth in “Innovation in Technology: What’s on the horizon? Where are advancements most needed?” The panel discussion, held during the latter stages of the three-day conference in San Jose, Calif., featured a who’s who of telemedicine experts.
The session was moderated by Joel Barthelemy, managing director for GlobalMed, who said telemedicine is being validated in the marketplace and is now becoming part of the care continuum.
Rick Kates, global head of Viterion, the telemedicine arm of Bayer Healthcare, said telemedicine needs to understand its core competencies, get the foundational components in place and establish partnerships that will bring better solutions to the market.
“We should be working together so we can build a stronger product,” he said. “There’s a place for telehealth and telemedicine as part of the overall care.”
Kates sees a “tremendous opportunity” for user-based design and believes companies should look for innovative ways to go to market, including evolving the business model from capital to sales to leasing programs and programs that involve risk sharing so that “everyone has skin in the game.”
Timothy C. Wright, vice president of corporate and market strategy for InTouch Health, sees the industry undergoing a big transition.
“The market is beginning to segment,” he said. Business decisions, therefore, will be focused on where the company’s strengths lie and understanding how to complete in the different segments if diversification is a strategic goal.
“As a company that’s trying to innovate, you have to pick your spot,” he said.
Wright noted that companies should have a regulatory strategy in place because the Food and Drug Administration (FDA) will become more involved if patient safety and immediacy are critical components in a telemedicine application, such as teletrauma and telestroke. He expects videoconferencing to be more regulated.
Telemedicine has evolved to become “more about medicine and less about tele-,” which is why the FDA will be more involved, Wright said.
Pete Killcommons, MD, CEO of Medweb, said he is seeing a “dissolution” of or a radical change in telemedicine. “Many of these technologies have been fully integrated into hospitals and enterprises,” he said.
Killcommons said the greatest thing the telemedicine industry can do is to provide objective data and statistical outflows that comes out of the clinical workflow, which can then be used to quantify the value of the telemedicine encounter. This will transform telemedicine into a business process and inspire a business practice, which would lead to more financial investments into the industry.
I just returned from the American Telemedicine Association 2012 annual conference in San Jose, CA. The conference was packed with people who were excited to share how they were using telecommunication technologies to deliver care. Some amazing demonstrations were also available within the ATA exhibit hall. And, people were using #ATA2012 to send tweets about the meeting.
As I listened to presentations, I noticed that some people used the term “telemedicine” while others opted for “telehealth”. And though a majority used these interchangeably, there is a difference between “medicine” and “health”, and I wonder if we’ll start hearing discussions around this over the next few years.
Let’s start by looking at the words “medicine” vs. “health.” Some may argue that the term telemedicine is too physician-centric and that telehealth is a broader, better term that encompasses other health care professionals like nurses, dentists, pharmacists, psychologists, etc. After all, physicians are the only ones who go to “medical” school. And, they’re the only ones prescribing “medicine.” The American “Medical” Association represents physicians. So, should we be using “health” to encompass a broader audience, or is it OK to stick with the term “medicine” as in telemedicine? I’m obviously biased, but I see this trend occurring in a number of areas.
To start, we can look at the common acronyms EHR and EMR. Docs still love using the term “EMR.” They have not adopted the phrase EHR, but this is the new “standard” term for the industry if you ask the U.S. government. We’re all creatures of habit, so EMR is still easier for people to say. But, over time, will EHR entirely replace EMR?
Here’s another example: schools that offer degree programs in informatics. Are they offering a degree in “medical” informatics, or “health” informatics? Is there really a difference?
Because of history and tradition, I anticipate that the ATA will always be the American Telemedicine Association. Likewise, AMIA will always be the American Medical Informatics Association (and I doubt we’ll see a new organization called AHIA competing against AMIA).
What’s going to happen in telemedicine? Will the phrase “telehealth” stick, or will it get swept away with everyone using telemedicine? Given that telemedicine is often used to treat patients or to deliver care for an active health condition, the term telemedicine seems more fitting. We also have terms like telesurgery, teleradiology, teledermatology, etc. So, maybe we’ll just get much more specific with our terminology in the future.
Last month, Medgadget announced the development of the Magnifi iPhone adapter from start-up Arcturus Labs (Palo Alto, CA), which connects your iPhone 4 or 4S to optical instruments ranging from microscopes to binoculars and telescopes.
To learn more about the evolution of the Magnifi, we spoke with newlyweds Xianne and Isaac Penny who came up with the rough idea for the device while in grad school at Stanford University. They began the development of the product after graduating. Isaac Penny also worked as an engineer at Intuitive Surgical (Sunnyvale, CA), where he helped create the daVinci Single-Site line of instruments.
“Somewhat related to what I was doing for research at Stanford, I was working on medical devices for the developing world,” Isaac Penny says. In the course of that research, he visited a number of clinics in Africa. “A lot of them don’t even have PCs or laptops but they have their cellphones and they were documenting stuff with cell phones, which they would attach to a camera,” he remembers. “Grad students at Stanford do that a lot, too. So we figured maybe other people who use microscopes do as well.”
While the idea was first developed for microscopes, they realized that it would work with other optical instruments such as binoculars and telescopes as well. “Feedback from customers and users that has helped us home in on the product,” Isaac Penny explains.
“There were some unexpected fields where we didn’t see that this would apply to,” Xianne Penny says. For instance, it can be used by optometrists and ophthalmologists because it would fit their slit-lamp microscope. It can also be used by endodontists—dental surgeons who do root canals and use microscopes to look inside the drill hole in teeth to observe what the root looks like from the inside of the tooth.
The device also helps in teaching situations that involve microscopes. With the Magnifi, multiple students can gather around the microscope and view a slide at the same time—instead of taking turns to do so. It also can be used with services such as Skype or Facetime to project images to a projector computer. “You could have a live demo for education in a classroom,” Isaac Penny says.
The functionality of the Magnifi can be further expanded with third-party apps. For instance, apps such as Camera Plus and Camera Awesome enable users to lock the focal length to prevent the potentially annoying autofocus issues. Another app known as Eye Microscope can be used to add scale bars, date and magnification to images taken with the phone.
The device works on eye pieces in the range of 1 to 1.5 inches in diameter. It must also be able to slide over the eyepiece at least 1 inch without obstruction, so that the camera’s optics can get close enough to align.
Arcturus Labs is planning on coming out with another adapter to enable Magnifi to be used for an even wider range of optical instruments, namely spotting scopes and other optics with large diameter eyepieces. The new adapter will be interchangeable with current Magnifi case and future cases within the product line.
Link: Arcturus Labs…
For at least the last 50 years, different to other industries, technological advancements in medicine have increased, rather than decreased costs. This has occurred for reasons whose analysis is outside the purpose of this paper. It’s sufficient, therefore, to note the truth of it and move on.
Recent developments in mobile health technology, known as “mHealth” to its adherents, give us hope that perhaps the technological tide is finally turning. It is our hope that these trends will cause tech to improve care (which it has always done) and drive down costs.
What gives us this hope? First, let’s examine a few interesting statistics. A recent Information Week article stated that 70% of polled hospitals and/or healthcare organizations plan to deploy the iPad by the end of 2012. This matches with market research that indicates that some 81% of physicians will own a smart phone or tablet by the end of 2012. Of those, move than 50% will use mHealth apps daily in 2012. Globally, it is predicted 500 million people will be using mobile healthcare applications by 2015. We think these estimates are low. The proliferation of iPads and iPhones among healthcare personnel literally makes these devices a Trojan Horse into GE- and Phillips-dominated healthcare.
All of these numbers are signs of a sort of sea change that is affecting not just the healthcare industry, but also the world. Competition has driven down the overall costs of these powerful pocket computers (tablets and smartphones) to the point that they are becoming as ubiquitous as simple cell phones were just 5 years ago.
We should point out that part of the reason this excites us is not just for the potential to reduce costs in the United States, but because of the ability of mHealth to improve care and outcomes in developing nations. These countries have neither the time, nor the resources, to build the healthcare infrastructure developed over the last 60 years in the industrialized world.
New innovators and existing players will be drawn to use these mobile platforms to come up with solutions because of the opportunity to do good, of course, but also because of new market possibilities. Predictions on the size of the mHealth market vary, but most put it anywhere between $5 and $35 billion dollars.
What will our mHealth future look like? While it’s tough to say, exactly, we can make a few educated guesses based on where companies (like those being shepherded by the promising Rock Health incubator) are developing now. By and large, they’re developing products and services that incorporate most of the following characteristics.
The user interface is visually interactive and engaging. Nothing highlights the importance of this point more than the rise of Pinterest.They have the ability to access best-practice and neutral information that is based on sound science, anytime and anywhere. It’s a mobile world.The information being provided is personalized and adapts to the uniqueness of each person’s condition.They are able to make real-time use of feedback loops. The article that brought this home for us was “Harnessing the Power of Feedback Loops” by Thomas Goetz in Wired July 2011.So-called ‘gamification’ of products and services is used appropriately. These efforts will continue to blur the line of reality—therein lies their power.Secure and trustworthy use of utility and monitoring. This is made possible on a large scale by the rise of cloud computing.Everything is social and sharable (to the extent that they want to be social and share about their health). This means they are able to engage, discuss, research, and respond to one another with up-to-date information, experience, and support.Use of geo-location. Here, again, the importance of mobile and all that goes along with it from apps and web apps (read: HTML5) to mobile-optimized websites.Price comparison: In concert with geo-location, health consumers will be able to ‘shop’ for the best, least expensive medical product/service.
While it’s difficult to say exactly what healthcare will look like and how it will develop in the next few years, these are the early signs of what we believe will be an mHealth future which drives down costs and improves outcomes for everyone on a global scale.
This article suggests that you health future may contain:
* GPS pacemakers and defibrillators.
* Targeted medicine using nanorobots.
* Embedded tracking chips.
* Artificial intelligence to boost lost human function.
* Rare visits to healthcare professionals
[AS: AI and wearable tech we already have. However, IMO embedded tech is going to have a short history, if it has one at all. Non-invasive technologies, scans and triggers seem more likely.]
Via Andrew Spong, Bart Collet
With recent statistics showing Kenya’s maternal mortality ratio at 488 per 1000 live births, a new monitoring system for expectant mothers is set to ease the number of deaths during childbirth.
The app ensures the health workers, midwives and the pregnant mothers share health information and care tips using SMS and prepaid calls.
Via Alex Butler
|Rescooped by dbtmobile from 7- DATA, DATA,& MORE DATA IN HEALTHCARE by PHARMAGEEK|