Wireless shoe insert senses foot numbness that can lead to diabetic ulcers, amputation

By: Neil Versel | Jul 16, 2012        

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Orpyx Surrosense RxA Canadian startup company is developing a wireless shoe insert that will help people with diabetes manage peripheral nerve damage and hopefully prevent amputations that often stem from diabetic foot ulcers.

Orpyx Medical Technologies, based in Calgary, Alberta, will soon be seeking regulatory approval in the U.S. and Canada to sell SurroSense Rx, an insole that that collects data of where wearers are putting pressure on their feet. The sensor wirelessly transmits data, following the ANT+ standard, to a wristwatch-type display or to a smartphone, alerting users that they might be putting too much pressure on their heels and risking numb feet that can lead to ulcers.

“Many cases [of diabetic peripheral neuropathy] are because people have no idea of the pressure they’re putting on their feet,” Amanda Hehr, VP of marketing at Orpyx, tells MobiHealthNews.

According to the company, more than 60 percent of diabetic patients will suffer from foot numbness, and the inability to feel pain is a leading cause of ulceration and eventually amputation. Prevention can reduce the risk of amputation by as much as 85 percent, Orpyx says in its marketing material.

Hehr says SurroSense Rx, should go on sale by November as a Class I medical device, pending, of course, clearance from the FDA in the U.S. and from Health Canada north of the border.

Orpyx, which was co-founded and is headed by Dr. Breanne Everett, a resident in plastic and reconstructive surgery at the University of Calgary, also is working on a product called SurroGait Rx, which pairs the shoe insert with a sensor worn on the back. The insole wirelessly sends pressure information to the back sensor, which transposes sensation to the back that a numb foot cannot feel, based on the concept of neuroplasticity.

The idea, according to Hehr, is for users to learn to “feel” their feet via their backs and eventually train their brains to recognize signs of diabetic peripheral neuropathy. Orpyx will start clinical trials on SurroGait Rx early next year in hopes of bringing the product to market by 2014.

Everett explained the technology – along with the “democratization of data” in healthcare and innovation in medicine – at TEDxYYC, a TED-affiliated event held in Calgary on May 25. Watch a video of that presentation here.

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Study: iPhone better than a PC for some ophthalmology images

By: Neil Versel | Jul 16, 2012        

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Using the iPhone for ophthalmology imagesAnother study has come along to support the iPhone as a reliable tool for remotely reviewing medical images and assessing patients when a standard workstation is not available. This time, the Apple smartphone is proving its mettle in ophthalmology.

In an article appearing in the July issue of the Archives of Ophthalmology, researchers from Emory University in Atlanta studied images from 350 patients with headache, focal neurologic deficit, visual changes or high diastolic blood pressure and were surprised to find neurophthalmologists generally rated images to be better on the iPhone 3 than on a desktop PC.

“We expected equal- or lower-quality ratings for photographs displayed on the iPhone compared with the desktop computer, but instead we found that reviewers assigned higher ratings on average for photographs displayed on the iPhone,” wrote the researchers, who represent the ophthalmology, neurology, emergency and neurological surgery departments at Emory. “[W]e believe this occurred because the advantages of the iPhone’s display (e.g., higher dot pitch and brightness) outweighed its disadvantages (e.g., lower resolution and smaller screen area).”

The researchers noted that the popularity of smartphones “provides a unique opportunity for telemedicine,” and see applications in emergency departments, which do not usually have photographic services and high-resolution ophthalmic devices. But while smartphone images have been studied extensively in radiology and dermatology, there is not much existing literature related to smartphone viewing of clinical photographs in eye care.

They also said that the iPhone has limited usefulness in ophthalmologic diagnosis. “We are not suggesting using the iPhone to screen for subtle conditions (e.g., diabetic retinopathy) or as a replacement for in-person ophthalmologic consultation. Rather, we believe the iPhone, and similar devices, in combination with nonmydriatic photography can complement ophthalmologic consultations in settings such as the emergency department by allowing for rapid and remote identification of obvious conditions affecting the posterior pole such as papilledema and malignant hypertension,” the Emory researchers wrote.

This study did have some other limitations, too. The researchers worked with JPEG images even on the desktop PC screen. JPEG is considered a “lossy,” compressed format, with lower resolution than might be found on diagnostic-quality equipment.

Also, the iPhone 3G, released in July 2008, has a resolution of 320 by 480 pixels and a screen density of 165 pixels per inch. Expect better results on newer iPhones with higher-resolution images, particularly the current iPhone 4S with “Retina” display, featuring 960-by-640-pixel resolution at 326 ppi. An LCD computer monitor typically has a density of 100 ppi or less.

University of Michigan Health System offers skin cancer app

By: Brian Dolan | Jul 12, 2012        

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UMSkinCheck appPhysicians at the University of Michigan Health System launched an app for patients at-risk for skin cancer to use at home to self-exam their moles and other skin lesions over time. The free app, called UMSkinCheck, is just the latest in skin cancer tracking and near-diagnostic apps to hit Apple’s AppStore in the past year. UMSkinCheck is available for iPhone and iPad users.

Unlike many other skin cancer detector and analysis apps, UMSkinCheck, mostly sends reminders to users and enables them to monitor changes in their skin lesions by instructing them to take photos of various regions of their body for storage in the app and comparison to future images the users take. The physicians who developed the app believe it could be a helpful tool for patients to bring into the exam room during consultations with their own care providers.

“Whole body photography is a well-established resource for following patients at risk for melanoma. However, it requires a professional photographer, is not always covered by insurance, and can be an inconvenience. Now that many people have digital cameras on their phones, it’s more feasible to do this at home,” Dr. Michael Sabel, associate professor of surgery at the U-M Medical School, the lead physician involved in developing the app, said in a written statement.

According to the University of Michigan Health System, more than 2 million people are diagnosed with skin cancer each year in the US, and of those about 50,000 will be diagnosed with melanoma. The UMSkinCheck developers state that regular skin checks can help people discover cancer sooner. The app also includes a skin cancer risk calculator.

A similar app, called Skin Scan, which has been available for download since last summer, instructs users to take photos of their moles and upload them to Skin Scan’s servers for analysis. The app then provides a risk rating for the mole and highlights any abnormalities that it can detect in the lesion — despite some reports, it does not claim to diagnose skin cancer.

In February, Skin Scan’s Mircea Popa told GigaOM that the company’s longterm plans include connecting physicians to its platform so that doctors could examine patients remotely, or without in-person visits. According to Skin Scan, its app can accurately predict the severity of a mole 70 percent of the time, while dermatologists can do so with 85 percent accuracy.

Of course, not everyone is enthusiastic about skin cancer detector apps.

“The [apps] that worry me are ones for instance where you can take an image of a skin lesion and then map it back to a database in the cloud and be told whether it should be evaluated for a melanoma or not,” Dr. Joseph Kvedar, a dermatologist by training, and the head of Partners Center for Connected Health in Boston, told NPR in an interview this week. “It just seems a little scary right how to have software making decisions about moles.”

How Happtique plans to certify health apps

By: Brian Dolan | Jul 12, 2012        

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Brian Dolan, Editor, MobiHealthNewsThis week Happtique, the healthcare-specific appstore and mobile app prescription technology vendor, published its draft document for the mobile health app certification process its panel of advisors has been developing over the course of the past few months. Happtique is looking for public comments on its draft, which certainly seems a lot like the process the FDA used for its draft guidance on the regulation of some mobile medical apps as medical devices. The FDA’s draft guidance document published last summer and the agency has yet to publish a final guidance document.

Happtique’s effort is less focused on the safety risks associated with a given app and more so on the app’s operational integrity, security, privacy policies, and content. Happtique’s panel of advisors for the certification process includes Franklin Schaffer, EdD, RN, FAAN, the CEO of the Commission on Graduates of Foreign Nursing Schools; Shuvo Roy, Ph.D., a director at the School of Pharmacy at the University of California in San Franciso; and Dave deBronkart (“ePatient Dave”) a prominent spokesman for patient engagement. While the original panel included Dr. Howard Luks, an associate professor of orthopedic surgery at New York Medical College, as its chairman, Happtique appointed Dr. David Lee Scher, a former practicing cardiologist and mobile health consultant as the panel’s new chairman after Dr. Luks had to bow out due to other commitments.

Happtique says it culled best practices and received guidance about mobile security, privacy, and usability from a number of government agencies and other organizations, including the Association of American Medical Colleges (AAMC), Mobile Marketing Association (MMA), GSM Association (GSMA), mobile Healthcare Information and Management Systems Society (mHIMSS), Association for Competitive Technology (ACT), U.S. Food and Drug Administration (FDA), Federal Communications Commission (FCC), Federal Trade Commission (FTC), and the Office of the National Coordinator for Health Information Technology (ONC).

Those areas of the draft guidance appeared substantial and based on similar efforts previously undertaken by some of the groups listed above. Some of the requirements bulleted out in the content section of Happtique’s draft guidance appear to be more novel. Here are five content-related requirements that I found worth considering:

> “The app is based on one or more credible information sources such as an accepted protocol, published guidelines, evidence-based practice, peer-reviewed journal, etc.” (So, no certified apps will be making use of a new and innovative practice that leverages this new technology?)

> “The date/source of the app’s content is provided through an ‘About’ section (tab, button or equivalent).” (All certified apps will then need an “About” section or the equivalent? How many health apps have this kind of section today?)

> “For any app derived from a third-party source that does not contain the original source’s complete content, the app provides a link, reference, or other appropriate method to enable the user to locate the complete content.”

> “Information in any app that constitutes advertising is denoted by the message ‘This is an advertisement’ or equivalent.”

> “The content of an app that is intended primarily for use by laypersons is designed and written in a way that is readily understood by the target audience (e.g., appropriate use of technical terminology).” (This will be an interesting one to judge. Which words do laypersons not understand? Aren’t some laypersons more tech-savvy than others?)

Happtique is crowdsourcing feedback on its draft certification requirements over the course of the next month. Read the full certification requirements draft over at Happtique’s site here. (PDF)

New Zipit app provides paging with HIPAA accountability

By: Neil Versel | Jul 12, 2012        

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Zipit WirelessNew pager-replacement Android and Apple iOS apps from Zipit Wireless, a Greenville, S.C.-based maker of wireless IP devices and software, not only add paging capabilities to smartphones, but allow hospitals to get a better handle on many forms of staff communication.

On Thursday, Zipit introduced the two apps, branded as Zipit Confirm, and also announced a significant partnership with Verizon Enterprise Solutions to provide secure voice-over-IP services for the company’s Zipit Now ruggedized messaging devices.

The Zipit Confirm app is a free download, but requires a subscription to the Enterprise Critical Messaging Solution, a partnership between Zipit and Verizon Wireless that was launched at HIMSS11, with monthly service starting at $10 per user. The subscription provides access to the cloud-based Zipit Remote Administration Portal, or RAP, that tracks when messages arrive, what they say and whether the recipient opened the message.

“It gives you accountability that you don’t get with pagers,” says Michael Vitale, VP of sales at Zipit Wireless. “Because it has a full record of accountability, it becomes HIPAA-compliant.”

This eliminates what Vitale calls the “page-and-pray” process and perhaps leads to safer care. For example, he says, the emergency department can know right away that the cardiac catheterization lab or STEMI team is ready for a patient in critical condition, helping to reduce door-to-balloon time for someone having a heart attack. “Today, with a pager, we don’t know if someone received [the message],” Vitale says.

The same kind of readiness can apply to departments such as patient transport, labs and nutrition, making for more efficient operations throughout the hospital.

Vitale believes that the market for pager replacement in healthcare is huge because while other industries abandoned the once-ubiquitous belt accessories en masse years ago, this one hasn’t. Zipit says that 58 percent of pagers still in use today are in healthcare – and that doesn’t even include pagers on private networks.

But the service is more than just paging. The system also provides accountability for e-mails and what the company calls ZText, SMS that runs on internal Wi-Fi networks so users can send and receive texts in cellular dead spots such as hospital basements. The e-mail follows standard Simple Mail Transfer Protocol (SMTP), providing controls and monitoring over alarms and sensors. “We can communicate with machines and alarm systems,” Vitale says.

Smartphones do not have to be on the Verizon Wireless network to use the Zipit app, so the technology supports the bring-your-own-device trend, according to Verizon product manager Jeff Pierson, though the app is exclusive on Verizon Enterprise Solutions infrastructure. (Verizon Wireless is a joint venture of Verizon Communications and Vodafone, while Verizon Enterprise Solutions is the business-to-business unit of the telecommunications powerhouse.)

Interestingly, the app initially is only available for Apple and Android, even though Vitale spent eight years at Research in Motion, whose BlackBerry line once dominated institutional smartphone deployments and still finds strength at the enterprise level. “We saw a decline in BlackBerry use,” he says, particularly in healthcare, where physicians overwhelmingly seem to favor the iPhone. “We went where the demand has come from.”

Still, Vitale would not rule out future apps for BlackBerry or Windows Phone.

Merkle acquires mobile health partner of Pfizer, Medtronic

By: Brian Dolan | Jul 12, 2012        

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5th Finger MerkleMerkle, a customer relations management (CRM) company has acquired San Francisco-based 5th Finger, a mobile marketing and mobile health vendor for an undisclosed sum. While 5th Finger has a number of big retail brands as clients, including Jos. A Bank and Safeway, it has also powered Pfizer, Medtronic, and GlaxoSmithKline’s mobile health initiatives.

The company set up a text messaging-powered pediatric vaccine adherence program for Pfizer called Vaxtext in April 2011. The pilot program launched in four states last year in partnership with local health groups like state vaccine boards and physicians groups. It leveraged in-clinic marketing and providers to drive adoption. The text messages included educational messaging, schedule reminders and health care provider data to help parents meet child vaccine goals.

5th Finger also helped develop an app for Medtronic, the Medtronic VCF Mobile app, which aims to help healthcare providers, potential patients, and surgeons to make treatment options for vertebral compression fractures, including Balloon Kyphoplasty as an alternate procedure. The first version of the app launched more than two years ago and Medtronic has since created an iPad version of the app.

5th Finger has previously described its product suite for mobile health, called RedShop Rx, as focused on medication adherence, health tracking, wellness education, engagement, gamification, and sales support functions.