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is looking for public comments on its draft, which certainly seems a lot like the process the FDA used for its draft guidance on the regulation of some mobile medical apps as medical devices. The FDA’s draft guidance document published last summer and the agency has yet to publish a final guidance document.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Those areas of the draft guidance appeared substantial and based on similar efforts previously undertaken by some of the groups listed above. Some of the requirements bulleted out in the content section of Happtique’s draft guidance appear to be more novel.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.

Asthmapolis secures FDA clearance for inhaler sensor

By: Brian Dolan | Jul 11, 2012        

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AsthmapolisAsthmapolis announced today that the US Food and Drug Administration (FDA) has granted its asthma sensor and companion software 510(k) clearance. The company’s device is a sensor that sits atop (most) inhalers used by patients who have asthma or COPD. The sensor transmits data to a companion app on the user’s mobile phone every time the inhaler is used. The app can then track the time and location of each medication discharge, which can then be used to help patients and their care givers better understand their asthma triggers. The company submitted its asthma system to the FDA on June 1, 2012 and received clearance on July 2, 2012, according to regulatory filings.

The company has described its device as ”small and lightweight” and “easy to mount securely on the end of most inhalers, and simple to transfer to a new canister,” according to the company’s website. “Lights on the device let you know when it has detected use, and also show remaining battery level.”

“We are thrilled to have achieved this important milestone to support our mission of providing tools to help patients and their healthcare providers better understand and control their asthma symptoms,” Inger Couture, Chief Regulatory Officer of Asthmapolis, said in a written statement. “Despite all we know about asthma and how to treat it, the majority of patients still do not have the disease under control, and traditional approaches to self-management have been time-consuming and complicated. The Asthmapolis technology makes it much easier to track symptoms and use of metered dose inhalers, allowing patients, their families and their doctors to gain a valuable new perspective on the disease.”

Earlier this year Asthmapolis announced that it was partnering with Dignity Health, formerly known as Catholic Healthcare West, to equip its Sacramento-based asthma patients with its inhalers sensors to send real-time breathing data to physicians’ smartphones. The company is currently conducting similar studies with the City of Louisville and Norton Healthcare in Kentucky.

Asthmapolis has also previously announced partnerships with organizations that include the Air Pollution and Respiratory Health Branch at the CDC as well as the California HealthCare Foundation. At the end of 2011, the company announced plans to add connectivity to its device through the Qualcomm 2net platform, too.

Back in April 2009 MobiHealthNews reported that Asthmapolis co-founder and CEO David Van Sickle, then a recent Robert Wood Johnson Foundation Health and Society Scholar in the Department of Population Health Sciences at the University of Wisconsin-Madison, was developing a GPS add-on for asthmatics’ inhalers to map where and when environmental exposures cause asthma symptoms–as well as alert users and encourage them to puff on the “rescue inhaler.” The project was also aimed at mapping the unknown causes of asthma in the environment.

“In addition to driving better patient-physician communication about asthma management, the tool also gives physicians the ability to quickly identify how patients in their population are doing and take steps to help patients get their disease under control,” Van Sickle stated in the recent FDA announcement. “Our mission is to make it easier for patients and their physicians to do a better job of managing asthma with less effort than traditionally required.”

Medstartr to launch after Kickstarter rejects (some) health projects

By: Brian Dolan | Jul 10, 2012        

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Brian Dolan, Editor, MobiHealthNewsThis week health and medical-focused crowdfunding platform Medstartr plans to officially launch on Wednesday. As the name suggests, the website is following in the footsteps of the leading crowdfunding website, Kickstarter, which has helped launched at least two health-related startups that we have covered in MobiHealthNews: smartwatch maker Pebble and smartphone-enabled, inexpensive microscope developer SkyLight.

Pebble actually became the poster child for crowdfunding when it raked in more than $10 million in funds from Kickstarter earlier this year. That made Pebble the most funded project Kickstarter had ever supported. With that kind of success are other crowdfunding sites really necessary? Is there really a need for health, fitness or medical-focused ones?

You bet.

Officially, Kickstarter does not allow startups or developers working on health, fitness, or medical projects to hawk their wares through the site. For that matter, you can’t use Kickstarter for baby products, causes, automotive products, pet supplies, electronic surveillance equipment, or pharmaceuticals either. The list of prohibited categories of projects numbers at least 30 by my count.

What’s so interesting about the most successful Kickstarter campaign is that while the smartwatch maker didn’t position itself as a fitness device at the beginning of its campaign, when it still had two more weeks to raise money it announced that the first app it would integrate with its platform was a leading fitness app. RunKeeper is its first partner. That’s some trick. Had the smart watch maker started with the fitness app as part of its core pitch, it seems likely that it would have been denied entry.

MobiHealthNews has learned of two startups that were denied entry to Kickstarter assumedly on the grounds that their offerings were medical or health-related: Duet Health’s EndoGoddess diabetes management app and Axio’s EEG sensor-enabled concentration device.

Duet Health co-founder and endocrinologist Dr. Jennifer Shine Dyer told MobiHealthNews that when she submitted her Kickstarter campaign to the site earlier this year, she received a notification about a week later that it had been denied because it did not follow the site’s guidelines. Axio’s co-founder Arye Barnehama told MobiHealthNews a similar story: The startup had planned to launch a Kickstarter campaign in mid-June only to realize by way of rejection from Kickstarter that its device also did not follow the site’s guidelines.

EndoGoddess has since turned to a health and medical-focused crowdfunding site that is set to officially launch this week: MedStartr. Alex Fair, founder of FairCareMD and organizer of the NYC Health 2.0 chapter, is the founder of MedStartr, too. The crowdfunding site was built by Mike Pence, who was the original lead developer on the Kickstarter project, Fair told MobiHealthNews in a recent interview.

Like Dr. Dyer, Fair applied to Kickstarter earlier this year for his other company FairCareMD, an online marketplace that enables patients and healthcare providers to meet and agree on fair prices, and like Dr. Dyer his application didn’t work out. So he started pursuing the launch of Medstartr, invited Dr. Dyer to crowdfund her project there too, and began using the site to raise funds for FairCareMD and Medstartr itself.

Fair talks about the need for Medstartr and what sets Medstartr apart from other sites that are not health-specific in similar terms as the health incubators used when they launched last year. Medstartr understands healthcare and it will help its “Medstartrs”, which is what Fair calls the projects that leverage his platform for funds, to succeed. Fair also said that Medstartr will help projects reach patients, physicians, hospitals and big pharma companies, medical device companies, and payers. Most crowdfunding sites only target consumers.

As Health 2.0 News reported last week, a few other health-focused crowdfunding sites plan to set up shop soon, including Health Tech Hatch and WeFundr. Fair also pointed to Petridish, the life sciences-focused crowdfunding site as another parallel effort.

Kickstarter will likely embrace fitness projects, Fair believes, because of the success of projects like Pebble and the simple, consumer-facing business model most of these devices and apps adopt. Fair points to the recent success of LUMOback, the health startup that is working on a good posture sensor and app, which raised more than $100,000 in recent weeks on Kickstarter — another exception to platform’s stated guidelines. Isn’t back pain a health issue?

Fair said that Medstartr will also work hard to bring the right crowd to its funding platform. It has already held an event in New York City to introduce its beta “Medstartrs” to would-be early adopters and it plans another when it launches in the coming days. It also plans to hold events at upcoming mobile health industry events, including the mHealth World Congress here in Boston later this month.

At that event Fair plans to announce an incentive program and partnership with the makers of the Pebble smart watch. Pebble will donate one of its devices to each of the first five developers who submit projects for medical app projects that will run on the smart watch.

That’s right — Pebble, Kickstarter’s $10 million poster child. Whether through rejection or exceptions, Kickstarter started this trend of crowdfunding health projects. Should be interesting to watch whether this new crop of platforms will be able to replicate any of its forbearers’ success.

OrSense hemoglobin screening device goes wireless

By: Neil Versel | Jul 10, 2012        

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GlasswingA new, non-invasive, wireless hemoglobin measurement device has been shown in two separate trials to be as accurate as invasive devices in testing for anemia and in screening potential blood donors, the product’s manufacturer reports.

OrSense, an Israeli maker of non-invasive medical devices for testing blood, this week is introducing Glasswing, its first wireless hemoglobin meter, at the annual Congress of the International Society of Blood Transfusion (ISBT), now underway in Cancun, Mexico. The device, which aids in detecting anemia and hemorrhage as well as in screening blood donors for adequate hemoglobin levels, measures light transmitted through the patient’s finger, eliminating the need for a needle stick.

Glasswing has a rechargeable battery for portability and can wirelessly transmit data in real time to electronic health records and printers, the company says.

“OrSense’s non-invasive solution improves anemia screening and monitoring by eliminating pain, reducing infection risk and enabling a simple and fast diagnosis. Hemoglobin measurements obtained by our system in multiple applications, showed accurate performance compared with the gold standard invasive reference values,” OrSense CEO Lior D. Ma’ayan says in a press release.

Two posters being presented in Cancun this week back up his statement.

One study, led by OrSense researchers and conducted in the hematology department at Assaf Harofeh Medical Center in Zerifin, Israel, found that the OrSense NBM200, the wired precursor to the Glasswing, was just as accurate in detecting anemia as an invasive test. “This study supports the use of the device as an accurate, simple and fast measurement technique for measurement of hemoglobin and for anemia screening,” the poster says.

The other poster reports similar results from a trial at the Blood Transfusion Center at Laiko General Hospital in Athens, Greece, that screened potential blood donors. Because the test is non-invasive, the Greek researchers surmise that the prospect of a more comfortable screening process might help in recruitment of donors.

OrSense sees opportunities for the Glasswing in perioperative and critical care units, emergency departments, blood banks, primary care practices, public health clinics and home care. A company spokeswoman tells MobiHealthNews via e-mail that the product has not been installed in a U.S. facility yet.