| 01.21.10 | Big Pharma Courts Wireless Health

Can technology address medication adherence?

Brian DolanIt’s a widely known statistic that between one-third and one-half of patients in the U.S. do not take their medications as instructed, which leads to poorer health, more frequent hospitalization, a higher risk of death and up to $290 billion each year in increased medical costs. Stacked against that figure, Novartis’ recent $24 million investment in intelligent medicine / medication adherence startup Proteus Biomedical is a pittance. Given the $290 billion in increased medical costs, Proteus’ prediction that its technology has a $100 billion market opportunity appears — almost — a bit low.


What is perhaps less widely known is that just last April, Novartis CEO Dan Vasella had this to say about adherence monitors: Internet programs that provide feedback loops to patients, instruments that can measure biometrics and transmit the data to caregivers, and new pill bottles that can remind you (by text message or blinking lights) to take your medications are not enough, Vasella told an audience at a health IT conference.


“These solutions are all fine and good, but I do not believe these technical approaches will solve the equation,” Vasella said. “People are not just machines. People are human beings with social, biological and psychological aspects that need to be addressed” if these solutions are to be effective.


Vasella is right, of course. Poor patient medication adherence includes not taking the medication on time, in the proper doses, or at all. Reasons for non-adherence include everything from unpleasant side effects, confusion, and forgetfulness to language barriers or feeling too well to need the medication.


Show me a text message that can convince a patient that they are, in fact, not “feeling too well to need the medication.”


So, can physicians work with patients to increase adherence? A recent study soon to be published in the Journal of Acquired Immune Deficiency Syndromes, found that providing clinicians with more data on their HIV+ patients’ antiretroviral (ARV) adherence does not ultimately equal increased adherence. The study found that collecting data on adherence and providing it to clinicians was not enough to help clinicians work with patients to improve their adherence. Or, it’s not the data, it’s how you use it. The researchers suggested that clinicians planning to use adherence monitoring services receive training on medication adherence counseling techniques.


Perhaps the key is not the text message, but who the message is from. Proteus Biomedical, RememberItNow, Medic8’s Personal Caregiver app and others plan to keep caregivers, friends and family members in the loop and enable them to know when a user has strayed from their medication regimen — with the user’s permission, of course.


Until clinicians take their medication adherence counseling lessons, those closest to us might be in the best position to provide some of the missing aspects of medication adherence that Vasella noted many technology solutions are unable to address. Either that, or there’s more embedded in Proteus Biomedical’s intelligent pills than the freshly cash-infused startup is letting on.

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FDA OKs Corventis mobile cardiac telemetry

Big news for the first startup shepherded by the West Wireless Health Institute: The FDA has greenlit Corventis’ Nuvant system, a mobile cardiac telemetry system. The 510(k) clearance for Nuvant enables Corventis to begin marketing the service in the U.S. — Corventis secured FDA clearance for its PiiX sensor, which is a part of the Nuvant system — last April. According to the company, it has also secured approval from the Centers for Medicaid and Medicare (CMS) for its monitoring facility and is now able to bill for services provided to patients with Medicare.


The Nuvant services look to fall under the same billing code for mobile cardiac telemetry as CardioNet’s MCOT system and LifeWatch’s MCOT system. Reimbursement for mobile cardiac telemetry services took a blow last year when CMS decreased the reimbursement rate for the services by about 33 percent: From $1123 to $754.


The most obvious difference between the solutions listed above is device form factor: Continue >>

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Japan: Startup launches wireless ECG

Wearable Information Networks (WIN) Human Recorder, a Japanese startup, just brought a wireless ECG sensor service to market, according to a report in Japanese news portal Nikkei. WIN’s Human Recorder system collects data from a lightweight wireless sensor attached to the user’s chest that transmits data wirelessly to a mobile phone or PC.


The Human Recorder system is capable of measuring ECG signals, heart rate, brain waves, accelerated velocity, body temperature, respiration, pulse wave and more.


For its first product however, WIN Human Recorder released a device called HRS-I, which tracks electrocardiographic signals, body surface temperature and activity levels (three axis accelerometer).


The company says the device can run for three to four days with a simple button battery. HRS-I is intended for use by health monitoring service providers. The startup said the service fee will be around $111 a month and the device itself will cost about $333 to purchase.


For more, read this report from DVICE

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Study: 42 percent of U.S. uses a smartphone

Rob Havasy, a business analyst at the Boston-based Center for Connected Health, which is a part of the Partners Healthcare group, penned a thoughtful column on the state of the mHealth market. Havasy’s central point is that mobile health solutions need to be “meaningful” and “available” to all patients. That’s certainly an ideal wireless health service providers should be working towards.


Havasy argues that while devices are in the market and services are on the way, mobile health technology has yet to achieve an ease of use that opens it up to the majority of users. He points to a statistic that states less than 3 percent of the U.S.’s 276 million wireless subscribers use iPhones. What Havasy fails to mention, though, is that the iPhone is not the only smartphone available or in use in the US today. It’s certainly not the only smartphone platform offering health or medical apps. According to one research company’s longitudinal surveys, about 42 percent of Americans owned smartphones in December 2009. That stat comes from a recently released ChangeWave Research study that is based on more than 4,000 surveys conducted in early December of last year.


Continue >>

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Huntington Hospital inks deal with Voalte

Huntingon Hospital has inked a deal with Sarasota, Florida-based startup Voalte, to equip its nurses and other point of care workers with iPhones that leverage Voalte’s voice, alarm, text message communication platform. Voalté (its name comes from Voice, Alarm, Text) enables healthcare workers to send and receive text messages, make voice calls, and receive critical care alarms all through their iPhones, which the company says helps to provide faster response times to patients’ needs.


“Our nurses were carrying hospital provided pagers, wireless phones, separate pagers designed to alert them of critical patient alarms,” Ron Rutherford RN, Huntington’s director of informatics stated in a press release. ”There were too many bells and beeps requiring attention, not to mention their pockets were literally overflowing with electronic devices.”


The deal is the first Voalte has announced since completing a pilot program for the communications platform at Sarasota Memorial hospital.


Continue >>

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Should mHealth cos want FDA regulation?

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to the commenter’s.)


At the risk of insulting my new friends in Silicon Valley, I submit that traditionally-unregulated IT companies may want to adopt a different view of federal regulation. Over the last couple years, I’ve had the opportunity to observe firsthand the culture clash as free-spirited, libertarian Silicon Valley meets Rockville, Maryland, the home of the decidedly more buttoned-down U.S. Food & Drug Administration. Rather than fleeing in fear of the federal bureaucracy, I would argue that at least some IT companies should consider embracing federal regulators. Well, maybe start with at least shaking hands.


This article is the fourth in a series (one, two, three) of seven planned articles about FDA regulation of mHealth. The series started off by explaining the scope of FDA regulation, and then the second and third articles explained how companies could comply with FDA regulation in the cell phone accessory and software app fields. With that basic framework behind us, this article will explore the burdens and benefits of entering FDA regulated territory. Yes, I said benefits.


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Haiti survivor credits iPhone health app

An NBC affiliate in Miami, Florida has a report about an American film producer, Dan Woolley, who was trapped in the ruins of a hotel in Port-Au-Prince, Haiti during last week’s earthquake. Woolley used the light from his digital camera to examine his broken foot and head wound. He then used a medical application on his iPhone to look up how to dress his wounds, which included a broken foot and a head wound, according to the report. Woolley said that during the 65 hours that he spent in the ruined hotel’s elevator shaft, he also looked up symptoms for shock using his iPhone medical app. Woolley told his story to NBC in the video clip below: Continue >>

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12 EMRs with remote access iPhone apps

MobiHealthNews broke the news last week that the mobile EHR product that came out of Apple’s pilot with EMR vendor Epic Systems was an iPhone app called Haiku, but Haiku was not the first EMR to grant iPhone and iPod touch users remote access. Epic aside, a number of EMR vendors launched iPhone apps for their clinicians during the past year — what follows is a list of 11 EMR systems that have gone mobile for the iPhone.


A note on the apps’ descriptions: The content is from the company that made the app — this is how they describe their offering. Also, the pricetag was pulled from Apple’s AppStore, but most of the “Free” apps are actually only free to those users who already have accounts with the EMR vendor. Many of the “free” offerings actually require monthly subscriptions for the ongoing service.


As one might expect, the applications’ in the following slideshow have a wide range in quality of design and seriousness: One systems vendor featured the character Hans Solo (played by Harrison Ford) from the Star Wars movies as the example patient. Other apps look more like experiments judging by their lack of design. There were a few standouts, however, and those should be obvious to any one who scrolls through the screen shots and descriptions of the iPhone EMR apps in the slideshow to follow.


Continue >>

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Vitality: 4 pharmas testing out GlowCaps

Vitality, developer of medication adherence device GlowCap, announced during a 2009 company wrap-up video that “four of the top pharmaceuticals companies have committed to distribute their medications for hypertension, transplants and diabetes in GlowCaps.”


Vitality’s GlowCap offering is a medication reminder and compliance service: GlowCaps fit the standard pill container top as a lid that uses short-range wireless technology to monitor when a pillbox is open and when it isn’t. It uses a close-range wireless signal to connect to a gateway hub, which looks like and functions as a nightlight but includes the guts of a mobile phone. That repackaged mobile phone technology runs on AT&T’s network.


Vitality noted that during 2009 it ran clinical trials with both Duke University and Harvard University in order to gather data on how well GlowCaps works. The studies showed that GlowCaps users were compliant to their medication regimens more than 90 percent of the time, according to the company.


In 2009 the company also filed a couple of patents, including one for a button underneath the GlowCaps lid that calls the patient’s pharmacy when pushed. The video’s narrator described the button as “OnStar for your pills.”


Be sure to watch the full 2009 update from Vitality in the video clip here

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AccuWeather offers up WeatherMD app

Here’s an interesting twist for a smartphone application offering from a big brand: AccuWeather announced today the release of an iPhone application called WeatherMD, which helps users predict when symptoms their various medical conditions might be at their worst during the day because of weather. The app targets users with arthritis, asthma, migraines, allergies and sinus problems. WeatherMD, however, is not just intended for use by those with top of mind medical ailments, however, it also provides fitness enthusiasts with suggestions for different kinds of exercise based on the week’s weather conditions.


WeatherMD is also GPS-enabled so it displays “highly visual” weather maps, according to the company, based on where the user is currently located. The maps can display concentrations of pollen from grass, weed, tree and other allergens for the next two days. It costs $3.99 in the iTunes AppStore.


Source: AppScout

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Rationale and challenges to Novartis-Proteus

According to a report in the Economist, pharmaceuticals company Novartis’ $24 million investment in intelligent medicine startup Proteus Biomedical may be just as important in the long run as Novartis’ $50 billion takeover of eye-care firm, Alcon. Proteus Biomedical’s venture capital round actually brought in $25.4 million, which makes us wonder if the difference came from an additional pharmaceuticals company investor. In April we noted that two major drug companies were set to trial Proteus Biomedical’s technology.


(While note precisely related to the Proteus-Novartis deal, the Economist report also includes a metric from research from Kalorama, which predicts that sales of wireless health services will leap from $4.3 billion last year to $9.6 billion by 2012.) Continue >>

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Juniper: 412M M2M devices by 2014

Juniper Research analyst Anthony Cox writes that a forthcoming report from the research firm predicts that the number of machine-to-machine and embedded devices worldwide will increase to nearly 412 million by 2014. Cox writes that number “represents the tip of the iceberg of its future potential.” The analyst’s blog post wonders if M2M will drive the next 5 billion wireless connections. While the M2M market includes just about any object with an embedded mobile SIM card (excluding mobile phones), Cox believes that the healthcare market could see one of the biggest growth spurts over the next few years:


“It is likely that one of the smallest current mobile M2M markets represents one of the largest growth opportunities for M2M,” Cox writes. “Though there are significant obstacles to be overcome in creating a vibrant market for mobile M2M applications in the healthcare market, not least that life itself may depend on such applications, in time rising populations alone will guarantee a very large market for m-Health monitoring.” Continue >>

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2010: mHealth apps get sophisticated

Chilmark Research’s John Moore set about reading the tea leaves on 2010 a few weeks into this already busy year, and came up with a list of top ten trends to for healthcare IT. Smartphone medical and health apps made it onto the trend list at number five:


“Second Gen mHealth Apps Enter Market – Melding of Smartphones and Devices Remains Nascent: With literally thousands of mHealth apps now available, most of them crappy one dimensional apps, we will begin seeing more sophisticated mHealth apps enter the market. These apps will also command a price, but their value will easily justify the purchase for many consumers. In 2009 there was also a lot of buzz around the melding of med devices and smartphones, (remember the iPhone 3GS intro with J&J onstage demo’ing Lifescan). That buzz faded rapidly when FDA showed up to inquire about compliance. FDA approval requirements/process (and aforementioned strengthening of enforcement by this administration) will limit introduction and thus proliferation of new innovative devices hinged to a smartphone.” Continue >>

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Shorts: Epilepsy meds; ECG Patent; Mayo

BBC covers text message reminders for epilepsy patients: The National Hospital for Neurology and Neurosurgery (NHNN), has begun offering a new service to help patients remember to take their meds through text message reminders. More


Patent for handheld ECG: NewCardio secured a U.S. patent for 12-lead handheld ECG monitoring device, CardioBip: “Patients can carry the CardioBip with them and use it to generate and transmit synthesized, accurate 12-lead ECGs at physician prescribed intervals of time, during ordinary daily activity or when symptoms develop. What makes CardioBip unique is its extreme ease of use, combined with the ability to generate recordings substantially equivalent in quality with standard 12-lead ECGs. The CardioBip works without any cables, cumbersome leads, wires or inconvenient skin electrodes, as the device’s electrodes are integrated, offering potential compatibility with popular hand-held PDA platforms.” More


Mayo Clinic to remotely monitor “medical miracle” runner: This from an article in the New York Times: About 12 years ago, Diane Van Deren underwent brain surgery to find relief from debilitating epileptic seizures. Following the surgery, however, Van Deren has become one of the world’s top endurance runners. Mayo Clinic plans to remotely monitor Van Deren on an upcoming endurance challenge down a mountain in South America to see how her body and mind can accomplish such feats in records times. More


LA Times covers the pedometer trend: “When we ask people to start an exercise program, it’s important to have measurable, achievable goals, and adding this self-monitoring component is very critical,” says Simon Marshall, associate professor of exercise and nutritional science at San Diego State University. “We don’t know why exactly, but keeping a number, a prompt, in our consciousness on a regular basis is important, and that’s why pedometers are superior to other methods. It’s on you all the time.” Comprehensive read with lessons for all stakeholders in connected health. More


CardioNet appoints new CFO: Wireless cardiac monitoring company CardioNet has appointed Heather C. Getz as Senior Vice President and Chief Financial Officer. More


Value-added Resellers (VARs) begin to eye market for mobile technologies in healthcare: “Healthcare has a lot of segments, including hospitals, clinics, physician offices, labs and testing facilities, nursing homes, emergency services and home healthcare. HIS companies are into mobile apps, such as point of care, lab/pharma/materials tracking, but, ‘There are a lot of white space opportunities that are not obvious,’ said Global Bay’s Sandeep Bhanote.” More

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January 21 , 2010 Edition
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