Free online weight loss community SparkPeople improves outcomes in peer-reviewed study

By: Jonah Comstock | Feb 19, 2013        

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sparkpeopleA researcher at the University of Texas has published a study in the Journal of Medical Internet Research looking at efficacy of a free online weight loss program. The study looked at 1,258 randomly selected users of SparkPeople.com and found that those who entered their weight into the site at least four times per month lost an average of 11 pounds per month more than those that didn’t, and those who made at least one post on the site’s forum during the time they used the site lost over three pounds more than those that didn’t. (Correction: A previous version of this article misstated the weight entry as four times total, rather than per month.)

Dr. Kevin Hwang, the lead researcher on the study, approached SparkPeople for the dataset in 2009, and the company ended up providing him with a random sample of users who joined the site in 2008, with extreme outliers (like users who reported heights of more than 10 ft.) eliminated. The sample included data entered by users through 2010, and researchers completed the analysis in 2011. Hwang writes in the study that looking at SparkPeople’s data has two advantages over previous work with online weight loss communities. First, as a “naturalized cohort” study, the subjects were not volunteers for a research study and were not aware they were being studied.

Second, SparkPeople is a free service, which Hwang suggests could make the results more relevant for public health than studying paid subscription services.

“The public health impact of an intervention is determined by efficacy and dissemination,” he wrote. “Because this online program is free, scalable, and widely disseminated, the potential public health impact is significant.”

The downside to the format is that the data is self-reported. But researchers found that participants entered weight gains as well as losses, and SparkPeople representatives maintain that there’s no reason for users of the site to lie.

SparkPeople was founded by former eBay employees in 2001, originally as a paid site. But the founders decided to switch to a free, ad-supported model in 2005. In 2009, the site passed Weight Watchers to become the dieting site with the most unique hits in America, according to comScore.

“We felt our software was very strong, but we were competing with companies that spent a lot on marketing,” Chief Operations Officers Dave Heilmann told MobiHealthNews. “We realized that going free would expose a lot more people to our technology.”

The site combines written content like recipes and articles, tracking tools (primarily based on manual weight entry, but increasingly integrating with digital tools), and an online forum for social support. Members are encouraged to take advantage of all three services to meet their weight loss goals. The site’s average user starts out about 35 pounds overweight, according to Heilmann, and the user base is about 90 percent female (as was the sample in the study).

“I’m proud of that 10 to 12 percent,” said Heilmann, referring to the number of men on the site. Heilmann says he thinks the social aspect of the site appeals more to women. The company also offers a number of mobile apps, which they begin offering in 2009, including one that focuses solely on tracking. With that app, he says, it’s more like 65 percent female.

In addition to ads, SparkPeople generates revenue by charging for its apps, selling recipe and diet books, and recently began offering a premium subscription to the website that provides direct, personal access to trainers.

Tools other than weight entry and forum usage did correlate with increased weight loss in the study, but not a statistically significant amount. In addition, SparkPeople offers tools now that weren’t available when that data was collected between 2008 and 2010. Nonetheless, Heilmann said the results are encouraging for the company.

“It does reinforce how we’ve spent our time,” he said. “Honestly, a big part of the study was to show people this works. People need to believe in a diet they’re on to stick with it. We do want to do more potentially with corporate wellness and things like that.”

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Discharge app, hospital porter request tool win early GE Hospital Quest prizes

By: Neil Versel | Feb 19, 2013        

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Hospital Discharge Roadmap AppSubmissions to GE Healthcare’s $100,000 Hospital Quest app challenge were due Friday, but even before the contest closed, the company already announced two early winners of $5,000 each.

The first winner, Discharge Roadmap, facilitates communication between hospitals and community-based care providers and helps standardize processes for transitioning patients out of hospital care. This iPad-based mobile app consists of separate portals for patients, physicians and outside caregivers.

The patient portal takes users through the discharge process, discussing such topics as each person’s care team and a list of post-hospitalization needs, and lets individuals choose homecare providers and telemonitoring equipment. Both patient and caregiver sections offer updates of progress toward discharge, educational material and personal health assessment tools.

The app also allows users to schedule follow-up physician visits and other necessary appointments, according to contest material. Similarly, healthcare professionals can set preferences, including preferred appointment times, while physicians also can publish referral notes and discharge summaries to other care providers via the iPad.

Discharge Roadmap, created by a team from Buffalo, N.Y., took home its prize in December for best meeting the contest’s first development milestone. The other early winner, Request-a-Porter, from British startup company ClearStream Health, won the second development milestone in January.

Request-a-Porter is meant to speed up the processes of transporting patients and specimens within hospitals by automating porter requests. It helps reduce waiting times for patients and laboratory tests, make porters more efficient and reduce downtime for diagnostic equipment, according to a video provided by the developer.

The smartphone app also keeps an audit log of transport requests, providing better accuracy and accountability than current phone-and-paper-based call processes. ClearStream suggests that it could track the location of porters either by a smartphone’s GPS, by triangulating based on WiFi access points or with RFID tags.

A companion porter control system for dispatchers runs on either tablets or PCs.

GE, in partnership with New Orleans-based Ochsner Health System, will award eight grand prizes and one “Lean startup” winner on March 4, during the annual HIMSS conference in New Orleans.

Canadian mobile healthcare company raises $1.5M, headed to US

By: Jonah Comstock | Feb 19, 2013        

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Health Outcomes Worlwide

Corrine McIsaac, president and CEO, Health Outcomes Worldwide; Nova Scotia Deputy Premier Frank Corbett (Photo Credit: Vaughan Merchant)

Canadian company Health Outcomes Worldwide, which uses mobile tools and record-keeping to promote healthcare best practices, has received a $1.5 million investment from the provincial government of Nova Scotia, bringing the company’s total public funding to $2.5 million, according to a report in Canadian newspaper Cape Breton Post.

The New Waterford, Nova Scotia-based company offers mobile tools that help healthcare workers electronically report data to help track treatment and recovery practices, then analyze that data to maximize outcomes and efficiencies. The company incorporated in 2005 and switched from web tools to mobile devices in 2009. Since then it’s expanded its offerings from Apple devices to include Android and BlackBerry phones and tablets.

The company’s first use case has been in the area of wound care, but they have also completed a module for diabetes management and they are working on chronic disease, physiotherapy, and occupational therapy. President Corinne McIsaac told MobiHealthNews that wound care is a complicated area for caretakers like home care nurses (the company’s biggest user group) to master.

“Even though there’s a large volume of wound cases, it’s not really a sexy kind of care treatment,” she said. “For whatever reason it’s not covered well in curriculums, and not a lot of people in healthcare really know how to take care of these different wound types.”

Health Outcomes Worldwide’s how2track software has some functional overlap with an EHR, according to McIsaac, but what sets it apart is a huge database of past cases. The database is large enough that the company is beginning to move into predictive analysis.

“We want it to be able to say ‘If you do A, B, C, and D, you’ll heal the wound in this amount of time and it’ll cost you this much money,'” she said.

She said as it develops the additional modules, it might develop into an EHR, or the company might make a practice of integrating with EHRs, something it already does with some clients.

Health Outcomes Worldwide plans to use the funding to grow the company and expand its user base. The company will double its workforce of 15 employees and hopes to expand out of Canada and into the US, possibly starting with Boston and Washington, D.C. — company executives are visiting those two cities in March to meet with some prospective customers, including some connected to the VA.

“People in the US think everything is free in healthcare in Canada and that’s not so, especially with home care. In home care, you do have to pay for some services,” McIsaac said. “The pay for performance mantra we see as an absolutely perfect fit, because it would help folks to ensure they’re doing the minimum number of visits for the best outcome. We’d love to be able to get into some of these larger home care chains in the US. We see a great fit for our product there.”

Ping4 raises $3.8 million for hyper-local emergency alerts

By: Jonah Comstock | Feb 19, 2013        

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Ping4 Alerts iPhone AppSmartphone-based public safety company Ping4 has raised $3.8 million to develop a next generation emergency alert system and market it worldwide. With more than a million from the founders of the company and $1.8 million raised between January and March last year, the new round brings the company up to $7 million in funding, Ping4 CEO Jim Bender told MobiHealthNews. The $3.8 million raise is made up of individual angel investors, and between two-thirds and three-quarters of the investors were returning from previous rounds, Bender said.

Ping4 creates an app-based alert system called Ping4alerts! for such diverse cases as nuclear reactor breakdowns, Amber Alerts for missing children, and disaster relief. The company sells its system to emergency services, who then reach the public by the means of a free app on their smartphones. They’re planning to use the money to add additional features to their product, file for more patents, and develop a worldwide marketing team to sell their service outside the United States.

Ping4alerts! has a number of advantages over a traditional emergency alert system. For one thing, the alerts can be targeted hyper-locally, not just to residents of an area, but to visitors as well. This allows people to only be bothered by alerts relative to them, and allows the alerts to be tailored in cases where people in different areas need to take different precautions. Additionally, the system can send rich data, including pictures and videos, which can be especially useful in the case of a missing child, for instance, since app users can get pictures of the child and even snippets of security footage.

Finally, the app allows for two-way anonymous messaging. Users don’t have to give up any information about themselves other than their location in order to get updates, and the system allows them to respond to alerts with anonymous tips in applicable cases.

Ping4 is years ahead the US government. In mid-2011 FCC chairman Julius Genachowski announced a plan to overhaul the existing 911 service to bring not only texting, but photo, video, and data support to what he called the Next Generation 911 service within five to ten years. Last year he announced plans to accelerate the rollout of the texting component.

For Ping4, one potential drawback is that it can only alert smartphone owners. But Bender argues that smartphone adoption is climbing quickly, especially in developing countries.

“It is what it is, but the numbers of smartphones are absolutely staggering, and so is the trend line,” he said. “TVs were invented in the 1940s and in those 70-plus years we’re just now getting to 2 billion screens. The personal computer was invented in 1980, now there are 1 billion units. Smartphones already dwarf both TVs and PCs, and the rate of adoption in 3rd world countries is very fast.”

The free app currently runs on Apple and Android devices. The company has plans to develop for Microsoft eventually, said Bender, and will be watching BlackBerry to determine whether to invest development resources in the platform.

Health applications are among the uses the company potentially provides for, giving information about outbreaks and the location of medical services in cases of natural disaster. As the company moves toward global penetration — and considers donating their system to the World Health Organization — one area where the service could be immensely helpful is cholera outbreaks, Bender said.

“In the case of cholera, being able to tell mothers or caregivers that massive hydration can make a difference at the very start of an outbreak is something we can do through the smartphone without knowing anything about the people receiving those alerts,” he said.

What risks do docs who prescribe devices like AliveCor take on?

By: Jonah Comstock | Feb 18, 2013        

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AliveCor officialIf there’s one device that’s recently become a symbol for the promise — and potential pitfalls — of mobile health, it’s AliveCor Heart Monitor, formerly known as the AliveCor iPhone ECG, which received FDA clearance for prescription use in December. Dr. Dave Albert, AliveCor’s chief medical officer, outlined some next moves for the company recently in response to an online conversation about the device.

The AliveCor Heart Monitor has a lot of potential for detecting and gathering data on asymptomatic arrhythmias, which is difficult to do in a clinical setting. But how does a prescribable home-use device fit into a physician’s workflow? What are a doctor’s responsibilities and liabilities?

Dr. Westby Fisher, an internist and cardiologist who blogs under the name “Dr. Wes,” wrote a must-read post last week elucidating some of these questions in the context of the AliveCor device. The post spurred a flurry of comments, comprising a microcosm of the ongoing digital health debate about mobile health, patient rights, and doctor availability.

“Once a doctor ‘prescribes’ such a device, what are his responsibilities?” Fisher writes. “Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely? At this point, no one knows. We are entering into new, uncharted medicolegal territory.”

Fisher points out that according to an email he received from the company, AliveCor doesn’t currently “provide any ECG interpretation, diagnosis or analysis of the data obtained with the monitor.” The email goes on to say that “[p]atients will be instructed to contact you, their physician, regarding any questions they may have regarding their recordings.” Answering these questions, whether by phone or secure emails, Fisher points out, would not constitute billable hours, and physicians might not be confident enough in the capacity of a home-administered single-lead EKG to deliver a diagnosis for which they would be legally liable, especially in emergency situations.

In the comments, a debate ensued about whether the device was even valuable, with some healthcare professionals arguing that EKG data, without the expertise to interpret it, would be harmful to patients. A number of heart patients, including noted ePatient Hugo Campos, argued the contrary, citing their own examples of how AliveCor and similar devices had helped them address heart problems, and also suggesting that reading an EKG is not as difficult as some suggest. Many suggested that the root of all the problems Fisher mentioned is that the device is prescription at all.

“The problem here is exactly the requirement that all patients obtain a prescription from a physician before ordering the AliveCor heart monitor,” Campos wrote. “Get rid of the prescription prerequisite and you get rid of the problem altogether.” He pointed out that the company plans to offer the device in Europe over the counter.

Perhaps most notably, AliveCor inventor and co-founder Albert chimed in, responding to comments and giving some hints about the future of AliveCor. Albert reaffirmed what MobiHealthNews reported in December, that the over-the-counter version of the device is still coming, pending FDA clearance. He also said that the lack of interpretation for results is temporary, based on their planned offerings. The company plans to offer both automated and human interpretation services directly to consumers, on a sliding fee scale, noting that their atrial fibrillation detection algorithm had a 100 percent sensitivity and 96 percent specificity in a trial recently presented at the American Heart Association.

Albert said that having different confidence levels of reads for different prices is part of a disruption he thinks is crucial in medicine.

“[P]eople have to buy the case and will have to pay for the reads — that will make them think about using it appropriately,” he wrote. “Personal financial feedback has been missing in medicine but it is in every other part of our life. Open loop anything is bad for controlling costs and medicine is a prime example of that.”

Although the release of an over the counter version and interpretation services might curtail the problems for AliveCor, the concerns about physician workflow Fisher brought up will continue to be present in other prescription remote monitoring devices that follow AliveCor’s lead. The conversation isn’t going away any time soon, and would-be device developers would do well to keep it in mind.

In a recent interview with MobiHealthNews, Campos elaborated on his belief that anyone can learn to read an EKG, and everyone should be given the chance to do so.

“We often underestimate peoples’ ability to make sense of the information,” he said. “Atrial fibrillation is not that hard to recognize. The hallmark of atrial fibrillation is an irregular heartbeat. I can recognize that and I never went to medical school. This is the kind of stuff we all think belongs to the physician but there are some things that people can know and do know. We need to unlock the potential that lies in these devices and their ability to democratize this data — we need to stop being so fearful and be a little more brave, but no one seems to be brave enough to take some risks.”

Average time to FDA clearance drops again, mobile medical apps still shorter

By: Brian Dolan | Feb 18, 2013        

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Mobile MIM 3.0 iPadPerhaps more than any other metric, the time it takes to secure clearance is the one that gets the most attention for 510(k) devices. An updated analysis from medical device quality assurance and regulatory consultants, The Emergo Group, finds that the average time it took for a medical device to complete the 510(k) process was about 138 days in 2011, down from 146 days in 2010. The company determined those averages by analyzing the times for thousands of devices that completed the process those years.

Many mobile medical app developers cite the time to clearance as a significant barrier, but compared to the overall average time to clearance for all medical devices, mobile medical app device makers have a shorter wait.

In a recent study MobiHealthNews found 76 cleared mobile medical apps in the FDA’s 510(k) database, and the average time to clearance for devices that had a mobile component was considerably less than the overall average that Emergo Group found. The average time to secure clearance for mobile medical apps is shorter by 25 days and for these devices, which were cleared between 1997 and 2012, the average time it took was 110 days, based on MobiHealthNews’ data.

For the 75 FDA Regulated Mobile Medical Apps report, MobiHealthNews used the FDA’s own definition of a mobile medical app to determine which cleared medical devices to include. The FDA laid out its definition in late 2011 when it published its draft guidelines for how it should regulate medical apps moving forward.

Of course, this “time to clearance” data is based on the dates provided by the FDA for the date the agency officially received the 510(k) application and the date the FDA described as its “decision date”. However, some companies have described their actual time to clearance as being much longer since discussions that occur before the official application is filed are not counted.

For example, Proteus Digital Health and MIM Software worked with the FDA for years to gain 510(k) clearance. Proteus offers an ingestible sensor, wearable vital sign monitoring patch, and companion smartphone app. Proteus first sought FDA clearance for both the ingestible sensor and the patch in 2008, but didn’t get clearance for the ingestible sensor until mid-2012. MIM Software had a well-documented, frustrating experience with the FDA. It received a lot of publicity in 2008 as it was one of the only medical apps to give an on-stage demo at the Apple Worldwide Developer Conference that launched the AppStore, but a few months later MIM Mobile was taken out of the AppStore and told by the FDA that it needed to seek a 510(k). It wasn’t until early 2011 that it received FDA clearance — and the FDA made a big deal out of the app’s 510(k).

The Emergo analysis shows that between 95 percent and 97 percent of all cleared 510(k) submissions occur within one year of submission. The firm also found that half of all medical devices submitted for FDA 510(k) clearance fall under orthopedic, cardiovascular, general and plastic surgery, or radiology categories. Radiology devices generally have the shortest review periods, while chemistry-related devices like blood glucose testing systems take the longest – about 180 days on average.