Pew: Americans with chronic diseases are less connected

By: Jonah Comstock | Oct 1, 2013        

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Susannah Fox

Susannah Fox

Self-tracking is gaining traction, and data-driven wellness companies are thriving, but that trend is still falling short of what people with chronic conditions — the largest draw on our national healthcare resources — really need. That was the message hidden among the hype at the Health 2.0 opening sessions in Santa Clara this week, where Susannah Fox from the Pew Internet Project shared some preview data from Pew’s upcoming report on people with chronic diseases.

Fox said that while seven in 10 Americans in general self-track, eight in 10 Americans with two or more chronic conditions track their health.

“Tracking data is not a hobby for them,” she said. “They may not have a choice. They’re trying to use data as a mirror to stay well.”

Pew’s new data finds that 45 percent of US adults are living with a chronic disease, and that those adults are actually less likely to have internet access or a mobile phone than their healthier counterparts. They are more likely to track using specialized devices like glucometers and more likely to take formal notes, but less likely to use apps or spreadsheets to track.

In addition, Fox said her data shows doctors don’t encourage their patients to self-track.

“It seems like clinicians are pursuing a ‘don’t ask, don’t tell’ policy,” she said. “They don’t ask people if they’re tracking. They have such a short time with people: do they really want to spend it looking at spreadsheets?”  Keep reading>>


Fitlinxx offers device through SparkPeople for direct-to-consumer play

By: Jonah Comstock | Oct 1, 2013        

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pebble_angle_lights_loFitlinxx, the activity tracker hardware company, is partnering with health and wellness website SparkPeople to provide a branded version of its Pebble activity tracker for users of the site. This is Fitlinxx’s first venture into direct to consumer wellness.

“We’ve been predominately focused on the corporate wellness and healthcare provider space,” David Monahan, President and CEO of Fitlinxx told MobiHealthNews. “Our model’s unique, we’re not trying to be out front. …We focus on devices that can be integrated and embedded with our partners.”

Fitlinxx’s Pebble tracker is clip-on device that runs on a coin cell battery, which gives it about 12 months of continuous life, according to Monahan. It tracks steps, distance, calories burned, and active time and is waterproof. The tracker syncs wirelessly and automatically through a proprietary syncing technology.

SparkPeople will have its own app for the branded version of the device, called the Spark.

“We focus on making that experience great, so there’s not multiple logins,” said Monahan, contrasting it with integrations of consumer trackers, which sometimes involve users downloading both the device app and the integrated app. “You log onto SparkPeople, and your data’s there. It’s one experience and it’s a SparkPeople experience.”

Spark will be available for $59.99 to anyone via the SparkPeople website. SparkPeople founder and CEO Chris Downie said the device fits in with the website’s “four-pronged engagement strategy”, which involves activity tracking, expert content, community participation, and coaching.

“We really stress to members that they get started with small steps,” he said. “By having the Spark activity tracker, that’s a great new motivational tool.”

The SparkPeople companion app for the device will run on Android and iOS devices.

“The app is going to give a lot of information from the activity tracker itself, but it’s also going to include a new program that will help people reach goals very quickly,” Downie said. “It’s like a light version of SparkPeople we can attach to the activity tracker.”

Monahan feels strongly that focusing solely on the hardware and partnering with clients with a focus on engagement and user experience is a better strategy than trying to do both. He compared Fitlinxx’s approach to Android, which focused on building a smartphone operating system and left the devices to device makers, as opposed to Apple, which built a whole closed ecosystem. Although Apple had the early lead in the market, he said, Google is now starting to pull ahead because of that focus — and because they chose the right partners.

“I don’t go into partnerships lightly. We don’t have thousands of partnerships,” he said. “We work at the partnership to make sure its valuable.”

Why the new HIPAA is good for mobile health developers

By: admin | Sep 30, 2013        

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by Grant Elliott, Founder & CEO, Ostendio

Grant Elliot_Bio PicBy simply following the media hype around the recent September 23rd implementation deadline, you could be forgiven for thinking that the final omnibus rule is bad news for mobile health application developers. To recap, the final omnibus rule came into effect on March 23, 2013 but “business associates” were given six months from that date to become compliant with the new requirements.

Among other things, the final omnibus rule expanded federal liability for the HIPAA privacy, security and breach notification rules to now include business associates. Before this, business associates were liable only to the covered entity they were doing business with and only for whatever terms were included within the business associates agreement (BAA) they signed. While the covered entity was required to include standard terms within the BAA, in theory if no BAA was ever executed the business associate had no legal obligation whatsoever. Which might have been good for the business associate, but no so good for the covered entity or the end user.

But now whether a BAA is in place or not, if the supplier is operating as a business associate then the Office of Civil Rights (OCR) has the authority to hold them federally liable for all aspects of the security rule, the privacy rule and the breach notification rule. That liability can be significant with potential fines reaching up to $1.5 million per breach, where a business associate is found at fault.

So where is the good news? There are two areas that offer encouragement to mobile health application developers.

The first is within the final omnibus rule itself and related to the breach notification rule where business associates now have greater flexibility to decide what is reasonably considered to be a breach. For example, previously if a laptop containing personal health information (PHI) was lost or stolen the covered entity or the business associate would have to report this event whether the data was accessed or not. But now the final rule allows the BA to make a reasonable determination based on risk so, if the laptop was securely encrypted or the data could be remotely wiped before access could be obtained, then it could be reasonably determined that no breach had occurred. In such a situation the BA would not be required to report the incident, avoiding unnecessary cost and potential damage to their reputation.  Keep reading>>

Protecting mobile health innovations from regulation

By: admin | Sep 30, 2013        

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by Bradley Merrill Thompson

Brad2As just about everyone knows, last week the FDA published its final guidance on mobile medical apps. That guidance explains in plain English the types of mHealth apps the agency regulates. Over the coming weeks, many of us will be dissecting that guidance to assess what it really means and how the guidance affects the numerous apps already released, as well as those on the drawing board. I have made plans to meet with various mobile medical app developers in the next few weeks to hear their questions regarding how this guidance should be applied, and I plan to post my findings as we start peeling the onion of our understanding.

But the guidance, really only address the scope of FDA regulation; it does not explain how the various regulations are actually applied to mobile apps.

This fall, with help from ONC and FCC, FDA will draft the government’s strategy for how to regulate mHealth. In doing so, FDA might consider such things as which types of regulated apps need to undergo FDA premarket clearance, and how the quality system regulations will be applied to mobile apps. In formulating the government’s strategy, the agencies are supposed to encourage continued innovation in mHealth as much as possible. The question is, how should they do that?

It seems to me they ought to start by understanding the factors that drive innovation in mHealth. So what are those factors, beyond the availability of pizza?

In this post, I’m going to share what I think are some best practices that support innovation. But I’m merely an observer, not a participant, so I would love it if readers would tear these thoughts apart and put forth what you’ve seen as the key drivers of innovation. Here we are not talking about macroeconomics and policy such as the availability of venture capital and good IP protection, but rather microeconomics and company conditions that need to exist for innovation to thrive. After giving readers some time to comment, I will offer a second post on how these factors mesh with FDA requirements, in an effort to identify those FDA requirements that need to be modernized.  Keep reading>>

18 percent of dermatology apps track or diagnose lesions

By: Jonah Comstock | Sep 27, 2013        

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Mole DetectiveThere are 229 dermatology-focused medical apps in the Apple, Android, Blackberry, Nokia Windows app stores, according to a study recently published in the Journal of the American Medical Association Dermatology. More than half of the apps are patient-facing (51 percent), with 41 percent targeted at health care providers and 8 percent aimed at both groups.

The authors excluded certain apps form their count, such as advertisements for products or practices, apps for cosmetics or entertainment, or claims to cure skin diseases. The latter category evokes two apps that were removed by the FDA a few years ago, which claimed to cure acne using colored lights. Researchers didn’t download or evaluate the apps; they merely drew data from the public descriptions in the app store.

Just over half of the dermatology apps were free of charge (51 percent) while paid apps ranged from 99 cents to $139.99. The high end was mostly medical textbook apps, however, and the median was $2.99.

The largest category of apps was reference apps, which included both medical textbooks and informational guides for the general public. These made up 27 percent of the apps found.

The next largest group, making up 18 percent, was self-surveillance or diagnosis apps, which allow users to take pictures of their moles or skin lesions, track them and, in some cases, analyze those pictures to give the user a risk assessment. These have been among some of the most controversial apps in not just dermatology, but medicine in general. Apps like this are a common talking point in discussions of mobile health regulation, including being mentioned in the Congressional Hearings on health app regulation as a potentially dangerous app.

Nearly as many apps (17 percent) were characterized as disease guides — apps that are focused on a particular disease like acne, rosacea, psoriasis, or eczema. Other categories included sunscreen recommendation apps (8 percent), educational aids (9 percent), dosing calculators for dermatology medications (5 percent), dermatology journal and conference apps (5 percent), and teledermatology apps (3 percent).

The study was notably completed and written before the FDA published its final guidance on mobile medical apps. Those guidelines place some dermatology apps, like skin lesion trackers, in the category of devices over which it will exercise its enforcement discretion, meaning they will choose not to regulate them. Apps that provide diagnosis, however, will likely require 510(k) clearance.

Care Innovations names ex-Humana VP to replace retiring CEO Louis Burns

By: Neil Versel | Sep 27, 2013        

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Sean Slovenski-001Louis Burns, CEO of Intel-GE Care Innovations since the joint venture launched in early 2011 and, before that, head of Intel’s Digital Health Group, will retire at the end of the year, Roseville, Calif.-based Care Innovations announced Thursday. Taking his place will be former Humana executive Sean Slovenski, who brings a background in behavior change and wellness to the three-year-old maker of wireless home monitoring technology.

Slovenski, who will take over Oct. 7, is new to remote patient monitoring, but not to digital health, consumer engagement in healthcare or immature marketplaces. Burns, a former Intel CIO, will be helping Slovenski transition into the CEO role until November and should remain with Care Innovations through the end of the year, according to a company spokeswoman.

Slovenski was VP for health and productivity solutions at Humana, a segment of the insurance company focused on wellness services for employer groups. Humana in 2010 bought Hummingbird Coaching Services, a provider of online wellness coaching and behavior management services that Slovenski co-founded and was CEO of.

In the 1990s, he led development of wellness, fitness and integrative medicine centers at Mercy Health Partners in Cincinnati.

Slovenski believes this background will help as he tries to figure out how humans engage and interact with the technology, then make the appropriate product adjustments. “This industry very much reminds me of a lot of the spaces I’ve worked in before,” he told MobiHealthNews, in what he said was his first interview representing Care Innovations.  Keep reading>>