QuantiaMD raises $10M to support ACOs

By: Neil Versel | Sep 5, 2013        

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QuantiaMDQuantia Communications, parent company of physician social networking site QuantiaMD, has raised $10 million in Series B venture capital. The money will allow Waltham, Mass.-based Quantia to start marketing its “physician relationship management” services and online community of more than 200,000 physicians to health systems.

Publicly traded venture capital firm Safeguard Scientifics contributed $7.5 million, while previous Quantia investors, including Fuse Capital, provided the remainder, according to the companies involved. Quantia had closed a $12 million round, led by Fuse, in October 2012.

The investment comes as Quantia looks to move into a growth phase and provide support to accountable care organizations, according to CEO Mike Coyne. “What they’re really looking for are [physician] behaviors to influence outcomes, revenue, quality, and cost,” Coyne told MobiHealthNews. “You have to communicate to doctors why accountable care is important.”

To this end, Quantia will be hiring new sales staff to focus on health systems, augmenting the sales force already in place to target pharmaceutical and medical device companies that want to promote their products to physicians. The company also will continue to expand its physician audience now that executives are confident that the platform is solid.

“A lot of the super-hard work has been done,” Coyne said.

Coyne said Quantia has recently signed its first multiyear service agreement with a health system. He would not divulge the client’s name yet, but said to expect an announcement in a few weeks. “We also have a number of pilots underway,” Coyne added.


Colorado-based hospital group to form digital health subsidiary

By: Neil Versel | Sep 5, 2013        

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AirStrip ONE OB

AirStrip ONE OB

The massive Catholic Health Initiatives health system, with 87 hospitals in 18 states, is ramping up its digital health efforts while also getting ready to establish a distinct business unit dedicated to what the Englewood, Colo.-based organization calls “virtual health services.”

(Correction: The original version of this article incorrectly described the unit as a standalone company that was spinning off from CHI.)

CHI will soon move its virtual health services into a wholly owned subsidiary with a new name the organization isn’t ready to divulge yet, according to Proteus Duxbury, whom the organization brought on at the beginning of the year to be director of technology strategy for virtual health services. The category includes not only traditional telemedicine and telehealth, but also mobile, social media and elements of gamification.

The new subsidiary will market these services to employer groups and payers, a departure from earlier telehealth efforts that concentrated on hospitals.

CHI has already commercialized its ePharmacist Direct telepharmacy services, which grew out of a statewide project in North Dakota that started in 2004 to aid critical access hospitals and other rural facilities that can’t afford on-site pharmacists around the clock. Nearly a third of the 25 hospitals on the telepharmacy network are outside the CHI system, Duxbury said.

The virtual health services group – which, interestingly, is part of CHI’s clinical services division, not the IT department – is slowly expanding into medication therapy management and tele-mental health with various digital technologies. “We see there is a huge desire for mental health services in America,” Duxbury said.

That one of the first two phases in a four-stage strategy. “Our initial focus is on consolidating our core telehealth platform.” Duxbury said. CHI is trying to standardize its telehealth services with Polycom telecommunications equipment and Microsoft Lync software.

“We don’t just dive into things,” Duxbury explained. “We have to make sure we’re doing the right thing nationally.”

Later, Duxbury wants to move into home monitoring for disease management and, eventually, crunching data in the cloud for real-time and predictive analytics.

The plan is to provide a suite of integrated products and services, part of a desire to break down silos that currently exist in telehealth and digital health and also to address care coordination, Duxbury said. Someone who has been diagnosed with congestive heart failure, for example, not only needs to stay on prescribed medications, but also might be depressed because of the diagnosis, according to Duxbury.

Already, CHI is starting to move into home monitoring. CHI and Adventist Health Services jointly own Centura Health in the Denver area, which has had some success with remote patient monitoring, Duxbury noted. The Catholic health system also is beginning to use AirStrip OB, an obstetrics app from San Antonio-based AirStrip Technologies, he said.

Most of the technology the new subsidiary will offer will come from third parties and, preferably, be white-labeled. “We want to find solutions that work well and we will become an aggregator,” Duxbury said. “The key thing is, they have to have the ability to scale, we have to be able to brand them and they have to be integrated.”  Keep reading>>

Virgin HealthMiles adds family members, teases new tracker, plans to change name

By: Jonah Comstock | Sep 5, 2013        

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Virgin HealthMiles’ current GoZone pedometer.

Virgin HealthMiles, a gamified employee wellness program, announced that, starting in October, it will let employees invite up to three family members to use the program for free. Between adding family members and drawing in new members because of the perk, Virgin HealthMiles expects its user base to see a big boost in the next year.

“On the scale side, we’re hoping to quadruple our number of users in the next 12 months based on adding friends and family,” Ron Hildebrandt, VP of product marketing, told MobiHealthNews. “So we are making big investments in our operations to make sure we can scale.”

Because of privacy concerns, only family members 14 or older will be able to participate in HealthMiles’ online and mobile platform, at least at first. Overtime, Hildebrandt said, he expects the platform will support younger participants.

Focus group testing revealed that the app and website didn’t need to be modified to appeal to teenagers, so the company isn’t changing it much. It is, however, adding features that enable families to compete in challenges together as a team, challenge one another, and see the whole family’s statistics on one page.

Virgin HealthMiles also has its own activity tracker available to employees as part of its system, called the GoZone Pedometer. The company is planning a major update of that device — with a new name — partly to appeal to kids in the program. The new device will be launched at CES 2014.

“Our next version of our device will have much more of a personality, a very large screen,” said Hildebrandt. “We expect the device to be the largest engagement vehicle for the kids in the family, and it’s built with that in mind.”

Virgin HealthMiles has 200 customers including large companies like Coca-Cola, AOL, and SunTrust. About 20 percent of those customers were already including spouses in their HealthMiles plans and eating the costs themselves, according to Hildebrandt. One of those companies is Ascend Performance Materials.

“The response has been overwhelmingly positive with an 83 percent overall enrollment rate in the program and 52 percent of our members and 45 percent of spouses in the active or highly active category,” Ascend’s Total Wellness Director Michael Martin said in a statement. “With every wellness program that we offer today, we go out of our way to make sure that spouses are eligible to participate and receive incentives — as we have seen the impact it’s had on employee engagement and productivity.”

Virgin HealthMiles made the decision to extend its offering to family members based on employee feedback, as well as a number of studies showing that including family members increases engagement and improves employees’ opinions of their companies. One such study, from the Health Enhancement Research Organization and Mercer, found that extending a program to spouses caused participation rates to double.

Hildebrandt also told MobiHealthNews that the company is planning to rebrand and change its name, due partly to concerns about being confused with the airline.

Virgin HealthMiles announced a partnership integration with MyFitnessPal earlier this summer, adding it to a roster of existing integrations that includes Fitbit, Runkeeper, and Polar.

Part 2: Set FDA’s mobile medical app guidance free

By: admin | Sep 4, 2013        

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Brad2By Bradley Merrill Thompson

In response to my prior post on this topic, athenahealth’s VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions.

As I said in my original post, it’s important for us all to keep in mind that FDA is already regulating mHealth and the purpose of this guidance is to reduce the scope of that regulation. So the question is–  is it useful for FDA at this time to come out with a final guidance on mobile health?

I will explain further why I think it clearly is.

Mr. Haley offers the view that FDA guidance is unnecessary at this point because there will be a new statutory scheme within about a year. After consulting his blog that he referenced in his prior comments, it appears that Mr. Haley is a government affairs professional and an attorney, so I know that he well-understands the process for creating new statutes, but let me recite it for everyone’s benefit.

Step one — FDA drafts a report to Congress, with the input of ONC and FCC

In section 618  of FDASIA, Congress asked for a report from FDA, together with ONC and FCC, on “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications.” At this juncture, because it hasn’t yet been written no one knows what that report will say, except perhaps FDA and the other two agencies that are working with FDA to write it. We in the public do not know, for example, whether the report will recommend a series of incremental improvements to the existing regulatory framework or an entirely new one.

Not to quibble, but in Mr. Haley’s comment he says we are “on the eve of a proposal for a statutory framework.” But we do not know at this juncture that it will be a statutory one. And even if there are statutory elements to it, we do not know that it will be a new, comprehensive statutory scheme, but perhaps fine-tuning of the existing statutory framework. Bottom line is, we just don’t know what the agencies will propose.

Step two – Congress may debate what to do

Presumably sometime in 2014 (the agencies aren’t always punctual in meeting deadlines), Congress will receive this report and if they are so inclined will debate it through the normal congressional channels. Now I know Mr. Haley understands that process much better than I do, but in my experience, Congress isn’t always quick to act, or decisive in its approach. And indeed, the timeline is influenced by other factors such as whether we are at war and generally other priorities of the moment.

If, and I emphasize if, Congress decides to move forward, Congress still has to draft a new regulatory program and presumably get input from all sorts of people.  Here is where I see extreme uncertainty because there is no consensus as to how software should be regulated. I just participated in the summer long process of making recommendations among the FDASIA working group, and as I’m sure others already know, that process was a difficult one that produced a number of high level observations. It also revealed a number of differences that still need to be worked out.

I’ll give an example. As I study the work product of the Bipartisan Policy Center which is one of the leaders of the organizations that signed the letter to the HHS Secretary, one of the key recommendations of that group is that Congress ought to create a new category for clinical software with its own separate regulatory scheme. It seems to me and others that there’s a major problem with that approach. The problem is that technology is trending in the direction of systems that combine medical devices with health IT and to separate the two will cause confusion and result in duplication, which the agencies were tasked in avoiding. Consider:

  • Medical device hospital beds becoming electronic hubs into which the various patient monitors and therapeutic devices such as insulin pumps are connected and coordinated, and through which data are collected for deposit into the EHR.
  • Medical devices being electronically networked together to directly coordinate the delivery of care, for example an oxygen monitoring device might tell an intravenous device to stop delivering narcotics if hypoxemia is detected.
  • Enhancements coming from the EHR side, including middleware to directly connect the EHR to medical devices so the data might be transferred automatically.
  • In the later part of the 20th century, professional care basically stopped when the patient went home.  Now we are seeing a whole slew of technologies that allow for connected health. These include cell phone apps that might extract data from a pacemaker or defibrillator and send it back to a cardiologist, as well as home-based hubs to which all sorts of medical devices might be connected, and the data ultimately relayed to a doctor and into an EHR.
  • Now laboratory testing is getting into the act. There is a cell phone app that basically uses the camera to measure color changes in a test strip for urinalysis. Further, laboratory testing itself is now connected through middleware directly to caregivers and EHRs.
  • Medical imaging is not to be left out, with ultrasound and other clinical images being transmitted to tablets and cell phones that the doctor can use at the bedside, or even at the doctor’s home. It seems reasonable to expect that these mobile monitors will get more sophisticated, and begin to apply computer aided diagnostic software to the images.
  • Orthopedic implants can now have sensors attached that allow doctors to remotely monitor the wear and tear on the implant. All of this data then gets stored and trended in an EHR.
  • Sensors can even be used preventatively, for example monitoring the environment for allergens and alerting a patient with asthma or his caregiver to potential danger. This data can get stored and analyzed in the EHR.

Given those and other technology trends, it will be increasingly difficult to separate out many categories of so-called clinical software from the connected medical device software. Developing a separate regulatory scheme for HIT that connects with medical devices represents a tremendous conceptual challenge to the design of an HIT regulatory scheme.

As I think everyone in this debate agrees, it is very difficult to serve two masters. If, for example, medical device manufacturers must satisfy FDA, and if in this example HIT developers must satisfy ONC, it is not hard to imagine complexities and duplications when the HIT is intimately connected to the medical devices.  In many of these cases, the HIT might actually control the medical device, in other cases the safety and effectiveness of the medical device will be entirely dependent on the software accurately capturing and presenting the data generated by the medical device. This is not to say HIT, regardless of risk, should be regulated by the FDA. Certainly not. The point is simply that clinical software is not some isolated product category that can be regulated unto its own without implications for other technologies like the medical devices that are more and more interconnected with that HIT.

So if Congress is considering creating a separate a new regulatory scheme for clinical software, separate from FDA regulation of traditional medical devices, legislators will have their work cut out for them. This is not an easy challenge to resolve.  Keep reading>>

Mobile health oversight: Stability will come with clarity, not rush

By: admin | Sep 4, 2013        

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Dan Haley athenahealthBy Dan Haley, VP of Government Affairs, athenahealth

In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile health stakeholders clamoring for final guidance to provide “clarity” and, by extension, confidence to potential mobile health investors waiting impatiently on the sidelines.

A lot has happened in those many intervening months. For one thing, the once-rational distinction between “mobile” information technology and everything else has become less and less connected to the reality of the technological world that we live in. Put another way, all communications technology is now “mobile” to one degree or another.

More importantly, in July of last year, via FDA Safety and Innovation Act (“FDASIA”) Congress instructed the Obama Administration to recommend a “risk-based” framework for oversight of health IT with three clearly-stated objectives: (1) to protect patients; (2) to promote innovation; and (3) to avoid unnecessary regulatory duplication. Crucially, Congress explicitly included mhealthIT in its FDASIA mandate.

In April 2013, Health and Human Services (HHS) Secretary Sebelius convened a stakeholder workgroup (the “FDASIA Workgroup”) to inform that recommended framework. The FDASIA Workgroup has solicited public comment, held meetings on a more-than-weekly basis, and is on track to issue its recommendations in September.

Some industry stakeholders have urged the FDA to release its final Mobile Guidance as quickly as possible, despite the clear, intervening Congressional call for a comprehensive framework. Others (including athenahealth) disagree emphatically. That’s why in June we helped to pull together a broad coalition of more than 140 healthcare stakeholders, including nearly two dozen consumer groups, 18 medical societies and physician groups, six hospitals, 75 health IT start-ups, and dozens of other potentially-impacted entities and groups. That coalition sent a letter (read it here) to key Administration figures, including Secretary Sebelius, asking FDA to hold off on issuing final Mobile Guidance until the FDASIA Workgroup has provided its Congressionally-mandated recommendations and the Administration has crafted the required comprehensive oversight framework. Emphasizing Congress’s clearly-expressed instruction that HHS should avoid unnecessary regulatory duplication, the coalition letter argued that final Mobile Guidance issued before release of the FDASIA-required recommendations for a comprehensive oversight framework, encompassing mobile health IT, would increase rather than alleviate uncertainty in the mobile health marketplace.

This is very much a live issue in Washington right now, with the FDASIA workgroup preparing to issue its recommendations, rumors persisting about potential final mobile guidance from FDA, and continued uncertainty about the prospects for and the final form of the Congressionally-mandated comprehensive oversight framework. We continue to believe that true regulatory certainty will be provided not by regulatory haste, but by careful deliberation to produce a clear, non-duplicative, risk-based approach that protects patients while fostering innovation. Congress clearly mandated such a framework. The Administration should honor that mandate and resist well-intentioned but ultimately counter-productive calls for rushed, piecemeal regulation.

(This post first appeared over at athenahealth’s blog.)

Survey: More medical students look to mobile first for reference

By: Jonah Comstock | Sep 4, 2013        

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epocrates survey 2For the next generation of doctors, 66 percent turn to the Internet or a mobile device first for clinical answers, according to a recently released survey by physician reference app maker Epocrates.

In their eighth “Future Physicians of America” survey, the company, which is now an athenahealth subsidiary, talked to 1,026 current medical students about a number of topics, including digital habits. The survey was conducted online in July and respondents came from over 200 medical schools in all 50 states and included first- through fourth-year students.

Of the 66 percent who turned to digital sources first, 53 percent went to mobile sources while 47 percent consulted the internet. The study found that 54 percent of medical students surveyed used a tablet in their training, a 31 percent increase from 2012. Of those, only 18 percent are required to use tablets for their training; the other 82 percent use them voluntarily. The top 3 use cases for tablets cited by participants were: looking up clinical data, accessing patient records, and communicating with colleagues. Fifty-three percent of the whole group reported using Epocrates daily.

Medical students were less bullish on social media questions: 91 percent said it was unacceptable to friend a patient on Facebook and 82 percent were opposed to posting pictures of a case or discussing a case online. However, 82 percent said they would recommend a health-related app to future patients.

On the subject of patient engagement, 72 percent of students said they planned to practice patient-centered care, with 67 percent saying they were satisfied with their patient-centered care training.

Physicians felt less informed about Accountable Care Organizations. In fact, 72 percent said they felt uninformed about ACOs, down only slightly from 76 percent in 2011. This information discrepancy is important, because while uninformed students were split fifty-fifty on whether ACOs would have a positive or negative effect on medicine, those who claimed to be informed about ACOs were more inclined to believe they would have a positive effect — 41 percent said they would, as opposed to 16 percent predicting a negative effect (the other 43 percent didn’t respond or weren’t clear.)