The regulatory landscape for mobile apps (audio)

mHealth regulatory expert Bradley Merrill Thompson of the Epstein, Becker & Green law firm and Bakul Patel, Policy Advisor for the Center for Devices and Radiological Health, FDA, will be discussing mHealth regulation on the mHealthZone program on BlogTalkRadio tomorrow (Thursday, 7 March) from noon to 12:45 pm (US) Eastern Time. The interview will be available later as a podcast at the same link.

Tuesday’s telehealth short takes: CommonWell, Medikly, accelerators, mHealth savings, Televero

In HIMSS13 news, healthcare/EHR/practice management heavyweights Cerner, McKesson, Allscripts, athenahealth, Greenway and RelayHealth are forming the CommonWell Health Alliance to foster interoperability and care integration, enabled by ‘data liquidity’ (a term new to this Editor, but perhaps the result of ‘data exchange’). With Cerner and Allscripts taking some heat for lobbying for Federal stimulus funds that helped fuel the explosive growth of EHRs [TA 20 Feb], diverting to this albeit necessary issue seems to be a good move. HealthcareITNews

Medikly raises $1.2 million in series A financing from Easton Capital: A recent graduate of the Blueprint Health accelerator in New York City, it springboards data analytics on multiple touchpoints of physician behavior and preferences, enabling pharma companies to more effectively distribute content, achieve cost efficiencies and perhaps in the long run, change behavior. It also doesn’t hurt to be on track to have $5.6 million in revenue in 1st Quarter, according to their CEO. TechCrunch

Accelerators, and what to look for in them, are the subject of this California HealthCare Foundation report, “Greenhouse Effect: How Accelerators Are Seeding Digital Health Innovation”.  They do the most good when focused on business models–and whether they meet the survivability test, utilize health subject matter experts for guidance, narrowcast their sector and customer type, work closely with sponsors and partners, and tailor programs by stage of development.  White paper PDF

Update 8 March: And if you’ve experienced the frustration of applying to an accelerator, there is a video parody on the usual clip from the Hitler-last-days film ‘Downfall’ which sends up the whole process as well as some of the Silicon Valley figures in the tech funding area: Dave McClure of 500 Startups and The Gimlet Eye’s favorite VC, Vinod Khosla. Cautions for Hitler, profanity, raving, German uniforms and your tolerance for yet another ‘Downfall’ takeoff.  

mHealth saving over $400 billion by 2017:  Released at Mobile World Congress in Barcelona last week, the GSMA/PwC study ‘Connected Life’  calculated that mobile health could save developed countries $400 billion by 2017 four ways: detection of sudden incidents, remote medical home monitoring, mobile EHR access by physicians and nurses, and the (good old reliable) SMS (texting) for appointments, reminders etc. Gigaom, link to study PDF (see pages 5-8). 

Waldo has left the building: Waldo Health is now reinvented, according to an announcement by CEO Vincent Salvo, as Televero Health. Based on the website, there is more focus on patient population management and visualized analytics than on individual adoption. Waldo Health debuted at ATA 2010 and combined telehealth, telemedicine, med reminders and patient education into an easy-to-use touchscreen monitor format. Last year, they also made news when they licensed Bosch Healthcare’s patents to settle infringement issues [TA 30 Apr 2012]. Mr. Salvo is also an operating/venture partner with TEXO Ventures, a main investor, and joined the company in late 2011. Founder and original designer Sam Fuller has left the company.

The billion-dollar valuation horizon

When will a health tech company hit the magic billion-dollar valuation?  A survey of nearly 140 entrepreneurs and over 50 health care information technology VC investors, conducted venture capital firm InterWest Partners, showed (probably naturally) far higher expectations by the entrepreneurs that several companies would hit that mark within five years. Using the most negative measure–none of the companies would hit a $1 billion valuation–only five percent of entrepreneurs agreed, while nearly 25 percent of VCs did.  Likely companies agreed by both  groups were free EHR Practice Fusion, employer health management platform Castlight Health and doctor appointment setter ZocDoc in the top three, with AirStrip, TelaDoc and FitBit just behind. ‘Big data’ (whatever that is) equals big investment, but they split on where the rest of the funding goes: VCs liked insurance exchange/benefit selection, care coordination and clinical decisions; entrepreneurs preferred telehealth and mobile diagnostics.  Investors are from Mars. Entrepreneurs are from Venus (plus charts in The Health Care Blog) When will we see more billion-dollar health tech companies? (Gigaom)

Safety, fast (US)

[grow_thumb image=”” thumb_width=”150″ /]What, no OnStar? Plug Splitsecnd into the cigarette lighter (or utility outlet) of your MG, 1938 Buick or 2013 VW Beetle, and if you have a serious collision, the M2M back end uploads the car’s location, alerts a response call center and establishes two-way voice contact. Have a problem–health or otherwise–in the car? Push the ‘help’ button and get in touch. Is your daughter reenacting ‘Corvette Summer’? The Family Finder feature maps her location online or on smartphone. Available in US only, $199 with $14.99 monthly fee, online sales only at present. The two developers started working on Splitsecnd while at Vanderbilt University, and the company accelerated at Nashville’s JumpStart Foundry. Splitsecnd calls for help when you can’t in a car crash (VentureBeat)

WebMD goes mobile, at last, with Qualcomm

Timed for the HIMSS annual conference kickoff today in New Orleans, health information giant WebMD announced a collaboration with Qualcomm Life’s 2Net platform to integrate mobile device data for consumers with WebMD’s information resources. The press release phrases buzz and buzz:  “drive mass adoption of a quantified-self environment” (yes), “apps, devices and tools… to better understand and manage their health”, “connected, automated and seamless data collection experience”, “first-in-class health channels to enhance our multi-screen experiences.”  But given WebMD’s sinking relevance as the go-to place for consumer and provider health information,  and its PHR (which may or may not be included with this) under fire for patent infringement by MMRGlobal [TA 20 Feb], is all this added “context and insight” too little, too late? (Even with Eric Topol, MD now Editor in Chief of WebMD’s Medscape)  WebMD/Qualcomm press releasemHIMSS

Practice Fusion EHR buys a ‘nudger’

Practice Fusion, a leading US EHR which is free to practices, bought predictive modeler 100Plus. Besides sharing a founder (Ryan Howard) and a focus on healthcare data, 100Plus uses individual data to ‘nudge’ (there’s that word again) people into healthier behaviors. The interest of Practice Fusion of course, is that it is awash in patient data–but HIPAA privacy regulations limit direct, identified use. 100Plus plans to stay safe by focusing on medication adherence and tools that doctors and patients can use together to encourage engagement. Forbes

What it takes to deliver sustainable global health: sustainable financing

The mHealth Alliance and consultant/research company VitalWave have published a globally-oriented study detailing what holds back mHealth from scaling up in low to middle-income countries, centering on financing. Hundreds of projects are in the field, but practically all are dependent on short-term financing or grants, and few have viable plans beyond the next grant. Projects also by their nature are stand-alone and don’t integrate in their design and delivery with other often similar projects. This study evaluates five financial models and transferring from external funding to a revenue stream from buyers. Case studies include VillageReach (maternal SMS/phone support), Switchboard (free calling network for health workers), Sproxil (drug verification), SMS for Life (SMS for anti-malarial drug distribution) and Changamka (affordable health care). Sustainable Financing for Mobile Health (42 pages)

Smart tech=dumber people?

[grow_thumb image=”” thumb_width=”220″ /]Is the real goal of ‘smart gadgets’ not to help solve our problems or keep us from harm, but to fix, per the Google paradigm, the “broken” place that is the real world and the bad behavior of fools like us? (For example, not recycling properly, having too much trash, eating too fast,  too much chocolate? Then tattling to our Facebook friends so they can chide us?) Evgeny Morozov, in this discomfiting Wall Street Journal article, cuts through the Silicon Valley hype around gadgets that marry cheap sensors, software and social networks to ‘nudge’ (that hateful word)/reward/shove us to the New Jerusalem of social engineering and some developer’s nannyish idea of ‘better behavior’. Yes, there are ‘good smart’ devices that help us make decisions, lifesaving tech such as gait sensors that monitor the elderly for propensity to fall, and breath analyzers that cut the car’s ignition when the driver’s had too much alcohol, but these are being drowned out in both the public consciousness and the VC wallet by shame-making trash cans and HapiForks. Rather than empowering us, it may be… Is Smart Making Us Dumb?

Another perfect example of condescension to the end user is observed in Google’s Sergey Brin’s recent remarks during his endless flogging of Google Glass, now just Glass. Now looking down at your smartphone is ’emasculating’ (interesting choice of words) because you are ‘walking around hunched up, looking down, rubbing a featureless piece of glass’ rather than interacting. Aside from the fact that you can put it away, and that Google’s made a fair amount of coin from Nexus smartphones and tablets, it’s obvious that Glass is meant to be worn ALL THE TIME, serving up whatever Google wants you to have ALL THE TIME. Surely the California TEDx folks raved at this maximum cool, but this Editor is skeptical that this world will be actually be better with all Google, all the time. In other words, enough. Google’s Sergey Brin rips smartphones, shows off Glass (Computerworld)

Rewiring the brain through electrical stimulation on the tongue

[grow_thumb image=”” thumb_width=”200″ /]We don’t think much about it, but the rich network of nerves (and musculature) on the human tongue is also a direct route to the brain.  Now the U.S. Army Medical Research and Materiel Command (USAMRMC), collaborating with the University of Wisconsin-Madison and the NeuroHabilitation Corporation is developing and testing the Portable NeuroModulation Stimulator, or PoNS, for treatment of brain injury and related disease: TBI, stroke, Parkinson’s and multiple sclerosis. The PoNS is an electrode-covered oral device which is used for 20-30 minutes of stimulation therapy, called cranial nerve non-invasive neuromodulation (CN-NiNM). Specific stimulation patterns are paired with physical, occupational, and cognitive exercises customized for each patient. Effectively it helps to rewire the brain’s neural pathways and mitigate damaged functioning. NeuroHabilitation will be commercializing it but the US Army is testing it at hospital and veterans’ facilities, and will be spearheading FDA approval. Three articles with different looks at this: the US Army website, Popular Science and GizMag.

Health apps finally get a certification body (US)

Happtique has now published the standards it will use to certify apps under what they have dubbed the Happtique Health App Certification Program (HACP). The published final guidelines include both the Certification Standards and associated Performance Requirements, which assess operability, privacy, security, and content. Happtique, a subsidiary of GNYHA Ventures, has also brought in initial HACP Partners to serve as subject matter experts for evaluating apps: the Association of American Medical Colleges (AAMC), CGFNS International, and Intertek. While Happtique is not yet ready to evaluate medical, health or fitness apps, companies can register for a submission form and be notified when the application portal is opened for submissions.

Fast Company: not quite as fast as TA

[grow_thumb image=”” thumb_width=”150″ /] The Gimlet Eye is not so much squinting at Fast Company’s 2013 ‘The World’s Top 10 Most Innovative Companies in Healthcare’ , but wondering what took them so long. Your diligent Editors picked up on some of these top innovators back in early days:

#1 Sproxil’s first mention here was March 2010; Editor Donna also interviewed Alden Zecha, CEO of Sproxil, at the Mobile Health Expo in Nov 2010

#4 Proteus was first mentioned here in September 2009 (back when the whole notion of tracking pills in the body was ‘creepy’)

#6 GE Healthcare–the laptop-portable Logiq scanner is all well and good, but The Eye wonders what happened to the portable handheld ultrasound Vscan, used heavily at the 2010 Winter Olympics?

#9 TelaDoc profiled by Editor Steve in June 2008 and (unhappily so with their press releases) in August 2008

Those which have escaped scrutiny, but should be in our scope, are #3 D-Rev and #5 Dexcom.

(Editors: Nobody’s perfect!)


PHRs, ‘meaningful use’ and patent infringement (US)

MMRGlobal CEO Robert Lorsch’s interview by HIStalk today is a fascinating follow-up to our recent stories in several areas. First is the story of how he came to found MMRGlobal, and how this personal health record (PHR) stores both electronic ‘hard copy’ and user-entered health history data which is generally accessible. It is a little different than Microsoft Health Vault or the late and unlamented Google Health, with access based on a 10-digit telephone number ‘lifeline’ and a subscription model. MMRG claims 750,000 members to date. While MMRG’s legal track record has raised quite a few health tech industry eyebrows almost to the hairline, your Editor has to admit their actions are quite different from your usual non-operating ‘patent troll’ which preys on vulnerable early-stage companies [TA 10 Feb].  MMRG’s big legal actions are to hook ‘big tunas’–Walgreens, WebMD–plus ‘investigations’ of the Australian and Singapore Governments, based on its seven US and international patents building up in their portfolio since 2005. They have also announced similar scrutiny of Microsoft and AARP for their projected joint PHR. [TA 10 Feb, 20 Feb]

But…there’s more. Mr. Lorsch proceeds to draw the proverbial line in the sand for hospitals and practices which intend to achieve Stage 2 Meaningful Use (MU) compliant EHRs this year into 2014. Stage 2 MU has at least five core measures that depend upon patient access, one of which requires a patient-facing portal that permits viewing, downloading and transmitting their own health information.  (Useful bite-sized explanation by Dr. Rowley at HITECH Answers.) MMRGlobal is taking the stance that they believe that any of these portals which store information, or are full PHRs, infringe on their patent portfolio:

If somebody complies with that Stage 2 Meaningful Use, we believe that they will infringe on one of seven patents that we have issued in the US Patent Office an additional patents that we have issued in 12 additional countries around the world. What we have done is we’ve gone to the hospitals, providers, vendors, laboratories, and we’ve said, “Look, if you’re going to comply with Stage 2 Meaningful Use or you’re going to offer products and services that enable healthcare professionals to meet Stage 2 Meaningful Use, they’re probably going to infringe on one of our patents.”

We’re suggesting that they license those patents at very reasonable license fees, such that whatever they decide to do to comply with Stage 2, Stage 3 Meaningful Use, they have a license – a safe harbor — that they’re grandfathered in, where they never have to be concerned about infringement on any of our patents or other intellectual property. If those same hospitals say, “Are there any other ways to address this?” they could also use our products — our MyMedicalRecords products, our professional products — which are embedded with licenses for the technology.

The interview then proceeds to the money points: how hospitals, especially non-profits, and associations can ‘reasonably’ (again) pay to MMRG (or negotiate on behalf of members) those licensing fees, or simply buy the MMRG PHR.

Which leaves this Editor with a question: these systems are supplied by major companies: Cerner, Epic, McKesson, GE. The hospitals and large practices are only system users, albeit with considerable user HIT customization. If the PHR is part of the Epic, Cerner (etc.) system, and the hospital buys the system, isn’t the true source of the patent infringement the supplier, not the end user? Or is this MMRGlobal’s strategy to avoid being a snack for some very large and aggressive sharks? It remains….fascinating. HIStalk Interviews Robert Lorsch, CEO, MMRGlobal  Hat tip to reader Vince Kuraitis via Twitter.  Also to be noted are the on-fire comments under the article which clarify many of the US patent issues, and possible defense strategies which hospitals and associations/groups may follow.

Update 28 Feb: The latest MMRGlobal pre-HIMSS press release announces ‘going mobile’ with their own wellness app, built with MyVitaLink (note that website indicates a restructuring) that ties into their PHR, and their collaboration with Alcatel-Lucent. Second graph puts mobile companies on infringement notice.


Aetna introduces Healthagen brand for health tech, ACO businesses

US health insurer Aetna announced Friday a new business unit under a name not used since 2011–Healthagen, the name of the company that developed the iTriage consumer symptom research/health provider locator app purchased by Aetna in December of that year. In the Healthagen division will be current units that were grouped under the less smartly named Aetna Emerging Business:  iTriage, ActiveHealth Management (population health management), Medicity (health information exchange), Practice iQ (to transition independent physician groups into value-based care models) and a slightly rebranded Accountable Care Solutions (ACS) from Aetna (large hospital systems, integrated delivery networks/IDN and hospital ACOs). The formal premiere will be at the HIMSS annual conference in New Orleans, 3-7 March, along with a new Healthagen website to follow. According to Aetna SVP Joseph Zubretsky, over $1 billion was invested to acquire and build the Healthagen businesses. New titles as well: Emerging Businesses CEO Charles E. Saunders, M.D., is now Healthagen CEO; in addition, Nancy Ham recently joined Medicity as CEO. As a ‘pointer to the future,’ it indicates that this insurer is willing to establish a separate brand and division that represents connecting, not siloing, services and tech that benefit both providers and consumers–and to keep the identity fairly, but not wholly, separate from Aetna. They also did not let a good coined name they own go to waste. Aetna press release

Related reading: Neil Versel in InformationWeekHealthcare

Bosch Healthcare, GreatCall strategically partner (US/Canada)

Last week, Bosch Healthcare in the US announced a strategic partnership with GreatCall, best known for its Jitterbug simplified mobile phone/call plans and 5 Star mobile-based urgent response/PERS services targeted to the senior consumer. The joint offering is to be rolled out later this year (Bosch/GreatCall release). Bosch’s mobile moves should come as no surprise to our readers, who learned late last fall that Bosch had developed a similar mobile strategic partnership with Doro, the GreatCall of Europe, for Germany and Switzerland initially [TA 16 Nov 12].  Bosch US also added a partner last fall in the hot area of medication compliance, MedMinder, whose Maya mobile-based medication reminder system is integratable with Bosch’s in-home Health Buddy and their T400 clinical Telehealth System [TA 26 Oct 12].  You could say that this indicates that Bosch is ‘mobilizing’ its monitoring into consumer-friendly platforms both in North America and Europe.

Update 27 Feb: David Doherty pointed out on his mHealth group on LinkedIn (members only) that judging by these moves, Bosch is positioning itself as a substantial ally to mobile companies seeking to add telehealth features, which has proved to be a sticky issue for the latter. (Editors’ note: if you are a LinkedIn member and not a member of David’s mHealth group, we recommend joining it for the topics and discussions.)

Related: On his mHealth Insight blog yesterday, David notes Doro’s survey indicating that 50% of over 65+ are interested in smartphones. As a result, Doro is introducing a featurephone that incorporates cloud-based smartphone features, along with an secure online control portal accessible by the user and authorized others. This contradicts the direction that mobile companies are taking here in the US:  the target market for smartphones ends at about 45, so load up those smartphones with complexity, incomprehensible apps (‘cool stuff’) and expensive plans.  If applicable to the increasingly saturated US market, there’s an opportunity to open up the market by taking down barriers–phone, plan cost, visibility and ease of use, adding off-phone control access. Is this a message for GreatCall?  

EHR backlash brewing. But one day, you’ll mine the data

On Twitter, there’s a new hashtag: #EHRbacklash  No, this Editor did not invent it (it would have been #EHRmisery), but after writing about it since November, it seems like the zeitgeist is turning, or EHRs are sliding down the Gartner hype curve….This Government Health IT article quotes managing partner Doug Brown of the Black Book Rankings research organization as stating “meaningful use incentives created an artificial market for dozens of immature EHR products” and that 31% of 17,000 EHR users surveyed would consider switching. (The actual number of practice EHRs is hundreds–respected consultants in the field have estimated about 600, and the rate of switching 50%. Adding to the problem is that many of these EHRs are offshoots of offshore IT companies, which makes customer service spotty at best. Ratings and certifications? Near meaningless.) Federal standards for ‘Meaningful Use’ fade into the distance as interoperability doesn’t seem to be baked into the EHR business model–not with hundreds of  practice EHRs fighting for miniscule share. Also HealthcareITNews.

Related articles: Confusion, consolidation and collapseMore EHR misery: EHR payment cutoff, data breachRevealed: Hospital EHRs lobbied for stimulus funding

But no worries, at one point the mining of data–the analysis of ‘big data’ generated on patients–will come from those same EHRs. Privacy concerns of course but this data can be invaluable for research: quick clinical feedback, comparative effectiveness, clinical trials, epidemiology, social acceptance of medication and similar. John Sharp in iHealthBeat reviews Electronic Health Record Data Mining — Is It a Dirty Word?