Following on their October heads-up on AirStrip Technologies working with Toronto-based Diversinet on security relating to AirStrip’s use with the US government, the two have formally announced a licensing agreement where Diversinet’s mobiSecure SDK platform will be used for secure messaging in AirStrip’s mHealth application suite. This enables AirStrip military, government and commercial customers to comply with Federal security requirements. Diversinet recently received the FIPS 140-2 validation for their cryptographic technology underpinning their MobiSecure platform which is required for US and Canada government use [TA 18 Oct]. Earlier this month, they announced the mobiHealth Wallet, which allows patients to create unique health profiles and configure/integrate data from compatible apps. Diversinet/AirStrip release mobiHealth Wallet release

Editor Donna’s note: Non-US readers will note the reference in the mobiHealth Wallet release to the Federal ‘Blue Button Initiative’ which, in plain language, simply enables users of personal health records (PHRs) to download their health information as an ASCII text file. Various Federal entities such as the VA, Department of Defense and CMS have all signed on. Our friend The Gimlet Eye is ‘barrel rolling’ at this bit of jargon which is, in certain quarters, being tossed around with insider abandon. And it comes complete with cute logo!

The European Commission last week issued a plan of action to address barriers preventing the full use of digital solutions in Europe. Measures covered by the plan include:

• clarifying areas of legal uncertainty
• improving interoperability between systems
• increasing awareness and skills among patients and healthcare professionals
• putting patients at the centre with initiatives related to personal health management and supporting research into personalised medicine
• ensuring free legal advice for start-up eHealth businesses [Editor’s emphasis]

The Commission has also pledged to issue a mHealth (Mobile Health) Green Paper by 2014 addressing quality and transparency issues. EU issues action plan for digital healthcare InnovateUK

A new survey by Philips reveals that one in four Americans trust mobile health resources as much as their own doctor…one in ten participants believed that without web-based health resources, they might already be dead or severely incapacitated. One in three participants believes that monitoring their health through mobile technology is the key to a long and healthy life…The implications of this information are far-reaching. Patients may not believe that their symptoms are worth the hassle of seeing their physician, and serious conditions may go undiagnosed. One quarter of Americans trust mHealth apps as much as their doctor EHR Intelligence item. Philips press release.

The much touted HIMTA (Healthcare Innovation and Marketplace Technologies Act, H.R. Bill 6626) as introduced by Silicon Valley’s Representative Mike Honda, if passed would establish an Office of Wireless Health at the FDA for starters. Then it adds layers, like cake: establish specific mhealth software responsibilities for the Health Information Technology Research Center (new?), ‘Challenge Grants’ and prizes for IT developers, an HHS department supporting mHealth developers on designing in line with privacy regulations, workforce retraining, provider loans and tax incentives. The intent is spelled out in the HealthWorks Collective article–Rep. Honda’s public statement is that it would only seek to clarify current regulations, especially privacy, for mHealth developers and reduce barriers to entry, but read to the bottom which then states the intent is to reshape the mHealth industry. Also see Rep. Honda’s press release.

In Editor Donna’s view, it only serves to add another gaggle of chefs in the mHealth government kitchen, which is already packed with FDA, FCC, HHS and NIH elbowing for burners and oven space.

But…there’s more. The FCC just announced their search for a new Health Care Director to head up their initiatives, involving a lot more than sorting out spectrum policy. There’s delicate maneuvering between more working groups with initials than pumpkin or mince pies at Christmas Eve dinner. There’s doling out the ‘Health Care Connect Fund’ for broadbanding providers including a pilot in SNFs (skilled nursing facilities a/k/a nursing homes), etc. But nothing about better, longer studies that might prove things like ROI and better outcomes necessary to gain adoption in the far bigger, wider private market.

Conclusion: The only companies which will be able to advantageously sort out this tangle are those with batteries of lawyers on call, thus putting paid to Rep. Honda’s stated objective of encouraging startups. The only small saving grace is that H.R. 6626 was introduced in a Congress that is ending in three weeks (thus will die and presumably be reborn next year). And there are far higher ‘cliffs’ that need climbing…out of.

Related: Speaking of cliffs, David Lee Scher, MD approaches the one with the HEALTHCARE sign, looks over the edge, and sees a pile of money tossed over it willy-nilly. The healthcare cliff.

The United States will look to Africa to gain knowledge about advances in mobile health technologies…While it’s still the early days of mHealth and the digital revolution, “we will see huge breakthroughs in Africa and South Asia,” said Jeffrey Sachs, director of the Earth Institute at Columbia University, speaking at a Monday afternoon mHealth Summit ‘Super Session’ on global implications for mHealth technologies. Africa’s mHealth breakthroughs to pave way for U.S. GovernmentHealthIT.

Or maybe it won’t… Why Nigeria Needs a National eHealth Strategy AllAfrica.

Earlier this week, Editor Donna, in reviewing David Shaywitz’ Forbes ‘2013 awards’ article on the top book for 2012, noted that disease management (and telehealth overall) has had difficulty with determining traditional ROI. Our long-time readers might remember this editor’s lamentations on the lack of large N studies done over extended periods–the studies which are hard to finance, justify and conduct objectively, especially by early-stage companies struggling to survive. Mr. Shaywitz has graciously commented on our article here noting the ‘outsized claims’ that many programs make, and the difficulty in actually calculating valid ROI not only for health but also wellness outcomes. A further whacking on the same subject was given at the close of the 2012 mHealth Summit by Francis Collins, MD, PhD, the National Institute of Health’s (NIH) director. NIH has only conducted 20 randomized trials of mHealth, and less than half documented any clear evidence of improvement. Despite his own personal commitment (he was a test subject for AliveCor‘s heart monitor), he correctly chides us that ‘the plural of anecdotes is not data.’ Companies, the scientific/academic and healthcare ‘communities’ need to work faster. Here’s his suggestion: a national research network of millions of people, linked through electronic medical records platforms, which would create a database of real-time data. The EMR linkage is ambitious–and probably not workable due to HIPAA privacy regulations–but Ed. Donna has two additional suggestions: incentivize people to do it through a small stipend, like mystery shopping–or use crowdfunding tools to enlist subjects. NIH’s Collins says mHealth needs evidence, not anecdotes (mHIMSS)

David Shaywitz, co-founder of the Boston-based Center for Assessment Technology and Continuous Health (CATCH) and advocate for humanism in digital health [TA 6 Nov], surprises in his Forbes picks for digital health company, person and book of 2012. First, the company: the EHR that dominates large hospital systems, Epic. Why? It may be awful and the bane of M.D.s, but the hospital system gets basic connectivity that chains together the bits, in a proprietary way, delivered with ‘flawless implementation’–the kind of customer services that holds every hand in MIS and HIT until the boo-boo is better. In other words, they delight the buyer. (Your marketing lesson for today.) Second, for person, none other than The Gimlet Eye’s circular bête noire Vinod Khosla. Shaywitz is this-n-that about the man, believing Khosla underestimates the human factors in medicine while agreeing with him on how behind healthcare is in capturing and using basic data, much less integrating more advanced data produced by monitoring. Editor Donna and the Eye take a dimmer view, believing that much of Khosla’s ‘disruption’ is to gain notice for (OK, hype) his investments such as AliveCor’s iPhone case heart monitor (just receiving FDA Class II clearance), cellphone microscope Cellscope and data collection/platforming Ginger.io (leading $6.5 MM in series A funding). Finally, Shaywitz’s pick for book of the year is”Why Nobody Believes The Numbers,” by Al Lewis. Disease management takes longer, saves less, has difficulty in achieving any ROI but can work out best for the patient in the long run, if we ever get there. But didn’t we know that already? Forbes article

Related: Khosla vs. Kvedar at the mHealth Summit. From Khosla, the usual ‘80% of healthcare can be delivered without doctors’, ‘50% of doctors are below average’ and most Americans today understand health information at a fifth grade level (so much for everyone being Quantified Selfers!). Kvedar argues the same points from ‘60% of healthcare costs are labor’ and that computers are better than humans at algorithmic tasks. Not much of a debate here as Khosla gets 80% of the article lineage. mHIMSS

Based on reports coming in, the mHealth Summit this week in Washington D.C. had a greater focus on the US and patient engagement than the past two years, which emphasized governmental programs and non-profit NGOs, but with a twist–insurers are moving upfront in the picture. From Aetna‘s CEO Mark Bertolini keynoting and promoting their iTriage management app to the announcement of the open CarePass mobile platform that organizes 20 smartphone apps that help consumers manage their health and fitness, UnitedHealthcare Group‘s similar OptumizeMe and even AT&T insisting it’s a payer (self-insured), the rationale is better health for consumers, better care quality–but most of all reduction of that ‘$750 billion in waste’ that exists in the current system. Here’s select early coverage to get you started. Consumers will engage if mHealth is easy, Bertolini says (mHIMSS); Mobile tools help public, private payers be more proactive, Healthcare cathedrals and the consumer health bazaar (Mobihealthnews)

Update 7 Dec: David Lee Scher, M.D., well-known US consultant and former cardiologist, outlines five reasons why payers will be playing a major role in mHealth adoption (Ed. Donna comments): they hold the purse strings (very true), they can change physician behavior (ditto), they realize importance of patient engagement (uneven), they are the largest users of patient portals (of a limited type) and can perform clinical studies (they can, but not credible without academic involvement).  Why payers are critical to mHealth adoption (mHIMSS)

Neil Versel argues that Editor Donna’s question may very well be an understatement. To those of us in the technology community, the ‘button’ is a relic of an earlier time (and in the US, a reminder of an inadvertently funny ‘schlock shock’ commercial of the late ’70s). Starting in 2005, behavioral telecare elevated standards of safety (QuietCare then HealthSense, GrandCare, WellAWARE, etc.), and then fall detectors, telehealth-based care management and countless mHealth apps further raised the bar. The technology parade has passed PERS by. But to the implementers, the carers and community executives, the plain-jane PERS alert button remains a mainstay of senior housing on both sides of the Atlantic at least. Not that there are not abundant real-world alternatives. Yet more advanced ‘passive PERS’ with a fall detecting accelerometer built in (Philips Auto-Alert, Aerotel GeoSkeeper, AFrame Digital) and behavioral telecare, despite proving greater safety and proactive care metrics, are still in a low stage of adoption. But as Versel points out, PERS can no longer be considered the standard of adequate care, whether at home or in a facility–and moreover, provides little more than the false assurance of safety with the potential of a high, final and unconscionable human cost. Panic buttons for seniors must go (Mobihealthnews)  

Update 7 Dec: Editor Steve, in his comments under the article, makes two points: self-reporting safety confirmations (response to automated calls and similar systems) adds another security layer for older people and disabled living alone; current accelerometer-based fall detectors often miss ‘soft’ or gradual falls, especially to the seated or slumped position 

Also from Ed. Steve, continuing research in behavioral telecare’s quantification of the early detection of illness is being done by the University of Missouri at two locations in Missouri and Iowa. They are using Microsoft Kinect for gait assessment, which can predict propensity to fall, and are receiving NSF and other Federal funding for this (limited) ongoing research. Originally covered by us back in July [TA 3 July] and updated in this article from (UK) HealthCanal: Sensor Network to Protect the Elderly

mHealth is perceived as having the potential to be effective in changing behavior which will be effective in controlling chronic diseases such as diabetes, according to the mobile trade group GSMA in their latest white paper. The lead finding in this global study is that “89% of practitioners, 75% of patients and 73% of consumers believe that mHealth solutions can convey significant benefits.” While the finding may sound like the ‘perception is reality’ early-hype curve stuff, it’s being backed up by studies like the Clinical Therapeutics study earlier this year on how text (SMS) reminders significantly improved diabetics’ medication adherence and the just-published text4baby study of 90 women in a Fairfax County, Virginia Health Department program. Attitudes and behavior were measured among a primarily Hispanic new mother group, and text4baby had a significant effect on increased agreement with the attitude statement “I am prepared to be a new mother” and increased negative attitudes concerning alcohol consumption. GSMA: mHealth perceived globally as effective, Study: text4baby effectively helps new moms (FierceMobileHealthcare)

November was a busy month for the 3millionlives (3ML) team, as reported in their November newsletter (PDF). They have also released a video, below. (7½ minutes) The video contains interviews with doctors, patients and a nurse. It was made to be shown at the Making Sense of Commissioning conference held on 27 November 2012 at the Royal College of General Practitioners, London, which may explain the focus on telehealth and the absence of any references to the contribution telecare technologies can play in supporting people at home.

3ML is also showing up alongside the Digital First initiative as one of six ‘high impact innovations’ on the NHS innovation website. Coverage of the Digital First launch seems to have confused many commentators. Not just the UK press, but in the US too, e.g. FierceHealthIT: U.K. telehealth model, smartphone prescribing unlikely to take hold in U.S. mHiMSS: Adoption of mHealth technologies: UK vs. USA.