mHealth: evidence, not anecdotes, needed

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)

Food allergies? Maybe iTube for you…

For those of us who have food allergies, or even sensitivities, any new food or prepared dish holds a level of risk, but current testing is bulky, lab-based and for professionals only. A new device may be able to simplify the testing process with similar sensitivity, broadening usage to restaurant, facility or home settings. UCLA’s Aydogan Ozcan and a research team has developed a much shorter testing process using an attachment to an iPhone that runs the same test that a lab would. As developed, it takes about 20 minutes to process the food into a test tube sample, which is then analyzed by the iTube attachment using its camera and a smartphone app that runs an allergen-concentration test known as a colorimetric assay. The team’s study was published in Lab on a Chip (abstract). Ozcan also recently developed the iPhone based LUCAS miniature microscope which can detect E.coli [TA 2 March]. Got Food Allergies? You Can Now Test Your Meal On the Spot Using a Cell Phone (Science Daily)

FDA announces Medical Device Innovation Consortium (US)

The US Food and Drug Administration (FDA) announced the formation of the Medical Device Innovation Consortium (MDIC) with LifeScience Alley (LSA), a Minnesota-based biomedical trade association. More exactly, the MDIC consists of the FDA’s Center for Devices and Radiological Health (CDRH) and the LSA. For FDA this is unusual–according to the release it is “the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.” LSA includes in its nearly 700 organization membership the Mayo Clinic, Medtronic, St. Jude Medical and University of Minnesota. While this is about biomedical devices, if successful in 1) creating a review model and 2) speeding up the process, it will definitely impact the relations that FDA has with the connected health area, or even expand to include it. (Now if we could also get the FCC into this streamlining….) But the Feds give with one hand and take away with another, with the ACA’s 2.3% excise tax on medical devices (all those implants and stents) starting in January and IRS final regulations now released. FDA release LSA/MDIC release CBS News article

Tunstall UK’s managing director elected to TSA Board (UK)

Simon Arnold, Tunstall’s UK & Ireland Managing Director has been elected [by whom?] to be the TSA Director to represent supply sector members. In the TSA press release Tunstall’s Managing Director joins TSA Board (PDF) Chief Executive Trevor Single says “We are delighted that Simon as MD of the industry’s largest technology solutions provider has joined the TSA board [sic] at this pivotal time…” And Simon says “I’m delighted to be elected to the TSA Board to represent the industry. This is such a pivotal time…”

We wonder what readers make of this strengthening of Tunstall’s presence within TSA?

Health Technology: Driving Innovation, Improving Patient Outcomes

London, Tuesday 26th Feb 2013

Will provide delegates with insights on how technology can transform the NHS, their organisation and lead to better patient outcomes. Delegates will learn about the role of technology in the changing NHS landscape. There are some ‘limited discounted rates’ of £275+VAT per public sector delegate and £445+VAT per private sector if you contact organiser Paul Tyreman directly, by email or phone: + 44 (0) 161 200 8625 . Website for details.

‘Right meds at right time’ dispenser

Pre-filled multi-day medication boxes (versus large dispensers meant for an external service area) are becoming increasingly common both in the community and individual home setting, but there is always the risk of an individual’s confusion in taking more than one day’s dose, or the medications all at once versus at the right time. MedMinder’s Jon model, a new seven-day wireless M2M dispenser, can be controlled by the caregiver through their monitoring website to let the individual access only the correct compartment and also at the correct dosage time. It has reminders (beeps, phone calls, emails or text messages) and notes when the compartments have been accessed, similar to its existing Maya model. Their website feature page has a brochure link, but it is for the Maya, not the Jon, model. Editor Donna also finds interesting their payment model of no upfront cost and a monthly fee. (Note to MedMinder’s marketers/general counsel: ‘medminder’ is becoming a generic term for dispensers–the MedMinder team is well advised to register their trade name.) Website release (mind the typos)  Also noted is that Bosch is using MedMinder with its HealthBuddy and T400 programs. 

AskSARA goes mobile

It is a long time (March 2009 and September 2011) since we drew attention to the UK Disabled Living Foundation’s brilliant AskSARA ‘self-assessment’ and recommendation system which contains much useful advice and links to specific items of equipment for older and disabled people. It includes a telecare-related section and could be a good starting point for professionals who lack specific telecare training and who are asked to recommend equipment. (The reports do come with warnings about getting appropriate ‘live’ help.)

However, now is a good time to point readers back to AskSARA because it has now started to give a better, app-like experience to users reaching the site from a smartphone. Users can now go through the self assessment easily without any horizontal scrolling or straining to see small text. The ensuing report is also clear and can be printed out or a link can be emailed for viewing on a larger screen device later. However, the telecare information is a little buried – one has to choose the ‘Daily Activities’ topic tab and then ‘Help in Emergencies’ to start the self assessment. Worth exploring, though.

3ML: Discussion of future of telehealth with GP critics (UK)

Last week the GP’s publication Pulse held a ’roundtable’ discussion session on the issues for GPs around telehealth. It was funded by the 3millionlives (3ML) team, commissioned by the Department of Health (DH) 3millionlives (3ML) programme, and editorially controlled by Pulse to a brief agreed with 3ML. The 3ML contingent was headed by Paul Hitchcock who is the NHS workstream lead for 3ML at DH.

If you are interested in telehealth it is worth reading for some snippets from Professor Stan Newman and the ever-sceptical GP Margaret McCartney, and for the indication of the direction for 3ML from Paul Hitchcock “From my perspective at the Department of Health, our immediate next step is much closer engagement with the GP community than we’ve achieved to date.” This looks like it was a reasonable start, but will Pulse articles become less negative about telehealth from now on? The future of telehealth in Pulse – free registration required. Heads-up thanks to Mike Clark.

A tattoo sensor to delight–or scare–kiddies

tattoosensor 1You’ll find the design of this prototype skin sensor out of University of California, San Diego either endearingly goofy or just scary. This paper ‘tattoo’ is actually a solid-contact ion-selective electrode (ISE) made using standard screen printing techniques finished with an electropolymerization process on commercially available transfer tattoo paper. The two ‘eyes’ are actually electrodes which measure perspiration on the skin’s surface to determine stress-related changes in pH and clues to metabolic diseases such as Addison’s, or more simply fatigue or dehydration. The tattoo sticks to even wet skin. It can also measure sodium, potassium and magnesium with different sensing materials. There’s great potential for this not only in sports, but also in assisted living and rehabs where one of the most serious conditions is gradual, invisible dehydration of residents. Tattoo-based medical sensor puts a happy face on detecting metabolic problems (GizMag) Happy face tattoo does serious work (University of Toronto release)

Some ‘awards’ for 2012 digital health

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 (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