Tech that enables disabled to use…tech

October 30, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/tecla-shield-side.png” thumb_width=”150″ /]Toronto, Canada-based Komodo Open Lab has developed an assistive technology, Tecla Shield, that enables the upper-body disabled to use smart devices (smartphones, tablets, PCs) and other technology (home automation). It is battery powered and is a DOS that works with all assistive switches on the market (e.g. buttons, sip-and-puff controllers and head arrays), and is portable so it can be used in the home, in a wheelchair or other settings. The cost is moderate from C$ 349 and also couples with other Tecla kits. Springwise  Hat tip to our former Northern Ireland Editor Toni Bunting

Theranos/FDA update: nanotainers are ‘uncleared medical devices’

October 29, 2015 | by

And the battering of their USP continues. On the heels of Walgreens Boots Alliance (which this week proposed a merger with #3 Rite Aid to create the largest by location US drugstore chain) putting a screeching halt on expanding its 41 Theranos testing locations, the FDA has told Theranos that its nanotainers are actually ‘uncleared medical devices’ which further violate because they are being shipped over state lines. The company was also scored on handling complaints poorly, keeping poor records and failing to conduct quality audits including on the manufacture of the nanotainers. These were revealed on redacted FDA Form 483s filed as a result of a month-long inspection ending in mid-September, which were published per a Freedom of Information Act (FOIA) request. According to MedCityNews, the nanotainers were mistakenly classified as Class I and not II. Fortune quotes one of the reports: “The design was not validated under actual or simulated use conditions,” (more…)

New telehealth investment in Wales

October 29, 2015 | by

The Welsh Government is to invest £250,000 in expanding telehealth services in rural parts of the country, it has been announced [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/Welsh-Goverment.jpg” thumb_width=”150″ /]today. This is part of a £10 million investment that was announced in January to improve efficiency in the Welsh NHS.

Information available indicates that this telehealth investment is primarily in imaging technology enabling specialists in distant centres to access X-ray and other images taken at rural health facilities closer to the patients.

The press release from the Welsh Government quotes the Health Minister Professor Mark Drakeford as saying “Telehealth already means orthopaedic specialists in Abergavenny can look at X-rays from Brecon to avoid unnecessary travel for patients. This investment will take stock of all practices which use telehealth across NHS Wales (more…)

Paradox: increased digital health access doesn’t impact underserved

October 27, 2015 | by

An extensive online patient portal designed for a group of 2,800 kidney disease patients in western Pennsylvania remained unused by over 60 percent of the patients. The study by a team led by Vanderbilt University examined usage of features, impact on health factors and demographics over two years in four university-affiliated nephrology offices. Of the 40 percent who used the portal, the most used (80 percent +) were (in order) the ability to look at lab results, review their medical history and schedule or change appointments, followed by reviewing medications and obtaining prescription refills. Instead of narrowing disparity, it seemed to increase it, benefiting more upscale patients, who were likely to be white, married, young, on private insurance and with a higher neighborhood median household income. Non-users were more likely to be black, enrolled in Medicaid or Medicare, lower-income, older and unmarried. This latter group is also disproportionately impacted by chronic kidney disease. Results correspond to earlier studies on other chronic diseases like diabetes.

Most disappointing to the study authors is that participants did learn about the portal through fliers and pamphlets provided at the clinics, but weren’t trained on how to sign up or use the portal–a major gap. Other gaps pointed out were digital literacy, online access, privacy/security concerns, PC versus smartphone usage, online usage skills and not knowing preferences, for instance text messaging or delivering online information in a simplified mobile friendly format. Clinical Journal of the American Society of Nephrology, iHealthBeat, NPR.

Dartmouth-Hitchcock withdraws from Pioneer ACO

October 23, 2015 | by

Dartmouth-Hitchcock Medical Center has announced it will withdraw [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/Dartmouth-Hitchcock-MC.jpg” thumb_width=”150″ /]from the Pioneer ACO program after losing more that $3M over the past two years.

The Pioneer Accountable Care Organization (ACO) Model was designed by the Center for Medicaid and Medicare Services (CMS) Innovation Center to encourage the development of ACOs which are groups of healthcare organizations and providers (e.g. doctors) that work together to provide care for their patients at a lower cost to Medicare while maintaining (more…)

FDA’s ‘ossification tango’ side 2: what’s the social cost?

October 23, 2015 | by | 1 Comment

Catching up in the back file of articles is another in Bradley Merrill Thompson’s (Epstein Becker Green) series in Mobihealthnews on how the FDA is biased, by its very structure, against novel healthcare technology even if low risk. He further reflects on what’s truly novel, and what’s not. ‘Novel’ means Class III clearance and potentially millions of dollars. to gain it. He reckons that 80 percent of new digital health technology doesn’t qualify as ‘new’ in a regulatory sense–it may be ingenious in transferring the color reading of a test strip to, for instance, a smartphone and an analytic back end. All the new technology has to do is to demonstrate equivalence to the clunky traditional test–in other words, incremental improvement. What he’s worried about is the 20 percent that don’t fit any FDA classification, in particular software that automates what professionals do, repurposing non-healthcare technology for healthcare use (e.g. videogames for ADHD) or algorithms that automate what’s been done manually through a different method. The social cost is that the most in need, who would benefit from novel health tech that cuts cost and improves quality for individuals and populations (that old Triple Aim), will forever be blocked from having it by regulation. “We need a new paradigm where new technology is quickly evaluated for potential risk, and placed promptly into an appropriate regulatory category.”

There are certainly regulatory parallels ex-US. Much more here to ponder for your Weekend Reading.

Previously and related by Mr Thompson: Avoiding the FDA health IT-medical device regulatory trap for general IT companies, FDA, new technology approval and the Ossification Tango

23andMe returns to direct-to-consumer genetic testing marketing

October 23, 2015 | by

Nearly two years after the FDA shut the door on 23andMe‘s direct marketing of genetic testing, it is now back in the market with FDA clearance. The new Personal Genome Service (PGS) now meets FDA standards–and is now $199 where it was previously $99. It is as before a saliva-based test that in about two months, provides that person with an online report. There are multiple types, for instance the carrier status test on 36 inherited conditions, including cystic fibrosis and sickle cell anemia. The company is also bolstered by closing a $115 million round this month and in January a partnership with Pfizer to sell the company its Research Portal aggregated, anonymized data. Earlier this year, FDA cleared in Class II their Bloom Syndrome test [TTA 20 Feb] and late last year resumed DTC test marketing in the UK. Mobihealthnews also includes a helpful timeline of 23andMe’s troubles and recovery.

Does current digital health meet baby boomers needs and wants?

October 23, 2015 | by | 1 Comment

The answer, according to health tech industry analyst Laurie Orlov (Aging in Place Tech Watch, Boomer Health Tech Watch) is…not really. Despite its massive size (76 million in the US), spending power (by 2017, 70 percent of US disposable income), breadth (1946-64) and need (despite living longer, by 2030 37 million will be managing more than one chronic condition), most health apps, especially fitness apps, don’t resonate with boomers despite over 50 percent having smartphones. The reasons are many–they’re complicated, often hard to follow, view, and abandonment across all ages is still high. Even among Fitbit purchasers, abandonment is fully one-half. As income decreases, smartphone access also becomes a cuttable budget item. Much more in this paper published by the California Healthcare Foundation.

Blood is drawn: Theranos responds vigorously to TTA re WSJ

October 22, 2015 | by

From his very first interactions with Theranos, the reporter made abundantly clear that he considered Theranos to be a target to be taken down, and not simply the subject of an objective news story. The articles that appeared last week are the inevitable product of that approach.–Theranos Facts, 22 Oct

Breaking news. Blood is drawn. A spokesperson for Theranos (from FTI Consulting), Ms Shea Maney, has responded directly to this Editor regarding the content of the Wall Street Journal article, previously covered here (The $9 billion question mark) along with followup in primarily Fortune but also commentary in the Health Care Blog. Her note to me (which undoubtedly has gone to other press) is reprinted below in its entirety, save the standard closing line:

We read your coverage of Theranos with interest, and noticed you were particularly interested in accuracy and our finger-stick tests, among other themes. There have been a lot of inaccuracies in the coverage of these topics, which is why we have posted detailed information on our technology, accuracy, and conversations with The Wall Street Journal on our website: https://www.theranos.com/news/posts/custom/theranos-facts

On accuracy: Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve. We are confident in the reliability of our tests, because we have validated their accuracy. (more…)

‘Neuroprosthetic’ in development to ‘Restore Active Memory’ for PTSD, TBI

October 22, 2015 | by

The continuing work in PTSD and TBI of the Defense Advanced Research Projects Agency, better known as DARPA, is developing on two tracks. The first is memory manipulation for those with PTSD–altering how a memory is formed. An international team is already investigating optogenetics, a biological technique that uses a light tool (AS-PaRac1–Activated Synapse Targeting Photoactivatable Rac1) to change procedural (action) memories, which are located in specific parts of the brain. The other is restoring memory–developing a neuroprosthetic that fills in the gaps for those with TBI, which affects declarative (factual) memory–storing and retrieving. Two universities, UCLA and Pennsylvania, have received grants up to $22 million over four years for research on an implantable neuroprosthetic. UCLA’s approach is to focus on the entorhinal area of the brain which researchers previously demonstrated could be stimulated and with the hippocampus is involved in learning and memory. Initial research is testing brain electrodes for epilepsy and to develop a computational model of the hippocampal-entorhinal system. Medtronic is using those models and as the newest partner, evaluating a novel neural stimulation and monitoring system to restore brain memory function. A true neuroprosthetic–consider an assistance chip on or near the brain–is years away. In the meantime, HDIAC Spotlight, DARPA (from 2014) and Executive.gov on the program in 2015.

Have you signed up recently for our Alerts emails?

October 20, 2015 | by

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Primary care ‘virtual health’ could save $10 billion annually: Accenture study

October 20, 2015 | by

A newly-released Accenture study on US primary care estimates that savings of about $10 billion per year in US primary care could be achieved through use of ‘virtual health’, defined as “digital tools such as biometric devices, analytic diagnostic engine and a virtual medical assistant” that would allow much of the work of a typical office visit to be done prior to or separately from the visit, and follow up/check in tools such as video visits/telemedicine which would further offset costs. The cost savings were calculated by Accenture Insight Driven Health as a total of time-per-visit savings of five minutes–when aggregated, $7 billion, $300 million in telemedicine visits, telehealth self-management in diabetes alone $2 billion, health system savings $63 million. This could potentially solve the shortage of US PCPs now projected at 31,000 in the next ten years. Nary a mention of patient care savings, chronic care management or telecare for proactive behavioral home monitoring, however. Accenture release (BusinessWire), Accenture page and paper.

Will robotics lead to the ‘transcendent human’?

October 20, 2015 | by

Hugh Herr heads the biomechatronics research group at the MIT Media Lab, designing bionic limbs that emulate natural human limbs. In his presentation for DigitasLBi’s New FrontUK conference last week, he wants to go them one better: “We will design nature and change nature under our own power. In the future people will be wearing robots. You don’t need a missing leg to exploit this technology – we will give ourselves new bodies.” He can speak from personal experience, having lost both legs in a climbing accident 30 years ago and designing his own prosthetic BiOM legs to be more powerful and exceeding his previous rock climbing ability. “With technology I am released from these shackles of disability. We will end disability in this century.” The need here is huge, including exoskeletons as assistive devices; the consideration is cost. Marketing (UK) Magazine

Related: his 2014 TedX talk.

The Theranos Kerfuffle: a setback, but is it for the best? (updated)

October 20, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/question_mark.jpg” thumb_width=”120″ /]Some clarity emerges from the controversy around Theranos and last week’s Wall Street Journal exposé [TTA 16 Oct]. Last week’s rebuttal/denial released by the company said remarkably little, which disturbed Roger Parloff, the Fortune writer who profiled the company in June 2014’s high-profile cover story. He failed to reach CEO Elizabeth Holmes, who on her break from an all-day with the Harvard Medical School Board of Fellows, taped a segment with CNBC stock tout Jim Cramer (a questionable priority indeed–Ed.) Fortunately he received more specific answers via email from General Counsel Heather King. It clarifies among other things that venipuncture, not finger stick, is used in the majority of their tests in practice, and that dilution of samples is within industry practice for use in third-party analyzing machines. There also seem to be two sides to the proficiency-testing story. (Oddly, no mention of the sensational claims around British biochemist Ian Gibbons who was key to Theranos’ patent development and the alleged legal threats to his widow.)

For those who have difficulty getting through the WSJ paywall, Mr Parloff’s summary of the WSJ article’s main points is helpful. His conclusion: Theranos is wisely ‘dialing back’ its USP on drawing blood through finger stick to “Smaller samples. Smaller needles. Better experience.” (A neat pivot from what Theranos ‘made their bones’ on and still features–tiny finger-sticks.) His open-ended question (for, presumably, the next article): can it profitably run its low-cost testing business when it’s using the same analyzing machines as the big testing labs; and while cheaper, can doctors and patients trust the Theranos tests (which are a matter of health, and perhaps life and death) if they’ve flunked their first test at transparency?

Another view from Health 2.0 supremo Matthew Holt over at his Health Care Blog is that for Theranos, this blow is eminently recoverable if they play their cards right. Witness the recovery made by 23andMe, now in the good graces of FDA after having blown it badly to near-shutdown. (more…)

3 companies through to next stage in SBRI Telehealth/Telecare

October 19, 2015 | by

Three of the eleven companies through to the next stage of the NHS Small [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/SBRI-logo.jpg” thumb_width=”150″ /]Business Research Initiative (SBRI) are in the “Telehealth/Telecare for people with Learning Disabilities” category,  according to the latest news release on the SBRI website. Each will receive a further £1 million to continue with prototype development and product testing.

The three companies are Red Embedded, Maldaba and Cupris Health. The other companies going through to the next stage are BioSensors, Digital Creativity in Disability, Bering, Docobo, ADI, Folium Optics, Armourgel and MIRA Rehab.

SBRI Healthcare is an initiative from NHS England supporting a programme of competitions inviting companies to come forward with their ideas and new technologies for known NHS challenges.  In the last year, SBRI Healthcare has launched 10 new clinically-led competitions and awarded £22.4 million to 60 companies to develop products focused on specific NHS unmet need.

Read the full news release at SBRI Healthcare Funds Companies to Develop Game Changing Technologies.

Is Theranos a $9 billion question mark?

October 16, 2015 | by

Breaking News. According to an exposé published yesterday in The Wall Street Journal*, low-cost and fast growing small sample blood testing company Theranos [TTA 28 Aug] is not ‘doing what it says it does’. Four former employees allege that Theranos’ testing system, dubbed the Edison, which processes small finger-pricked blood samples collected in ‘nanotainers’, only handles a fraction of the tests claimed–19 out of 205. In a complaint to regulators, one Theranos employee accused the company of failing to report test results that raised questions about the precision of their proprietary Edison system–and that most of the tests were being run on traditional testing machines which required dilution of the tiny samples. The article reports on serious questions which have been raised on the accuracy of the Edison testing versus conventional testing, including the integrity of finger-pricked blood and sample dilution. Gaps in results were seen last year on tests for vitamin D, two thyroid hormones and prostate cancer, though Theranos has been reporting its tests to CMS in a process that all labs go through called proficiency testing, and has one test for herpes that has been FDA cleared.

In a follow up article, Theranos reportedly is no longer collecting nanotainers except for the FDA cleared herpes test.

Theranos is currently valued at $9 billion and has raised over $400 million in VC funding.

According to the first article, British biochemist Ian Gibbons, (more…)