Two US events: Health Wildcatters Pitch Day (Texas), mHealth Deep Dive (California)

November 3, 2015 | by

Health Wildcatters Pitch Day: 12 November, Majestic Theatre, Dallas Texas

This Texas accelerator will be presenting its 2015 class of 10 early stage companies in 10 days. Doors open at 2:30pm and the presentations are 3-5 pm. All attendees are cordially invited to the Pitch Day After Party which is a short two-block walk from the theatre at the Health Wildcatters office, 211 N. Ervay Street, 2nd floor. The $10 ticket cost is primarily to defray Eventbrite (having worked with them before!) as it is well-sponsored indeed. More information and registration here. Hat tip to Fiona Schlachter.

Deep Dive: Health/mHealth/eHealth: 8 December, 2825 Lafayette Street, Building 34 (EBC entrance), Santa Clara, California

Shrinking smart devices, sensors, cloud services, connectivity, and an aging population have all created tremendous changes in healthcare and fitness. This half-day deep dive meeting will discuss wireless and mobility solutions, as well as the fixed and fiber side that enables remote radiology and VR tele-surgery through robotic arms. If you are interested in the marriage of startup tech with the health and fitness industries, join in this discussion and networking. It probably pays to be a member as the non-member fee is steep. There are also ‘spotlight tables’ that are discounted 50 percent for pre-revenue startups. Sponsored by the Telecom Council of Silicon Valley. Information and registration. Hat tip to Editor Charles and Mike Clark.

In Big Genomics, preventing unwanted hacking and identification of individuals

October 31, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/Fotolia_41683185_S-Genomics.jpg” thumb_width=”150″ /]Two Stanford University researchers, through their own ‘hacking’, are making genomics research and data base usage more secure–and shutting the door on misuse of personal genome sequences which are now available through commercial saliva testing (23andme) and even through records on family research websites.

Genomic data sets have become more accessible to researchers through a network of servers, dubbed beacons, called The Beacon Project, organized by the National Institutes of Health (NIH)-funded Global Alliance for Genomics and Health. Genomics researchers are interested in looking for a particular genetic variant in a multitude of genomic databases. Using these beacons, when a researcher finds a gene of interest, they then can apply for more complete access to the data. They can find mutations and find other researchers working on the same one.

However, the risk is that some of this data is not sufficiently de-identified, and in the process of ‘pinging’ these beacons for genetic data, someone can create an unauthorized genomic profile of that person. For instance, a ‘nefarious user’ can find the match for an individual’s genome in a heart disease beacon, then can infer that the individual — or a relative of that person — likely has heart disease. (more…)

Med reminder app improves adherence 7-10 percent

October 30, 2015 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/Medisafe-IMS.jpg” thumb_width=”150″ /]Medisafe, a medication reminder app from Haifa, Israel with offices in Boston, partnered with IMS Health for a study of their app with a test group of 700 patients total with diabetes, hypertension and hyperlipidemia (high cholesterol). Over the study period–six months for hyperlipidemia and hypertension, three months for diabetes–adherence improved 10.7, 5.4 and 7.7 percent respectively versus a control group. The app was rated by IMS’ AppScript app curation team in a recent report as the highest-rated medication management app in terms of AppScript score. Medisafe also enables care collaboration among physicians, patients and families, and also provides personalized content. PR Newswire release. MedCityNews.

China’s Anthem hack: they just wanna understand US healthcare

October 30, 2015 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/02/gimlet-eye.jpg” thumb_width=”150″ /]Knock yersself out! The Gimlet Eye files via Bottle from A Dot On The Map off the New York coast. One of the stranger follow ups of the past week–one that is difficult to read with straight face–is the report in the Financial Times that the Chinese hacked into insurer Anthem’s 80-million strong beneficiary database in order to study up on the American healthcare system and benefit their aging population. Neil Versel with raised eyebrow in MedCityNews quoting the FT story: “The Chinese hackers had trained their sights on the U.S. health sector to help the country understand how other nations deal with medical care, people familiar with the Anthem investigation said.” You’d think it would be easier for the Chinese to go to a few conferences, meet a few executives and learn a few things first. Then maybe they could do a ‘deal deal’ with an insurer on their IP, or bring them into China on a JV. With so many services for sale from the thundering horde of data analytics companies and multiple middleware providers, write a check already. But that would destroy the Fun of Hacking!

How the FT could actually print without a hint of skepticism this ‘nothing to see here, move on’ story rolls the Eye. (more…)

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…)

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.

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.

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…)

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…)