HIMSS Connected Health Conference/mHealth Summit starts Sunday–save $100

Time is short! This Editor will be attending the HIMSS Connected Health Conference this November 8-11 in Washington, DC (actually outside The Puzzle Palace in National Harbor, Maryland). Telehealth & Telecare Aware has been a media partner (disclosure) since the 2009 mHealth Summit. Changes this year include that it is three conferences in one: the original mHealth Summit with the Global mHealth Forum, the new PopHealth Summit (concentrating on health improvement on the community, regional and national level) and the much needed new CyberSecurity Summit.

Attend all three for one registration, including a large Exposition floor and three pavilions for Population Health, Cybersecurity and Games for Health. Also, there are extra co-located and add on events, mainly on Sunday the 8th. The Global mHealth Forum focuses on mobile and connected health in low and middle income countries (LMICs) and is on Wednesday.

The Summit organizers have been kind enough to offer an excellent discount to our readers of $100. When registering, click on the advert (above, right hand side) and use the promotional code TELEHEALTH100 to receive it. (more…)

AdhereTech claims boost of 20 percent in med adherence

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/07/AdhereTech-pill-bottle-e1436497826583.jpg” thumb_width=”150″ /] Back in June at CEWeek this Editor viewed the newly redesigned, retro-looking AdhereTech medication bottle [TTA 10 July] and thought it a substantial step in appearance and feel in the hand above 1.0. It dispenses normally, lights are brighter, sounds are louder, it communicates wirelessly to track consumption and reminders, works internationally and has a three-time greater battery life.

Compliance is a huge US business with pharma companies baying at the moon for it as a raison D’être of digital health. AdhereTech is working with Cincinnati Children’s Hospital, Weill Cornell Medical Center, and Walter Reed Army Medical Center on clinical trials. AdhereTech’s studies now indicate that users get about a 20 percent lift in adherence versus a standard bottle, and 80 percent of patients given the option of using AdhereTech or a normal bottle opted into the smart bottle. Like Medisafe [TTA 30 Oct], their market is millions who have one or more chronic diseases, but they sub-target those who take more and more expensive medications which can justify this pill dispenser’s cost. Mobihealthnews, FT interview with team early last month

Wing: a device that warns prior to asthma attacks

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/wing-device-964×644.jpg” thumb_width=”150″ /]A St Louis, Missouri startup, Sparo Labs, has developed what they term an ‘early warning device’ for asthma attacks. The Wing pocket-size sensor which connects to a smartphone app (iPhone 5 and later, Android soon) measure both peak flow (how fast you can blow out air) and FEV1 (how much air you blow out in 1 second). The app measures it against personal levels (80-100 percent of best is fine, 50-80 percent is caution and below 50 percent is red zone) so that a person (or caregiver) receives an accurate reading of their breathing level; if something is wrong, the person can take their medication and/or seek assistance. For the 10 percent of Americans who have difficulty breathing, not just from asthma but living with COPD, cystic and pulmonary fibrosis, bronchitis and other respiratory conditions, the Wing’s compact design and under-$200 price point won’t leave them breathless. Wing is financing/testing on Indiegogo with a 20 Nov goal of $50,000 ($32,000 to date), awaiting 510(k) FDA clearance with an in-market date of August 2016. PSFK blog, Gizmag,Hat tip to Toni Bunting, our former N. Ireland Editor. 

Scottish Digital Health and Care Week

7-11 December, Strathclyde University’s Technology & Innovation Centre, Glasgow

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/digiweek15eps-_2.jpg” thumb_width=”120″ /]This year’s conference theme is “Using innovative technology to enable more integrated, sustainable & person-centered health and care”. It offers the opportunity to learn from across Scotland, the UK and beyond, with a mix of workshops and plenary sessions. Topics include the critical lessons learned when deploying technology enabled services at scale, drawing experiences from telecare, telehealth and eHealth; learning crucial lessons from the experience implementing the UK wide DALLAS programme. Delegates are encouraged to discuss current knowledge base on a range of topics; network with colleagues from across the relevant sectors; and actively consider application to their own practice. There are also multiple events during the week; more information at SCTT’s website. Registration. Hat tip to Mike Clark via Twitter

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

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 hereHat 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

[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

[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

[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

[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’

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

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?

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 companiesFDA, new technology approval and the Ossification Tango

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

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?

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

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

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.