In Big Genomics, preventing unwanted hacking and identification of individuals

click to enlargeTwo 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

click to enlargeMedisafe, 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

click to enlargeKnock 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

click to enlargeToronto, 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…)

New telehealth investment in Wales

The Welsh Government is to invest £250,000 in expanding telehealth services in rural parts of the country, it has been announced click to enlargetoday. 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

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

Dartmouth-Hitchcock Medical Center has announced it will withdraw click to enlargefrom 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?

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.

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

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’?

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.