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…)

Philips Healthcare partners with Amazon Web Services, adds more IoT

October 16, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/Philips_AWS-IoT-infographic.jpg” thumb_width=”200″ /]The once-quiet Philips is expanding its connectivity for HealthSuite through a partnership with Amazon‘s recently announced collaboration with Amazon Web Services (AWS). The objective in connecting through AWS is to expand to hundreds of million devices through a secure, stable IoT ‘device cloud’ that securely collects and analyzes data from apps (like the diabetes app in test with Radboud University, TTA 18 Sept), medical devices and EMRs/PHRs. The Philips HealthSuite Digital Platform is a product of Philips’ collaboration with Salesforce, and is also (for now) targeted to senior care for adults. Philips’ release and case studies are, unfortunately, buried in this very busy page. It’s another move for Philips that confirms their ‘Hospital to Home’ repositioning.

Tunstall’s security app for lone workers (Australia)

October 16, 2015 | by | 1 Comment
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/MyCareTrack.png” thumb_width=”150″ /]Tunstall Healthcare has released a smartphone app for the safety of ‘lone workers’ including community health nurses who, in Australia, may be traveling and working in isolation or at night. MyCareTrack is accessed by a lone worker with an individual ID, and provides check-in, check-out capability, activity reporting, GPS tracking and SOS emergency alerts. It leverages Tunstall’s existing 24-hour response centers for automatic check-up calls and SOS. We wonder if this will be marketed in other countries as, for instance, the US has many areas which are as isolated as Australia for health workers. Pulse + IT (Australia)

Telehealth in the ME – report from The Economist

October 14, 2015 | by

It is rare to hear about telehealth from the Middle East, so it is refreshing to see a report dedicated to this subject. [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/Enabling-Telehealth.jpg” thumb_width=”150″ /]”Enabling Telehealth: Lessons for the Gulf” is a new report from the Intelligence Unit of The Economist which identifies principles and practices relevant to the Gulf Cooperation
Council (GCC) region. GCC is a regional intergovernmental political and economic union consisting of all Arab states in the Persian Gulf except for Iraq – i.e. Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE.

The report has been commissioned by Philips and studies the environment in which telehealth operates – the policies, infrastructure, associated skills and institutional users. The Economist interviewed several experts for this report: the director of the Center for Connected Health Policy, associate Dean of the Mayo Clinic’s Center  for Connected Care, chief medical officer of the European Health Telematics Association, a senior lecturer in professional healthcare education at the Open University and CEO of the International Alliance of Patients’ Organisations.

As the report points out in its summary, “… access to telehealth depends not only on telehealth technology. Policy frameworks must be modernised, communications infrastructures such as broadband and mobile network coverage must be improved, and skillsets – both of clinicians and patients – need to be strengthened.

Five key findings in the report are

  • Ensuring access to telehealth depends not just on the technologies, but on the broader enabling environment, especially policy harmonisation, communications infrastructure, and skills.
  • Governments should consider more efficient licensing if telehealth is to enable patients to access medical expertise outside of their state, province or country. Here it cites the examples of USA and Europe. The state by state licensing in the US is a barrier to telehealth and the cross-state harmonisation in the EU helps telehealth.
  • Telehealth provision must go hand-in-hand with Internet infrastructure rollout, since vulnerable populations are the lowest users of the Internet.
  • Focus on systems integration: “… build usable systems with the requisite security and privacy” which “work seamlessly with those already in place”.
  • Health providers may need support in working with new technologiesThe full report is available to download here.

Still need some help with healthcare innovation? (UK)

October 14, 2015 | by

These days it seems you cannot get away from talk of innovation in the NHS – even the London Business School, this editor’s alma mater, is holding a conference on it, on 20th October. Then there’s the NHS Innovation Accelerator programme, the Accelerated Access Review (AAR), that this reviewer is involved with, the National Information Board (NIB), that this editor is also involved with, NHS Test Beds, the topic of a recent popular TTA blog, the NHS Vanguards, the NHS Pathfinders, the Integrated Care Pioneers and many others all seeking the holy grail of healthcare: improved patient outcomes, ideally at lower cost (or is that lower cost ideally with improved patient outcomes?).

If all this is too much and you have lost your way, the Royal Society of Medicine & NHS Innovations South West (NISW) have the solution: (more…)