FDA tells 23andMe genomic test to stop marketing (US)

November 27, 2013 | by | 2 Comments

Quantified Selfers and the D3H (Digital Health Hypester Horde) are in a swivet. This past Friday, FDA slammed the door shut on the 23andMe Personal Genome Service (PGS) saliva test. This past summer, the company broadly marketed to US consumers, including a TV campaign [Charles Lowe, TTA 7 Aug]. The FDA cease-and-desist letter cites that 23andMe never provided requested data on their July and September 510(k) filings, which are now ‘considered withdrawn’, and cites that “after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.” The danger is that people will make medical decisions based on the testing information and that the results produced may be faulty. It appears from FierceHealthcare that the kit has actually been marketed for five years. According to MedCityNews, it is backed by Google Ventures (the CEO/co-founder is the estranged wife of Google head Sergey Brin), New Enterprise Associates, MPM Capital and the Moscow billionaire Yuri Milner. A private citizen is petitioning the White House to overrule the FDA (as if that extra-legal move would be possible, but who knows with the influence of the Googlesphere?) and states that the agency ‘grossly overstates the risks’ (also MedCityNews). As of 2 Dec there are 3,306 signatures of the 100,000 needed; one suspects this administration has bigger slices of uncooked turkey on its plate such as Obamacare and a kind-of-achieved 30 Nov deadline on Healthcare.gov, which is now clearly seen as just one problem.

The 23andMe website is still fully up and still selling kits.

Editor Donna sorts through the noise for possible reasons why:  (more…)

Epocrates ‘Bugs + Drugs’ infectious disease app inaccurate, should be pulled: reviewer

November 27, 2013 | by

For clinicians who increasingly rely on major reference apps via smartphone and tablet, this sounds a loud cautionary note. This pharmacist’s detailed analysis of the errors and misinterpretation contained in the recently released and best-selling Epocrates reference app on the highly sensitive topic of infectious disease (including those that plague hospitals such as MRSA) culminates in a call to pull it from the Apple App Store. In several instances, the app pointed to the wrong antibiotic for an organism. The other faults are in using Athenahealth information to create what is called an antibiogram, “to identify what organisms are susceptible to what antibiotics in that locale”. The iMedicalApps analysis by Timothy Aungst, Pharm.D., professor at Massachusetts College of Pharmacy and Health Sciences has created quite a stir in the usual places. FierceMobileHealthcare covers this but decides to further blow up the balloon (or move off the point) in citing the IMS Institute for Healthcare Informatics and Journal of Cancer Education on the plain ineffectiveness and non-validation of the vast majority of healthcare apps–mainly consumer.

A fully loaded telehealthy clinic-on-wheels for rural medicine

November 27, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/11/wellcar-graphic3-588×379.jpg” thumb_width=”275″ /]The WellCar concept vehicle is mobile health on wheels. Based on a Ford Transit Connect wagon, this ongoing design project from the University of Kansas (KU) Center for Design Research incorporates technology practically in every corner to create a compact clinic that goes to patients rather than vice versa. The WellCar can be used by a nurse-practitioner team who can treat onsite, using onboard mobile telehealth devices sending to an EHR and virtual consult connectivity. A prototype is being constructed for test in 2014 to obtain National Institutes of Health and the National Science Foundation funding by fall 2014.  Partners include Ford, Abbott Point of Care, HealthSTATS, the National Nuclear Security Administration’s (NNSA) Kansas City Plant, Sprint (Wi-Fi), Voalté (telemedicine); KU Medical Center partners include the Diabetes Institute, Midwest Cancer Alliance and the Center for Telemedicine and Telehealth. According to MedCityNews, the WellCar is a reaction to ObamaCare in reducing readmissions, improving rural care and promoting telehealth/telemedicine–which is perhaps an overstatement. Also ‘Back to the Future’ (MedCityNews) and KU’s article. (Photo from MedCityNews)

Launches: MyHealthApps directory, mobile mental health app in Cambridgeshire

November 26, 2013 | by

MyHealthApps launches; Sun Network launches Crisis Card app for Cambridgeshire residents

Last year at this time, the PatientView patient research firm published The European Directory of Health Apps 2012-2013 with about 200 entries. Alex Wyke from PatientView has been kind enough to follow up and let us know as a comment on the original article [TTA 15 Nov 2012] that it has been expanded and relaunched as MyHealthApps. The site has grown to 307 apps selected by over 450 patient groups and with ‘heart’ ratings on a five-point system. While not comprehensive yet, notably it is now a truly international website with mirror sites in 48 languages from Albanian to Welsh, including four varieties of English (!) There are also submission links for patient groups and developers. PatientView developed this with support from: GSK, Janssen, Novo Nordisk, O2/Telefonica Europe, Vodafone Foundation, NHS England’s Library of Health Apps, UK government body KTN CONNECT and the European Commission’s Directorate General for Communications Networks, Content and Technology (DG CONNECT). The patient group review and backing (more…)

‘Green Houses’ for older adults receive $2.77 million backing (US)

November 23, 2013 | by

Our July profile on the innovative ‘Green Houses’ model for older adults as a designed-from-ground-up alternative to nursing homes mentioned the considerable support that the Robert Wood Johnson Foundation (RWJF) has given to the Green House Project with an initial 10-year, $10 million low-interest credit facility in 2011. RWJF has added a $2.77 million grant for a three-year acceleration of the model to include an updated financial model and a stronger marketing plan to create demand. All good things for this care model for high acuity residents. Grant on the RWJF website. MedCityNews.

Much ado about Airo: the denouement

November 23, 2013 | by

Like the Maltese Falcon, ‘the stuff that dreams are made of’?

The madly touted Airo fitness band, with its claimed mini-spectrometer built into the band to detect nutritional blood metabolites for passive sensing of food consumption [TTA 30 Oct], has, after a firestorm in the industry press, conceded it lacked proof that it would ‘work as advertised’ and refunded money to its early backers. Very rarely have we seen mass disparagement in health tech, but the fact that the developers ginned up a lot of breathless publicity over a device without a working prototype and no studies to back a future design made it all too easy. (more…)

Another House bill supporting telehealth and telemedicine (US)

November 22, 2013 | by

One of the two US House representatives behind the expansion of telehealth services for active duty and veteran military members [TTA 19 Nov], California Rep. Scott Peters (San Diego area), has just introduced a bill, HR 3577, the ‘Health Savings Through Technology Act,’ to “create a commission to inventory existing data, examine the cost-savings that can be achieved by increasing the use of wireless health technologies, and develop a comprehensive strategy for integrating these technologies into federal health care programs, including Medicare and Medicaid, which often serve the mobility-impaired and elderly.”  What is notable is the backing that the bill has from health tech ‘heavy hitters’ such as Qualcomm, American Telemedicine Association (ATA), CONNECT (a San Diego-based innovation catalyst and accelerator) and CHI-California Healthcare Institute, as well as life sciences industry groups BIOCOM (San Diego area) and BayBio (its Northern California counterpart). However, this commission will be studying a rapidly moving target and best get its skates on, fast. Not helping matters is that there is a long, long road between the introduction of a House bill and its joint passage by both House and Senate–if it ever passes. Release (Rep. Peters’ website) Hat tip to ATA (@AmericanTelemed) via Twitter.

Voice-enabled devices–pointer to the future?

November 22, 2013 | by

LA billionaire and healthcare investor par excellence Patrick Soon-Shiong (his NantHealth raised $31 million earlier this year and owns Vitality, eviti, iSirona, iCOS) has just made a sizable $8 million investment in Fluential, which is developing a voice interface and speech-optimized recognition software for digital health, wellness, and weight management, to run on anything mobile including wearables, and to be released in the spring of 2014. If this works (and better than Siri), it has major implications across the board in the future shape of both consumer and clinical health tech, especially for older adults and those with mobility concerns. Mobihealthnews.

Sensors>>data>>what next?

November 22, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/11/17L_2.jpg” thumb_width=”150″ /]Three of our FBQs concern data–who’s looking at it, who’s taking action with it and how it’s integrated into records. MedCityNews examines two sensor-based monitors in considering how to extract meaning from the data. In the hospital, bed pressure sensor plate EarlySense already has a pressure sensor algorithm that reminds a nurse or aid to turn the patient, but their main emphasis is highlighting vital signs trending in heart and respiratory rate, which can be predictive of a deteriorating condition based on a set range. For the mid-range of the healthy fit who want to be fitter, MIO (left) is the first and at present, only device in a watch form which tracks heart rate monitoring at performance levels without a chest strap and downloads data to an iPhone–which doesn’t quite support the premise of the article, but then there’s that hint (MIO is sold in Apple Stores for $199) that the technology will wind up in smartwatches….but still, Magic 8 Ball says ‘concentrate and ask again’.

CATCH Launch Event 19 November: report

November 21, 2013 | by

Drs. Kenneth Law and Mutaz Aldawoud, GPs at the Hillside Bridge Health Centre in Bradford, attended the 19 November launch of the Centre for Assistive Technology and Connected Healthcare (CATCH). Here is their report, with your Editors’ appreciation and thanks!

The Centre for Assistive Technology and Connected Healthcare (CATCH) was officially launched on 19th November in Millennium Galleries in Sheffield. The launch offered an opportunity to explore the exciting research being undertaken at CATCH, based at the University of Sheffield, to help people live independently. (more…)

Marcus Agius, ex-Barclays chair, joins government consultant PA Consulting

November 21, 2013 | by

Our UK readers have undoubtedly noted the announcement yesterday that former Barclays chairman Marcus Agius has joined employee-owned management consultancy PA Consulting Group as Non-Executive Chairman starting 1 January, after the retirement of long-time Executive Chairman Jon Moynihan. This is one of several changes at the top including the retirement of board members Victor Halberstad (who according to The Times recruited Mr. Agius), Lady Judge and Martin Stapleton. Of the three additions, the most interesting is Esther Dyson, well known for her role in the early days of the internet and now best known as a space, healthcare and IT start-up investor and board member. Her position as founder of the Health Initiative Coordinating Council (HICCup) may signal further reach of PA Consulting’s healthcare sector. According to the FT, one of their largest clients is the British Government–they are finalists in a purchasing bid for the Ministry of Defence–and has extensive experience with the NHS and what’s termed ‘service change’ as made clear on their website. Also Telegraph, PA press release.

Exoskeleton to aid paraplegic in charity walk (US)

November 21, 2013 | by

This past Sunday, architect Robert Woo walked a mile in NYC’s Riverside Park for Generosity NYC 5K. Now that would not be remarkable at all except that Mr. Woo is a paraplegic, and he is walking that mile with the aid of an Argo ReWalk exoskeleton. He and his ReWalk-equipped teammates are raising funds as Team ReWalk to aid the Bronx Medical Veterans Research Foundation/James J. Peters VA Medical Center’s Exoskeletal-Assisted Walking Program. Mr. Woo’s story is a memorable and courageous one from the time of his injury in a horrific construction-related accident six years ago; more in Paralyzed By Seven Tons Of Steel, Man Now Walks With A Bionic Suit (Gothamist). Video in this local CBS News clip. This is certainly the most developed version of an exoskeleton and robotics to enable paraplegics to walk, yet it is still not easy and requires specialized training; most exoskeletons to date have concentrated on assisting lower body movement. Hat tip to Donald Andrews of New York-Presbyterian/Lev El Medical via LinkedIn Groups.

HSJ Awards–the winners are…

November 20, 2013 | by

The Health Service Journal (HSJ) Awards in 22 categories were presented Tuesday night (19 Nov) and their article has a comprehensive list of all the winners and respective categories, with a link to the Twitter discussion, a souvenir supplement (!) and a free best practice report incorporating all the shortlisted organizations.

Health 2.0 Latin America

November 20, 2013 | by

6-7 December 2013, Hospital Sírio-Libanês, São Paulo, Brazil

The first annual international Health 2.0 meeting in Latin America will be held at the historic hospital founded by the large Christian-Syrian and Lebanese community of São Paulo in 1931. Latin America’s fast-growing–and aging–population presents multiple health challenges and disparities. Yet as a region, it is a world leader in medical schools, internet usage growth (2nd largest for Facebook and Twitter) and the 4th largest mobile market. Topics include:

  • What the Health 2.0 movement can do for Latin America
  • Who should step up to finance Health 2.0
  • What will be the role of incubators in the region
  • Sensors and trackers – From quantifying the self to changing behaviors

Information and registration.

Opportunities in the mHealth Landscape: Encouraging Integration

November 20, 2013 | by

27 November 2013, Pinsent Masons LLP, 30 Crown Place, London, EC2A 4ES

A one-hour breakfast seminar focusing on opportunities and challenges being presented by mHealth developments. Presenting: Tim Davies, CEO of mHealth supplier Exco InTouch, Dr Andy Richards, recipient of BIA’s 2013 lifetime achievement award, Collette Johnson of Plextek Consulting, who has had a central role in advancing the adoption of mHealth technologies in the NHS, and Matthew Godfrey-Faussett, a partner at Pinsent Masons specializing in ICT and Healthcare. The seminar will be chaired by David Isaac, Head of Advanced Manufacturing & Technology Services at Pinsent Masons. Breakfast is 8am with presentations 8:30-9:30am. Free. Email megan.hanney@pinsentmasons.com for registration. Additional information here.

Bill to expand military telehealth services introduced (US)

November 19, 2013 | by

Two House representatives from California, Mike Thompson (Congressional District 5) and Scott Peters (District 52) have introduced HR 3507, the 21st Century Care for Military & Veterans Act. This expands coverage of telehealth services (including remote monitoring and virtual consults/telemedicine) for active-duty service members, their dependents, retirees and veterans, including physician reimbursement for telehealth services under TRICARE (the health plan for active duty and military retirees) and the Department of Veterans Affairs (VA). (more…)