The inevitable: class action lawsuit against 23andMe

December 3, 2013 | by

Breaking News (which is No Big Surprise)

Updated 6 December: 23andMe continues to sell kits, but will provide only minimal genomic information and has suspended advertising. The Washington Post reports that “In a statement Thursday night, the firm went a step further, announcing that it would only provide ancestry information and raw health data. A spokesperson for the company said that “interpreted results” would not be included.” 23andMe had earlier this week suspended advertising (Cnet/Reuters). Customers who had purchased kits prior to the FDA letter on 22 November will receive full reports. 23andMe statement on website. Matthew Herper in Forbes today on how both parties were in a ‘kind of detente’ until the bolder claims (and undoubtedly the adverts with those claims) started. And for weekend consideration, the CoreGenomics (UK) blog looks at the genomic truth-or-consequences.

The Class Action Lawsuit:  Gigaom reports that a California plaintiff, Lisa Casey, filed on 27 November against 23andMe in the US District Court, Southern California citing false and misleading advertising of the Personal Genome Service (PGS) without “‘analytical or clinical validation” and that 23andMe “advertises and markets PGS as a reliable health aid”. Included in the class action complaint is (of course) every online and advertising claim regarding diseases and conditions that 23andMe’s genetic testing can assist a consumer, that (of course) FDA has not approved the marketing of the kits and that 23andMe markets the information to others even though “the test results are meaningless”. The lawsuit seeks damages extending well beyond the cost of the kit (of course), a jury trial and importantly to certify the class action and the attorney’s representation of same. Most interesting is the seemingly modest representation of Ms. Casey, Mark Ankcorn of his eponymous law firm (see his blog entry here). However, in tracing back his email domain, this Editor discovered that Mr. Ankcorn, a trial lawyer with a major-league track record of wins, recently joined the high-powered CaseyGerry firm of San Diego, which specializes in high-profile personal injury/death class action lawsuits including litigation against the NFL on TBI and CTE plus the 2011 Reno Air Races crash.

Our readers should not be surprised as our article last week was blunt on the red carpet 23andMe was figuratively rolling out for the lawyers: Get what your product does (your implied warrant of service) rock solid (23andMe is not at this point) and backed up by studies. Structure your claims as if a trial lawyer will come after you, because they come with the territory.

Well, they are here, and the mystery remains why 23andMe has chosen a path that for most early-stage companies would be corporate annihilation. 23andMe hit with class action over “misleading” genetic ads  Filing (PDF) Hat tip to David E. Albert, MD of AliveCor via Twitter (@DrDave01)

Related articles of interest: Dan Munro in Forbes, writing at the same time as this Editor on the kerfuffle, analyzes far more than here on the ‘test results are meaningless’ point. My comment is below his article (expand comments). See also Mr. Munro’s comment on Illumina (which 23andMe uses for its testing–and just gained premarket clearance for their MiSeqDx test) also confirming that 23andMe lost its Chief Legal Officer in July without a replacement, which would tend to cramp dealings with FDA.  See also Bernard Munos’ ‘fumbling gene’ takedown, from a scientific POV, of same. KPBS (San Diego) coverage.

Previously in TTA: FDA tells 23andMe genomic test to stop marketing

Misfit Shine goes ‘Droid, at last

December 3, 2013 | by

Monday’s big news in the wearable sensor world was that the 10p/US quarter-sized Misfit Shine is out in an Android version, as promised back in their distant Indiegogo days before the Khosla and Founders Fund VCs discovered it. Delayed at the end of May, and reset for mid-July [TTA 30 May] then for early 2014, the Shine is now a bright spot at places like Best Buy and Target at prices from $99 to $120, though it only works on Android 4.3 or later devices and TechCrunch is reporting that early reviewers have found it crash-prone. VentureBeat raves that the Shine now has what Nike FuelBand does not–Android. It’s also far more wearable; it now comes online in the hot new ‘champagne’ and azure colors even if the initially touted jewelry-like concepts have yet to materialize.

Update 4 Dec (Breaking News): According to TechCrunch, Misfit just raised $15.2 million from Hong Kong-based Horizons Ventures. Current investors participated in the round. This now leads to a total funding of $23 million according to CrunchBase. According to AllThingsD, founder/CEO SonnyVu claims they are on track to ship 200,000 units by end of 2013 and that the funding will go to other areas of wearable sensing such as wearable feedback, identity and payments technology as well as wearable controls and gaming. Also Mobihealthnews. Are we seeing here another hype curve?

For more on wearables, AllThingsD spotlights clothing: Athos’ workout gear, Notch’s snap-on sensors and clothing, Push’s strap for weightlifters, Heapsylon’s heart-rate monitoring t-shirts and sports bras. And HIT Consultant has a nifty infographic on the future of wearable technology in healthcare which includes the new Reebok Checklight (previewed at CES Unveiled last month) and Push. (hat tip to reader Luca Sergio via Twitter @lmsergio).

Brain stimulation therapy explored by DARPA

December 2, 2013 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/12/SUBNETS_144_144.png” thumb_width=”150″ /]The US Defense Advanced Research Projects Agency (DARPA) is investigating the use of DBS (deep brain stimulation) implants for possible treatment of several chronic neuropsychological conditions. They are seeking to evaluate neural and behavioral processes in PTSD, TBI, major depression, borderline personality disorder, general anxiety disorder, substance abuse/addiction and fibromyalgia/chronic pain through the SUBNETS program (Systems-Based Neurotechnology for Emerging Therapies). All these conditions are on the rise with service members and veterans. DBS is currently used in neurological diseases that impair motor function–Parkinson’s and dystonia–and is being researched for treatment of depression, obsessive compulsive disorder, Tourette’s and epilepsy. SUBNETS is also linked to NIH’s BRAIN Initiative. Armed With Science article, the SUBNETS pre-solicitation (Photo courtesy of DARPA)

Happtique certifies 19 health apps

December 2, 2013 | by

Happtique, which started in 2011 as a health app certifier and curator, then ‘pivoted’ to what they term a “virtual marketplace and distribution platform” (?) after a major management change this spring, has mystifyingly announced the ‘Inaugural Class of 2013’ of 19 certified health apps. These presumably passed certification guidelines finalized in September 2012. But the bare list of apps and links leads this Editor to more questions. Is this meant for the clinical market as part of their mRx program? Consumer market? And how will they find out? While the apps range from the obscure (Amazing Abs) to the expected (MyNetDiary’s Diabetes Tracker) to the well-known from major names (GreatCall’s UrgentCare, which counts as two on the list), it’s hard not to feel a certain sense of underwhelm at this news: 19 out of nearly 30,000 counted by iMedical Apps [TTA 23 July] and even against the 200 listed in MyHealthApps [TTA 26 Nov]. MedCityNews’ light and oddly edited article only adds to the mystery. And Mobihealthnews reveals that the 10 companies listed paid for certification of their apps, which is not surprising, but if more than a nominal amount (application fee) very well takes away from the impression of objective certification. 

Ed. Note: Over the past three days this Editor has contacted Happtique to confirm the application fee and to generally comment on the program. As of this writing (Thursday 8:30pm NY time), no reply has been received. However, a FierceMobileHealthcare interview with then-CEO Ben Chodor gave a range of $2500-3000 to certify an app for two years, with a 30 day turnaround time.

Legrand purchases Tynetec, enters telecare market

December 2, 2013 | by | 7 Comments

Breaking News

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/12/Legrand-logo-2013.jpg” thumb_width=”125″ /][grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/12/Tynetec-Master-Logo-2011-White.jpg” thumb_width=”125″ /]The official announcement of telecare and nurse call system manufacturer Tynetec‘s acquisition by commercial and residential electrical company Legrand is here and attached (PDF). This follows on Editor Charles’ article of 24 September and the following comment by Stewart Smith. Terms of the acquisition were not disclosed. All signs (press announcement, website changes and reconfirmation with our contact at Tynetec) indicate that Tynetec will continue to be located in Blyth, Northumberland as a separate business unit within Legrand UK (HQ’d Birmingham) with its current line including the Advent XT Warden Call system, the Reach personal alarm system, the new Reach plus GSM system as well as the recently acquired Aid Call nurse call system as a separate brand.  Legrand UK’s stated aim is to enter the healthcare area to complement its existing areas in wiring devices and related areas. The parent, Legrand SA, is a French company with operations in 70 countries, marketing in 180 countries and €1.1 bn in annual sales, with an overall strategy of self-financed acquisitions of small to midsize companies of which Tynetec decidedly fits (see Bloomberg article). In the US, Legrand is best known for wireless lighting and home controls. Certainly this does provide Tynetec, after 34 years of ‘grizzled pioneering’ in the UK, a solid and VC-free parent in the UK–and access to worldwide markets.

Editor’s note: Tynetec has been a long-time supporter through advertising on this website, and Founder Steve and all the Editors appreciate their support.

3ml pivots, Lancashire telecare turns?

November 28, 2013 | by

3millionlives goes sideways, again…

NHS England formally scrapped the planned seven ‘pathfinder sites’ projected to enroll 100,000 residents, in favor of a more limited scheme to gain adoption of telehealth in areas where ‘energy already exists’ in a new plan, ‘Integrated Care for 3millionlives’ to be delivered by March 2014. Health Secretary Jeremy Hunt in November 2012 set the 100,000 goal for 3ml; NHS England took over the program in April from the DH The totals tell the tale. An independent review by GP 8 Nov gave the total patient count as of September as just 2,368 patients in 20 active pathfinder CCGs (clinical commissioning groups). A spokesperson for NHS England quoted in GP stated that the goal of 3 million patients is still valid for 2017; Rachel Cashman, head of collaboration for excellence at NHS England, indicated at a conference that the plan would cover telehealth, telecare, telemedicine and telecoaching . If this were Silicon Valley, the word used would be the done-to-death ‘pivot.’  NHS England abandons health secretary’s pledge on telehealth (GP), 3millionlives delivery plan by April (eHealthInsider)

As the world turns in Lancashire…

…it seems like a change in party control from Conservative to Labour has derailed the One Connect deal to provide telecare to county residents and possibly the career of the Conservative leader. The current Lancashire County councillors have charged that the deal, signed by the previous lead Councillor, would overcharge the county by £1.4million. One Connect is a 60/40 percent joint partnership between BT and the LCC. Muddying the waters is a personal dispute between the Conservative head and the Liberal Democratic leader. Tories turn on party leader (Lancashire Evening Post)

Swiss capsule monitors blood fat

November 28, 2013 | by

Without the hype of Airo, a Swiss research team at ETH-Zurich has designed and is testing on mice a blood fat-detecting capsule that releases a satiation hormone when excessively high fat levels are detected, suppressing appetite. The circuit in the capsule can measure several types of fat, including several saturated and unsaturated animal and vegetable fats. If further developed, this could have impact on weight loss for humans.  Gizmag, Daily Mail

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’.