The Theranos Story, ch. 34: It’s a conspiracy! It’s a vendetta!

click to enlargeUpdated Well, that is what one of her major investors says, and he would know! Just when we thought that a week would go by with not a peep about Theranos, we get three. Peeps, that is.

First, the Conspiracy Theory. This is being propounded by early Theranos investor Tim Draper of Silicon Valley VC Draper Fisher Jurvetson. It was all John Carreyrou’s ‘strange vendetta’ against her, to wit: “Elizabeth is the victim of a witch hunt.” The Wall Street Journal reporter set off a cascade of press coverage that compelled, nay, forced Federal regulators (FDA, CMS, SEC, DOJ) and state counterparts to go after Theranos and CEO Elizabeth Holmes. Mr Draper bluntly accused Mr Carreyrou of doing it for money; “the guy is getting $4 million to continue this charade”, referring to the advance on his book proposal “Bad Blood”. The most nauseating part of the Ars Technica interview is this mock-libertarian rejoinder from Mr Draper: “It’s the press creating a series of events that negatively impact technology, progress and our economy.”

So it was all a mistake, an illusion–there was nothing significantly wrong with the Edison Lab, or Theranos’ business practices! (Hat tip to Bill Oravecz of Stone Health Innovations)

Mr Draper perhaps did not consider that Mr Carreyrou’s reporting blew up the $100 million investment of the WSJ‘s owner, Rupert Murdoch (Ch. 27), not just DFJ’s. And SafewayWalgreens, Larry Ellison, Cox Enterprises, Bechtel Group….

Second, the belated reporting of deficiencies at the Scottsdale lab found by CMS (Centers for Medicare and Medicaid Services) on 29 September. According to the Wall Street Journal report (co-authored by Mr Carreyrou), “Theranos responded to the inspection findings in Arizona with a plan to correct its lab deficiencies, but the lab regulator in November rejected the plan and proposed sanctions for the Arizona lab as well.”  This preceded the closing of all labs and the ‘refocusing’ of Theranos on the miniLab. Their general counsel stated, “After months of careful consideration, and prior to CMS’s unannounced inspection in Arizona, Theranos decided to close its laboratories.” Usually, these CMS reports are issued after 90 days. Theranos is appealing the sanctions arising from the California lab inspection with an administrative law judge, which include lab license revocation and a two-year ban on Ms Holmes from blood-testing operations.

Third, Theranos announced an eight-person Technology Advisory Board (TAB) to be led by Dr. Channing Robertson and Howie Rosen. The academics, executives, and entrepreneurs will be charged with “reviewing specific Theranos technology initiatives associated with product development, design and deployment” as well as four other mandates. Analogies concerning horses, roads and the status of barn doors come to mind. Release.

And finally another Theranos Washington connection, besides new SecDef and ‘Warrior Monk’ James Mattis, now an alumnus. It seems that the vetting of Betsy DeVos, nominee for Secretary of the Department of Education, uncovered that she has an investment in Theranos of more than $1 million. However, the Office of Government Ethics also reported her whopping earnings of less than $201. Since others like Rupert Murdoch, Bechtel, Walgreens, Cox, and others ponied up $50 to $100 million, hers is a mere bag of shells by comparison. MedCityNews, who has dubbed it the ‘As Theranos Turns’ soap opera. Hat tip to Bill Oravecz of Stone Health Innovations.

See here for the 33 previous TTA chapters in this Continuing, Consistently Amazing Saga, including Arizona’s lawyering up for a prospective Theranos lawsuit (Ch. 33) the firing of 155 remaining staff (Ch. 32), the resignation of now-DOD Secretary General Mattis from the BOD (Ch. 31), and Theranos’ annus horribilis (Ch. 30).

Walgreens partners with Chicago health tech incubator MATTER (US)

Walgreens, the US retail pharmacy part of Walgreens Boots Alliance, on 20 December announced its own alliance with Chicago healthcare incubator and innovation community, MATTER. This Editor believes it is the first retail partnership with a health tech-focused incubator or accelerator in the US; most of these partnerships are with angel networks, VCs, health system venture arms or large commercial healthcare partners such as Qualcomm, Allscripts or GE Healthcare. Walgreens’ contribution will be to mentor and collaborate with MATTER entrepreneurs. Reportedly they have or have had more than 150 startups in their program. They are also part of Chicago’s push to slice itself some health tech cake versus cities like San Diego, Palo Alto, Dallas, Boston and New York via the recently launched Health Care Council of Chicago (HC3), which was co-created by MATTER and Leavitt Partners. Hopefully, Walgreens will get some of their $140 million back via their Theranos lawsuit ending their blood testing misadventure [TTA 17 Nov, Ch. 24] and spread their bets with legitimately promising startups. Press release, ChicagoInno

The Theranos Story, ch. 29: Blame the scientists! Bring on the lawyers!

click to enlargeIt was the fault of the scientists and the investors! That is the speculation of Quora poster Drew Smith, a former R&D director at biotech firms MicroPhage and SomaLogic. It was a round robin of founder/CEO Elizabeth Holmes’ all-too-rosy forecasts and scientists not wanting to toss a wet wool blanket on the fun by telling her what she didn’t want to hear. Mr Smith, from where his experience lies, believes that the scientists discarded the testing with bad results, passing on only the good even if flawed, in a delusional circle that ultimately went pear-shaped. Then there were the investors, who didn’t apply the usual Deep Discount to the Big Hype that all entrepreneurs weave around the Revolutionary Whatevers, for whatever reason. On this, Mr Smith doesn’t speculate. It must have been those wide-screen blue eyes, black turtlenecks, and nanotainers that kept them mesmerized. Theranos wouldn’t be the first company that failed because they believed their own press releases and pictures! Forbes  Hat tip to reader Bill Oravecz of Stone Health Innovations and WTO Associates.

And the law firms multiply. Continuing to fight Theranos’ many lawsuits in multiple courts are a bevy of Big Law firms. In Chapter 26, Boies Schiller exited, stage left, and Wilmer Hale (formally Wilmer Cutler Pickering Hale and Dorr) entered. Wilmer Hale is representing Theranos in the California class action lawsuit described in Chapter 27 and what we’ve deduced is the Partner Fund Management lawsuit filed in Delaware (Chapter 21). Here’s where Santa unloads his jolly pack of toys for the Law Boys. Cooley LLP (32nd on The American Lawyer’s 2016 Am Law 200 ranking) is busy representing Ms Holmes, who has been separately sued by Partner Fund Management, and defending an Arizona lawsuit (Chapter 22). And on deck for Theranos in the Walgreens action, also in Delaware? (Chapter 23) Newcomer Wilkinson Walsh + Eskovitz, founded earlier this year by top trial lawyers from larger firms. All those billable hours add up to gold in their stockings, coal in Theranos’. Law.com

See here for the 28 previous TTA chapters in this Continuing, Consistently Amazing Saga.

Categories: Latest News, Opinion, and Soapbox.

The Theranos Story, ch. 24: looking for the nadir in Walgreens’ lawsuit

click to enlargeWhen will we find the nadir of Theranos’ business practices? Between the excruciating details of the Walgreens lawsuit and the treatment of an employee who knew the truth in 2014 (part 2), the bottom, like Jacob’s Well in Texas at left, may be unfindable.

The first is what is revealed in the public version (filed 15 Nov) of the civil complaint filed with the US District Court, District of Delaware (PDF). While heavily redacted in parts of text and in the exhibits, it is damning if all true–and there is little available information that does not fit Walgreens‘ narrative, though this Editor was left wondering why red flags about Theranos didn’t flap ‘n’ fly at Walgreens much earlier, especially with a reported $140 million investment at stake.

The relationship began in January 2010. A March presentation by Theranos included some astonishing claims: the Theranos finger-stick blood draw lab analysis had been comprehensively validated by ten of the leading fifteen pharmaceutical companies over seven years; that bio-pharma companies, “prominent research institutions, and US and foreign government health and military organizations” had already used the technology; that Theranos was capable of launching it in retail stores by end of 2010. They also represented that they were positioned with FDA to introduce the technology outside of clinical studies. Johns Hopkins, contracted by Walgreens to validate their methodology, could only work with data provided by Theranos.

Did anyone at Walgreens think to check with said pharmas, researchers, government health and military organizations? There was time. The master agreement was not signed until 2012 and pilot stores opened in 2013.  (Pages 5-10, section 24 through 50). Interestingly, pages 11-12 which may deal with the labs, as well as many other parts, are heavily redacted.

In short, there is a gap of at least two years when Walgreens could have double-checked Theranos’ claims and methods, especially in the crucial period before pilot locations were opened. (To be fair, Theranos successfully maintained a veil of secrecy and a wall of PR smoke.) But the repercussions were huge.  It seems that Walgreens only woke up from the dream when the Wall Street Journal published its investigation another two years later in October 2015. In the immediate aftermath of the article, Walgreens learned that Theranos had abandoned the finger-stick draws…and that the head of the Newark CA lab was a full-time dermatologist onsite once a week (page 15).

After that point, the Theranos fan dance with Walgreens accelerates.

  • Theranos concealed the January and March 2016 CMS notices and subsequent reports on its labs to Walgreens until again the WSJ publicly revealed it (pages 17-18, 25). They also attempted to conceal the CMS rejection of the Plan of Correction for its labs (page 24).
  • Theranos accused Walgreens of breaching the agreement and confidentiality to the WSJ , and also cited delay in building out Wellness Centers–in February 2016 (pages 20-21)
  • Walgreens received nothing but evasions from Theranos including no notification of ‘tens of thousands’ voided results, including critical PT/INR coagulation results, until after the WSJ broke that bit of news on 18 May (page 26).

By 12 June 2016, the wheels were fully off (and the world was minding, indeed) and Walgreens called the breach of warranty. But even then, this was not until a final push–lawsuits were filed against both Theranos and Walgreens starting in late May.

One wonders how many reputations are on a stake (to mix two metaphors) at Walgreens Boots. Details in Ars Technica (which obtained the PDF and broke the story) and of course Neil Versel’s acerbic POV in MedCityNews. Hat tip to reader David Albert MD of AliveCor.

See here for the 23 previous TTA chapters in this Continuing Saga.

The Theranos Story, vol. 23: Walgreens drops the $140 million contract breach hammer

click to enlargeWalgreens Boots Alliance has finally sued Theranos in Delaware Federal Court in for breach of contract.  Walgreens is seeking $140 million, supposedly equivalent to their amount invested, according to sources cited in the Wall Street Journal article. Not many details are available, since Walgreens moved to seal the civil suit under their mutual non-disclosure agreement.

Allegations are flying, of course. Walgreens is officially mum, but according to the WSJ‘s ‘close to the matter’ sources, Walgreens claims that Theranos misled them about the state of their technology during their three-year partnership and even after the blood-draw centers were closed in June, which put their customers at risk. This sounds like the fraud and misrepresentation cited by Partner Fund Management, which moved in October to get its $96 million back like Lee Marvin as Walker in Point Blank. Earlier reports confirmed that patients did not learn for weeks or months, often not until forced to, that their Theranos test results were unreliable. There are reports that at least 10 patient lawsuits have been filed in Arizona and California.

(This Editor notes that their Theranos agita hasn’t soured Walgreens on funding health tech. They are a substantial investor in TytoCare, an all-in-one vital signs device with retail potential, and MedAvail, a kiosk dispenser for prescription and OTC medications)

Theranos has, no surprise, said a great deal, aggressively–the trademark of their legal supremo David Boies. They claim to be the aggrieved party: “Over the years, Walgreens consistently failed to meet its commitments to Theranos. Through its mishandling of our partnership and now this lawsuit, Walgreens has caused Theranos and its investors significant harm.” Theranos has exited the blood-testing business and is supposedly refocusing on developing technology to sell to outside labs. Also MedCityNews ‘coughs’, The Verge.  See here for the 22 previous TTA chapters.

The Theranos Story, ch. 22: the human cost of lab error (updated)

click to enlargeSave this one for the coffee or lunch break. What is the cost of a lab error on the human psyche? It can be mildly upsetting to you and your doctor, warning of a developing condition and some changes have to be made–or make for a very bad day/week/months. It can be falsely reassuring or simply confusing.

We know that in April, Theranos flunked a CMS review, and in May voided all test results from its proprietary Edison devices from 2014 and 2015, as well as some other tests it ran on conventional machines. The results were not only off, but way off, according to the WSJ. “Notes from the CMS inspection show that 834 out of 2,890 quality-control checks run on the Edison in October 2014, or 29%, exceeded the company’s threshold of two standard deviations from its average result. Standard deviation is a statistical measurement of variation. In addition, 80% of the 834 quality-control checks that raised a red flag under Theranos’s internal standards were more than three standard deviations from its average result, the inspection notes show.”

They also failed to notify patients for weeks or months, and often not until forced to. At least 10 lawsuits have been filed in Arizona and California. Some of the human stories of Theranos’ improbable lab results, which included tens of thousands of patients, with the cost of retesting, repeated doctor visits and agonizing suspense :

  • After five widely different Theranos blood coagulation tests in six weeks, a retired marketer living in Arizona and his doctor so distrusted the results that the latter recommended that he stop taking warfarin and switch to a milder medication. This patient found out only last Friday that Theranos had corrected a September 2015 test showing his blood taking more than six times longer than normal to clot. The other four tests showed the warfarin wasn’t thinning his blood enough. Contradictory results confusing both doctor and patient on treatment.
  • A thyroid cancer survivor got thyroxine results (T4) from three tests conducted in October 2014. The extremely high results could have indicated hyperthyroidism at the least, or a more serious condition. The results–false after retesting failed to confirm.
  • A breast cancer survivor had extremely high levels of estradiol, which could have been produced by a rare adrenal tumor that can secrete estradiol or an elevated risk of breast-cancer recurrence. Again, false results but found only after retesting.

The comments under the article are worth the long scroll. (They are running 98 percent in favor of Holmes for Prison 2017. Also there are a few shots at Walgreens’ role in legitimatizing Theranos by putting their centers in store; this embarrassing part of the story isn’t over, in this Editor’s opinion.) What is evident–fraud perpetrated on patients and doctors–and anyone who invested. David Boies, their legal supremo and board member, is gonna have a full docket between this and the various legal actions taken by the Alphabet Agencies.

Agony, Alarm and Anger for People Hurt by Theranos’s Botched Blood Tests. If the WSJ is paywalled, search under the headline text.

See here for the agony of TTA’s 21 previous Theranos chapters. We hope that John Carreyrou and the WSJ investigative team, which we’d assume includes Mr Weaver, this article’s author, are awarded the Pulitzer Prize.

The Theranos Story, ch. 20: How Arizonans fell hard and let Theranos change health policy

click to enlargeThe face is in the lake, and the yellow duck is upside down–augering in! A flatly-spinning Yak-52 no longer describes the glide path of Theranos, now at value 0. So as the dust settles, the Tales of When The Circus Came to Town are dusted off and published. Here Tim Steller, a writer and columnist with the Arizona Daily Star, reminisces on those dazzling Arizona days back in March 2015–18 short months ago–when Elizabeth Holmes swept into Phoenix in her bodyguarded SUV, trailing lobbyists and dropping names. The state legislature and Governor Doug Ducey, by this telling, were mere putty in her hands, star-struck into approving a bill permitting direct consumer ordering of lab tests, over the objections of the Arizona Medical Association and the questioning of the two doctors in the legislature. The Big Question–“does your blood-testing technology work?”–never was asked, and only two voted against the bill. At least Theranos only sought deregulation to facilitate its placement in Walgreens; Zenefits, another one-time Unicorn, gained employment incentives for its online HR-benefits brokerage, which were voided with recent layoffs. Tucson.com  See here for the 19 previous TTA chapters.

Jawbone bites back: Fitbit loses three patents (updated)

The wearables war continues, and the Law of Unintended Consequences seems unbreakable. This one was decided in a US International Trade Commission court, with the judge ruling that the three patents in question “don’t cover ideas eligible for protection” and dismissed the August trial between Fitbit and Jawbone. This is a reversal of fortune for the two competitors as a similar patent challenge to Jawbone was won by Fitbit back in April in the same court. In the new ruling, the judge said that Fitbit “seek(s) a monopoly on the abstract ideas of collecting and monitoring sleep and other health-related data.”

The skirmishing has a deeper context. Jawbone has accused Fitbit of hiring former employees and purloining trade secrets like product design and marketing plans, and alleges that the suits were “brought improperly by Fitbit in an attempt to burden Jawbone with having to defend invalid patents in multiple venues.” Fitbit reportedly has 300 patents, so that is a lot of defending for a company that has issues of its own.  Jawbone has struggled in past months with its products, with various (and contradictory) reports indicating it’s exiting the wearable business, working on a new wearable and selling its audio business (which has also been crushed by competition.) Undoubtedly this will continue as Fitbit plans to challenge the ruling. Your Editor suspects that their legal and IP offense/defense activity is a substantial budget line for them. Bloomberg (20 July and April), The Verge

Update: Jawbone is rumored to be up for sale, with reports that they have approached at least one hardware manufacturer about a purchase. Reportedly they missed an August payment to a business partner. Investor BlackRock has marked down their shares, formerly valued at $5.97 a share, to less than a single penny. Since 1999, Jawbone has had funding of over $900 million.  9to5Mac, The Verge  Even the much-publicized hiring of high-profile exec Adam Pellegrini from Walgreens to Fitbit to lead digital health has a Jawbone twist, as both the former and latter were partners. MedCityNews

Unspinning the Theranos scientific advisory board communications spin

click to enlargeSpinning oh so flatly…..As reported in MedCityNews (and here) yesterday, Theranos has made a Radio City Rockettes-showy move in opening at least part of its scientific books to a prestigious group of eight academic researchers from top-flight institutions. The Theranos press release is a masterpiece of positive spin to counter the negative results of the CMS report released last Thursday. However, when the fine-spun web is picked apart by Matthew Herper, a staff reporter for Forbes, it embarrassingly falls apart. The clues are all there, of course, in the elided language, the lack of specificity on numbers, the over-the-top quotes from the CEO and one of the advisory board members….

Upon interviewing three members of the scientific and medical advisory board, the glowing statement of Dr Helfet–who had been a co-chair of Theranos’ existing scientific board–was revealed as not quite accurate in the impression it gave.

  • The full advisory board has not met as a group yet. The impression was given in the release that they did.
  • They were split into three groups, each spending about a day at the Palo Alto HQ “viewing data shown to them by the company about its blood tests, examining Theranos’ Edison machines, and asking questions”. They did not visit any working labs, including the two under CMS fire.
  • Drs Ladenson and Spitalnik thought that what they saw looked “promising” and “intriguing” but would not answer questions on whether Theranos’ devices were ready to be used. Eight hours for Dr Spitalnik was, as he stated, was enough to whet the appetite, but not more than that.

It remains that Theranos has not published one peer-reviewed study, despite promises, promises. The company leadership took in a lot of investor money, gained a $9 billion valuation, got Safeway and Walgreens as partners (now rescinded)–never proving that Theranos’ tests would do what they said they would do. Besides being the bottom line and the one proposition that must be proved, they potentially endangered trusting patients in Arizona and California. And gave a black eye and probably a broken nose to innovation in and consumer access to lab testing.

At least the Yak-52 aerobatic aircraft and its pilot are in a planned, recoverable flat spin. Nothing about Theranos’ spin can be. Forbes

Outsourcing of retail clinics–another reason for HealthSpot’s demise? (US)

Walgreens earlier this week announced another round of outsourcing their in-store health clinics to a local health system, this time in the Midwest US with Advocate Health Care. It affects 56 locations in the Chicago, Illinois area which will operate as Advocate Clinic at Walgreens in May 2016. It’s an interesting spin on the much-touted integration of healthcare services into retail pharmacies. It gives an integrated health system a prime location for community services–a clean, well-lighted place (to quote Hemingway, minus the daiquiris) with minimal overhead that provides one-stop-shopping for patient pharmacy and OTC products. It also solves part of the ‘fragmentation of care’ problem for Advocate patients as their records will go straight into their EHR. For Walgreens, it offloads the licensure and operating expenses of a clinic, gives a strong competitive advantage lent by the legitimacy of a leading provider, and attracts Advocate patients to their locations. Walgreens release  Last August, Walgreens turned over the keys of 25 Washington and Oregon clinics to Providence Health & Services in what now can be seen as a trial balloon.

What is surprising is how few Walgreens have clinic services–400 of over 8,100–over nine years of operations, starting with the acquisition of former travel industry executive Hal Rosenbluth’s 25 or so TakeCare Clinics around Philadelphia back in 2007. Yet further clinic expansion has been difficult as many locations have no physical space, there are restrictive state laws and the competition is everywhere between over 1,000 CVS Minute Clinics and local urgent care clinics. CVS also recently acquired 80 Target pharmacies and walk-in clinics. It’s reported that profitability has been a challenge for Walgreens in the clinic biz. Expect to see more of these arrangements to grow Walgreens’ clinic network.

Why might this be a contributor to HealthSpot Station’s end? A change of direction and a need for cost cutting that wasn’t there a year ago.  (more…)

Is Theranos’ ‘blood testing for all’ a responsible selling proposition?

Theranos’ recent troubles on their blood testing (Walgreens halting expansion, FDA halting nanotainers as ‘uncleared medical devices’ and last week chain grocery/drugstore Safeway dropping their $350 million deal for 800 locations) have been well covered in media both here and elsewhere. But what if their Unique Selling Proposition–that people should have the ‘basic human right’ to order up their own inexpensive blood tests and then be responsible for their own interpretation–is counter-productive for many patients? After all, it’s what Theranos has been organized and raised $400 million+ on. Dr Robert Wachter of UCSF, who is no top-down Ezekiel-esque ‘nanny stater’, lends a caution: “There are a lot of companies, including Theranos, that have an interest in making you believe that more data will magically make you healthier. It won’t, at least not in the short-term.” When is ’empowerment’ confusing without recourse to interpretation? Some results are easier to read than others. Does having the data make the average person healthier for real? Personally, this Editor would welcome the ability to walk into her local Walgreens and order up a few to see what’s up–but then again she can do her own research and ask a doctor or nurse to help. Who can (inexpensively) close the interpretation gap? Theranos is wrapped in scandal but goes hard to change laws to its advantage (Mashable)

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…)

Integrating inexpensive lab testing, imaging to EHR–and vice versa

In the Dr Eric Topol patient-driven world, personal lab testing would be walk in, keep retail hours and not even need a doctor’s order. That is the model for Theranos, a well-funded low cost blood testing company operating 43 centers in California, Arizona (no doctor order needed) and one Pennsylvania Walgreens. Their latest alliance is with EHR physician practice giant Practice Fusion, which claims about 112,000 doctors actively using its cloud-based, ad supported platform, claims to be the fastest growing US EHR with at present 100 million patient records. The Theranos reporting app, which also connects patients with doctors who can help interpret the results (MD Connect) integrates with other EHRs (though not listed) and now the results will also show in their Practice Fusion patient record. Practice Fusion is also integrating imaging center RadNet‘s results.

Since the late 2000s, Practice Fusion has historically been the game changer in cost (one of the first in the cloud) and in catering to smaller practices. They are good at managing their hype, but as Neil Versel points out, there’s been a CEO ‘change-lobsters-and-dance’, there are questions about revenue and their awaited IPO seems far away, especially given the recent market upset. Hospital EHRs Cerner, Epic and NextGen now all have lower-cost practice versions that integrate with hospital versions. An American College of Physicians (ACP) 2014 survey identified that Practice Fusion is third (and tied with others) among most used practice EHRs behind Epic and eClinical Works, though strongest in solo practices. On the polar opposite of Mr Versel’s skeptical article is this breathless Forbes piece which confuses partnerships with acquisitions. Perhaps self-made billionaire Theranos CEO Elizabeth Holmes may decide to buy Practice Fusion!

2014: a few quotes

As a coda to yesterday’s review of our predictions for 2014, here are a few quotes that particularly struck this editor as of interest in 2014, sometimes because of what was said and sometimes because of who was saying it – it’s left to the reader to decide which.

Arthur L. Caplan, Director of Medical Ethics at the New York University Langone Medical Center at the end of an interesting piece in the New York Times on the finer points of genetic testing said:

If you want to spend wisely to protect your health and you have a few hundred dollars to spare, buy a scale, stand on it, and act accordingly.

Three months later, Anne Wojcicki, the founder of 23andme – one of the genetic testing organisations mentioned in the last clip – was quoted in this Medcity News piece as saying: (more…)

Looking back over Telehealth & Telecare Aware’s predictions for 2014

Looking back over our predictions made on 31st December last year, it’s hard to quibble with any, and worth hanging on to those that didn’t come good this year.

Our first was

Security and data privacy issues will become a serious mHealth issue in 2014; developers failing to take great care over security and privacy issues will risk very adverse publicity and worse.

Job done: that certainly proved correct, with many being exposed as either selling or potentially selling private information. Clinicians were not immune from privacy invasion eitherHere is a US summary of the issues. Attention was drawn to an EU Article 29 data protection opinion (actually published in 2013) that sought to clarify the legal framework applicable to the processing of personal data in the development, distribution and usage of apps on smart devices, and the obligations to take adequate security measures.   Many apps got hacked too, including FDA-approved ones. There were also items, such as this one, demonstrating how complex the law is in this area in the US. In the EU, the arrival of the Data Protection Regulation in 2015 (now some say 2016) will undoubtedly improve data privacy significantly, though the failure to treat data used for health purposes differently from (more…)

Tunstall’s challenging year: results reported

click to enlargeBreaking News. The topline of Tunstall Healthcare Group’s 2014 results (through 30 Sept 14) is now (partly) public thanks to the Yorkshire Post, Tunstall’s ‘hometown paper’. (We do note that it was published on 23 Dec, in the ‘dead of night’ rolling up to the Christmas holiday.) Notably, there is no report on the Tunstall website and it is too early to show on standard corporate reporting sites such as DueDil and CompanyCheck. The YP article appears to be written partly in press release-speak, which we do not fault them for on limited news available. In summary:

  • In the 2014 FY ended 30 September, revenues were £215 million. FY2013 was £221 million, a decrease of £6 million (2.7 percent).
  • A corresponding but greater EBITDA (earnings before interest taxation depreciation and amortization) drop to £43.0 million. FY 2013 was £52.7 million, a decrease of £9.7 million (18.4 percent).
  • The good news: revenues up 6.8 percent in the Nordics, Southern Europe, Central Europe, and Australasia; Spain’s Televida as a market leader also a bright spot [TTA 19 Dec].
  • No such good news in UK and the US  (more…)