Babylon Health: correcting earlier NW London CCG report; other concerns raised by CQC report (updated)

Correcting and commenting on our earlier report. This Editor had earlier published on 11 Dec, as follow up to the extensive coverage on Babylon Health’s ‘GP at hand’ pilot activity in London, summarizing a report in Digital Health stating that the North West London Collaboration of Clinical Commissioning Groups (CCG) ended plans for expanding a test of the Babylon video consult/symptom checker app for GP practices in that area and that the app could be ‘manipulated’ to secure GP appointments faster and would not reduce demands on GPs. The original article was first corrected at an NHS England‘s representative’s request to reinforce that this was a local CCG project and that NHS England was not involved. The second request we received last Friday was from Babylon Health’s PR representative, Giles Kenningham, principal at Trafalgar Strategy. It was certainly strong and quoted here, edited as indicated to remove the link to the original article and Mr. Kenningham’s signature:

Your recent article on Babylon is factually wrong and misleading (link removed):
You claim the babylon app was dropped after being manipulated by patients. The term ‘manipualtion’ has been removed from the board papers and is wrong. Similarly the planned pilot had never begun so there so nothing to roll out.
This story is based on incorrect board papers which have now been corrected.

Please find a spokesman quote below. (closing signature removed)

A spokesperson for Babylon said:

“No pilot was ever carried out, nor any agreement signed with Babylon for such a pilot.

“Discussions were held after Babylon was selected in a competitive procurement exercise as the best technology to trial in GP practices across North West London. Subsequently, a decision was taken not to fund the pilot.”

This Editor then checked on the Digital Health article and found it had been removed without any follow-up or correction. Thus on Friday 8 Dec, this Editor removed the article, thanked Mr. Kenningham for bringing it to attention, and added that our report cited Digital Health as the source. I also requested a reference or third-party confirmation of his corrections. (This last request was not received as of the time of this writing.)

Wanting to get to the bottom of this for our Readers–and as a marketer who’s corrected more than a few inaccurate reports, your Editor has located the CCG’s report which is here published 22 November. It corresponds with Mr. Kenningham’s full note. The CCG report appears to have been revised (the URL indicates a v3), there never was a Babylon pilot, this version does not use the word ‘manipulation’, and the end result was that the CCG decided not to proceed to the pilot stage. In short, it appears to this Editor that the Digital Health report was based on an earlier and incorrect version of the report (perhaps as early as 25 Oct) and we are of course happy to correct. My fault and apology to our Readers and to Babylon in that I should have located the 22 Nov revised report prior to publishing the article and essentially provided a correction to Digital Health‘s report.

However, the CCG’s report on their Babylon evaluation contains two findings that were included in Digital Health‘s now-deleted article and give some pause. The CCG used focus groups of potential users, which surfaced that, in the CCG’s words, “The focus groups had also commented that there is a risk of some people gaming the symptom checker to achieve a GP appointment. The insights gathered therefore revealed that the symptom checker in particular was unlikely to reduce demand for GP services.”

Updated: Our Editor Chrys has pointed out the Pulse article which also comments on this and was corrected for the CCG’s revised report. The comments here by practicing GPs are worth reading. Scroll down and you’ll see that  ‘gaming the system’ has happened using direct triage in practices using personal phone consults–no app required. Can this even work?

Focus groups are highly subjective, but they are great ways of surfacing the flaws that developers and companies have gone blind to.

We hope that Babylon Health does take this feedback seriously. This Editor makes no secret of her advocacy of technology that can speed the obtaining of care, but based on her experience with early-stage companies, every critique, every hole kicked in a service, delivery, and logistics should be appreciated–and ruthlessly scrutinized for flaws that need solutions. This becomes harder to do when you’ve achieved Big Funding. Babylon is typically burning a hole through it (The Times, 1 Oct–hat tip to Chrys). The pressure on now to find The Road to Breakeven is stunning.

Speaking of finding solutions, Babylon should also note the findings of the Care Quality Commission (CQC), not to be confused with the CCG, in their report published on Friday 8 December. The CQC is the independent regulator of all health and social care services in England; the closest US equivalent would be the Joint Commission. The CQC uses a five-point evaluation measure (page 3) developed via staff, stakeholders, organizational documents, and sample medical records. Their extensive evaluation is published here.

In most aspects, it’s a highly favorable evaluation by the CQC, except in three care areas: prescribing decisions were not always made appropriately, that prescribing information wasn’t always shared with the patient’s GP to ensure safety, and there was no system in place to give assurance that patients’ conditions were being appropriately monitored. This means to the CQC that Babylon is not meeting Regulation 12 HSCA (RA) Regulations 2014 ‘Safe care and treatment’ in three aspects which are summarized on page 13 and detailed in the report.

What was distressing is that the HSJ (paid subscription only) reported that “Babylon Health Services has failed to stop the publication of a Care Quality Commission report that states it is not providing a safe service in some areas.” and that the CQC report was published after an injunction was lifted. It is one thing to differ with the findings, another thing to use legal action to stop a regulator’s report, but at this point we only have the HSJ article stating this. This Editor is standing by for further reports on this matter and Reader citations of further information. Hat tips to Roy Lilley, Editor Emeritus Steve Hards, and Editor Chrys.

Analysis of the CVS-Aetna merger: a new era, a canary in a mine–or both?

click to enlargeThis Editor has been at two healthcare conferences in the last four business days (with tomorrow being a third). They should be abuzz about how the CVS-Aetna merger may transform healthcare delivery. To her surprise, there’s been a surprising lack of talk. There is a certain element of ‘old news’, as the initial reports date back five weeks but the sheer size of it ($240bn combined future value, $69bn purchase, an estimated $750 million in near-term synergies), being the largest health insurance deal in history, and the anticipated effects on the health delivery model normally would be a breaking news topic. To this Editor, it is a sign that no one truly knows what to make of it, and perhaps it’s too big–or threatening–to grasp for provider and payer executives especially.

For an overview of what we saw at the time as reasons why and possible competitor reaction, Readers should look back to our original article [TTA 28 Oct]. It’s being presented by both companies as a vertical merger of two complementary organizations, which already were moving towards this model, integrating their different services into “America’s front door to quality health care” (CVS CEO Larry Merlo)–a lower cost setting that saves premium dollars and brings integrated care to consumers’ doorsteps.

CVS brings to the table huge point of care assets: 9,700 pharmacy locations, 1,100 MinuteClinics, Omnicare’s senior pharmacy solutions, Coram’s infusion services, and the more than 4,000 CVS Health nursing professionals providing in-clinic and home-based care. Aetna has about 23.1 million medical members, 14.5 million dental members, and 15.2 million pharmacy benefit management (PBM) services members. Aetna also has a wealth of advanced data analytics capabilities through two subsidiaries, ActiveHealth Management and  Medicity’s health information exchange technology.

Seeking Alpha has an intriguing POV on this entry into a ‘new era’: that both CVS and Aetna consider this to be a long-term reshaping of their business model under the threat posed by Amazon, and are willing to do this despite little short-term financial benefit for either company. The problem as the writer sees it: execution. This is re-engineering care on a national scale, and its benefits are based upon combining intangibles, a murky area indeed especially in healthcare. Time is also a factor, as Amazon is getting pharmacy licenses in multiple states, and is rather an expert at combining intangibles.

Does it signal that the approach to a ‘new era’ in healthcare is accelerating? If this is a preview, 2018 will be extremely interesting. Our ‘canary in the coal mine’ may tweet–or fall over on its perch, asphyxiated.

Some additional points to consider: (more…)

HeyDoctor! Come and get your diagnosis via text here!

An app that makes this semi-grizzled pioneer feel…not quite on board the wagon. HeyDoctor is not for horses, but for those who Text to Live. Yes, all you need to do if you feel under the weather is to download the app, text the doc, get your diagnosis, and prescription. Like that. No need to comb your hair and wash your face for that video visit. According to the website, you can get anything from a UTI to acne to erectile dysfunction diagnosed and treated. Out of birth control? Handled. You can get tests ordered up for blood typing, HIV, and metabolic analysis. Not happy with your lash thickness and growth? Here’s the topical med for you! Trying to quit smoking? Done. All you need do is text one of their in-house board-certified physicians and live in one of 19 states where it’s offered.

For our UK Readers, this is a service with similarities to Babylon Health‘s chatbot service but without the decision support ladder–it goes straight to the doctor.

They claim on the website that most visits are five minutes and under $20 in cost, plus affiliations with leading medical centers like UCSF and Georgetown, although this Editor doubts that Amazon Web Services (AWS) is a ‘healthcare organization’ in the same category.

MedCityNews confirms their playbook, for now, is B2C, but the San Francisco-based founders are considering partnering with health systems. According to Crunchbase, funding so far is seed from the two founders, Brendan Levy, MD, a SF-based family medicine practitioner, and Rohit Malhotra, an attorney. LinkedIn counts three employees.

So why not on board the Conestoga? While the convenience is very attractive, there’s also the opportunity for misdiagnosis–the kind of thing we used to worry about with telemedicine. Does the app secure the texts for privacy? Many of these conditions aren’t hangnails–HIV and UTIs come to mind. Oddly, photo upload isn’t mentioned–important with acne. Testimonials point to convenient prescription renewals, but that information can be falsified–easy to do with text. Identity too with smartphones can be faked. A video consult also permits the doctor to see the patient and pick up at least some physical signs of illness. Also not inspiring confidence: a website that crashed when I looked for FAQs and had a chatbot named Brendan (same face as Dr. Levy’s) constantly popping up after X’ing him out. To this Editor, it feels like some verification and diagnostic layers are…missing.

Some reflections on ATA and a future CEO–your ‘nominations’ wanted!

This Editor and publication have had relationships at different levels with the American Telemedicine Association (ATA) since at least 2006. Our Readers know of TTA’s long-standing support of ATA’s annual meeting as a media partner. As a marketer, I’ve negotiated booths, sponsorships, and sent staff (including myself) to meetings, which makes this experience like many of our Readers.

It is worth reflecting that in 1993, when Jon Linkous took the ATA helm, few of us other than academics had email or used the Internet except in limited ways like IBMMail or Minitel. Once telemedicine, video consults, and vital signs data capture were the future and mostly theory. We went through the whiz-bang gadget phase, where every new one was going to change healthcare as we know it. Now we are past the buzzy cocktail party hangover into trying to make it work. We are in 2.0 and 3.0 where it’s all about integration of telemedicine and telehealth into patient engagement, behavior change, data analytics, predictive care, genomics, improving life for the aging and chronically ill population, managing the tsunami of patient data for better outcomes, smart pills, hacking and data security, EHRs, ACOs, meeting standards such as MACRA…and heavy engagement with national (Federal) and local entities. And always–getting paid enough to stay afloat!

As an organization, ATA faces an ever-expanding HIMSS, which has expanded far beyond its health information/IT/data analytics raison d’être to media properties, multiple health tech conferences, and now presence with early-stage companies through acquiring Health 2.0.

Dizzying changes, and more to come.

Who do you want to see at the helm of ATA? What will be the new CEO’s problems to solve? List your choices and thoughts in Comments below! (If you wish to be anonymous, email Editor Donna in confidence.)

The Theranos Story, ch. 37: the Object Lessons for future healthcare entrepreneurs

click to enlargeThere’s an interesting take on the Theranos debacle in Entrepreneur by management consultant/author Steve Tobak. He takes a step back from the healthcare technology that didn’t work, the big money lost and the puffery, where most of us have concentrated. Mr Tobak instead sketches a case study of a Startup House of Cards as an Object Lesson in how entrepreneurialism is NOT supposed to work.

Theranos was a Top Ten List of fatal errors. This Editor’s summary:

  1. They generated no revenue. In just over a decade, Theranos blew through hundreds of millions in funding (he says $700 million, the WSJ has estimated $900 million).
  2. They weren’t anywhere near break-even. By the time Theranos was in 40 Walgreens Wellness Centers, it should have been on a road to break-even and scalable.
  3. The company was built as a fraud from the start or near-start, much like Enron and WorldCom
  4. The company was doomed by a culture of utter secrecy (Editor’s note: none of their technology was peer reviewed, tested or published)
  5. The company was doomed by Ms Holmes’ falsity and hubris in not having a backup plan; black turtlenecks aren’t it
  6. The company was doomed by its own hype: a PR machine AND gullible press, who created a Steve Jobs-esque icon sans accomplishments out of Ms Holmes
  7. The company sold a bill of goods to EVERYONE, including multiple Federal regulators, patients and the public (Editor’s note: he doesn’t mention the Board of Directors and Stanford University!)
  8. Investors, swept up in the private equity bubble, didn’t do their due diligence (though some did)
  9. Ms Holmes had no ability to run this business, but she controlled it 100 percent so no one said boo
  10. “This is what happens when people treat ventures so casually and callously that risk becomes immaterial.”–Mr Tobak

Perhaps we should be grateful that the Edison lab didn’t actually work with all these dysfunctions on parade!

The close to this article is sobering: “Today, there are 186 venture-backed startups valued at $1 billion or more and countless companies valued above $100 million, according to CB Insights. Not too long ago, Theranos was near the top of that unicorn list with a valuation of $9 billion. We still have no idea if it’s a one-off or the beginning of a trend. Remember the Theranos saga as a cautionary tale. Nothing about it is the way business should be. Nothing.” And it will continue, because $900 million makes Theranos a Big Cautionary Tale. Hat tip to our Eye on Theranos, Bill Oravecz of Stone Health Innovations.

See here for the 36 previous TTA chapters in this Continuing, Consistently Amazing Saga

Anthem to Cigna: That’s Sabotage! You’re staying, like it or not! (updated 21 Feb)

Breaking News in The War of the Payers. Late on Wednesday (15 Feb), Anthem received a temporary restraining order to block Cigna from terminating the merger. Judge Travis Laster’s decision in the Delaware Court of Chancery maintains the “legal status quo’ until an April 10 hearing, where he will hear arguments from both sides. Anthem is now able to proceed with a fast-tracked appeal in the DC Federal Court of Appeals to overturn the February 8 DC District Federal Court decision that denied the merger. The sole extension in the merger agreement is to April 30, which will be preceded by the Chancery Court hearing 20 days prior. Bloomberg, WSJ (via 4-traders.com)

Wednesday morning, Anthem had filed a temporary restraining order in Chancery Court to keep Cigna from ankling the merger, which would make an appeal moot. It was positioned in their February 15 release as “a temporary restraining order to enjoin Cigna from terminating, and taking any action contrary to the terms of, the Merger Agreement, specific performance compelling Cigna to comply with the Merger Agreement and damages.” Cigna wanted out immediately, as we noted on Feb 14, seeing no hope in challenging the District of Columbia Federal District Court ruling as Anthem does, and took the position that the extension was invalid. They also sought an additional $13 billion in damages for shareholders beyond the $1.85 billion breakup fee.

The language Anthem used in Wednesday’s release to justify the filing was harsh: “…Cigna does not have a right to terminate the Merger Agreement at all because it has failed to perform fully its obligations in a manner that has proximately caused or resulted in the failure of the merger to have been consummated.” Anthem then accused Cigna of actively working to sabotage the merger: “Cigna’s lawsuit and purported termination is the next step in Cigna’s campaign to sabotage the merger and to try to deflect attention from its repeated willful breaches of the Merger Agreement in support of such effort.”Also Forbes

Bottom line: ‘Cigna, you’re a bad and faithless partner, but we are going to force a merger by any means possible anyway.’ Cigna blames Anthem for botching the merger approvals. Does prolonging any of this make sense?

Updated 21 Feb The differences started at the very beginning, with C-level disputes on who would lead a merged company and other areas of governance, so obvious (and public) they were cited by DC Federal District Judge Amy Berman Jackson’s Feb. 8 decision. David Balto, an antitrust lawyer in Washington, dubbed it ‘a shotgun marriage that went sour’ and not to discount Cigna’s case for damages due to business harm. After reading this article, you’ll wonder why they even started. Hartford Courant

Analysis Any merger between Anthem and Cigna has become, despite the language, a hostile takeover, worthy of Frank Lorenzo in this Editor’s airline days, or more recently, Carl Icahn. Having worked for Mr Lorenzo years ago, observing from my tiny chair way over on the sidelines, I learned that hostile takeovers and poorly thought-out mergers don’t work out well, in service delivery or economics, short or long term. They usually end badly, in bankruptcy court, with many tears shed and lives wrecked.

Memo to Anthem and Cigna–is this really necessary? Here we are dealing with insurance, and service to policyholders/members, affecting both their health and wealth. You both talk a good game about saving on medical costs, accelerating the progress of value-based care, delivering value to shareholders, and improving quality. But you hate each other and have from the start. Playing the game of Who Blinks First, and the distraction of a long and bitter legal battle, cannot be anything other than harmful to your members, employees, doctor and health system providers, your bottom lines, and your future.

This is not the airline business, beverages or detergent. It’s people’s lives here–have you both forgotten? Enough! Stop now! Get back to the business of healthcare!

Previously and related in TTA: Cigna to Anthem: we’re calling it off too, Aetna’s Bertolini to Humana: let’s call the whole thing off, Anthem-Cigna merger nixed

Action This Day in US healthcare, coming to pharma, insurance, home care and innovation

Action This Day, in Churchill’s words. Today’s news of President Trump meeting with the CEOs of US pharmaceutical companies– Novartis, Merck, Johnson & Johnson, Lilly, Celgene, and Amgen–along with the PhRMA association head, indicates the speed of change that this two-week old Administration intends in healthcare. Trump’s points to the Pharma Giants: drug prices need to be brought down, especially for Medicare and Medicaid patients, through competitive bidding not price-fixing; bringing home production to the US; and that there is ‘global freeloading’ on US drugs. This last is a bit vague, and the pricing part may stir some Standard Republican Resistance, but what Trump also came down firmly for is speeding up the drug approval process. In return, the execs asked for tax reform.

Notable here is this quote:  “I’ll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market,” Trump said. “That includes price-fixing by the biggest dog in the market, Medicare, which is what’s happening.” The Hill, Business Insider

Does this mean an open door and encouragement for healthcare technology?

Certainly many startups, early-stage companies, and Grizzled Pioneers are eagerly anticipating a more open healthcare business environment than the many dictates, restrictions and the constant changing of goalposts they have faced for the past eight years. The hope is an openness of the Powers That Be on the Federal side (CMS, HHS, FDA) to innovation, patient-centered care and a change away from hammering constantly on lowering cost through a multitude of controls and top-down diktats on what Healthcare Should Be.

This Editor has seen companies straining to hang in there, playing the niches, moderating their equity raises, merging, projecting profitability sometime in the future. Some have not made it. One is the pioneer telehealth company Viterion Corporation, which was quietly dissolved by its parent company in Japan for various reasons at end of last year. (Editor’s disclaimer: I was marketing director for the company.)

Already innovation is reaching long-neglected areas like home care. Home support for the aging population isn’t buzzy, analytic or sexy, but it’s ready for change. The Financial Times takes a look at this $40 bn US market, focusing on the Hometeam caregiving service presently in New York, New Jersey and Pennsylvania, which has over $43 million in investment after only three years (Crunchbase); Honor, which has over $65 million in funding, operating California and Texas. Their points of difference from traditional home care agencies involve models and technology. Hometeam employs carers who are full employees with benefits and an average of $15/hour pay, double that of the usual minimum wage paid to independent contractors. They equip carers with iPads to track what happens in the home, and to report daily to families. Honor has an algorithm to help it scale up from the 100 or so carers who are the ‘break point’ in matching carers with patient needs. In contrast, the UK is far behind in development. The article looks at Vida which uses a mix of carers and technology for its private pay clients. Now approved by the Care Quality Commission, Vida is already in talks with local councils across London and Brighton. But funding is thin: £400,000 of start-up funding and planning to raise £1 million. Tech start-ups try to fix ailing US elderly care sector. If paywalled, search on the title. Hat tip to Susanne Woodman

Action Next Days? Predictions have been all over the place since the election. Many have been overheated (and highly political), but others explain the complexities of undoing the past six years. A reminder: the PPACA did not go into effect until 2010 and most of the provisions kicked in during 2011. Health tech law firm Epstein Becker Green trotted out its crystal ball (more…)

What are the impacts of NHS CCGs forcing disabled and LTC patients into care homes? (UK)

click to enlargeCare for elderly and disabled goes off the tracks again. A report in the Health Service Journal (subscription required), covered in an opinion piece in the Guardian, indicates that thousands of patients who are disabled and also those who require long-term care may be forcibly put into care homes (US=nursing homes) rather than being treated and maintained in home care. According to the HSJ, “Freedom of Information (FOI) requests from campaign group Disability United found that 37 NHS clinical commissioning groups (CCGs) in England were introducing rules about ongoing care that could force up to 13,000 people with health conditions into care homes.” CCGs due to NHS cuts have been setting limits on financing home care, between 10 and 40 percent above the care home option. In other words, where a care home is cheaper, the CCG will withdraw payment for home care, and unless the individual can self-pay or has an advocate who can organize a care plan, that person may be involuntarily moved.

The word ‘institutionalization’ deservedly strikes fear on both sides of the Atlantic as a recipe for patient decline, physical and verbal abuse, theft and generally bad care. It’s a blunderbuss solution to ‘bed-blocking’ which we discussed here [TTA 7 Sep 16]–the care plan becomes ‘move ’em out’. By going this way in policy, NHS England is going counter-trend, against more personalized care delivered in home settings, and setting an unfortunate trend for other countries like the US.

Outside the scope of the article, but in this Editor’s thoughts, is the knock-on effect it will have on the UK’s developers and providers of telehealth and telecare services/TECS designed to support home care. Many of these technologies are in a transition period to the greater capabilities (and freedom from land line) of digital from analogue care, which was discussed in TTA here. Cutting domestic demand may not only be critical not only to companies’ survival, but also to their expansion in the (now far more open to the UK) US market. Readers’ thoughts?

TechLaw: NDAs are not one size fits all; they are dangerous!

The subject of nondisclosure agreements–NDAs–is often treated as routine, not only in the US but also in the UK and Europe. Editor Donna has reviewed and signed a few, modifying only limited areas of ‘boilerplate’. Our contributor today is an attorney specializing in technology law, Mark Grossman, JD, and he explains to us that an NDA should not be treated quite so cavalierly–and that red flags should fly any time a trade secret is involved. (Editor’s emphases are italicized and bold.)

In the world of tech deals — more than other types of deals — my clients want to sign nondisclosure agreements quickly. I’m sure that many people will disagree with me on this one, but I like to avoid NDAs in the early stages of a deal. My feeling is that you shouldn’t be exchanging secrets with strangers and that doesn’t change no matter what they’ve signed.

Experience tells me that most deals at the “initial feeler” stage never reach fruition. It’s a long way from that first lunch to a closing and a bottle of champagne. I say skip the paperwork and legal entanglements until you’ve at least gone as far as thinking: “This is getting interesting and serious.” In the meantime, keep your secrets to yourself.

Usually, you can get through the early stages of a negotiation with a demonstration of what “it” can do without revealing how it does it. Of course, if what it does is as much a secret as how it does it, then my generalization may not be true for you.

In case you’re not familiar with NDAs, the idea behind them is that you’ll reveal confidential information only if the other side agrees not to improperly disclose or use the information. Right here, it starts getting tricky because you have to decide to whom they can disclose it and for what use.

Watch out for a form with a line for your company name. If you’re tempted to sign it, I have some simple advice: Don’t. Not ever.

Every NDA is customized. Since tech lawyers see NDAs constantly, writing a good one should never be an exercise in reinventing the wheel. Still, they do require some thought. (more…)

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.

WLSA merger with PCHAlliance: the digital health conference scene contracts a bit more

Over the weekend, the Personal Connected Health Alliance (PCHAlliance) and the Wireless-Life Sciences Alliance (WLSA) announced that the San Diego-based WLSA would be combining its operations with the PCHAlliance. This follows on the earlier announcement [TTA 21 Oct] that the Boston-based and Partners HealthCare- owned Connected Health Symposium would be folding its operation into the PCHAlliance. Both Robert B. McCray, co-founder and CEO of WLSA, and Dr Joseph Kvedar of Partners HealthCare are now Senior Advisers to the PCHAlliance, with Mr McCraw heading Thought Leadership and Dr Kvedar now Program Chair of next year’s event.

WLSA has been largely inactive on the conference scene since 2015, when it staged its last Convergence Summit in May and the Wireless Health event in October of that year. The Convergence Summit has been merged into PCHAlliance’s Connected Health Conference kicking off today near Washington, DC. The Wireless Health event will continue through a collaboration with IEEE/EMBS cooperating with the National Institutes of Health (NIH) and the National Science Foundation (NSF).

In their release, PCHAlliance emphasized WLSA’s experience in research within engineering, computer science, biomedical and health disciplines. Patricia (Patty) Mechael, PhD, Executive Vice President, PCHAlliance in the release was quoted that “Their focus on medical and health research communities is a perfect compliment to our commitment to accelerate the adoption of clinical grade technology in consumer-friendly health outcomes- based business models.” Life science companies will be welcomed for membership in the PCHAlliance. PCHAlliance also includes Continua, which for well over a decade has been promoting engineering standards for device interoperability.

As this Editor looked back in October, when most of these organizations and events started about 2007-8, there were few Big Health conferences that took what was then dubbed eHealth and mHealth (later Digital Health) seriously. Now, of course, they do. There are also multiple events, large and small, expensive and popularly priced, every month in many cities–we attended and reported on #MedMo16 which will be branching out to multiple cities in 2017.

In looking back at our articles, the WLSA was engaged with the conference almost from the start, when the mHealth Summitwas one of the first ‘big name/big support’ conferences. Its tack then was governmental policy and what international NGOs were doing as a model for developed nations. It was organized by the Foundation for the National Institutes of Health, the National Institutes of Health and the mHealth Alliance up to 2012, when HIMSS took it over.

Grizzled Pioneers, and even the non-grizzled, can testify to the multiple phases in a decade up and down the Hype Curve: device-driven, mobile-driven, sensor-driven, telehealth, wearables, Big Data, population health, patient engagement, analytics, data integration, outcomes-based and a few others. This move confirms that many factors are blending: academic, engineering, software, biotech, genomics, social, behavioral, governmental–and that technology is not standalone or sitting in isolation, but is integrating and manifesting itself in all sorts of interesting places both behind the consumer scene and in policy, and to consumers on mobiles and in the home (IoT, which hasn’t resolved its multiple and obvious security problems).

Also Neil Versel in MedCityNewsTTA is a media partner of the PCHA CHC for the 8th year, starting in 2009 when it was the brand new mHealth Summit. Conference tweets on #connect2health.

Patients as People: creating clinically relevant social insights (part I)

Guest Editor Sarianne Gruber (@subtleimpact) reviews how one of the #MedMo16 Crowd Challenge winners, Aloha Health, has the ambitious goal of putting the ‘patient as person’ into the present healthcare model. They aim to provide and integrate into the patient record social factors and the context of everyday life, including environmental factors.

“The need to see patients as people is very real. It is an ideal that will drive healthcare transformation.”  Mandi Bishop (@MandiBPro) Founder & CEO of Aloha Health (@Aloha_Health).

Mandi Bishop prefers to be called the Chief Evangelist rather than the Chief Executive Officer.  Her new start-up, Aloha Health, launched this past July and she is making considerable traction.  I caught up with Ms. Bishop in New York at MedStartr Momentum, an equity Crowd Challenge, where she won the People’s Choice award. (Congratulations to Mandi and the Aloha Health team!)

Here is an edited transcript of our conversation.

What makes Aloha Health “unique” as a healthcare data and analytics company?

Bishop: Aloha Health was designed with a singular mission – to allow providers, care managers, and people who are participating in the patient’s care to “view” a patient as a person.  All contextual information about “you” is what makes you unique. This view of  “clinically relevant social determinants” is important because it impacts  your ability to manage your health on many levels such as your ability to follow instructions, how you  interpret information,  who you trust and how you engage. It is really important because we [providers] are all pressed for time. We are already seeing the patient revolution and hearing a lot of talk about engaging patients.  Aloha Health is providing an opportunity to see patients as people without imposing additional time. We give you specific insights to help you see your patients as people.

How do see non-clinical insights adding value to value-based care metrics?

Bishop: As our industry moves from volume to value and from fee for service to more programs like comprehensive joint replacement and bundled payment methodologies such as ACO models. These types of shared savings programs involve shared risk. When you have a capitated payment structure where you are being asked to manage the care of an entire population, including people with a set number of funds. Obviously, you have to find ways to be very effective in that care delivery. You have to understand all the things about that population, and each patient as an individual to help him or her to help themselves become healthier.  In turn, this saves money for organizations through improved health outcomes.

What types of data would be considered as the “other 95 percent”?

Bishop: The first 5 percent of the health data happens in the clinical setting.  The remaining data is what we refer to as the “other 95 percent” and is what happens at home, at work, and in the environment.  (more…)

Optum’s Utopia of proactive patient care–without telehealth

click to enlargeAnd we wonder why telehealth patient monitoring is floundering and telemedicine is only starting to take off? In this Editor’s reading today, up came this rather glossy, beautifully designed advertorial web page in The Atlantic sponsored by healthcare services provider/holding company Optum. It describes a proactive, highly supportive care process that starts with the diagnosis of a chronic condition (in this case developing CHF) through a ‘health scare’ handled at an urgent care versus a hospital ED, then to care at home (from a highly engaged nurse-practitioner no less) and a patient who, suitably engaged, is “responsibly managing her condition through a wellness approach” and has an improved lifestyle.

Other than an EMR (integrated between provider and urgent care–but EHR is the more current term), no other technology other than telephonic is mentioned in this rosy picture. Where’s the telehealth app that touches our patient, letting her chart her weight, breathing and general wellness, sending it to her EHR and alerting that nurse so she can truly be proactive in seeing changes in her patient’s health? Where’s the telemedicine virtual visit capability, especially if our patient’s out of breath outside of normal office hours, or there’s a blizzard and that nurse can’t visit? Here’s all the infrastructure built up for integrated care, but where’s the technology assistance and savings on home health visits and transportation for the patient?

It can’t be that Optum doesn’t know about what telehealth/telemedicine can do and the role it already plays in care? It can’t be that it doesn’t fit in the integrated care infrastructure? Or does it have to do with reimbursement? (Optum is the parent of giant insurer United HealthcareReaders’ thoughts?

The Theranos Story, ch. 28: when the SecDef nominee is on the Board of Directors

click to enlargeDoes ‘Mad Dog’ ‘Warrior Monk’ James Mattis, General, USMC (ret.) have a blind spot when it comes to Theranos? President-Elect Donald J. Trump has selected him as the next Administration’s nominee for Secretary of Defense. A remarkable leader and, yes, scholar (check his background in various sources), but he has some ‘splaining to do, in this Editor’s opinion.

This Editor leads with this question because those who have been following the Continuing Saga (which, like the Nordics, seems never-ending) know that Theranos stuffed its Board of Directors (BOD), prior to last October, with a selection of Washington Luminaries, often of a great age: Henry Kissinger, George Shultz, Sen. Sam Nunn, Sen. Bill Frist (the only one with an MD), William Perry and Gary Roughead, a retired U.S. Navy admiral. It also reads like a roster of Hoover Institution Fellows except for Sen. Frist, who sticks to the East Coast. Another interesting point: Hoover is based at Stanford University, an institution from which Elizabeth Holmes dropped out to Follow Her Vision. Obviously, there was an accompanying Vision of Washington Pull.

Also joining the BOD as of July 2013, well before The Troubles, and shortly after his retirement, was Gen. Jim Mattis (also a Hoover Fellow, photo above). When the Washington Luminaries were shuffled off to a ‘board of counselors’ after the Wall Street Journal exposé hit in October, Gen. Mattis remained on the governing BOD. Unlike his fellow Fellows, he had actually been involved with a potential deployment of the lab testing equipment. As we previously noted, as commandant of US Central Command (CENTCOM is Middle East, North Africa and Central Asia), he advocated tests of the Theranos labs under in-theatre medicine conditions in 2012-13. Leaked emails cited by the Washington Post (in Gizmodo) and also in the Wall Street Journal indicate the opposition from the US Army Medical Research and Materiel Command at health-intensive Fort Detrick MD, which oversees medical research, based on the undeniable fact that the equipment and the tests weren’t FDA-cleared, which remained true two years later…and which Gen. Mattis tried to get around, being a good Marine. Nonetheless, the procurement of Theranos equipment was halted. DOD permitted him to join the BOD after retirement as long as he was not involved in any representations to DOD or the services. (Wikipedia bio)

Yesterday, Theranos also announced that it is dissolving (draining?) the ‘board of counselors’. They led with a BOD shuffle, with Daniel J. Warmenhoven, retired chairman of NetApp, replacing director Riley P. Bechtel, who is withdrawing for health reasons. (Warmenhoven also serves on the Bechtel board, so they are keeping an eye on the estimated $100 million they invested). Gizmodo and Inc. While effective January 1, the Theranos website has already scrubbed the counselors and updated the BOD.

However, Gen. Mattis remains a director, until such time as he actually becomes Secretary of Defense, which is not a lock for Senate approval by a long shot. First, he requires a Congressionally approved waiver demanded by the National Security Act of 1947, as he has been retired only four years (as of 2017) not the required seven. Second, his involvement with Theranos has already been questioned in the media. After all, it is a Federal Poster Child of Silicon Valley Bad Behavior: censured by CMS, under investigation by SEC and DOJ. It is a handy, easily understandable club with which to beat him bloody (sic). WSJ’s wrapup.

In this Editor’s opinion, the good General should have left in October, but certainly by April when CMS laid the sanctions down, banning Ms Holmes and Mr Balwani from running labs for two years in July. What is going on in the ‘Warrior Monk’s’ mind in sticking around? Is there anything to save? 

If the WSJ articles are paywalled, search on ‘Gen. James Mattis Has Ties to Theranos’ and ‘Recent Retirement, Theranos Ties Pose Possible Obstacles for Mattis Confirmation’.  Oh yes…see here for the 27 previous TTA chapters in this Continuing, Consistently Amazing Saga.

The Theranos Story, ch. 19: the dramatic denouement, including human tragedy

click to enlargeThe deconstruction of Theranos continues, con il dramma, rounding back to those who touted it. There isn’t all that much new in Nick Bilton’s Vanity Fair article, but it adds context and color to this (literally) Bloody House of Smoke and Mirrors. (Ah, where’s Christopher Lee when you need him?–Ed.) There’s the usual Inside Baseball of closed-door meetings in ‘war rooms’, G150 jetting to awards, bodyguards, threatening lawyers, crisis managers, COO ‘enforcers’ (Sunny Balwani) and playing the Silicon Valley investor game (with Google Ventures taking a very smart pass). Where this gets unusual is the portrait of Elizabeth Holmes as an obsessive, secretive, blondined Steve Jobs knockoff from the age of 19, with a hot idea that never matched scientific reality from the start, but with a great line of ‘making the world a better place’ magnified by Silicon Valley’s incessant, We’re The Top And You’re Not narcissism.

Even Narcissus ultimately saw a fool in that pool. Played and tarred to a greater or lesser degree were: the only major SV VC lured in, Draper Fisher Jurvetson, and off-SV investors like mutual funds and private equity have lost it all; Fortune, Forbes, CNN plus much of the tech and financial press; and respected people lured to the board like Marine Gen. James Mattis, who had initiated the pilot program in DOD, Henry Kissinger and former Senator Bill Frist MD. Then the alphabet agencies marched in after the author: FDA, CMS, SEC and DOJ.

Oh yes, that Zika test announced in early August? Withdrawn at end of August. Ms Holmes is appealing her two year lab ban. But she still has absolute control of what’s left of the business. Business Insider

Finally, the lede in many articles is the suicide of British chief scientist Ian Gibbons and Ms Holmes reaction. Already ill with cancer, (more…)

Robot greeter on the job at Ostend, Belgium hospital–and those killer robots

click to enlargeThis humanoid (but not Terminator-like, its developers are careful to say!) robot is currently on the job as a receptionist at Ostend, Belgium hospital AZ Damiaan. Equipped with healthcare-oriented software developed by local company Zora Robotics, the Aldebaran/SoftBank Robotics’ demure Pepper robot stands 1.2 meters (just under 4 feet), speaks 19 languages and works for about 20 hours on a single charge. Pepper communicates via its tablet interface but also is responsive to actions and emotions in what SoftBank calls a natural and intuitive way. The Pepper robot was first deployed in the hospital’s maternity area. The video has an awwwww…. illustration of a newborn grasping Pepper’s fingers. Previously, the toddler sized Nao robot worked with patients at AZ Damiaan for physical therapy. (Nao robots have also been featured in modern dance and as greeters at Japanese hotels and banks.) Reuters (video 1:51)

click to enlargeThis is a far more benign take on robots than the Daily Mail‘s recent screamer that “Killer robots are ‘quickly moving toward reality’ and humanity only has a YEAR to ban them” which conflates drone weaponry (human guided) with ground robots (human guided). As of now, They’re Still Puppets (more…)