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…)

Unintended consequences: American Well loses, loses patent, to Teladoc

On Tuesday, the Federal District Court of Massachusetts not only dismissed the American Well patent infringement lawsuit against Teladoc, but also invalidated American Well‘s patent, held by co-founder Dr. Roy Schoenberg since 2009. It was invalidated on the grounds that the claims in the patent were “too abstract” to be patentable and do not “amount to an inventive concept.” American Well is appealing the court decision.

Teladoc started this call-and-response in March 2015 by petitioning the USPTO (US Patent and Trademark Office) to invalidate several American Well patents. (AW claims to hold 28 patents and 22 pending applications). Shortly before Teladoc’s IPO on the New York Stock Exchange last June, American Well sued Teladoc on patent infringement. Those in the industry saw an effort to scupper the IPO. Our Editor Chrys at the time took a decidedly jaundiced view of American Well’s grounds for infringement:
This author is wondering who thought this was such a novel technology as to warrant a patent? What were they thinking? Having worked on developing unified messaging systems for a mobile phone operator at the turn of the century (now that’s a scary 15 years ago) I am just picking myself off the floor after reading this.
Surely all these functions are no more than what is in every instant messaging program, dating back to 1990s? Replace the words “medical service provider” by “friends” or “contacts” and “consultation” by “chat” or “call” it seems to me you get … Skype and Face Time and more! [TTA 9 June 15]
No matter, the result was yesterday’s double shot of a decision. In addition, three Teladoc complaints against American Well‘s patents to invalidate them are still in progress with the USPTO. A triple, anyone? MedCityNews, Teladoc press release, American Well press release
All this is despite the sobering facts that telemedicine has been unprofitable to date–and that IP wars have unintended consequences. (more…)

The difficulty in differentiating telemedicine and telehealth

Our Editors have always tried to cleanly define the differences between telemedicine, telehealth and telecare, even as they blur in industry use. (See our Definitions sidebar for the latter two.) But telemedicine, at least on this side of the Atlantic, has lost linguistic ground to telehealth, which has become the umbrella term that eHealth wanted to be only two or three years ago. Similarly, digital health, connected health and mHealth have lost ground to health tech, since most devices now connect and incorporate mobility. And there are sub-genres, such as wearables, fitness trackers and aging tech.

Poor telehealth grows ever fuzzier emanations and penumbra! Now bearing the burden of virtual visits between doctor and patient, doctor-to-doctor professional consults, video conferencing (synchronous and asynchronous), remote patient monitoring of vital signs and qualitative information (ditto), and distance health monitoring to treat patients, it also begins to embrace its data: outcome-based analytics, population health and care modeling. Eric Wicklund accumulates a pile of studies from initial-heavy organizations: WHO, HIMSS, HHS, Center for Connected Health Policy (CCHP), ATA, TRC Network. All of which shows, perhaps contrary to Mr Wicklund’s intentions, how confusing simple concepts have become. mHealth Intelligence

Congressional investigation confirms NFL attempted to influence concussion, CTE research

Not shocking to our Readers. In December, sports network ESPN reported that the National Football League (NFL) refused to fund research on detecting in vivo chronic traumatic encephalopathy (CTE) from a long-term $30 million unrestricted grant to the National Institutes of Health (NIH) [TTA 23 Dec 15]. A 91-page report by Democratic members of the House Committee on Energy and Commerce, which started after the December reports, confirmed that the NFL improperly attempted to shape the research after the grant, violating NIH peer-review process policies that stipulated no grantor interference. The NFL specifically objected to the objectivity of Boston University’s Robert Stern, MD heading up the $16 million project before the award in 2015, then tried to redirect the money, so to speak, in-house–to a group including Dr. Richard Ellenbogen, a member of the league’s panel on brain injuries and their bid for the project. Ultimately, the NFL withdrew the funding from the NIH, which went ahead with it. The project was awarded to BU, the Cleveland Clinic, Banner Alzheimer’s Institute (Arizona) and Brigham and Women’s Hospital in Boston.

The Congressional report’s six major conclusions were highly critical of the NFL in several ways and also scored the Foundation for the NIH for not acting as a ‘buffer’:

  1. The NFL improperly attempted to influence the grant selection process at NIH.
  2. The NFL’s Head, Neck and Spine Committee members played an inappropriate role in attempting to influence the outcome of the grant selection process.
  3. The NFL’s rationalization that the Boston University study did not match their request for a longitudinal study is unfounded.
  4. FNIH (Foundation for the NIH) did not adequately fulfill its role of serving as an intermediary betweenNIH and the NFL.
  5. NIH leadership maintained the integrity of the science and the grant review process.
  6. The NFL did not carry out its commitment to respect the science and prioritize health and safety.

When the grants were announced in September 2012 [TTA 7 Sept 12], there was great cheer that finally the NFL had decided that denial was, to use the old joke, a river in Egypt, and to do something about it. This also followed Army research on TBI being supported by the NFL. The first indicator that the funds were going elsewhere, as we noted a year later, was that a year later the Sports and Health Research Program (SHRP) funds were going to other medical problems like joint diseases and sickle cell anemia. While worthy, it had not been the prime publicized objective of the funds. The Congressional committee report also details how the NFL tried to steer the research away from Dr Stern, one of the leading researchers in the field, citing his support of players who refused to accept the CTE settlement in 2014. Beyond the NFL, research on CTE and concussion will impact any contact sports as well as the military and other head traumas. This Editor has previously reported on Dr Stern’s CTE research presentations in NYC and from other researchers in the field; search on NFL and Dr Stern both in current index and the back file. Congressional report, ESPN.com, New York Times.