TTA’s Autumn Action 2: a Digital Health 150 Hot List, Bubble Watch, WOT for TB, EHR alla voce, and latest on Theranos

 

As the Big Chill of Autumn sets in, there’s a new Hot List of Digital Startups, an IPO for the Bubble Watch, a fresh term for your lexicon, and a voice-activated EHR in your future. And Theranos’ Elizabeth Holmes can’t pay her legal bills. (Sigh)

CB Insights names a Top 150 of digital health startups (Quite attention-getting)
WOT with Proteus found equal to or better than DOT in TB medication adherence trial (Wirelessly Observed Therapy a new add to the lexicon)
The Theranos Story, ch. 61: Elizabeth Holmes as legal deadbeat (Priorities, priorities)
Health tech bubble watch: Alphabet-backed One Medical reportedly prepping for 2020 IPO (Letting the IPO dust settle?)
Does healthcare need a new EHR system? A major health system thinks so. (Allscripts gets a Northwell boost, alla voce)

We reflect in this fall season on the overuse of AI versus machine learning terminology–and why the TEC/telehealth boats aren’t rising with the market tide.

The confusion within TEC/telehealth between machine learning and AI-powered systems (AI is trendy, but trendy is not necessarily good when non-techies are buying your system)
If the market’s expanding, where’s the telecare and TEC boom? (A question we’ve been asking for years.)

Editor Charles jumps on the Analogue versus Digital Soapbox. (One of our most commented articles)

Telecare – time to sweat the analogue assets, not dump them (Editor Charles asks that you do your homework before you cart in that shiny new digital kit and throw the old out the window)

Summer may be winding down but activity is winding up. Doro acquires Invicta, Amazon’s PillPack hits a data wall, Humana first payer to join CTA. Judge Leon finally blesses CVS-Aetna’s merger after 9 months. And events, including Digital Mental Health at the RSM 23 Sept.

News and event roundup: Amazon PillPack, Humana joins CTA, NH’s telemedicine go, Fitbit Lives Healthy in Singapore, supporting Helsinki’s older adults, events
Shock news: the CVS-Aetna merger officially approved after 9 months (Judge Leon’s Final Judgment delivered. But what about future healthcare mergers?)
Doro AB acquires Invicta Telecare from Clarion Housing, increasing to nearly 200,000 users (UK) (Consolidation continues)
Digital Mental Health for Adults – a one day conference at the RSM on 23 September 2019 in London (Sponsored by the RSM)

Being contrarian, we consider that AI and machine learning may be doing real damage both in its workings and in the quality of all that medical data being fed into it. Regrettably, telemedicine in nursing homes looks like a permanent failure. And CMS takes the lead in the PFS with three new telehealth codes on opioid treatment.

A realistic look at why telemedicine isn’t succeeding in nursing homes (It should, but it’s the economics of the business)
Are AI’s unknown workings–fed by humans–creating intellectual debt we can’t pay off? (Building dangerous error upon error with bad data, destroying theoretical thinking–and that’s for starters)
CMS’ three new proposed telehealth codes, changes on inclusions, in 2020 Medicare Physician Fee Schedule (US) (CMS takes initiative in opioid treatment)


Have a job to fill? Seeking a position? Free listings available to match our Readers with the right opportunities. Email Editor Donna.


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We thank our present and past advertisers and supporters: Tynetec, Eldercare, UK Telehealthcare, NYeC, PCHAlliance, ATA, The King’s Fund, DHACA, HIMSS, Health 2.0 NYC, MedStartr, Parks Associates, and HealthIMPACT.

Reach international leaders in health tech by advertising your company or event/conference in TTA–contact Donna for more information on how we help and who we reach. See our advert information here. 


Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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The Theranos Story, ch. 61: Elizabeth Holmes as legal deadbeat

Did her lawyers expect otherwise? This weekend’s news of Elizabeth Holmes’ legal team at Cooley LLP withdrawing their representation services due to non-payment should not have caused much surprise. Cooley’s attorney team petitioned the court to withdraw from the case, stating that “Ms. Holmes has not paid Cooley for any of its work as her counsel of record in this action for more than a year.”

Cooley was representing Ms. Holmes in a class-action civil suit in Phoenix brought against her, former Theranos president Sunny Balwani, and Walgreens, charging fraud and medical battery. (When they withdraw, will she seek public representation based on poverty?)

Perhaps Ms. Holmes is the one who’s setting priorities, as the civil suit would be for monetary damages, and no money means there will be none for the plaintiffs to collect. The DOJ charges are a different story. She is on the hook for nine counts of wire fraud and two counts of conspiracy related to her actions at Theranos. Conviction on these could send her to Club Fed for 20 years plus a fine of $250,000 plus restitution for each charge. [TTA 16 June]

Last Wednesday, both Ms. Holmes and lawyers for her and Mr. Balwani were in Federal court in San Jose on the wire fraud and conspiracy charges, demanding that the government release documents from the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that allegedly would clear them. After an hour, Judge Davila set 4 November as the next hearing date. 

Defending oneself does not come cheap, but after your company’s value crashes to $0 from $9bn, one might be looking for change in your Roche-Bobois couch and wondering if your little black Silicon Valley-entrepreneur formal pantsuit/white shirt ensembles will last through the trial. CNBC 2 Oct, CNBC 4 OctFox Business, Business Insider

Events coming up soon–and in the autumn: Hunter College 13 May, Aging 2.0 London 21 May; NYeC’s November Gala, Connected Health Summit (16-18 Oct) poster call

Health Tech and the FDA: What You Need To Know, Monday 13 May, from 5-7pm is a discussion on what you need to know if your health or medtech service or device needs FDA approval. The main presentation is by Rebecca Wood, Partner at Sidley Austin LLP and former Food and Drug Administration Chief Counsel, and moderated by Charles Platkin, PhD, JD, MPH, the co-executive director of the Hunter College Center for Health Technology. Tickets are free but registration is required here (Eventbrite). Location is Hunter College, 2180 Third Avenue @ 119th Street, Main Auditorium (on 2nd Floor), NYC. Hat tip to Sonia K. Gonzalez in the Health 2.0 NYC Community.

And in London 21 May, conveniently the evening before the Digital Health and Care Congress, warm up at Aging 2.0 London to learn how age-tech “Zebras” (Z) a/k/a businesses, can take advantage of age-tech advances and hear from a panel of five from start ups, investors and government on the opportunities, challenges and realities of the UK tech business. Hurry–the website indicates only 25 tickets left. London, 21 May, 5.30 pm at Google for Startups London Campus, 4-5 Bonhill Street London.

Save the date, and plan ahead! The New York eHealth Collaborative, a regional non-profit organization that promotes the integration of health information through exchanges (HIEs), hosts an annual Gala that is one of the major events on the local New York healthcare business calendar. This year, the Gala will be the evening of 20 November at the Edison Ballroom in Manhattan. Your Editor attended in 2017 (missed 2018) and it was a memorable event. It annually honors three to four national healthcare executives who are also leaders in healthcare technology. If you are at all engaged with healthcare systems and technology in the New York metro area, it’s worth your time and fisc to attend this event to be the company of over 250 C-suite executives, leaders, and policymakers. Gala and Awards website  

Your Editor still misses their conferences, the last of which was one of the best she ever attended in (unbelievably) 2016 [TTA 17 Jan 17]. In 2014, their conference was also the site of an epic Eric Topol/Ezekiel Emanuel ‘face-off’ of radically diverging visions. That was hard to top! Their Executive Director Valerie Gray shares NYeC updates on YouTube including updates on Federal health tech initatives: TEFCA enabling nationwide health information exchange, and two similar proposed rules from CMS and ONC on interoperability, both with comment periods ending in June. 

Call for Poster Abstracts starts 27 May for the Connected Health Conference in Boston 16-18 October. Now a joint presentation of PCHAlliance and Partners HealthCare, the Call for Abstracts for Posters starts on 27 May and ends 27 June. The 2019 theme is Designing for Healthy Habits and Better Outcomes. For more information and application, see here. Winners receive a complimentary registration to the conference for the presenting author and discounted tickets for co-authors. TTA has been a past media sponsor of both the Connected Health Conference and NYeC’s Digital Health Conference.

The Theranos Story, ch. 59: there’s life left in the corporate corpse–patents! And no trial date in sight.

You can get blood out of this. Really! The US Patent and Trademark Office (USPTO) awarded five–count ’em, five!–patents to Theranos in March and April. All of them were filed between 2015 and 2016, when the whispers of fraud were getting louder, as were the legal threats.

The five patents are:

1. Systems, devices, and methods for bodily fluid sample collection, transport, and handling
2. Systems, devices, and methods for bodily fluid sample transport
3. Systems and methods for sample preparation using sonication
4. Systems and methods for sample preparation using sonication (cell disruption)
5. Rapid measurement of formed blood component sedimentation rate from small sample volumes

The CB Insights Research article has the details on what they cover, including patent application illustrations. It’s not stated, but looking back to TTA’s many articles, in this Editor’s judgment, the heir to these patents cannot be Elizabeth Holmes or her many investors now feeling the lint in their pockets, but the company holding the last note, the $65 million (not $100 million) loan from Fortress Investment Group LLC, part of Japan’s SoftBank Group [TTA 28 Dec 17]–collateralized by the portfolio of over 70 patents. Hat tip to HISTalk 19 April

If you hunger for a deep dive into the design of Theranos’ blood analyzers that never really worked, and can appreciate that the miniLab was what “one expert in laboratory medicine called “theater … not science”, this Design World article is for you: Schadenfreude for Theranos — and satisfaction in how engineering doesn’t lie

Meanwhile, back in the US District Court in San Jose, California, we learn that the trial of Ms. Holmes (now engaged to William “Billy” Evans, a 27-year-old heir to the Evans Hotel Group, which has three West Coast resort properties and who is also a techie) and former Theranos president Ramesh ‘Sunny’ Balwani has been delayed indefinitely. Originally reported to be summer entertainment with a start date of 8 July, the judge set the next status conference for the case for 1 July, but refused to set a trial date, which means that the trial may not begin till next year. According to the San Jose Mercury News, the defense is seeking materials from the FDA and CMS, which are, according to defense lawyer, lawyer Kevin Downey, are “in many instances exculpatory.”

Ms. Holmes’ lawyers are also seeking information on the communications between John Carreyrou of the Wall Street Journal, the FDA, and CMS. In a motion filed last week, they accused Mr. Carreyrou under the guise of investigative journalism of “exerting influence on the regulatory process in a way that appears to have warped the agencies’ focus on the company and possibly biased the agencies’ findings against it.” Stat

The bubbly Ms. Holmes and Not-So-Sunny Balwani are facing Federal charges of two counts of conspiracy to commit wire fraud and nine counts of wire fraud. They each face a maximum of 20 years in prison and up to $2.7 million in fines.

TTA’s Week: Eric Topol does the NHS’ future, robotic therapy for autistic children, telehealth’s wind at back, and Editor Charles’ roundup

 

The Topol Review’s relationship to reality explored by Roy Lilley. Robotics effects in therapy for children with autism and CP. The wind’s even more at the back of telehealth–but there are caveats. Plus Editor Charles is back with a UK digital health roundup.

And scroll below for news of The King’s Fund’s Digital Health and Care Congress–plus 10% off registration for our Readers!

Roy Lilley’s tart-to-the-max view of The Topol Review on the digital future of the NHS (This week’s Must Read)
Robots’ largely positive, somewhat equivocal role in therapy for children with autism and cerebral palsy (HIMSS)
The wind may be even stronger at the back of telehealth this year–but not without a bit of chill (VA, Virginia as indicators–and the hurdles when you get there )
A selection of short digital health items of potential interest (Editor Charles is back with views on AI and events)

The telehealth entrepreneur and the $5 million fraud = 15 years in prison. Scotland’s Current Health wins FDA clearance, Latin America telemedicine’s uncertain state, women in eHealth, and studies on digital health in health systems.

News roundup: Current Health’s Class II, Healthware Italy’s €10 million boost, the low state of Latin America telemedicine, weekend reading on digital health in health systems
Digital health versus eHealth: ‘here we go again’ with the confusion and the differences. Plus Women in eHealth (JISfTeH) (Reviving the terminology discussion)
The telehealth ‘entrepreneur’ whose $5 million funding bought stays at the Ritz and portfolios at Bottega Veneta (And 15 years in the Federal pen. Tell your mum or uncle to be wary of good stories)

Our lead this week is the sale of Tunstall’s US operation. Unicorns need to hype less and publish studies more. The King’s Fund’s two events in March and May, Bayer’s accelerator winners, and news from Apple to teledermatology for São’s spotted!

Short takes: Livongo buys myStrength, Apple Watch cozies with insurers, Lively hears telehealth and $16 million
Tunstall Americas sold to Connect America
(Tunstall conceding their business is outside the US)
Where’s the evidence? Healthcare unicorns lack the proof and credibility of peer-reviewed studies. (Unicorns need to add substance to the sparkle)
News roundup: Virginia includes RPM in telehealth, Chichester Careline changes, Sensyne AI allies with Oxford, Tunstall partners in Scotland, teledermatology in São Paolo
The King’s Fund ‘Digital Health and Care Explained’ 27 March
(Readers also get a 10% discount at the 22-23 May Congress)
Bayer’s G4A accelerator awards agreements with KinAptic, Agamon, Cyclica (DE) (A truly international accelerator program)

Latest through the revolving door is NHS’ chief digital officer, digital health may be more ‘bubbly’ than you would like, telemedicine and telehealth gain important consumer and Medicare facing ground, and fill your calendar some more!

NHS England digital head Bauer exits for Swedish medical app Kry, but not without controversy (The revolving door reveals a self-made cloud over her head)
Events, Dear Friends, Events: UK Telehealthcare, Mad*Pow HXD, dHealth Summit (Get out the calendars–and the checkbooks/app)
Telemedicine virtual visits preferred by majority in Massachusetts General Hospital survey (Over 94% loved the convenience alone)
Medicare Advantage model covering telehealth for certain in-person visits starting in 2020 (The needle moves–slowly)
It’s not a bubble, really! Or developing? Analysis of Rock Health’s verdict on 2018’s digital health funding. (‘Bubbly’ factors that may influence this year–not for the better)

We round up the Official Healthcare Circus of CES, Verily rolls along with $1 bn in investment, and Walgreens Boots finally makes an alliance splash with Microsoft

It’s Official: CES is now a health tech event (updated) (And still a circus! We round up the top coverage so you don’t have to)
News roundup: Walgreens Boots-Microsoft, TytoCare, CVS-Aetna moves along, Care Innovations exits Louisville
Verily, Google’s life sciences arm, gathers in another billion to go…where? (Updated for Study Watch clearance) (Still a mystery)

Our first full week in January is full of news and events, from CES to RSM, plus lots of healthcare acceleration!

News roundup: CES’ early beat, CVS-Aetna pauses, digital health fizzes, Yorkshire & Humber Propels
Events, Dear Friends, Events part 2: Newcastle and Texas accelerate, Aging2.0 NYC gets happy, AutoBlock’s Meetup, Wearable Tech, HealthImpact East
Events, Dear Friends, Events: Hancock at the RSM, MedStartr NOLA Challenge, RSM and The King’s Fund

We start our 2019 first in West Africa with a health facility mapping initiative addressing epidemics and service distribution. On to the UK with Babylon Health’s chatbot problems revealing an increasingly fractious relationship with the business press–one of our most read articles ever. And 3rings may be exiting, but doing so with grace and consideration–another Top Read.

Healthsites, eHealth Africa mapping health facility locations in West Africa to improve emergency care (Fighting epidemics and improving disaster response using health tech)
Is Babylon Health the next Theranos? Or just being made out to be by the press? (Soapbox) (A few best practices might stop a growing pile-on–or a Big Problem)
3rings’ well-handled transition to their March shutdown (updated) (Referring their clients to other UK companies based on the customer’s needs) 


The King’s Fund’s annual Digital Health and Care Congress is back on 22-23 May. Meet leading NHS and social care professionals and learn how data and technology can improve the health and well-being of patients plus the quality and effectiveness of the services that they use. Our Readers are eligible for a 10% discount using the link in the advert or here, plus the code Telehealth_10.


Have a job to fill? Seeking a position? Free listings available to match our Readers with the right opportunities. Email Editor Donna.


Read Telehealth and Telecare Aware: http://telecareaware.com/  @telecareaware

Follow our pages on LinkedIn and on Facebook

We thank our present and past advertisers and supporters: Tynetec, Eldercare, UK Telehealthcare, NYeC, PCHAlliance, ATA, The King’s Fund, HIMSS, Health 2.0 NYC, MedStartr, Parks Associates, and HealthIMPACT.

Reach international leaders in health tech by advertising your company or event/conference in TTA–contact Donna for more information on how we help and who we reach. See our advert information here. 


Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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A selection of short digital health items of potential interest

Editor Charles has taken time off recently from assessing mHealth apps to give us a selection of short news items and event notifications.

CE and FDA certification

This editor recently stumbled over the first list he’s ever seen of approved digital health medical devices. As of today there are some 151 products on there which is hugely impressive. One of the reasons for the relatively poor showing of CE certifications on the list is that there is no official list yet: latest forecasts for Eudamed, which will provide this, are Spring 2020 amid much uncertainty about whether enough Notified Bodies will be approved to certify to the MDR in time. Immediately spotted as a CE certification missing is Walk with Path’s Path Finder device for helping people with Parkinson’s to avoid a freezing of their gait (though CE certification is well hidden on their website) and doubtless there are others. Clearly the list points up potential benefits were it ever possible to harmonise the approval process across the Pond.

Longevity 

The first Longevity Leaders event took place on Monday, perhaps the first large event in the UK on that topic. Based on the enthusiasm of attendees, clearly it won’t be the last. Doubtless in due course it will fragment into a myriad of specialist topics though currently it is a fascinating combination of almost every medical/pharmaceutical and digital discipline, plus housing and a range of other considerations. Timescales varied widely too – for example I talked about the immediate benefits of digital health including keeping people in their own homes, thus minimising sarcopenia from being confined to a hospital bed and avoiding exacerbating dementia by a change of environment, whereas others spoke of how best to make DNA immortal and whether the first person destined to live to 1000 had already been born.

Clinical  Homecare

From the sublime (last item) to the The National Clinical Homecare Association‘s conference on 31st January, where this Editor also spoke on how digital health could help people to be treated in their own homes. Notable was the absence of any Twitter handle for the Association, no hashtag for the conference and just two people it seemed out of 250 using social media. Clearly there are huge opportunities here for digital health suppliers, particularly as so much of what was said by other speakers, and what was being shown in the exhibition was very much manually-intensive stuff: join the NCHA and start a revolution in clinical homecare! 

Recent developments in AI

Since this editor stopped active involvement in conference organisation for the Royal Society of Medicine it is encouraging to see that the younger generation has picked up the baton and is running even harder, such that the above event, on 26th February, has proved so popular that it has been moved to the largest (300 seater) lecture theatre at the Society, and on current sign-up rate will sell out.  Speakers from Babylon, Ada Health, DeepMind, Kheiron Medical, BenevolentAI, UCL Life Sciences & Alan Turing AI partnership, and many more will ensure that delegates gain a comprehensive understanding of how AI is being used across healthcare. Book here to experience the delights of the new RSM all-new website which makes signing up for an event so much easier than in the past. Fear not though: the RSM’s legendary low ticket costs are maintained!

Wayra and Novartis

A most exciting event this week was the announcement of the joint Wayra and Novartis health call now looking for their next cohort of remarkable start-ups to join their new programme called The Health Hub. This is built together with their new partner Novartis, one of the leading pharma companies. Their focus is on how healthtech can be used drastically to innovate long-term disease management. Apply here, by February 17th. Hat tip to Professor Mike Short for this item and other observations in this post .

Rewired Pitchfest

Early health tech entrepreneurs should consider taking part in the Rewired Pitchfest at the Digital Health Rewired Conference and Exhibition, Olympia London on 26 March. Sponsored by Silver Buck, this provides the opportunity for early stage digital health start-ups to showcase their disruptive ideas and prototypes to NHS IT leaders. Applicants will compete before a judging panel featuring investors and successful start-up founders. It’s a great way to gain significant exposure and make connections with a diverse range of UK digital health leaders…and the winner will be announced, and congratulated, by Matt Hancock himself! There is also the chance of winning a mentoring programme with the experts on the judging panel and PR features in Digital Health News. (Disclosure: this editor is on the Programme Committee of Rewired, as well as being a Pitch judge)

Punning headlines

It’s rare that a single item is worthy of its own paragraph on TTA these days however an exception must surely be made for one of the few punning headlines to be found in digital health, especially as it’s for such an old – and until now undelivered – idea: “Smart toilet seat is flush with possibilities to monitor patients’ health”

The Theranos Story, ch. 52: How Elizabeth Holmes became ‘healthcare’s most reviled’–HISTalk’s review of ‘Bad Blood’

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2018/07/holmes-barbie-doll-1.jpg” thumb_width=”125″ /]A Must Read, even if you don’t have time for the book. During the brief Independence Day holiday, this Editor caught up with HISTalk’s review of John Carreyrou’s ‘Bad Blood’, his evisceration of the Fraud That Was Theranos and The Utter Fraud That Is Elizabeth Holmes. Even if you’ve read the book, it’s both a lively recounting of how the scam developed and the willingness–nay, eagerness!–of supposedly savvy people and companies to be duped. The reviewer also reveals that Mr. Carreyrou wasn’t the first to raise questions about Theranos after raves in the press and kudos from the prestigious likes of Eric Topol. Mr. Carreyrou’s first article was in October 2015 [TTA 16 Oct 15] whereas Kevin Loria wrote the first exposé in Business Insider on 25 April 15 which raised all the fundamental questions which Theranos spun, hyped, or otherwise ignored–and Mr. Carreyrou eventually answered. (Our blow by blow, from him and other sources, is here.)

The review also picks out from the book the scabrous bits of Ms. Holmes’ delusions; her makeover to become the blond Aryan female Steve Jobs mit Margaret Keane-ish waif eyes–something she took far too literally; the affair between her and Sunny Balwani, certainly in violation of the usual ethics–and her Hitler in the Bunker, April ’45 behavior as Theranos collapsed around her. 

The review concludes by telling the healthcare community something we need said plainly, often, and written in 50-foot letters:

Theranos is a good reminder to healthcare dabblers. Your customer is the patient, not your investors or partners. You can’t just throw product at the wall and see what sticks when your technology is used to diagnose, treat, or manage disease. Your inevitable mistakes could kill someone. Your startup hubris isn’t welcome here and it will be recalled with great glee when you slink away with tail between legs. Have your self-proclaimed innovation and disruption reviewed by someone who knows what they’re talking about before trotting out your hockey-stick growth chart. And investors, company board members, and government officials, you might be the only thing standing between a patient in need and glitzy, profitable technology that might kill them even as a high-powered founder and an army of lawyers try to make you look the other way.

In other words, what you (the innovator, the investor) is holding is not a patient’s watch, it could be his heart, lungs, or pancreas. (Musical interlude: ‘Be Careful, It’s My Heart’)

The Theranos Effect is real in terms of investment in small companies out there on the ‘bleeding edge’. The cooling is mostly salutory, and we’ve been seeing it since late last year (see here). But…will we remember after it wears off, after the fines are collected, the prison time is served?

The Theranos Story, ch. 46: “F for Fake.” SEC’s fraud charges force Elizabeth Holmes out (finally).

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Our New Year’s 2018 prediction (after December’s $100 million loan from Fortress Investment Group): “Ms. Holmes will be removed and replaced, then the company will be reorganized and/or renamed.”

Fortress did not have to wait long or get their hands dirty. Today, the Securities and Exchange Commission (SEC) charged both founder and now former CEO Elizabeth Holmes and past CEO/president Ramesh ‘Sunny’ Balwani with securities fraud. While Mr. Balwani will fight the charges, Ms. Holmes escaped trading her black turtleneck for an orange jumpsuit by agreeing to pay a penalty of $500,000 to the SEC, give back 18.9 million shares to the company, give up her uniquely Silicon Valley perk of super-voting equity rights, and is now barred from serving as a public company director or officer for 10 years. From the Theranos release: “As part of the settlement, neither the Company nor Ms. Holmes admitted or denied any wrongdoing.”

This penalty may seem puny in the light of other securities fraud cases, but it appears that Ms. Holmes took little salary out of the company, with most of her long-gone billions in presently worthless remaining stock. 

The exact meaning of fraud, as determined by the SEC in cases like these, is not casual. We can say that we never believed the Edison or miniLabs would work despite the press hype. We can observe that patients and doctors were misled in test results, resulting in major human cost (our Ch. 22).  The fraud here is directly tied to representations made to investors that enabled Theranos’ massive funding, in multiple rounds, of over $700 million between 2013 to 2015. These misleading representations included demonstrations, reports on the functioning of its analyzers, inflating its relationships such as with the DOD, and its regulatory status with the FDA.

It also does not matter that all the funds were privately raised. The SEC in its statement firmly stated that it will treat private equity as it does public when it comes to investments (pay attention, health tech companies): (more…)

Breaking: FDA approves the first drug with a digital ingestion tracking system

Not many drug approvals warrant an FDA press release, but this one did and deservedly so. The US Food and Drug Administration (FDA) approved a version of the psychiatric drug Abilify (aripiprazole) equipped with the Proteus Digital Health ingestible tracking system. Abilify MyCite has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It is the first approved commercial version of a drug equipped with the Proteus Discover system, which tracks the ingestion of the pill from a sensor in the tablet activated by gastric juices to a patch worn by the patient and then to a smartphone app. The patient, caregivers, and physicians can track medication usage (timing and compliance) through the app, adjusting dosage and timing as needed.

The Proteus press release states that the rollout is gradual through select health plans and providers, targeting a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder. It is contra-indicated for pediatric patients and adults with dementia-related psychosis.

Abilify, developed by Japan’s Otsuka and originally marketed in the US with Bristol-Myers Squibb (BMS), has been generic since 2015. This Editor finds it interesting that Proteus would be combined with a now off-patent drug, creating a new one in limited release. Proteus’ original and ongoing tests were centered on combining their system with high-value (=expensive) drugs with high sensitivity as to dosage times and compliance–for instance, cardiovascular and infectious disease (hepatitis C, TB). Here we have a focus on managing serious mental illness and treatment. 

Editors (Steve and Donna) first noticed Proteus as far back as September 2009. Looking back at our early articles, Proteus has come a long way from ‘creepy’ and ‘tattletale’. With nearly half a billion dollars invested and a dozen funding rounds since 2001 (Crunchbase), approvals were long in coming–nine years from submission of patch and tablet sensor to the FDA (2008), seven years from the patch approval (2010), five years from the tablet sensor approval (2012), to release of a drug using the Proteus system. The only thing this Editor still wonders about is what happens to the sensors in the digestive tract. They contain copper, magnesium, and silicon–copper especially can be toxic. If the sensors do not dissolve completely, can this be hazardous for those with Crohn’s, colitis, or diverticulitis/diverticulosis?  Hat tip to Bertalan Meskó, MD, PhD, via Rob Dhoble, on LinkedIn.

Also, if you can stand it, a lengthy article from the New York Times with lots of back and forth about the existential threats of monitoring drugs, potential coercion (preferable to injected Abilify), how some with schizophrenia already manage, and Proteus as a ‘biomedical Big Brother’. (Some commenters appear to have the very vapors about any digital trackers, including AiCure and etectRx.)

A random selection of what’s crossed my screen recently

One of the signs of autumn for this editor is the first email from Flusurvey. This is a brilliantly simple system that sends you an email every week asking if you have flu-like symptoms, then produces a map of the UK that gives advance warnings of epidemics. It costs nothing to join and is a great contribution to public health so why not sign up?. (They also have some exciting developments that may surface soon such as a small device that you blow into the connects to a smartphone and can tell almost immediately if you have flu’.)

Increasingly of concern to this editor, due to his deep involvement in digital health regulation, is who is working out how to regulate self-learning algorithms. It is therefore good to see the issue breaking cover in the general press with this article. For what it’s worth this editor’s view is that as technology begins to behave more like humans, albeit in a much faster, and narrow, way by learning as it goes along, perhaps an appropriately adapted use of the way human clinicians are examined, supervised and regulated, might be most appropriate. Sitting next to an AHSN CIO interested in the topic at a Kings Fund event last week, I was pleased to hear him offer precisely the same suggestion, so perhaps there is a little mileage in the idea. 

DHACA (disclosure: run by this editor) has just renewed its website after a long delay, and will be updating content over the next few weeks. First off is the events page advertising:

Our Digital health safety conference on 7th November at Cocoon Networks, London, is being run jointly with DigitalHealth.London – the MHRA has now confirmed they will present so we have almost all the relevant organisations and experts in the UK speaking at this event which should be essential attendance for all involved with the development and use of digital health & care. Attendance has increased substantially in the past few days so do book soon to be sure of securing a place. Much more, including an almost-finalised agenda, is here.

DHACA Day XV – we are back to our usual location at the Digital Catapult Centre on 10th January where are building an agenda of some extremely interesting speakers. To check out the agenda development and to book in advance, go here.

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

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/12/jim_mattis.jpg” thumb_width=”150″ /]Does ‘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.

A tricorder one step closer: Tyto Care gains FDA clearance for its digital stethoscope (US)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/11/Mom_using_on_child_ear.jpg” thumb_width=”150″ /]Only a few years ago, the Star of the Future of Digital Health was the ‘tricorder’–that all-in-one vital signs device that Bones on Star Trek wielded with such élan (when he wasn’t uttering ‘He’s dead, Jim’). We haven’t heard much from Scanadu since early last year when it raised $35 million for its Series B and when it teamed with with Northern Ireland’s Intelesens as a finalist for the seemingly never-ending Qualcomm Tricorder XPRIZE. (Seven finalists are now in consumer testing with awards in early 2017.)

In the meantime, others have been proceeding in bringing their devices into reality far sooner, for real people with everyday health problems who want to examine a child, another family member or even themselves at home. One of these companies is Israel’s Tyto Care (picture above at left), which received FDA 510(k) Class II clearance for its digital stethoscope snap-on to the main device to monitor heart and lung sounds. The device also includes a digital imaging otoscope for ear exams, a throat scope, a skin camera and thermometer swipe. The Tyto home device includes video guidance instructions as part of the smartphone or tablet platform to enable a correct reading. It connects to an online platform to send the information, either in real time or store-and-forward, to a primary care physician the user selects. Tyto Care has been in investigational marketing in the US as well as Israel, bolstered by over $18 million in international investment. They are targeting home DTC as well as professional markets through practices, payers, virtual visit providers and possibly retail (one of their investors is Walgreens Boots). Release If you are attending MEDICA 2017 in Düsseldorf on 16 November, you can see Tyto Care demonstrated at the 5th Annual MEDICA App Competition.

Another all-in-one device is Las Vegas-based MedWand, which is still in pre-marketing. MedWand seems to feature clinic and ‘group’ packages as well as the individual device which includes a pulse oximeter. They received another round of undisclosed financing from Maxim Ventures, the venture arm for semi-conductor developer Maxim Integrated Products at end of September. Release.

Catch-up: what you may have missed whilst on holiday

This was the month when the UK Press seemingly finally woke up to the existence of STPs (Sustainability & Transformation Plans). This article by Derek du Preez and this in Digital Health are two one of a few that pick out the hope that digital health can help with making the NHS more sustainable. Sadly the headlines were grabbed with concern over closing hospital beds, which politicians in the UK still seem to consider to be a Bad Thing. Even though hospital beds have been reduced in most European countries over recent years, and those such as Denmark now trumpet reductions in hospital beds as progress, we have still to break the connection in people’s minds in the UK that beds are a good surrogate for health service delivery volume, (even though when pressed no individual seems keen to spend longer in hospital than absolutely necessary, or would prefer a treatment as an inpatient over treatment as an outpatient.)

Though not directly connected, the NHS offered over £100m to acute care trusts for “global digital excellence” – in line with the previous comments, perhaps the money could alternatively be spent on the UK building on its excellent primary care IT with the specific intention of moving more treatment out of hospitals…and follow that up with a proposal to put the hospital that is judged to be the least “globally digitally excellent” (more…)

Theranos denouement: CMS closes lab, fine, 2-year ban on Holmes (breaking)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Breaking News. Theranos has been slapped very soundly by the Centers for Medicare & Medicaid Services (CMS) for violations arising from operations at their Newark, California laboratory. The fine is not disclosed. CMS has revoked the lab’s certificate and also prohibits the owners and operators of the lab from operating a lab for at least two years. That means that Elizabeth Holmes, the CEO, her management and anyone immediately involved with the Newark lab is effectively out of a job.

As the Theranos press release was issued well after hours Thursday night US Eastern Time, there’s no mention of the board actually removing her, but that is another shoe that this Editor expects to drop sooner, not later. COO Sunny Balwani was removed in May [TTA 19 May] Who is not tainted who can actually run the company? Is there a capable person in the industry who wants to touch it? As has been revealed, Ms Holmes still controls the company [TTA 27 Apr].

The revocation will be in effect in 60 days, according to the Wall Street Journal*, but the Newark lab has been closed. There is no mention of the Palo Alto lab which was also under scrutiny [TTA 20 Apr].

The details appear to be lifted or nearly lifted from the CMS order, and are quoted directly from the Theranos release: (more…)

A weekend potpourri of health tech news: mergers, cyber-ransom, Obama as VC?

As we approach what we in these less-than-United States think of as the quarter-mile of the summer (our Independence Day holiday), and while vacations and picnics are top of mind, there’s a lot of news from all over which this Editor will touch on, gently (well, maybe not so gently). Grab that hot dog and soda, and read on….

Split decision probable for US insurer mergers. The Aetna-Humana and Anthem-Cigna mergers will reduce the Big 5 to the Big 3, leading to much controversy on both the Federal and state levels. While state department of insurance opposition cannot scupper the deals, smaller states such as Missouri and the recent split decision from California on Aetna-Humana (the insurance commissioner said no, the managed care department said OK) plus the no on the smaller Anthem-Cigna merger are influential. There’s an already reluctant Department of Justice anti-trust division and a US Senate antitrust subcommittee heavily influenced by a liberal think tank’s (Center for American Progress) report back in March. Divestment may not solve all their problems. Doctors don’t like it. Anthem-Cigna have also had public disagreements concerning their merged future management and governance, but the betting line indicates they will be the sacrificial lamb anyway. Healthcare Dive today,  Healthcare Dive, CT Mirror, WSJ (may be paywalled) Editor’s prediction: an even tougher reimbursement road for most of RPM and other health tech as four companies will be in Musical Chairs-ville for years.

‘thedarkoverlord’ allegedly holding 9.3 million insurance records for cyber-ransom. 750 bitcoins, or about $485,000 is the reputed price in the DeepDotWeb report. Allegedly the names, DOBs and SSNs were lifted from a major insurance company in plain text. This appears to be in addition to 655,000 patient records from healthcare organizations in Georgia and the Midwest for sale for 151 – 607 bitcoins or $100,000 – $395,000. The hacker promises ‘we’re just getting started’ and recommends that these organizations ‘take the offer’. Leave the gun, take the cannoli.  HealthcareITNews  It makes the 4,300 record breach at Massachusetts General via the typical unauthorized access at a third party, once something noteworthy, look like small potatoes in comparison. HealthcareITNews  Further reading on hardening systems by focusing on removing admin rights, whitelisting and endpoint security. HealthcareDataManagement

Should VistA stay or go? It looks like this granddaddy of all EHRs used by the US Veterans Health Administration will be sunsetted around 2018, but even their undersecretary for health and their CIO seem to be ambivalent in last week’s Congressional hearings. According to POLITICO’s Morning eHealth newsletter, “The agency will be sticking with its homegrown software through 2018, at which point the VA will start creating a cloud-based platform that may include VistA elements at its core, an agency spokesman explained.” Supposedly even VA insiders are puzzled as to what that means, and some key Senators are losing patience. VistA covers 365 data centers, 130 separate VistA systems, and 834 custom installations, and is also the core of many foreign government systems and the private Medsphere OpenVista. 6/23 and 6/24

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/01/Overrun-by-Robots1-183×108.jpg” thumb_width=”150″ /]Dr Eric Topol grooves on ‘The Fourth Industrial Revolution’ of robotics and AI. (more…)

Silicon Valley’s betting on ‘citizen doctors’, ‘citizen science’ and useful data

A fascinating and slightly cynical overview of Silicon Valley’s ideological view of health tech that will fix our ‘deeply flawed healthcare system’ and what is getting funded (or not) is in next month’s San Francisco magazine. It profiles the ‘citizen doctor’ founders of vital signs ‘tricorder’ Scanadu (Sam–who’s not often mentioned–and Walter De Brouwer), bacteria tracker uBiome, ‘personal data recorder’ and experience charter We Are Curious (founded by Linda Avey, a long-departed co-founder of 23andme) and touches on the Theranos debacle. While these stories are bracing and in the instance of the De Brouwers, courageous, the notion of ‘citizen science’ (defined as direct-to-consumer health data) and its companion, Dr Eric Topol’s patient-centered/controlled medicine, has its drawbacks, viewed through the slightly gimlety ‘digital doctor’ eye of UC San Francisco’s Dr Robert Wachter. “The overarching message—not just from Theranos but from other companies struggling to get a toehold—is that, ultimately, the laws of economic gravity hold. The companies will have to produce products that add real value, either to patients or to payers. If they don’t, the market—or the regulators—won’t treat them kindly.” Flatly, there aren’t enough Quantified Selfers right now to support these companies. And Mr Market is a hard master. 23andme is back in the good graces of the FDA after a two-year scuffle and back doing direct response TV here in the US. Scanadu’s two products, Vitals (formerly Scout) and Urine are still not through the long slog of FDA clearance. The jury’s out on Theranos. And all these companies, including ‘unicorn’ Theranos, are bleeding cash and nowhere near turning a profit. ModernLuxury. Hat tip to Dr Topol via Twitter, who had a patient-centered conversation with Dr Wachter that we covered back in September.  Another recent podcast with Dr Wachter is here (Community Health Center radio).

Update: ‘Citizen science’ is nothing new, as revealed by the Science Museum (London)–it’s over 300 years old. While it entered the OED in 2014, ‘in 1715, Edmund Halley used Philosophical Transactions to ask colleagues to help him observe a total solar eclipse, prompting observers from all over the country to respond.’ Other examples are from Benjamin Robins in the same publication in 1749 on fireworks, Charles Darwin and evolution, to the present day. The difference is the flow–similar to what we now call crowdsourcing versus the individual using the data to affect their care.