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)


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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

The Theranos Story, ch. 47: the post-mortem, blaming–and ghost chasing–begin

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Now that Elizabeth Holmes is the former CEO of Theranos, many of the publications who huzzahed their ‘revolutionary’ blood testing system three short years ago are publishing their post-mortem analyses, often of how the wool was pulled over their eyes.

Jenny Gold from Kaiser Health News and NPR has a short ‘alarming’ tale of her press visit in November 2014 to a Theranos testing site at a Palo Alto Walgreens for an NPR feature. At Walgreens, she spoke with patients on the record and was invited to witness their blood draw–not the finger prick Theranos (and Walgreens) promoted, but a standard volume blood draw. After multiple and telling upset reactions from her company press handlers, including demanding Ms. Gold erase her audio recording (!) and accusing her of harassment, alarms went off at the Walgreens store for a non-existent fire. She was baited with an interview with Ms. Holmes–which never happened–and wound up with a corporate attorney instead who made unsupported statements. Ms. Gold canceled her story, which if she tracked the bad smell would have been likely the first press shot across the bow. What this post-mortem tells us is the extent of the coverup and the sheer (and unethical) fawning flackery that appeared in places like the New Yorker, Forbes, Inc., and Fortune.  NPR

The FT further digs into our gullibility, our wanting to believe that someone in a black turtleneck could put the Big Labs out of business,  how we in the press hungered for a new and female Steve Jobs to shake up the status quo. Andrew Hill: “Trouble often hits, though, when leaders stick to their story after it has diverged from reality, swerving into embellishment, mythmaking and, in Ms Holmes’s case, apparently fraud.”

But we were no smarter than those who gave Ms. Holmes and Mr. Ramesh ‘Sunny’ Balwani $700 million in Mad Money. (more…)

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…)