Public Policy Projects, Tunstall UK release joint TECS study finding growth during pandemic, recommendations

Weekend reading. Public Policy Projects and Tunstall Healthcare UK & Ireland have released a joint study finding, unsurprisingly but encouragingly, that the usage of technology-enabled care services (TECS) has accelerated during the COVID-19 pandemic. The nine-part, 62-page study electronically available here examines TECS through case studies in England, Scotland, and Wales as well as in France, Sweden, and especially Spain. There is a worthwhile examination of the types of TECS currently existing, a look back at the Whole System Demonstrator (WSD), barriers to adoption, and recommendations for policy going forward. ECHAlliance/Tunstall release.

Tunstall UK also won the ‘Leading Innovators in Assisted Living Technology 2020’ award at the Healthcare & Pharmaceutical Awards 2020, and the ‘Best Non-Clinical Equipment, Product or Service Supplier’ for their nurse call system, Tunstall Carecom, in the Care Home Awards 2020. ECHAlliance release

The Theranos Story, ch. 65: Elizabeth Holmes’ “mental disease or defect” defense revealed

Going the ‘Twinkie Defense’ one better? While this Editor was enjoying a much-needed break from the Insanity of the World, hurtling across the wires was the revelation that Elizabeth Holmes’ pricey defense attorneys have prepared a defense for her that includes evidence “relating to a mental disease or defect or any other mental condition of the defendant bearing on the issue of guilt.” Interpreted, her mental state may have affected her intent and judgment in her business dealings. 

According to the filing, the defense is introducing testimony from Mindy Mechanic, Ph.D., a clinical psychologist and professor at California State University at Fullerton. According to her bio, her “work focuses on the psychosocial consequences of violence, trauma, and victimization with an emphasis on violence against women and other forms of interpersonal violence. Her work has addressed the mental health consequences of violence, such as Post-Traumatic Stress Disorder and depression as well as other important physical and social health outcomes.” 

The defense attempted to introduce this evidence without further examination by the Federal prosecution. Unfortunately, US District Judge Edward Davila did not agree. Ms. Holmes will be examined by two experts for the prosecution: Daniel Martell, Ph.D., a forensic neuropsychologist for the forensic litigation consulting firm Park Dietz & Associates, and University of California San Francisco psychiatrist Renee Binder, MD. Over the objections of the defense, the examination will be videotaped. The trial will commence with jury selection on 9 March 2021 [TTA 27 Aug].

Most of our Readers who care about this will be wondering, after they’ve picked themselves off the floor laughing at the above notion, that any person with a mental defect of this type could have fooled the savviest Sand Road VCs, Stanford/Hoover Institution luminaries, an admiral, a Marine general later Secretary of Defense, and Rupert Murdoch for years, to the tune of nearly $1 bn. That they should be gulled and fooled is disturbing enough. What is equally disturbing is the desperation of the defense to attempt an ‘insanity defense lite’ that sources and justifies Ms. Holmes’ inability to discern right from wrong.

This then proceeds to exactly what was the ‘interpersonal violence’ or post-traumatic stress that caused her judgment to warp quite this way. Was it her upbringing, which apparently was a bit upper-middle-class flaky–the ‘it’s not High Anxiety, it’s parents!’ reason? Was it a head trauma (the Howard Hughes defense), drugs, or surgery gone wrong? Did Sunny get Blue (in more than one way) on her? Stock up on the popcorn–la scandale Theranos has just gotten even more interesting. CBS Bay Area, Bloomberg News, Forbes, MedCityNews

A historical footnote. The term ‘Twinkie Defense’ came into usage in 1978 during the defense of the murderer of San Francisco mayor George Moscone and the better-known supervisor Harvey Milk. While not used per se by the defense team, the testimony of a psychiatrist for the defense that the murderer excessively consumed junk food, including Twinkies, as an indicator of depression and a sign of diminished capacity was hyped by the press as the ‘Twinkie Defense’. The term has passed into the vernacular. Ironically, both trials are occurring in the Bay Area.  Hat tip to The Crime Report.

The book of ‘Thank and Praise’ with a selection of their 1,000 messages (UK)

James McLoughlin of the UK organization Thank and Praise has reached out once again to this Editor with an update on their social thanking of the ‘unsung heroes’ in healthcare during the depths of the COVID-19 pandemic. TAP has compiled a free e-book of a selection (64 pages) of their over 1,000 messages–print and video (page 65)–posted on their thanking walls. The messages thank healthcare workers, teachers, shop workers, church staff, food deliverers, social workers, homeless outreach, and many others who helped others. The illustrations were contributed by children and young adults. The book is also being sent to the organizations mentioned in the book. Reach out to James if TAP can help your organization. Our previous coverage: TTA 10 Apr, 12 June   Press release

Tunstall funding by M&G, Barings passes European Commission ‘concentration’ review

The European Commission, in a brief filing on EUR-Lex, has stated their ‘non-opposition’ to the ‘concentration’ in Tunstall Group Holdings’ additional funding obtained by M&G Investment Management and Baring Asset Management via share purchase. Tunstall announced this funding in April [TTA 10 April] and filed with the European Commission on 3 June (prior notification).

The definition of ‘concentration’ in the EU is the legal combination of two or more firms by merger or acquisition. The prior notification from the Commission considers that this concentration may fall within the scope of the Merger Regulations but reserved a decision on this.

Charterhouse Capital Partners, the prior controlling investor, is not mentioned in the prior notification. Revealed in the notification is that Baring is actually controlled by MassMutual in the US, a surprise to this Editor. Hat tip to a Reader in the UK industry who wishes to remain anonymous.

Anthem-Cigna merger lawsuit finally wraps with ‘No damages for you! Or you!’

Not with a bang, but a whimper and a large bill. The long, drawn-out (May 2017!) lawsuit and countersuit in Delaware Chancery Court between payers Anthem and Cigna ended with the decision by Vice Chancellor J. Travis Laster to refuse to award damages to either party in the litigation.

Cigna, which was seeking nearly $15 bn from Anthem, seemed to receive the worst of his judgment. In his decision (PDF), VC Laster stated that Cigna was unable to prove that Anthem breached the Efforts Covenants and in fact, Cigna sought to derail the deal by pulling back on integration efforts, thus itself breaching the covenants. Thus, Cigna was not entitled to the $1.85 bn breakup fee or additional damages. Anthem proved that they sought to complete the merger and Cigna did not, thus seeking $20 bn in damages. In counterpoint, Cigna was able to prove that the deal would have been blocked regardless of their actions to demo the deal.

VC Laster’s conclusion, “In this corporate soap opera, the members of executive teams at Anthem and Cigna played themselves. Their battle for power spanned multiple acts….Each party must bear the losses it suffered as a result of their star-crossed venture.” The testimony revealed the deep divisions and battle lines between both companies during the merger preliminaries, until the Federal courts and DOJ put paid to it.

Yet the denouement of this Merger Made In Hell may not be fini. Anthem said in a statement to Fierce Healthcare that it feels “this decision is in the best interests of Anthem and our stakeholders.” But a Cigna spokesperson said they are not finished and considering a potential appeal. “We are pleased that the Court agreed with us that Cigna did not cause the merger to fail. We continue to strongly believe in the merits of our case, and we are evaluating our options with respect to appeal.” Certainly not the peaceful-in-public parting after the Federal denial of their merger by Aetna (acquired by CVS) and Humana (still in play).

The chief beneficiaries of this three-year drama? The law firms listed on page 1 of the opinion. Also Wall Street Journal (paywalled in part).

As practices reopen, telemedicine visits continue to plunge from 69% to 21%: Epic (US)

The extreme high tide has receded–but still way up than before the pandemic.  The Epic Health Research Network (yes, that Epic EHR), updated its earlier study through 8 May [TTA 22 July] to compare in-office to telehealth visits through 12 July. The trend that EHRN spotted (as well as Commonwealth Fund/Phreesia/Harvard) continued with telemedicine visits declining as practices reopened. As of mid-July, telehealth visits, as a  percentage of national ambulatory visits, declined to 21.2 percent compared to 78.8 percent in-office. 

The new EHRN study used a broader sampling than previously. They surveyed healthcare providers of data: 37 healthcare organizations representing 203 hospitals and 3,513 clinics in 50 states. The decline in telehealth visits noted in early May continued, with May finishing with a national 50/50 split.

But in context, telehealth visits immediately before the COVID-19 pandemic were a whopping .01 percent

Regionally, the Northeast leads in July telehealth visits with 25 percent. The South has the least adoption of telehealth with only 13 percent. In terms of total office visits, neither the South nor West have rebounded to pre-pandemic levels, whereas the Northeast and Midwest have.

The key to the future of the telehealth bubble bath is if telehealth usage versus in-person stabilizes for several months. But there’s another factor which has come about through higher telehealth usage. Noted in our July article was speculation on the reasons why the sudden decline, other than practices reopening, most of which pointed to practice training, reimbursement, and older/sicker patients falling into the smartphone/digital divide. The STAT article has statements from telehealth providers which are quite bubbly and quotable, with the CEO of MDLive stating that new bookings are up 300 percent and mental health hasn’t declined. But a problem now surfacing is providing patients with the right care at the right time–and fitting it into the office schedule. What visits can best be handled as telehealth and which require an in-person visit? This Editor recalls that Zipnosis, a white-labeled telehealth system we haven’t heard from in a while, incorporated for health system applications a triage intake which would direct the patient to the right level of care. Can this be rolled out in a similar way to the practice level?

Is the NHS ready to adopt telemedicine through and through–and is telemedicine ready?

This analysis by Dominic Tyer in Pharmaphorum discusses the rapid adoption of telehealth during the COVID pandemic, both telephonic and online, to keep people in touch with their doctors. Health Secretary Matt Hancock quantified the changes wrought as “I’ve lost count of the number of times someone said to me: ‘what would have taken months took minutes’.” The article goes on to quote him as saying that COVID-19 has “catalysed deep structural shifts in healthcare that were already underway”, citing as examples data-driven decision-making, working as a system, and telemedicine. In fact, to Secretary Hancock, “From now on, all consultations should be teleconsultations unless there’s a clinical reason not to.”

For all the advances, Mr. Tyer points out flaws such as safeguarding sensitive health issues, particularly for young people, use by rare disease patients and those with a genetic condition, and reaching the 10 percent of the population who do not use the internet. All of these are significant. He concludes that “in the UK there’s clearly the political will and healthcare backing for wider use of telemedicine by the NHS, despite some, as-yet not entirely resolved, technological and safety issues.”

Will the UK revert to ‘underuse’, as the US has rolled back as well as practices have reopened? (What is ‘underuse’ defined as anyway?) Will these issues be resolved or ignored in a push forward for telehealth? And teleconsultations as a norm, with in-person an exception, is perhaps at this time, and in improving health outcomes, an overreach? Hat tips to Roy Lilley of the nhsManagers.net newsletter and Steve Hards

News roundup: CVS cashing out notes, catching up with ISfTeH, India’s Stasis Labs RPM enters US, Propeller inhaler with Novartis Japan, Cerner gets going with VA

CVS Health is pricing out a tender offer for some notes. If you are holding one of a potpourri of notes with due dates of 2023 and 2025 from CVS, the company is making a cash tender offer, meaning they are cashing these notes out. This is usually done as part of rearranging financing, especially appropriate in the wake of the Aetna acquisition. The details are here in their release of 12 August. The collective value for both note years is approximately $3 bn each. An update is here on Seeking Alpha.

We have been remiss in not maintaining our following the Swiss-based International Society for Telemedicine and eHealth (ISfTeH) so we will direct your attention to their August update which features the effect of COVID on teledermatology, women’s health, teleurology, and news on members and developers. Their Journal, still edited by Professor Maurice Mars of South Africa, has published once this year in January.

India’s Stasis Labs, developer of a remote patient monitoring (RPM) platform utilizing a smartphone, vital signs devices, a bedside monitor connected into a platform, is entering the US market. It monitors six vital signs in a single monitor: heart rate, blood oxygen, electrocardiogram, respiratory rate, blood pressure, and temperature. Awarded a 510(k) clearance in April, Stasis, out of the Cedars-Sinai Accelerator program, has had a limited deployment at Texas-based emergency-care provider Hospitality Health ER and California-based Glendale Surgical Center and Orthopedic Surgery Specialists. It has also deployed to 50 cities in India. Mobihealthnews

Smartphone-connected inhaler sensor company Propeller Health has inked a deal with Novartis in Japan. Patients prescribed Novartis’ drugs for uncontrolled asthma, the Enerzair or Atectura Breezhaler, can now enroll in Propeller’s digital-management program. Data about their inhaler use will be transmitted from the sensor on the inhaler to Propeller’s smartphone app. The app also pings users with reminders and usage data. Propeller was acquired last year for a stunning $225 million by ResMed. Propeller this past May gained 510(k) FDA clearance for a sensor/app for use with AstraZeneca’s Symbicort inhaler.

Cerner’s EHR implementation with the US Department of Veterans Affairs finally took a step forward after many delays with the launch last Friday of a new scheduling system at the VA Central Ohio Healthcare System in Columbus, Ohio. Cerner migrated the information of some 60,000 veterans in preparation. The full EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, originally scheduled for March, will go live this fall. Healthcare Dive

QuivvyTech: a ‘telehealth’ company, sued by Humana in telemarketing scheme (US)

It was inevitable–the first alleged fraud and lawsuit involving a ‘telehealth’ company. The interestingly named QuivvyTech, which has styled itself as a telehealth company with “virtual care in general medicine, mental health, and complex care”, has been sued by insurance giant Humana. The grounds are that QuivvyTech telemarketers cold-called Humana members, who are generally members of Medicare plans, asked them about common ailments, and claimed they were working with Humana. They then recorded information that was sent to QuivvyTech physicians who would prescribe the members pricey and unnecessary creams (content undisclosed) fulfilled by co-conspirator pharmacies with QuivvyTech. The physicians listed in the suit electronically signed prescriptions for the members without reviewing patient history or having a prior relationship with the patient.

Humana not only is alleging harm in the payer-member relationship, but also lost millions in fraudulent claim payments for visits and medications. 

The lawsuit by Humana seeks treble damages, plus interest and fees, from QuivvyTech. It was filed in the US Southern District of Florida as many of the scammed members lived in Florida. QuivvyTech is based in Boca Raton.

Defendants in the suit include Frank Michelin, associated with QuivvyTech; Reliable Medical Supplies and Reliable Document Solutions, a telemedicine company with about 200 physicians; and physicians Jeffrey Mahon, MD, Elie Hercule, MD, Samuel Teniola, MD, Louis Mojicar, MD, Ananda De Silva, MD, and Jeffrey Stern, MD.

One wonders where QuivvyTech obtained Humana members’ phone numbers and information. 

QuivvyTech is still recruiting for physicians on job boards such as ZipRecruiter and StaffPhysicians.com. Becker’s Hospital Review, Healthcare Finance, Fierce Healthcare

The Theranos Story, ch. 64: Holmes’ trial moved to March 2021

What a difference two years makes. Once the subject of breathless headlines and breaking news, the latest news on the trials of Elizabeth Holmes and Ramesh ‘Sunny’ Balwani in la scandale Theranos earned hardly any notice in the healthcare press. Only this Editor’s search for an update found information that the Federal court trials, due to the pandemic and corresponding difficulty with trial preparation and jury selection, have been moved to 2021. Pretrial hearings for both have been moved to October and December.

So not to further punish our Readers who are dreaming of mountain lakes and ocean beaches, your Editor, a/k/a Glutton for Punishment, has summarized the Court’s next steps. 

  • The Holmes and Balwani trials have been severed–legalspeak for separated
  • Holmes will go first starting on 9 March 2021 with jury selection in the Federal Court, San Jose, Judge Edward J. Davila presiding. Balwani’s trial will not start until Holmes’ trial is concluded.
  • The next court hearings for Holmes will be 6 October (pretrial motion), 2 December (status), and 16 February 2021 (status)
  • Balwani will have a status hearing on 8 December

In early August, the Department of Justice (DOJ) prosecutor added a 12th fraud charge to Holmes’ list, relating to a patient’s blood test. A grand jury was empaneled in June during the midpoint of the pandemic, leading to Holmes’ legal team attempting to obtain 21 broad categories of documents on the jury selection. Their intent is to overturn the indictment as improper.

No need to stock up on popcorn till a month before Easter 2021, but it will be munch-worthy as rumored witnesses will be ‘faces’ such as General James Mattis (ret.), former board member and customer; Henry Kissinger; and Rupert Murdoch. This Editor’s bet is that these aged titans will not appear, with the exception of the youngest, General Mattis. More likely to be called to appear, in this Editor’s view, are executives from Walgreens who did the deal with Theranos, the last-ditch investors at Fortress Investment Group, major investors such as Partner Fund Management, and early unrepentant backer Tim Draper of Silicon Valley VC Draper Fisher Jurvetson.

The Federal charges are summarized in TTA 13 May]The full sturm und drang by chapter are here.

CNBC, US Department of Justice, Northern District of California published notice  The 14 June indictment (15 pages)

Amwell plans $100 million IPO, plus $100 million from Google as a kickoff

As expected [TTA 6 Aug], Amwell on Monday filed S-1 forms with the US Securities and Exchange Commission (SEC) registering them for an IPO to raise about $100 million. The number and amount of shares on the New York Stock Exchange, under ticker symbol AMWL, were not disclosed. Interestingly, and somewhat unexpectedly, Google’s cloud business is taking a private placement of $100 million in shares equal to the IPO price, to be executed on the IPO closing.

The partnership will mean that Amwell’s cloud services on Amazon Web Services (AWS) will be moving to Google Cloud. Amwell will also move some video performance capabilities to that platform, and will also cooperate on technology plus build out a dedicated sales effort to expand Amwell’s footprint in the sector.

Amwell’s telehealth business, like Teladoc’s, skyrocketed during the worst of the pandemic shutdown. According to the CNBC article on the IPO, Amwell told them in May that it’s seen a 1,000 percent increase in visits due to coronavirus and closer to 3,000 – 4,000 percent in some places (which without further data is meaningless). The IPO filing stated that revenue was up 77 percent January-June 2020 versus same period 2019, from $69 million to $122 million. Profits are not following, however. Its net loss nearly tripled over the same period, growing from $41 million in the first six months of 2019 to $111 million in the first half of this year. Seeking Alpha has the operating loss at a slightly higher $113.58 million.

This past May, Amwell also raised $194 million in a second Series C [TTA 23 May]. Their financing to date is over $700 million.

Amwell states that it provides telehealth solutions for over 2,000 hospitals and 55 health plan partners with over 36,000 employers, covering over 80 million lives, a higher metric than members. This is in comparison with Teladoc which claims 51.5 million members, 50 health plans, 70 global insurers, and 12,000 clients in 175 countries. Amwell is having to compete with a larger suite of services that a Teladoc-Livongo combination will eventually offer. Amwell’s by-contrast modest IPO and private placement corresponds to their relative size, but a contrarian would also look at Teladoc’s huge expenditures for InTouch Health ($1bn) and Livongo ($18.5bn) and rightly be concerned about their runway to ROI and profitability.

‘Before the Ashes Fall’: the story behind the book and the movie in development about dementia

Editor’s Note: The author of the post below, David Serafine, is a corporate security professional in the US. He is not like most of our Readers, a professional in healthcare technology or social care. What compelled him to write a novel about a father and son, and a family affected by the onset of Alzheimer’s Disease, is his own family’s story. We deal with dementia as professionals, but it has also touched and affected our family lives, and in many cases, our work lives. 

David reached out to me through a post on LinkedIn and after some discussion, I have decided to share his message with you. He and his production team are now reaching out to people like us to find financing for a film treatment, to be shot in Western New York State. Through the film, they will tell not only a story, but also to use the film to promote education and societal awareness, especially among minority and underserved communities heavily impacted by this disease.

Through our networks and our companies, you may know a funder, or funders, who are interested in backing this cause. More information on the production is attached (Release–PDF). You may contact David at serafinedavid@gmail.com, phone 512.571.0418, or via LinkedIn .


Before the Ashes Fall by David Serafine

I first encountered Dementia in June 2016.  It was my wife’s grandfather, a sturdy and tough as nails Texas farmer, who was diagnosed with Alzheimer’s.   The man’s diagnosis came only a  year removed from tending crops beneath the relentless noon sun while seamlessly conversing with a razor-sharp precision. “And we need to hide his truck keys for good”. The words, stinging with an exactness and finality, didn’t quite measure up.  The man still looked normal.

One year later, I observed half of the same man blankly staring at a birthday cake, not realizing it was his. The celebration carried on around him, with each attendee recalling stories of his life. I stared hard at his face, almost willing a quiver or smile, anything to suggest the words resonated. Nothing moved. Finally, I noticed his jutting collarbones which resembled a cheap wooden hanger. My eyes traced the sharp rise and fall around his shoulders and the blanched fabric which hung from them.

I contemplated whether Alzheimer’s solely left this wake of damage. Or, was it exacerbated by his daughter’s own Frontotemporal Dementia diagnosis, relegating her final days to a Memory Care Facility?  I never knew the answer as two months later, the man succumbed to Alzheimer’s complications.  To this day, his daughter was never told that he died.   That type of message, with a woman in her condition,  could be a potential catalyst for further emotional distress. 

Sometime during that journey, I wrote a fictional novel called ‘Before the Ashes Fall’.   In short, the novel is a race for “Love, Forgiveness, and Redemption” between a father and son beneath the cloud of Alzheimer’s. The process was as equally heartbreaking as cathartic. I mostly bled and cried into pages for a year, completed it, and put it to bed.

However, the book elicited correspondence from Malaysia, Ireland, Brazil, and Chile. The messages always began the same: “I had a (insert family member) die from various forms of Dementia.  Thank you for writing this story”. Two observations became clear over time. First, ‘Dementia’ didn’t stay in lanes, either geographically or demographically.  It was global and touched everyone either directly or indirectly.

Secondly, and arguably the crueler facet, is the insidious nature of Dementia.  In many circumstances, the readers’ initially described  Dementia as a ‘normal’ part of aging.  It wasn’t until an unequivocal tipping point- “my husband left the stovetop gas on’’-that it was no longer ‘normal’. That same moment generated guilt within the de facto caretaker (spouse, daughter, etc.) of what could have been prevented.

I researched the diseases of Dementia -Alzheimer’s is but one diagnosis and it alone will cost over $1 trillion (globally) in 2020 alone.  I also learned life choices and even traumatic events had a dramatic impact on the diseases’ progression.  Those two points are the most critical: we have some control and hope with increased awareness.

In July of 2020,  my book was adapted for film by a multiple award-winning Director. The story and approach are unique, unlike the other Dementia-based films. As we will target 60 global film festivals, three primary goals materialized.

First, and the most unique aspect of the approach, is our desire to facilitate pragmatic and current medical forums.  The engagements will include not only allopathic guidance but more importantly, non-allopathic guidance.  We seek to educate communities on life choices – diet, exercise, early testing before the disease has advanced. There are informed choices we can make that can delay and lessen the impact of Dementia. This is least understood globally.

Secondly, we will use film and outreach to galvanize communities.  A search of Dementia-themed films will yield 2  most recognizable (Still Alice and The Notebook).  Our film will feature a different demographic, one illustrating the ‘absence of lanes’ with the disease.  This will be represented in the cast, crew, and artwork produced by local Dementia patients.

These goals have been welcomed by medical practitioners, podcasters, and Corporate Social Responsibility Executives.  In addition to a strong storyline, we believe film fans will sense a collective ownership of this film during its production and engagement in their communities.   Additionally, it’s supportive and empowering to overcome tragedy alongside others, particularly those who strive for a better future.

Finally, and unique to the film industry, we seek to re-invest 50% of all profits into Dementia-related awareness campaigns.  If funded, we believe “Before the Ashes Fall” has a 3X delivery back into the programs we seek to support.

“Before the Ashes Fall” is a fiscally sponsored film through the Film Collaborative and individual or corporate donations are tax-deductible.   It’s an amazing opportunity to shape the future for current and generations to come, all desiring the same goal: a cure for Alzheimer’s. 

[More information on the production here: PDF]

Will the rise of technology mean the fall of privacy–and what can be done? UK seeks a new National Data Guardian.

Can we have data sharing and interoperability while retaining control by individuals on what they want shared? This keeps surfacing as a concern in the US, UK, Europe, and Australia, especially with COVID testing.

In recent news, last week’s acquisition of Ancestry by Blackstone [TTA 13 August] raised questions in minds other than this Editor’s of how a business model based on the value of genomic data to others is going to serve two masters–investors and its customers who simply want to know their genetic profile and disease predispositions, and may not be clear about or confused about how to limit where their data is going, however de-identified. The consolidation of digital health companies, practices, and payers–Teladoc and Livongo, CVS Health and Aetna, and even Village MD and Walgreens–are also dependent on data. Terms you hear are ‘tracking the patient journey’, ‘improving population health’, and a Big ’80s term, ‘synergy’. This does not include all the platforms that are solely about the data and making it more available in the healthcare universe.

A recent HIMSS virtual session, reported in Healthcare Finance, addressed the issue in a soft and jargony way which is easy to dismiss. From one of the five panelists:  

Dr. Alex Cahana, chief medical officer at ConsenSys Health.”And so if we are in essence our data, then any third party that takes that data – with a partial or even complete agreement of consent from my end, and uses it, abuses it or loses it – takes actually a piece of me as a human.”

Dignity-Preserving Technology: Addressing Global Health Disparities in Vulnerable Populations

But then when you dig into it and the further comments, it’s absolutely true. Most data sharing, most of the time, is helpful. Not having to keep track of everything on paper, or being able to store your data digitally, or your primary care practice or radiologist having it and interpretation accessible, makes life easier. The average person tends to block the possibility of misuse, except if it turns around and bites us. So what is the solution? Quite a bit of this discussion was about improving “literacy” which is a Catch-22 of vulnerability– ‘lacking skill and ability’ to understand how their data is being used versus ‘the system’ actually creating these vulnerable populations. But when the priority, from the government on to private payers, is ‘value-based care’ and saving money, how does this prevent ‘nefarious use’ of sharing data and identifying de-identified data for which you, the vulnerable, have given consent, to that end? 

It’s exhausting. Why avoid the problem in the first place? Having observed the uses and misuses of genomics data, this Editor will harp on again that we should have a Genomic Data Bill of Rights [TTA 29 Aug 18] for consumers to be fully transparent on where their data is going, how it is being used, and to easily keep their data private without jumping through a ridiculous number of hoops. This could be expandable to all health data. While I’d prefer this to be enforced by private entities, I don’t see it having a chance. In the US, we have HIPAA which is enforced by HHS’ Office of Civil Rights (OCR), which also watchdogs and fines for internal data breaches. Data privacy is also a problem of international scope, what with data hacking coming from state-sponsored entities in China and North Korea, as well as Eastern European pirates.

Thus it is encouraging that the UK’s Department of Health and Social Care is seeking a new national data guardian (NDG) to figure out how to safeguard patient data, based on the December 2018 Act. This replaces Dame Fiona Caldicott who was the first NDG starting in 2014 well before the Act. The specs for the job in Public Appointments are here. You’ll be paid £45,000 per annum, for a 2-3 day per week, primarily working remote with some travel to Leeds and London. (But if you’d like it, apply quickly–it closes 3 Sept!). It’s not full time, which is slightly dismaying given the situation’s growing importance. The HealthcareITNews article has a HIMSS interview video with Dame Fiona discussing the role of trust in this process starting with the clinician, and why the Care.data program was scrapped. Of related interest is Public Health England’s inter-mortem of lessons learned in data management from COVID-19, while reportedly Secretary Matt Hancock is replacing it with a new agency with a sole focus on health protection from pandemics. Hmmmmm…..HealthcareITNews.

CB Insights rounds up a 2020 Digital Health Top 150

Actually this Editor added the ‘Top’ to the Digital Health 150, as it emulates the Top 40 or Top 100 when Music Radio ruled, but Billboard or Melody Maker would hardly recognize the format. CB Insights evaluates the promising, primarily US digital health startups from its research. It’s their second Digital Health 150 and like last year’s, it organizes the aspiring hot companies into groups and sub-groups. Many companies are repeats, though the categories are different than last year’s, reflecting a change in what is considered ‘hot’:

  • Administrative automation and digitization
  • Disease management and therapeutics
  • Screening and diagnostics
  • Drug discovery
  • Clinical trials
  • Clinical intelligence and enablement
  • Online-offline care
    • Primary and urgent care
    • Specialty care
  • Pharma supply chain
  • Health plans and benefit management
  • Real-world evidence (RWE)
  • Virtual care delivery

Telehealth is hot (of course) in the Online-Offline and Virtual Care categories. CB Insights singles out in telemedicine Heartbeat Health, Doctor On Demand, and Livi (UK) (Kry in the Nordics), while in remote monitoring they named Oura (a ring), Element Science (a cardiac wearable), and Dental Monitoring (a dental treatment/care management platform different than The Teledentists). We also noted Parsley Health’s NY clinics and VillageMD, a Chicago-based primary care provider group which just inked a major deal with Walgreens Boots [TTA 9 July]. Early-stage companies do well when they have big partnerships. 

CB Insights also provided a compare/contrast summary against the 2019 Digital Health list [TTA 10 Oct 19]:

  • Unicorns: 17 of the 2019 Digital Health 150 (11%) have remained or since become unicorns with a $1B+ valuation
  • Exits: 2 companies have gone public and 2 have been acquired
  • Deals, funding, and mega-rounds:  raised over $4bn across 70+ deals, including 14 mega-rounds ($100 million+ investments), as of 10 August

They do not mention that one, Proteus Digital Health, one of those unicorns, went bankrupt this year and was sold on Wednesday for its IP for $15 million.

2020 Digital Health 150

News Roundup of acquisitions, funding: Health Catalyst-Vitalware, Change Healthcare-Nucleus.io, Medtronic-Companion Medical, Cecelia Health; Proteus Health sale contested, but sold (updated 20 Aug)

Spin that lasso, round up the dogies, because we’re going to the rodeo! Data and analytics company Health Catalyst is acquiring Vitalware, which provides ‘chargemaster’ revenue workflow optimization and analytics SaaS technology to healthcare organizations. The deal is expected to come in at about $120 million with a $30 million earnout, funded by stock and cash, and close later this year.  Health Catalyst is on a buying tear, having acquired Healthfinch, a prescription refill management and visit planning platform to close care gaps, for $40 million in cash and shares in July. Health Catalyst went public in July 2019 and is trading at a market cap of nearly $1.3 bn (Unicorn Status isn’t what it used to be!). They’ve also inked a partnership deal with Northwell Health, the largest provider in New York State, to expand Northwell’s enterprise data and analytics capabilities with EHR integration. Health Catalyst releases on Vitalware, Healthfinch, and Northwell Health. Also FierceHealthcare.

Updated. Another major 2019 IPO, Change Healthcare, is acquiring Nucleus.io, a  cloud-based imaging and workflow platform, from San Diego-based developer NucleusHealth. This is a significant move, fitting into their Enterprise Imaging area and accelerating their implementation of a complete cloud-based, end-to-end solution within their Enterprise Imaging Network. Nucleus.io serves over 7,500 organizations and will add to Change Healthcare’s imaging customer base. Change is acquiring the Nucleus.io technology and team. NucleusHealth will continue to operate under its own name; they also operate a teleradiology platform, StatRad. Terms were not disclosed. Release. HealthcareITNews (Updated to clarify that the Change Healthcare acquisition is the Nucleus.io technology and not NucleusHealth the company)

Medtronic, which insiders dub the 9,000 lb. elephant of medical devices and remote patient management, has been quiet of late, but that doesn’t mean the elephant isn’t moving and sitting where it wants to sit. Continuing to build in diabetes care, they have just acquired Companion Medical, developer and marketer of the InPen, a insulin pen with a companion app, which was FDA cleared in 2016 and remains the only ‘smart insulin pen’ system. Eli Lilly and K2 Health Ventures were Companion’s major funders. Closing is expected within two months. Terms were not disclosed. Medtronic is clearly constructing a closed-loop diabetes management system through acquisitions such as Companion as well as diet-management startups Klue and NutrinoRelease, Mobihealthnews

And in diabetes management, Cecelia Health (the renamed Fit4D), scored a healthy $13 million in Series B funding. Rittenhouse Ventures and Endo Investors co-led the round, with participants Boston Millennia Partners, SustainVC, G100 Capital and others, for a total of $22.4 million in funding (Crunchbase). Fit4D developed clinical virtual coaching with certified diabetes educators, and partners with health plans, self-insured employers, medical device and pharma companies. The funding will go to developing a first-in-kind ‘Virtual Clinic’ for diabetes, which will offer continuous glucose monitoring (CGM) training, education on medication adherence and lifestyle and behavior change, mental health screening and counseling. These will be then supported by algorithms recommending necessary dosage and titration changes that will be reviewed and approved by Cecelia Health’s Certified Diabetes Care and Education Specialists (CDCES) and endocrinologists.  ReleaseMobihealthnews  A few days before the funding, Cecelia announced their participation with the Jaeb Center for Health Research Foundation in Tampa in their research to develop a virtual specialty clinic model, funded by a $5 million grant from the Helmsley Foundation. Release

Updated for Proteus sale. The troubled ‘smart pill’ pioneering company and one-time unicorn Proteus Digital Health, which filed for Chapter 11 (reorganization) bankruptcy on 16 June [TTA 17 June], planned to exit it with a $15 million ‘stalking horse’ deal with Otsuka Pharmaceuticals in advance of a bankruptcy auction. ‘Stalking horse’ deals set a floor at an auction and essentially set a minimum price. Investors, including Novartis and two Hong Kong funds, contested that fire sale earlier this week, claiming the sale to Otsuka was undervalued and if the IP and other assets were divided, a higher price would be obtained. One could understand their feelings, as Proteus raised nearly $500 million from them which essentially has vanished.

On Wednesday 19 August, the US Bankruptcy Court for the District of Delaware approved the sale to Otsuka, which was filed on Thursday. A key part of the hearings was Proteus’ investment banker, Raymond James & Associates, fruitlessly reaching out to over 240 potential buyers. What scared them off was Proteus’ burn rate–between $2 million and $2.5 million a month–with no clear prospect of positive cash flow or profitability (the latter quite elusive even in public companies). The purchase by Otsuka, which was deemed fair in the ruling with the opportunity for others to provide higher offers, covers information technology assets, intellectual property, and equipment, including equipment used to design and manufacture wearable sensors. Related court documents.

Otsuka was Proteus’ last major partnership for Abilify MyCite that ended suddenly in January. From the case documents schedule, this will be wrapped by end of September. FierceHealthcare 12 Aug, 27 July    STAT+ (paywalled) 20 Aug, HealthcareITNews

Medical education going digital, virtual, and virtual reality (US/UK)

How do you educate medical and nursing students when class is no longer in session? What about clinical training when hospitals are restricted due to COVID? It’s no surprise that remote learning and pre-recorded classes plus active lecturer-student discussions on Zoom (or more secure video meeting platforms) in the spring filled the gap of the first two years of med school, which are primarily tied to class instruction. For incoming and resuming classes, most have a mix of online and in-person classes, depending on school location. Nursing schools faced and resolved similar situations.

But what happens in the second two years, when lectures mix with in-person clinical learning? Most schools pulled students from clinical work in the spring, but some, like Mount Sinai in New York, continued. The University of Houston has developed some other approaches. Their medical school, starting this year, was co-founded with insurance payer Humana as part of the Humana Integrated Health Systems Science Institute. Nursing school students who would typically join nurses on house calls shadowed these nurses on virtual visits as part of their clinical training. 

The Association of American Medical Colleges (AAMC) is also looking at ways to integrate telehealth into medical school curricula, and is publishing a guide this fall detailing core competencies around telemedicine.  FierceHealthcare

Virtual reality (VR) is providing a more interactive training environment for clinicians with realistic scenarios and feedback. Computer simulations have been common for years in specialty surgery and diagnostics. With reductions in pricing on headsets like the Oculus Rift and Quest, several companies are introducing a different kind of virtual visit, one in a realistic clinic setting, simulating a pressured situation. These come complete with interaction between doctors, nurses, and other clinicians, can be ‘multi-player’, and provide performance analysis/feedback. This Editor noted Oxford Medical Simulation’s work with NHS England in Wessex on treatment for diabetic emergencies [News Roundup, TTA 3 Apr 19] and another pilot at OxSTaR (Oxford Simulation, Teaching and Research) center [News Roundup, TTA 8 Aug 19]. In surgery, Southern Methodist University (which has a leading graduate school for video game design), Virti, and Medical Realities (the latter two UK firms) have pioneered training in US, UK, and Europe plus specialized trainings for surgeons in Africa replicating conditions faced in ORs there. The trainings not only teach procedure, but reduce surgeon and fellow clinician stress. Digital Trends