Coming up *this* Tuesday: UKTelehealthcare All IP Forum Webinar Tuesday 2 March

Our long-time supporters UKTelehealthcare are presenting a two-hour webinar this coming Tuesday (2 March) on the digital switchover from copper to fibre digital internet protocol (IP). It’s available to all (registration is free) but is likely of greatest interest to those doing business in the UK (and more than likely, you’re a UKTHC member…aren’t you?)

The webinar is 11.00 to 13.00 London UK time. There are two short presentations plus an all-IP panel.

More information and registration link are here. Or click our UKTHC advert at the right of this page to go to their main website, then go to Events.

Highlights:

  • All IP update and panel including representatives from BT, Openreach, Virgin Media, TalkTalk, Ofcom and OTA2. Hosted by Steve Smith (CEO of TECS Advisory Ltd.) and presentations by Hawkeye and Medequip.
  • Presentation by Hawkeye – Gary Doran (Managing Director)

    Panelists on the all IP Panel – Hosted by Steve Smith (Director, TECS Advisory)
    BT – Sodhi Dhillon (Device Partnerships Special Services)
    TALK TALK – Phil Cain (Industry and Vendor Liaison)
    Virgin Media – David Christie (Senior Regulatory Specialist)
    Openreach – John Livermore (All IP Industry Engagement Manager)
    Ofcom – Huw Saunders (Director, Network Infrastructure and Resilience)
    OTA2 – David Halliday (Managing Director)
    Hawkeye – Gary Doran (Managing Director)

    Presentation by Medequip – Kristian Knight (Operations Supervisor)

UKTelehealthcare also has an All IP page to read about the latest updates from BT, Virgin and other providers on the digital switchover.

Upcoming UKTHC Digital MarketPlace events are at 11.00 am on 9th March and 16th March. UKTHC also is part of the Naidex event in Birmingham, now 15th-16th November. Follow them on Twitter @ukthcnews and LinkedIn

“All That We Let In”: health apps’ APIs are vulnerable and easy to hack, exposing and altering PHI and PII

Mobile security company Approov has issued a scary report on the hackability of popular health apps. They tested 30 apps (not named in the report) of the 300,000-odd health apps in the market, and found that the application programming interfaces (APIs) used in 100 percent of these apps had hardcoded vulnerabilities that could allow hackers to access protected health information (PHI), personally identifiable information (PII), identity, and billing information. According to the report (registration required), these apps used by patient care organizations for remote account management and telemedicine appointments may expose 23 million individuals. Of the 30 apps tested:

  • 77 percent contained hardcoded API keys, some of which do not expire
  • Seven percent had hardcoded usernames and passwords in plain text
  • 50 percent of the doors that these API vulnerabilities opened led to PHI and billing information
  • 100 percent of the API endpoints tested were vulnerable to Broken Object Level Authorization (BOLA) attacks. These involve a relatively simple process of falsifying user IDs and swapping out numbers. For some apps, the hack could gain clinician-level access and alter medical histories and records (including issuing prescriptions for medication).
  • 100 percent of the apps were vulnerable to man-in-the-middle attacks due to failure to implement certificate pinning, which forces the app to validate the server’s certificate against a known good copy

Alyssa Knight, the ‘recovering hacker’ who authored the report, also hacked into one hospital’s EHR and changed its values by one digit. She was then able to access health records and registration information. She used a hacking tool that looks like it is generating data from a mobile health app.

The use of mobile apps for telehealth and portals has become far more widespread as a result of the pandemic, yet security has lagged–even though the level of sophistication in the apps, and the amount of information they integrate, has accelerated to become the norm. It’s a wakeup call to developers, health systems, and digital health companies that off the shelf and old APIs don’t meet security demands. Unfortunately, Gartner projects that APIs will become the vector for most data breaches by 2022. CPO Magazine, FierceHealthcare

Deal and news roundup: Cigna acquires MDLive, Oscar Health $1bn IPO preview, Teladoc’s smash revenue–and losses, Medisafe’s $30M Series C

The big news this week in Telehealth World is Cigna’s agreement to acquire MDLive. MDLive will be part of Evernorth, Cigna’s health services portfolio. From the release and news reports,  Cigna has been a long-time partner of and investor (through Cigna Ventures) in MDLive, which has grown to 60 million members. No purchase price nor management changes have been disclosed. Headquartered in Florida, since 2009 MDLive raised close to $200 million in investment in five rounds, the last $50 million in private equity in September, and was rumored to be prepping an IPO. 

Evernorth was rebranded within Cigna last September for management services which can be sold outside of Cigna, a move that follows both CVS Aetna and UnitedHealthGroup. It contains pharmacy benefit management company Express Scripts, specialty pharmacy Accredo, and medical benefit manager eviCore along with several other smaller related businesses. Last year, it brought in $116.1 billion in revenues for Cigna last year, a 20 percent jump from 2019, according to Cigna’s annual report. MDLive release, Healthcare Dive, FierceHealthcare

‘Neoinsurer’ Oscar Health’s IPO raise, scheduled for next week, is now estimated to be in the eye-blinking $1 bn to $1.2 bn range, with over 30 million shares valued at $32-34 per share. At the beginning of the month, it was estimated to be a modest $100 million [TTA 9 Feb]. Daffodils in February? More in TechCrunch, Reuters

Meanwhile, the Big Kahuna of Telehealth, Teladoc, ended 2020 with a smashing $1.1 bn in revenue and equally smashing losses. Their Q4 revenue was $383 million, up 145 percent from $156 million in Q4 2019. Visits skyrocketed due to the pandemic of course–10.6 million, up 156% from 2019. Paid membership hit 51.8 million, up 41 percent from 2019’s 36.7 million. Both membership and visits are expected to increase in 2021. Livongo, acquired in October, added substantially to 2020’s losses of $485 million, up 389 percent from 2019’s $99 million. Q4 losses were $394 million in the fourth quarter, up from $19 million in 2019. FierceHealthcare, Teladoc release

And happily, but more modestly, Medisafe’s smartphone-based medication management app has raised a $30 million Series C, led by Sanofi Ventures and ALIVE Israel HealthTech Fund. From a basic app when this Editor first profiled the company and met Omri ‘Bob’ Shor over a coffee in 2013, the app now is more a digital drug companion and a platform for patient adherence programs. Kudos! Release

Comings and goings: Babylon Health, Seniorlink, Hinge Health

At Babylon Health, the US-based C-suite is now larger with the additions of Paul-Henri Ferrand, briefly of financial platform Brex and previously Google Cloud, as Chief Business Officer, Stacy Saal of Amazon as Chief Operating Officer, and Steve Davis from Expedia Group as Chief Technology Officer. Mr. Ferrand will lead business development, sales, marketing, and customer success efforts; Ms. Saal operational initiatives and goals; and Mr. Davis technology and data. They will concentrate on US growth plans plus refining and leveraging Babylon 360.  Babylon release

Seniorlink, a Boston-based provider of professional coaching, emotional and financial support services for caregivers through Medicare Advantage and Medicaid in nine states, and the developer of the Vela care coordination app, appointed Matt Marek as President and Chief Operating Officer. He comes from Further, a service company for healthcare spending accounts. He will be concentrating on strategy and increasing US growth and partnerships.  Release

Having raised $300 million in a January Series D [TTA 14 Jan] as a prelude to a rumored IPO, San Francisco-based Hinge Health has made some major management changes. Jim Pursley, longtime Chief Commercial Officer at Livongo Health who departed after the Teladoc Health acquisition, is now President. Lex Annison, formerly of Google, is now Chief Operating Officer. And their new CFO, Ron Will, comes from the financial world, most recently from Ripple, and apparently has experience with mergers. On their management roster, Hinge now has two presidents–Gabriel Mecklenberg, a co-founder, and Mr. Pursley. Hinge provides digital solutions that treat chronic musculoskeletal (MSK) conditions to the provider market. Hat tip to an industry insider.   

GAO tells VA to postpone Cerner EHR implementation–but VA will be continuing

The US Department of Veterans Affairs (VA) is still in the long rollout of the Cerner/Leidos EHR system to replace their home-grown, once groundbreaking VistA and to be interoperable with the Department of Defense’s Cerner Millenium system. The Government Accountability Office (GAO) issued a report (PDF link) that concludes that “VA should postpone deployment of its new EHR system at planned locations until any resulting critical and high severity test findings are appropriately addressed.” These potential system failure points were brought up by GAO to Congress last October at the time of the first implementation in Spokane, Washington. The sidebar on GAO’s report states that VA agreed with the postponement, but a news report in FedScoop indicates that VA believes, per their comments in the report, that:

  • VA and Cerner have resolved the major issues (down to 55 from close to 400)
  • They will resolve the rest by January 2022
  • They will proceed with the scheduled rollout to the VA’s Puget Sound Health Care System in Q4 2021.

Hat tip to HISTalk, which managed to summarize this in seven short sentences (!).

Deal and news roundup, 17-18 Feb: Sharecare goes SPAC for hefty $3.9 bn valuation; Humana Care Support pilots; AliveCor, AstraZeneca partner on renal, cardiac; Current Health RPM in clinical trials

Sharecare, a free/paid app platform that enables users to consolidate all their health and wellness data in one location and use proprietary health management tools, is going the SPAC route with Falcon Capital Acquisition Corp. It will trade on NASDAQ under SHCR. Initial enterprise value is expected to be $3.9 bn with approximately $400 million in growth capital. Closing is expected to be in Q2 of this year.

Founded in 2010 by celebrity doctor Mehmet Oz, MD (now on the board and not in active management) and WebMD founder Jeff Arnold, the current CEO, Sharecare will also have an undisclosed investment by strategic partners Anthem and Digital Alpha. Anthem is looking at the AI value plus consumer engagement and personalized care. Helping to fund both the public equity and cash position is a fully committed private investment in public equity (PIPE) of $425 million at $10.00 per share which is below market value. Falcon Capital will retain about 20 percent of the company. Mr. Arnold will join the board and be retained as CEO. After the closing, Sharecare and Falcon will donate about $4 million in stock to Sharecare’s charitable foundation.

Sharecare sells the platform to enterprises such as providers, employers, health plans, government organizations, and communities, as well as individuals on their free apps. Release, FierceHealthcare, Becker’s

Rival health plan Humana is also adding to its care management tools with a pilot of the Humana Care Support program. The platform creates an integrated, personalized experience for members, including a multi-disciplinary care team and SDOH integration. The pilot targets select groups of Medicare Advantage members in Kentucky, Pennsylvania, and West Virginia with multiple chronic conditions, complex congestive heart failure, and diabetes, with multi-disciplinary care teams. Humana Care Pilot is built on Salesforce’s Health Cloud platform for viewing the patient’s medical history and integrating clinician workflows. Its analytics are powered by Microsoft’s Azure and Power BI. The goal is lowering costs and improving outcomes for this high-cost group of patients. If successful, the program will roll out to other markets this year. Humana release, FierceHealthcare

AliveCor, the developer of the KardiaMobile mobile ECG/EKG, and AstraZeneca are partnering on research for new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas. This will use AliveCor’s monitoring system for blood potassium. The Kardia-K AI platform uses ECG/EKG neural network analysis to measure a patient’s potassium levels without a patient blood draw. Hyperkalemia (elevated blood potassium) is linked to renal issues and kidney disease as well as cardiac issues. Kardia-K received Breakthrough Device Designation status from the FDA to screen for elevated levels of blood potassium in September 2018, and was validated in a study with Mayo Clinic published in 2019. Release, Mobihealthnews

Current Health, a monitoring and care management RPM system for enterprise-level health organizations, announced its “Community” initiative to build diverse longitudinal datasets for decentralized clinical trials. Their platform is FDA-cleared and used at scale in phase III and phase IV drug trials by major pharmaceutical organizations for remote endpoint collection and for virtual trial delivery. Monitoring is performed through wearables and sent to the electronic data capture (EDC) vendor for the clinical research organization (CRO). Current Health is using Community for its own COVID-19 study to predict hospitalizations and inform clinical treatment. The study is recruiting US participants diagnosed with the virus in the last 48 hours. Current has locations in Edinburgh, London, Boston, and San Francisco according to their website. Mobihealthnews

The Theranos Story, ch. 70: the lab director turns Federal evidence

A Tasty Appetizer of what awaits in July in Federal District Court, San Jose, showed up in the Wall Street Journal today (paywalled, link to full article below). Theranos‘ lab director Kingshuk Das, MD will testify in Elizabeth Holmes’ trial that the Theranos lab and technology did not work accurately enough to use–and that the company’s leaders ‘pushed back’ against his assessment.

Dr. Das’ comments, revealed in new court filings, represent his most extensive (and only revealed, in this Editor’s estimation) remarks on Theranos. His one-hour interview with Federal agents took place on 1 February. They indicate that Federal prosecutors continue to dig for damning evidence prior to the July trial.

Dr. Das held the lab director, later medical director, position at the Newark, California lab facility in Theranos’ final years (December 2015 in the article, the LinkedIn profile states March 2016, to June 2018). The Centers for Medicare and Medicaid Services (CMS) had already put Theranos on notice for“deficient practices” in November 2015. The WSJ, around that time, revealed Theranos’ dodgy practices.

Dr. Das’ fully credible and extensive pathology training is listed in his LinkedIn profile. It includes his MD at Case Western Reserve, internship at UCLA, residencies in clinical pathology at Washington University (St. Louis) and USC, and return to UCLA for a fellowship in molecular genetics, then rising to Associate Medical Director, UCLA Clinical Laboratories. As for many others, Theranos was challenging,  could not have been good for his career, but perhaps gave him a taste of how to do entrepreneurship right. He has worked in several positions and is currently listed with consumer genetics tester Invitae as a molecular pathologist and founder of AnimanDX from 2018.

This Editor would bet that Dr. Das had far more to say than what was cited in the WSJ article. At least this is more like Joe Friday’s ‘just the facts’ (Dragnet) and not mired in the swamp of ‘motivations’ represented by the filings around Silicon Valley’s Lifestyles of the Rich, Famous, and Busted.

Full article at StockXpo. Hat tip to reader William T. Oravecz. For those interested in the full sturm und drang by chapter, it is here.

Airborne SARS-CoV-2 detection device for indoor use successfully tested

Smiths Detection, a UK-headquartered developer of threat detection and security screening technology, announced this week the success of the BioFlash Biological Identifier in detecting the virus that causes COVID-19 disease in an airborne state. This was proven in testing conducted by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Maryland.

The SARS-CoV-2 CANARY biosensor used in the BioFlash device detected and identified the presence of low levels of aerosolized, live SARS-CoV-2 in a Biosafety Level 3 containment area. The CANARY technology is a cell-based biosensor. Using proprietary aerosol-collection techniques, the Identifier can provide rapid, sensitive, and specific identification of biological-threat agents including viruses, toxins, and bacteria.

According to the release: 

  • USAMRIID’s test confirmed detection down to an estimated 6,000 airborne infectious particles of the SARS-CoV-2 virus within a controlled environment
  • 6,000 particles compares favorably to as many as one million particles emitted in a single sneeze by an infected person 
  • The test results also pick up the COVID virus without cross-reactivity with influenza and Middle East Respiratory Syndrome (MERS)

Additional testing is underway to reinforce the data on effectiveness and determine strategies for use in indoor settings. No mention is made of projected cost or anticipated release, but it is encouraging news for those of us who want to be back in the Great Indoors, in offices, and traveling. Photo courtesy of Smiths/FTI Consulting.

Funding roundup, 16 Feb: virtual mental health gains two (more) unicorns, Zocdoc’s fresh $150M, Owlet’s $325M SPAC

Virtual behavioral health continues its hot run with two companies’ funding launching them into Unicorn Stratosphere valuations. The latest is San Francisco-based Modern Health which closed a $74 million Series D investment round, led by Founders Fund with participation from Lachy Groom. Total funding now exceeds $167 million over the past two years. The company claims a valuation of $1.17 bn plus status as the fastest entirely women-founded company in the US to hit the magic unicorn mark. Modern Health provides for about 220 mid-sized companies an app platform combining therapy, coaching, and self-guided courses in 35 languages. On 1 February, Modern Health acquired Kip, another mental health platform that was also woman-founded, for an undisclosed amount.

In January, corporate mental health provider, Lyra Health, gained a Series E of $187 million, bringing its valuation to $2 bn. Lyra claims 2 million members in large companies like Pillsbury, Uber, and Morgan Stanley. Talkspace, a direct-to-consumer digital therapy provider, went public earlier in January via a $1.4 bn SPAC. [TTA 29 Jan] According to Crunchbase News, among mental health startups, 141 were venture-backed within five years to the tune of $1.3 bn in investment. The pandemic and ‘lockdown loneliness’, as we’ve noted, kicked digital health and mental health funding into overdrive. FierceHealthcare, Crunchbase 

Patient appointment setter Zocdoc also gathered $150 million in fresh funding–what’s termed growth financing from Francisco Partners, bringing their total financing to $376 million in 10 rounds. Zocdoc has changed its model in the past two years from a subscription basis–priced per provider–to a per-booking charge. They also added virtual visits. Zocdoc now claims to be profitable and has grown its network by 50 percent in some states. It was one of the early healthcare unicorns, controversial in its business practices as far back as 2016, with customer churn, low margins, and high customer acquisition costs leading to unprofitability [TTA 11 May 2016, 21 Jan 2019], plus a former CEO suing about his ouster after eight years. HISTalk, Zocdoc release

Owlet socks it to a Q2 SPAC. Baby monitoring system Owlet Baby Care becomes a unicorn of just over $1 bn through a SPAC (special purpose acquisition company) merger with Sandbridge Acquisition Corporation, backed by Sandbridge Capital and PIMCO private funds. It will trade on the NYSE (OWLT) and close in Q2. Anticipated value is as much as $325 million through cash ($230 million) and concurrent private placement (PIPE) of common stock ($130 million). Owlet started in 2013 with a ‘Smart Sock’ (left) using pulse oximetry to monitor baby heart rate, oxygen levels, and sleep patterns with readouts via their app, but has expanded to include an Owlet Cam. Owlet stated 50 percent revenue growth in 2020 after approximately $50 million in net revenue for 2019. Amazingly, Owlet in seven years raised a modest $48 million through 27 investors concluding with a two-year Series B. Awwww-worthy indeed. Release, Mobihealthnews

News and deal roundup: Signify Health’s $564M IPO, RapidSOS’ $85M Series C, Poland’s Telemedico raise, Livongo’s Zane Burke to Bardavon

The Big Deal of the Week is Signify Health‘s IPO which on 11 February raised $564 million on a sale of 23.5 million shares on the NYSE. Signify provides comprehensive care and management services such as complex care management, SDOH, episodes of care/bundled care programs, and specialized medical services in the home, utilizing technology and data analytics. Signify now has a market capitalization of $7.12 bn. FierceHealthcare, MarketWatch, Signify release.

RapidSOS, an emergency response data platform that provides Next Generation 911 and Emergency Services Network services to Emergency Communication Centers, had a Series C raise of $85 million led by Insight Partners and Global Venture Capital. The RapidSOS technology in global use links 350 million connected devices to first responders and 4,800 data centers. They have raised $205.7 million over 14 rounds since 2016. Crunchbase, release

On the other side of the deal continuum, Poland’s Telemedico, a telemedicine provider in multiple European and Middle Eastern countries, raised a modest €5.5 million (~$6.6 million) in a Series A round. The round is led by Flashpoint Venture Capital, Uniqa Ventures, PKO VC, Black Pearls VC, and Adamed. Mobihealthnews, TechCrunch

And in a coda to the Telavongo story (Teladoc and Livongo), former CEO Zane Burke joined as a director of workers compensation digital health company Bardavon Health Innovations. Mr. Burke led the $18.5 billion merger with Teladoc in his two years as CEO, after 20 years at Cerner. Becker’s Health IT, release (DigitalJournal)

NHS touts COVID-19 Test and Trace app; Livi’s MJog notifies users of vaccine jab info

The NHS Test and Trace app, launched in September in England and Wales, released its first report on notifications this week. 1.7 million app users have been advised to isolate due to close contact (not defined) with a person then found to test positive for the virus. The app notifies the user of the positive contact as quickly as 15 minutes after a user inputs a positive test result. Over 3.1 million test results have been entered into the app across England and Wales, of which 825,388 were positive. The testing combines both those booked through the app and manually entered there. 

The NHS’ analysis suggests (their term) that the contact tracing has prevented approximately 600,000 cases. Test and Trace incorporates a symptom checker that has been used over 1.4 million times.

As well as contact tracing and booking a test the app allows users to check their symptoms via the symptom checker. Coronavirus symptoms have been reported into the app over 1.4 million times in England and Wales since 24 September.

For a contact tracer, it’s been extremely successful with a download count of 21.63 million. It’s estimated that 56 percent of the eligible population aged 16+ with a smartphone has downloaded the app. It was 2020’s second most downloaded free iPhone app in the App Store in 2020. Gov.UK Department of Health and Social Care release, Mobihealthnews

Seeking info on your vaccine jab? Livi is supporting the NHS through its MJog app, notifying users of vaccination messages including vaccination eligibility, the latest information about vaccines, and whether or not users can phone their GP. Since the December rollout, 25 million vaccination text messages have been sent to NHS patients. The MJog platform saw a 220 percent increase in messages sent during the same period the prior year. The app in addition sent out five million appointment reminders. Livi acquired patient notification app MJog, a patient messaging service for the NHS during the past 12 years, last October. Mobihealthnews.

Lasting effects of the pandemic lockdown on health and wealth

A PR hook for healthcare-related companies is a survey that tells us More Bad News about the effects of the pandemic and the US lockdown. Some of it is marketing content scrum, but the quantification of lasting effects has value.

  • Early surveys came from non-profits working with (largely) non-vendors, such as the Epic Health Research Network and Commonwealth Fund/Harvard/Phreesia studies.
  • Then later tracking studies such as those published in PLOS One, by FAIR Health and the Harvard study published in Health Affairs.
  • Focused studies such as those by GoodRx, the prescription discounter, with a surprisingly deep survey concentrating on the CoronaDepressed–mental health and the worsening of anxiety and depression, inferring from prescription usage. SECOM CareTech in the UK concentrated on the effects of ‘lockdown loneliness’ on older adults.

The latest survey comes from another free prescription coupon platform, RxSaver, concentrating on financial and medication adherence:

  • 51 percent of adults reported a negative financial impact resulting from the pandemic. 65 percent of them were Hispanic.
  • Over 60 percent of millennials reported continuing financial impact one year after the pandemic’s start.
  • Where are they economizing? Unsurprisingly, medication.
    • 15 percent of adults surveyed stopped taking medication in the past year. Of this group, the under 30 cohort comprised the largest demographic segment at 23 percent.
    • Trying to manage, 21 percent have used a prescription savings coupon, but 31 percent either didn’t fill prescriptions, skipped doses, or split their pills/capsules–all of which are risky.

Phoenix Research performed a Public Insights Survey for RxSaver, N=1,000 nationally representative adults ages 18 and older, and performed 20-22 January. There was no disclosure on survey methodology. This Editor hopes that other entities use this directional information in conducting larger and less product promotional research to be used by health organizations and policy groups. RxSaver web page, release.

‘Neoinsurer’ Oscar Health goes for $100 million IPO; Clover Health’s big SPAC under SEC microscope

Oscar Health, one of a number of US ‘insurtech’ or ‘neoinsurance’ private health insurance companies that have nipped at the heels of the Big 9, announced late Friday an IPO on the NYSE. The number of shares and their value is not on the SEC S-1 filing but the estimate of the raise is $100 million. Timing is not disclosed but rumored to be by March or early Q2. The offering is underwritten by Goldman Sachs, Morgan Stanley, and Allen and Company.

Oscar was one of the first to offer members apps, telehealth, and fitness trackers–revolutionary back in 2012 but routine now. Expanding beyond its original base of individual health insurance coverage, it now offers Medicare Advantage and small group coverage in 18 states to over 500,000 members. Oscar remains a virtual-first platform with the majority of its members in Florida, Texas, and California. Oscar makes much of member engagement and its partnerships; 47 percent of its overall subscribing membership and 44 percent of its 55-and-up subscribers are monthly active users. Oscar has also partnered with Cleveland Clinic and other larger insurers like Cigna. 

Financing for Oscar to date is over $1.5 bn. It has tidily grown in geographic coverage, members, and revenue–$1.67 billion in 2020 and $1.04 billion in 2019–no simple feat against the Big 9. Oscar’s problem is profitability–operating losses grew proportionately, $402.3 million (+56% from $259.4 million). Operating expenses also grew by 16 percent. TechCrunch gives additional crunch in the financial analysis (article in part, full paid access). Mobihealthnews

Oscar is one of a few health-tech heavy survivors of insurance companies that bloomed like flowers–and wilted–during and post-Obamacare. Clover Health, which thrived in a slice of the Medicare Advantage market, went the SPAC (blank check) route 8 January with Social Capital Hedosophia Holdings. Now with an enterprise value of approximately $3.7 billion, the SPAC indeed put Clover in the clover [TTA 14 Jan].

But perhaps short-lived. Clover’s SPAC is now being scrutinized by the SEC based on last week’s explosive charges by short-seller maven Hindenburg Research (!). Hindenburg’s research report alleges that Clover “lured retail investors into a broken business” by not disclosing a Department of Justice (DOJ) investigation that started (at least) last fall. Clover countered that the investigation is “routine” since Clover is in the Medicare business. Thus, it was not disclosed by Clover to investors as ‘non-material’. DOJ investigations are far more serious than CMS fines for compliance violations, which are not uncommon. Back in 2016, Clover was fined just over $106,000 by CMS on misleading marketing practices.

In short, DOJ investigations are never routine. They usually are the start point for enhanced claims scrutiny and a concatenation of charges, as WellCare, then a scrappy upstart insurer, found out over six agonizing years, 2006-2012, that were serious enough to send much of top management to Club Fed.  The Hindenburg paper (linked above) details other business practices that if true, are dodgy at best and fuel for further investigations.

The SEC notice of investigation was disclosed by Clover last Friday evening, usually a good time to disclose Bad News. This SPAC may have feet of clay.  PYMNTS.com, CNBC

NHS digital triaging app eConsult closes £7 million funding round

Closing out last week was eConsult’s announcement of a new £7 million round of financing. The triage app is currently used by about 40 percent of NHS practices–3,200 NHS GP practices across the UK. The funding, on top of a £5 million Series A raise last October (Crunchbase, AngelNews) was via Gresham House Ventures (this raise and the Series A lead) and Calculus Capital, plus existing investors.

The fresh funding will boost eConsult capabilities for primary and secondary care, plus expansion into urgent care with an Urgent and Emergency Care tool, eTriage, and outpatient triage tool, eSpecialist. They are also developing a triaging service for Emergency Departments (EDs). 

eConsult was formed in 2013 by four NHS GPs. It uses a bank of over 10,000 questions from a number of clinical sources to direct patients to the most appropriate care, assign priority, and direct to a GP surgery. Their research indicates that 70 percent of GP enquiries can be closed without a F2F consult. 

Last August, eConsult, Q doctor, and Cognitant Group jointly created a toolbar that combined eConsult with Q doctor’s video consult technology and Cognitant Group’s ‘Healthinote’ verified patient information service. They later added HCI’s medical video library service. In June, eConsult added the Ministry of Defence; 183,500 service members and dependents in 124 international locations are able to access online consultations with Defence Primary Healthcare (release).

eConsult’s service volume exploded during the early pandemic and has held its leading share versus competitive services such as Babylon Health, Push Doctor, Infermedica, and Livi (Kry). Babylon has had its challenges in the UK market but is aggressively moving into enterprise accounts in the US and Canada, quietly raising just before Christmas $100 million (£74.5m) in a convertible loan led by VNV Global. Mobihealthnews. UKTechNews

Belfast’s B-Secur obtains FDA 510(k) clearance for HeartKey ECG/EKG algorithm library

A Belfast (NI) biometrics startup, B-Secur, on Thursday announced FDA clearance of its ECG/EKG software library that analyzes individual heartbeats and heart rhythms, which can be implemented across a wide range of health and wellness monitoring devices.

B-Secur received FDA clearance for the following algorithms part of HeartKey ECG/EKG: Signal Conditioning, Heart Rate, and Arrhythmia Analysis, which includes Atrial Fibrillation, Bradycardia and Tachycardia.

According to their release, the algorithms can be integrated into semiconductors for a broad range of devices, enabling rapid integration of medical-grade ECG/EKG software. It also can run embedded on devices, on the application layer, and via the cloud into systems. As a turnkey solution, it can speed the development of new devices or upgrade older types. By upgrading the monitoring capabilities of health and wellness devices, it can extend clinical-grade monitoring out of the clinic or hospital in less obtrusive ways, which is extremely useful for diagnosing transient cardiac conditions such as atrial fibrillation. 

Not yet cleared are HeartKey algorithms for heart rate variability (HRV), energy expenditure, and physiological stress. There is also a UserID feature that uses an individual’s ECG/EKG to personalize and protect that person’s physiological data. 

B-Secur has raised £11.5 million in multiple venture and one Series A round since its founding in 2002 and in its current iteration in 2014 (Crunchbase).

23andMe will go the SPAC route with Virgin Group in a $3.5 bn valuation

Have we reached a peak? 23andMe, the genomic testing and genome research company, has struck gold, oil, and platinum in a merger with ‘blank check’ SPAC (special purpose acquisition company) VG Acquisition Corp. VG was formed by Richard Branson’s Virgin Group for the purposes of the acquisition. By end of Q2, the company will be trading on the NYSE under the ticker symbol ME. The company’s valuation is estimated as $3.5 bn.

23andMe’s SPAC follows on December’s $85 million Series F round, bringing their total funding pre-SPAC to about $900 million. The transaction will result in 23andMe having around $984 million in cash to invest. The deal also includes the private investment in public equity (PIPE) transaction in which Richard Branson and 23andMe founder/CEO Anne Wojcicki will invest $25 million each. There is no disclosure of the status of GSK’s ongoing investment in 23andMe, reportedly 50 percent, and Sequoia Capital’s. 

For 23andMe, this is a massive turnaround–and exit from stagnant private ownership–from their precarious state one year ago, which required layoffs of 14 percent of their staff, about 100 people. While the direct-to-consumer testing for diseases and ancestry model fell apart after holiday 2019 (TTA examined why here), the gold in genomics is monetizing that data with large drug and clinical trial companies for drug discovery and therapies. With GSK, they began clinical trials of a cancer drug last year, as well as licensing its first drug candidate to Spanish dermatology drugmaker Almirall. 

Going public via a SPAC and with a PIPE is definitely a one-up on rival Ancestry.com. Last August, they sold 75 percent of the company to Blackstone Group for $4.7 bn. TechCrunch, Becker’s Health IT, Financial Times