Reflections in a Gimlet Eye: further skeptical thoughts on the Teladoc acquisition of Livongo (updated)

Gimlet EyePerhaps it’s Reflections in a Gimlet Eye, but this Editor remains bemused and slightly dyspeptic about the acquisition of ‘health signals’ remote patient monitoring management platform Livongo by telehealth giant Teladoc.

Here’s the latest, courtesy of Credit Suisse equity research analyst Jailendra Singh on deal rationale and the potential synergies, based on his Q&A with Teladoc and Livongo management (link here):

  • Livongo: “The company was not for sale, and LVGO did not view the transaction with TDOC as a sale. Instead, management views the deal as a merger of the two leaders in virtual care.” 
  • It had nothing to do with pressure from CVS and UnitedHealth Group (UNH). 
  • There are major cross-selling opportunities, starting with an overlap of 25 percent of their clients. There are also opportunities with the InTouch Health client base in acute care, Aetna plus UNH on the health plan side, and employer administrative services only (ASO) plans. This is part of the calculation of synergies totaling $500 million in 2025 which they believe are conservative given the math.
  • They are also seeking to approach their client base before the closing through a reseller agreement, as Teladoc was able to do with InTouch.

Mr. Singh’s analysis is conservative and sober from a strictly financial viewpoint. His two-page analysis is, as usual, worth the read. 

But then we stumble across one particularly helium-charged claim. It’s projected that Teladoc and Livongo would have a combined company market cap of $38 bn, whereas the pre-pandemic value of the companies was $8 bn. (Steve Kraus, Partner at Bessemer Venture Partners, now on the board of Ginger, as quoted in Forbes). That is optimistic, considering that patient primary care virtual visits have flattened down to about 7.4 percent of visits as of June (Commonwealth Fund/Harvard/Phreesia study). It’s assuming a great deal that people will continue to shy away from in-person care going forward. Perhaps to a degree this will, as in-person fear is only starting to flatten, but not everything can be done virtually, even RPM. Telehealth and RPM also present challenges for practices in value-based care models, in workflows, and even with the liberalization of Medicare reimbursements, financially.

Livongo’s great asset, which was understandably compelling for Teladoc, is chronic condition management, RPM, and all that patient data, which can be broadened past their diabetes base (with a small one in behavioral health courtesy of their myStrength acquisition) into other chronic conditions which was Livongo’s strategy anyway. To be determined is how compelling this will be for Teladoc’s customer base and for new customers, particularly if the economic environment is constrained and health plans don’t get on board. 

So why is Mr. Market not mad about this ‘merger’? TDOC has taken a spill since its (adjusted) close on 4 August at $249, and is trading below $200 at $193. LVGO took a lesser hit, from $144 to $121. Another Bessemer Venture Partners investor, Morgan Cheatham, in the Forbes article linked above, was quoted that Livongo had clear market leadership in the employer and health plan market, then expressed surprise at why Livongo agreed to be acquired: “The company had a real shot at becoming a $100 billion business by running the ‘digital hospital’ playbook. In some ways, the acquisition feels premature.” Teladoc’s COO David Sides promised that the combined company will aid practices in the transition from hospital to home care, touting the consumer focus of both companies. (Have they consulted already burdened and strained providers how this can be made easier for them and fit into value-based care models as well as their financials?) But they may have to make more acquisitions to facilitate this. So $18.5 billion plus $1 bn for InTouch isn’t enough to get the job done?

Is it synergy, the wave of the future, or an overloaded Christmas Tree of features, not benefits?

Reminder: to date, neither company has been profitable.

So, what does this mean for other digital health companies? Initially, it’s quite positive that Teladoc could round up nearly $20bn in six months. John Halamka MD, a well-known digital health visionary now at Mayo Clinic, sees it as a bridge to the digital health ecosystem including other companies. A contrarian view was expressed by Mr. Cheatham.  Teladoc-Livongo is a challenge for other digital health companies in that they won’t, and cannot, be Teladocs and Livongos–in other words, an unrealistically high bar for them. “Why can’t Telavongo build this?”

Finally, a personal and slightly jaundiced view from this Editor. Let’s take a good hard look at the Human Factors that make companies go. This is an acquisition by Teladoc of smaller Livongo, despite the merger statements. Employees in both companies are wondering who will go, who will stay, who they will report to if they stay, and where they will be. They have about four to six months to mull what their future might look like at a tough economic time. This will — not may, will–have an effect on operations and attitudes, especially at Livongo.

There are some doubleplus ungood signs that make the assertion that this is a “merger” of companies questionable:

  • Jennifer Schneider, MD, president of Livongo, has stated that both companies are currently hiring and don’t plan layoffs as a result of the merger (Becker’s Health IT). Blanket statements like this are usually made at the start to assure employees. Anyone who has been through a merger knows there are overlapping areas such as HR, marketing, and financial. There are only so many chairs at the organizational table especially at the director and above level. The happy talk doesn’t change the reality that not everyone will be given the option to stay.
  • Statements on similar cultures notwithstanding, the fact is that both companies have different cultures and experiences because they have radically different histories and personalities running them. This Editor would suspect that Livongo employees, having come up in a young and smaller company, in an intense entrepreneurial environment, with employees who were among the first 50 or 100, have a great identification with Livongo and pride in their success.
  • Not one Livongo senior executive was named publicly as taking a new operational role in the merged entity. (Board seats don’t count. But then again, they will be walking away with a major payday, reputed to be in the hundreds of millions for the top executives. What they will do with their future is a major unknown.)
  • The HQ will be in Purchase. Most Livongo employees are in California.
  • The company will be named Teladoc and will not be renamed. That says a lot, even though industry wags are calling it Telavongo and other names.

One would hope that both companies make every effort to reorganize the company staffs in a way where layoffs are minimal, those who are packaged out are treated generously, but better, valued employees from both companies are retained and incentivized to stay–sooner rather than in 4th quarter–in a fair and unbiased evaluative process in how they support their businesses presently and going forward as part of the combined companies future. But this is not typically the case.

One would also hope that the clients and individuals who pay the bills were told, timed with the public announcement, that this was happening and what it means for them. Leaving them to read the announcement online is usually what happens. It’s not automatic, and I’ve seen this treated as an afterthought in both large companies and small, with line of business folks scrambling to put together customer messages, and delayed in getting them approved as after all they have to go through both corporate and investor communications. This is typically the case, as communications cease to be a priority at the market/LOB level when the SEC or DOJ are involved.

Reminder: the Human Factors will fly this aircraft–or auger it in. 

Agree? Disagree? Comments welcomed.  TTA’s earlier ‘skeptical take’ commentary here.

More consolidation: BioTelemetry acquires population health platform from Envolve/Centene, inks agreement with Boston Scientific

BioTelemetry , a RPM company in the cardiac monitoring, population health management, and clinical trials research, quietly announced last week two agreements that once again confirm the consolidation of now the remote patient monitoring market:

  • The acquisition of the On.Demand remote patient monitoring (RPM) and coaching platform, formerly owned and operated by Envolve People Care, Inc., a Centene Corporation subsidiary. The population health management platform contains real-time monitoring of biometric data with cellular- and web-based technology (including Alexa), proactive and reactive health coaching, population health reporting, and customizable interventions. While acquisition cost was not disclosed, BioTelemetry retains through a strategic partnership agreement Envolve and its base with Centene health plan members for diabetes RPM for the remainder of 2020. BioTelemetry is also free to pursue business with other health plans. Release.
  • BioTelemetry will also be a sales agent in the United States for the Boston Scientific LUX-Dx Insertable Cardiac Monitor (ICM) System. Release.

If you go back to 1994, up to 2013, BioTelemetry was CardioNet and one of the Ur-Companies in the RPM space. They went public in 2015 on Nasdaq, and have quietly made many acquisitions both before and after the IPO. Their 2nd Quarter results were $99 million in revenue; operations were profitable, despite a downturn in revenues from the pandemic and beat their estimates (Zacks). Unlike Teladoc and Livongo, their shares have been solidly up since end of July and they’re rated a ‘hold’. Nothing flashy, but solid work.

TechForce 19 follow up: Alcuris’ results on testing Memo Hub (UK)

Often this Editor has been frustrated with lack of interesting follow up to these government initiatives to share with our Readers. Fortunately, Adrian Scaife of Alcuris, has stayed in touch, first on the experience of being a participant, and this week to provide their findings on their tested solution. From the release and the attached white paper, their results in testing the Activities of Daily Living (ADL) Memo service were as follows:

• Positive reassurance for families with the majority creating daily reassurance alerts and 40% creating alerts for events that worry them.
• 80% positive feedback from Memo Hub® users, with the remaining 20% neutral.
• An increase in early preventative interventions by families driven by new insight.
• 40% of care plans provided by Social Care amended due to the insight provided by the Memo service. Care plan size both increased and decreased, the common factor being a better-quality plan with a closer fit to user needs.

The study did not test other features in the Memo Hub suite, such as smart automated alerts, the alarm call safety net, and carer logging.

Alcuris’ press release and Executive Summary are available here. For a full report, email info@alcuris.co.uk

We invite other finalists to send us follow up on their Tech Force 19 studies and experience.

An admittedly skeptical take on the $18.5 billion Teladoc acquisition of Livongo (updated for additional analysis)

Gimlet EyeIs it time to call back The Gimlet Eye from her peaceful Remote Pacific Island? Shock acquisitions like Wednesday’s news that Teladoc is buying ‘applied health signals’ platform developer Livongo may compel this Editor to Send a Message by Carrier Seagull. 

Most of the articles (listed at the bottom) list the facts as Teladoc listed them in their announcement. We’ll recap ‘just the facts’ here, like Joe Friday of ‘Dragnet’ fame:  

  • The merged company will be called Teladoc and be headquartered in Purchase, NY. There is no mention of what will happen to operations and staff currently at Livongo’s Mountain View California HQ. 
  • The value of the acquisition is estimated at $18.5 bn, based on the value of Teladoc’s shares on 4 August. As both are public companies (Livongo IPO’d 25 July 2019, barely a year ago), each share of Livongo will be exchanged for 0.5920x shares of Teladoc plus cash consideration of $11.33 for each Livongo share. When completed, existing Teladoc shareholders will own 58 percent of the company and Livongo shareholders 42 percent. 
  • Closing is stated as expected to be in 4th Quarter 2020
  • Expected 2020 pro forma revenue is expected to be approximately $1.3 billion, representing year over year pro forma growth of 85 percent.

The combination of the two is, this Editor admits, a powerhouse and quite advantageous for both. It is also another sign that digital health is both contracting and recombining. Teladoc has over 70 million users in the US alone for telemedicine services and operates in 175 countries. Livongo is much smaller, with 410,000 diabetes users (up over 113 percent) and over 1,300 clients. They reported 2nd Q results on Tuesday with a revenue lift of 119 percent to $91.9 million but with a net loss of $1.6 million. 

What makes Livongo worth $18.5 bn for Teladoc? Livongo has made a major name (to be discarded, apparently) in first, diabetes management, but has broadened it into a category it calls ‘Applied Health Signals’. Most of us would call it chronic condition management using a combination of vital signs monitoring, patient data sets, and information from its health coaches to make recommendations and effect behavior change. Perhaps we should call it their ‘secret sauce’. For Teladoc, Livongo extends their virtual care services and provider network with a data-driven health management company not dependent on virtual visits, and integrates the virtual visit with Livongo’s coaching. It also puts Teladoc miles ahead of competition: soon-to-IPO Amwell, Doctor on Demand ($75 million Series D, partnerships with Walmart and Humana), MDLive, and ‘blank check’ SOC Telehealth. For Livongo’s main competitor in the diabetes area, Omada Health, it puts Omada certainly in a less competitive spot, or makes it attractive as an acquisition target.

It is also a huge bet that given the huge boost given by the COVID pandemic, the trend towards remote, consumer healthcare and management is unstoppable. Their projection is (from the release): expected 2020 pro forma revenue of approximately $1.3 billion, representing year over year pro forma growth of 85 percent; in year 2, revenue synergies of $100 million, reaching $500 million on a run rate basis by 2025. 

Taking a look at this acquisition between the press release and press coverage lines:

  • The market same day responded poorly to this acquisition. Teladoc was off nearly 19 percent, Livongo off 11 percent. (Shares typically recover next day in this pattern.) Livongo had, as mentioned, recently IPO’d and was experiencing excellent growth compared to Teladoc which was boosted by the pandemic lockdown. This Editor also recalls Teladoc’s financial difficulties in late 2018 with the resignation of its COO/CFO on insider trading and #MeToo charges.
  • The projected closing is fast for a merger of this size–five months.
    • Teladoc does business in the Medicare (Federal) and Medicaid (state) segments. It would surprise this Editor if the acquisition does not require review on the Federal (CMS, DOJ) and state health insurance levels, in addition to the SEC.
    • Merging the two organizations operationally and experiencing all those synergies is not done quickly, and cannot officially happen until after the closing. A lot is done formally behind the scenes as permitted, which has the effect of hitting the rest of the company like a hammer.
  • Unusually, the release does not advise on what Livongo senior executives, including Livongo founder Glen Tullman and CEO Zane Burke, will be coming over to Teladoc. The only sharing announced will be on the Board of Directors. It’s quite an exit for the senior Livongo staff.
  • Both have grown through acquisition. These typically present small to large organizational problems in merging the operations of these companies yet another time into yet another structure. There’s also always some level of client discomfiture in these mergers as they are also the last ones to know.
    • Livongo bought myStrength in 2019, RetroFit in 2018, and Diabeto in 2017. 
    • Teladoc just closed on 1 August its acquisition of far smaller, specialized hospital/health system telehealth provider InTouch Health. Originally a bargain (in retrospect) at $600 million in $150M cash and 4.6 million shares of TDOC stock, after 1 July’s closing, due to the rise in Teladoc’s stock, the cost ballooned to well over $1bn.
  • Neither company has ever been profitable

Your Editor can speak personally and recently to the wrench in the works that acquisitions/mergers of this size present to both organizations. Livongo is a relatively young and entrepreneurial organization in California with about 700 employees, compared to Teladoc’s approximately 2,000 or more internationally. Their communications and persona stress strong mission-driven qualities. On both sides, but especially on the acquired company side, people have to do their short and long term work amid the uncertainty of what this will mean to them. Senior management is distracted in endless meetings on what the merged organization will look like–departments, where will they be, who stays, who is packaged out, and when. Especially when the press releases make a point of compatible cultures, on the contrary, you may be assured that the cultures are very different. The bottom line: companies do not achieve $60 million in cost synergies without interrupting the careers of more than a few of their employees.

Another delicate area is Livongo’s client base, both individual and enterprise. How they are being communicated with is not necessarily skillful and reassuring. Often this part is delayed because the people who do this in the field aren’t prepared.

One has to admire Teladoc, almost without needing a breath, coming up with $18.5 billion quite that quickly from their financing partners after the InTouch acquisition. The growth claimed for the combined organization is extremely aggressive, on top of already aggressive projections for them separately. It’s 18x 2021 enterprise value to sales (EV/S) targets. The premium paid on the Livongo shares is also stunning: $159 per share including $550 million in convertible debt.  If patients start to return to offices and urgent care, Teladoc may have trouble meeting its aggressive goals factored into both share prices, as Seeking Alpha will explain.

Editor’s final comment: In the early stage of her marketing career, this Editor had a seat on the sidelines to much the same happening in the post-deregulation airline business–debt, buyouts, LBOs, and huge financings. Then there is the morning after when it’s all sorted out.

Wednesday’s coverage: TechCrunch, Investors Business Daily, STATNews, mHealth Intelligence, FierceHealthcare, MotleyFool.com

Joint announcement website    Investor Presentation    Hat tip to an industry observer Reader for assistance with the financial analysis.

For a follow-up analysis (with apologies to Carson McCullers): Reflections in a Gimlet Eye: further skeptical thoughts on the Teladoc acquisition of Livongo

SOC Telemed will go public in unusual ‘blank check’ acquisition

Acute care telemedicine developer/provider SOC Telemed, formerly Specialists On Call, will be going public in an interesting maneuver called a ‘blank check’ acquisition. They are acquiring an already publicly-traded company, Healthcare Merger Corporation (HCMC) (NASDAQ: HCCO). HCMC is a special purpose acquisition company (SPAC) that had its own assets of $250 million of cash from a December 2019 IPO. A group of institutional investors, including funds and accounts managed by BlackRock Inc., Baron Capital Group, and ClearBridge Investments, have committed to a private additional investment of $165 million in common stock when the deal closes.  HCMC will disappear and the company will trade as SOC Telemed. The companies estimate the combined value to be about $720 million. 

The combination of the two companies allows SOC Telemed to go public fairly quickly without the usual routine and steeper climb of an IPO by acquiring a purpose-built public company. Given that telemedicine is hot, but markets are post-COVID volatile, it’s a smart move that others (Hims) are already rumored to be following.

According to the release, HCMC will file a registration statement (which will contain a joint proxy statement/consent solicitation statement/prospectus) with the SEC in connection with the transaction as part of their Form 8-K. The closing is expected to be in 4th Quarter 2020, subject to the usual approval and timing procedures present in public company acquisitions.

SOC Telemed is also an interesting company in that it specializes in telemedicine for the acute care market, supplying virtual consults in specialty areas such as neurology, psychiatry, and ICU. It claims to be the largest national telemedicine provider to hospitals, health systems, value-based care organizations, post-acute care, and physician networks. SOC provides services to 847 facilities including 543 acute care hospitals in 47 states, including 19 of the 25 largest U.S. health systems. It is also the largest provider of acute teleneurology and telepsychiatry. The company has delivered over one million acute care consultations. Recent acquisitions include behavioral health telemedicine company JSA in 2018 and NeuroCall in 2017.

From the release, some details about how the acquisition will work:

  • SOC’s current management and equity holders, including Warburg Pincus, will roll a portion of their equity into SOC.
  • SOC Telemed’s existing majority equity holder, Warburg Pincus, will remain SOC’s largest shareholder.
  • Proceeds generated by the transaction will be used to pay down existing debt, purchase a portion of the equity owned by existing SOC shareholders, and capitalize the SOC Telemed balance sheet.
  • Assuming no redemptions of HCMC public shares, current SOC equity holders will own 40%, HCMC shareholders will own 32%, PIPE investors will own 21%, and HCMC’s sponsor will own 7% of the issued and outstanding shares of common stock of SOC immediately following the closing, respectively.

SOC’s management team, based in Virginia, will also shuffle a bit. Paul Ricci, Interim Chief Executive Officer, will be stepping down (presumably back to Warburg Pincus where he is an advisor). John Kalix, currently President, will become CEO. Hai Tran, presently COO and CFO, will continue in those positions. At HCMC, Steve Shulman, currently CEO and a director of HCMC, will become the Chairman of the SOC Telemed board of directors.  Mobihealthnews, FierceHealthcare  Hat tip to reader Paul Costello of Boost Health Network.

En Vogue: smart clothing and wearables to track COVID spread and progression

Wearables and smart clothing are having a ‘moment’ in the tracking of COVID symptoms and spread. After TTA noted Nanowear’s clinical trial with two major New York metro health systems last week, both POLITICO and Mobihealthnews catalogued additional trials and uses of innovative clothing and devices for detection: 

  • Apple watches and Fitbits
  • Oura rings (!) by the NBA to detect temperature and heart rate–at about $300 and up
  • Northwestern University and Shirley Ryan AbilityLab have developed a sensor that adheres in the visible dip at the base of the throat to monitor respiratory symptoms
  • Tufts University’s sweat sensor embedded in clothing, to analyze elements in perspiration such as electrolytes (sodium and ammonium ions), metabolites (lactate) and acidity (pH). NPJ Flexible Electronics
  • Paris-based Chronolife, which debuted the Nexkin smart T-shirt in December. It monitors heart rate, abdominal and thoracic breathing, body temperature, physical activity, and pulmonary impedance.

Part of the problem of wearable adoption is that without a specific ‘reason why’, wearables haven’t been all that compelling for the mainstream market beyond the trendy and pricey Apple Watch. Wearables have tried corporate wellness programs that almost give away the devices with the promise of lowering health costs long term. Venture funding (see the POLITICO chart) has been flowing into these companies for a decade. But in the eyes of many, wearables are a solution without a clear and compelling problem. COVID may resolve that.

Withings closes $60 million Series B round to fund expansion, B2B development

Withings, a digital health developer with devices ranging from smart scales to analog-style smartwatches , this week closed on a substantial Series B funding of $60 million. Led by Gilde Healthcare, the round also had participation from long-term Withings partners and investors, Idinvest Partners and Bpifrance through their Large Venture funds, as well as BNP Paribas Development, Oddo BHF Private Equity, and Adelie Capital. Their total funding is now estimated at $93.8 million. According to their release, Withings will be using the funds to globally scale its dedicated business-to-business division MED PRO and further develop consumer health devices. With this, they will also add about 100 positions in the US and France, including expansion of sales, marketing and R&D.

Founded in 2008 in France, TTA has tracked Withings since 2009 with a scale that Tweets your weight (at a hefty $159). In April 2016, the company was sold to Nokia for a hefty €170 million and became Nokia Digital Health. Nokia’s hope was to use Withings and its pricey (at least in the US market) but stylish and innovative IoT devices to spur its own development of consumer digital health. Two years later, Nokia sold back Withings to co-founder and former chairman Éric Carreel, having not experienced much success in the consumer sector. Shortly thereafter, they premiered a revived Go (with an e-ink face) and the Steel HR Sport smartwatch, then progressed into heart and sleep monitoring.

MED PRO is a relatively new division that concentrates on professional uses of their devices and data analytics within health systems, health plans, disease management programs, and academic and pharma research. Withings also appointed a new global Medical Advisory Board which includes Dr. John Halamka, President of the Mayo Clinic Platform, Dr. Stéphane Laurent, former Head of Clinical Pharmacology in Hôpital Européen Georges Pompidou in Paris, and Craig Lipset, former Head of Clinical Innovation at Pfizer.  MobihealthnewsCrunchbase

UK news roundup: Health Innovation Manchester winners, donate Phones for Patients in isolation, British Patient Capital funds SV Health with $65m, Memory Lane on the Isle of Man, SEHTA and Innovate UK briefings

A potpourri of health tech and funding news from the UK

Health Innovation Manchester announced the four winners of its 2020 Momentum Call. While the competition was initially scheduled to close in February (see Manchester home page), it was apparently delayed to address priority areas for the COVID-19 response. The winners are Cambio CDS T-MACS (risk evaluation for cardiac), Doc Abode (workforce deployment), Gendius diabetes AI-Intellin app, and Howz for Health (predictive ADLs). Two additional in-progress projects were halted due to the virus.  Each winner was awarded £50,000. Release on BuildingBetterHealthcare.com.

The Phones for Patients initiative helps isolated patients–for instance, those hospitalized with COVID or other infectious diseases–connect with family and loved ones by phone. This is made possible by temporary phones, older models donated by individuals and companies, which are wiped of all data and distributed to patients in NHS hospitals and care homes. This includes cables and chargers.

As a nonprofit initiative, Phones for Patients is organized by Bridgeway Security Solutions. Bridgeway secures, manages, and deploys communication and other apps to these devices for the NHS. Imprivata, a digital identity company that develops access management solutions for healthcare, is working with Bridgeway to secure mobile licenses and the software for the phones. 

According to Bridgeway’s managing director Jason Holloway,  “Bridgeway is providing this service free of charge, as our contribution to the effort to defeat COVID-19. We are delighted that Imprivata has been supportive and keen to be involved from the start. Using the Imprivata Mobile software has enabled us to process devices much more quickly, and therefore get them to the people that need them. We have had many heart-warming messages of gratitude and thanks from people working in care homes and in some cases, even from patients themselves saying how much they valued the service.” 

So far, over 8,300 devices have been donated. Both companies and individuals are invited to be part of this ongoing effort. Imprivata representative Melloney Jewell has advised that individuals can donate old phones, cables, and chargers through their JustGiving page.  Companies should go to the Phones for Patients website, review the requirements, fill out the form on the donation page or email donate@phonesforpatients.uk

In funding news, British Patient Capital committed $65 million to SV Health Investors’ latest fund, SV7 Impact Medicine Fund (IMF). SV7 is targeted to fund biotech companies producing high impact precision medicine drugs for poorly treated diseases. According to the release, the commitment increases British Patient Capital’s exposure to life sciences and health technology, building on a commitment to the Dementia Discovery Fund in 2018.

The Isle of Man’s Memory Lane Games, a charity and research partner with Hospice Isle of Man, launched their free app for iOS and Android on 14 July. The app features local nostalgia and familiar places, including visual images from Manx artists and photographers. There are also games based on popular themes like music, TV, animals, history, and sports which will be added to weekly. Hospice Isle of Man will also run proof-of-concept studies on the Memory Lane Games apps later this year to determine outcomes for improvements to the lives of dementia patients and carers. Release on News-Medical.net. Memory Lane Games is also an entrant in Zurich International Insurance’s Innovation Championships. Facebook

SEHTA is running free briefing webinars this week for the Innovate UK Biomedical Catalyst Competition. £30 million grant funding is available to UK health & life science SMEs. This is for early and late-stage projects with length from 12-36 months and total project costs between £250,000 and £4 million. Innovate UK can provide 70% of total project costs for SMEs. Previous webinars have been recorded. More information here Information from Innovate UK on how to apply for funding here on Gov.UK, though from 2018.

Weekend ‘Must Read’: Are Big Tech/Big Pharma’s health tech promises nothing but a dangerous fraud?

If it sounds too good to be true, it isn’t. And watch your wallet. In 14 words, this summarizes Leeza Osipenko’s theme for this article. It may seem to our Readers that Editor Donna is out there for clicks in the headline, but not really. Dr. Osipenko’s term is ‘snake oil’. It’s a quaint, vintage term for deceptive marketing of completely ineffective remedies, redolent of 19th Century hucksters and ‘The Music Man’. Its real meaning is fraud.

The promise is that Big Data, using Big Analytics, Big Machine Learning, and Big AI, will be a panacea for All That Ails Healthcare. It will save the entire system and the patient money, revolutionize medical decision making, save doctors time, increase accuracy, and in general save us from ourselves. Oh yes, and we do need saving, because our Big Tech and Big Health betters tell us so!

Major points in Dr. Osipenko’s Project Syndicate article, which is not long but provocative. Bonus content is available with a link to a London School of Economics panel discussion podcast (39 min.):

  • Source data is flawed. It’s subject to error, subjective clinical decision-making, lack of structure, standardization, and general GIGO.
  • However, Big Data is sold to health care systems and the general public like none of these potentially dangerous limitations even exist
  • Where are the long-range studies which can objectively compare and test the quality and outcomes of using this data? Nowhere to be found yet. It’s like we are in 1900 with no Pure Food Act, no FDA, or FTC to oversee.
  • It is sold into health systems as beneficial and completely harmless. Have we already forgotten the scandal of Ascension Health, the largest non-profit health system in the US, and Google Health simply proceeding off their BAA as if they had consent to identified data from practices and patients, and HIPAA didn’t exist? 10 million healthcare records were breached and HHS brought it to a screeching halt.
    • Our TTA article of 14 Nov 19 goes into why Google was so overeager to move this project forward, fast, and break a few things like rules.
  • We as individuals have no transparency into these systems. We don’t know what they know about us, or if it is correct. And if it isn’t, how can we correct it?
  • “Algorithmic diagnostic and decision models sometimes return results that doctors themselves do not understand”–great if you are being diagnosed.
  • Big Data demands a high level of math literacy.  Most decision makers are not data geeks. And those of us who work with numbers are often baffled by results and later find the calcs are el wrongo–this Editor speaks from personal experience on simple CMS data sets.
  • In order to be valuable, AI and machine learning demand access to potentially sensitive data. What’s the tradeoff? Where’s the consent?

Implicit in the article is cui bono?

  • Google and its social media rivals want data on us to monetize–in other words, sell stuff to us. Better health and outcomes are just a nice side benefit for them.
  • China. Our Readers may also recall from our April 2019 article that China is building the world’s largest medical database, free of those pesky Western democracy privacy restrictions, and using AI/machine learning to create a massive set of diagnostic tools. They aren’t going to stop at China, and in recent developments around intellectual property theft and programming back doors, will go to great lengths to secure Western data. Tencent and Fosun are playing by Chinese rules.

In conclusion:

At the end of the day, improving health care through big data and AI will likely take much more trial and error than techno-optimists realize. If conducted transparently and publicly, big-data projects can teach us how to create high-quality data sets prospectively, thereby increasing algorithmic solutions’ chances of success. By the same token, the algorithms themselves should be made available at least to regulators and the organizations subscribing to the service, if not to the public.

and

Having been massively overhyped, big-data health-care solutions are being rushed to market in without meaningful regulation, transparency, standardization, accountability, or robust validation practices. Patients deserve health systems and providers that will protect them, rather than using them as mere sources of data for profit-driven experiments.

Hat tip to Steve Hards.

The Year of the Sensor, round 2: COVID contact tracing + sensor wearables in LTC facilities; Ireland’s long and pivoting road to a contact tracing app

Wearables + sensors being used in long-term/post-acute care facilities for COVID contact tracing, decontamination. Historically ‘unsexy’ to digital health techies, long-term and post-acute care (LTPAC) came into sharp focus as the epicenter of COVID-19 deaths in the past four months. 45 percent of US COVID-19 deaths (over 54,000) occurred in nursing homes and assisted living residences, with the percentages being far higher in states like New Hampshire and Rhode Island (80%), Massachusetts and Connecticut (63%), Pennsylvania (68%), and New Jersey (48%). Freopp.org has a wealth of state-level information.

This created opportunities for companies that already had relationships with LTPAC to create systems to 1) contact trace individuals and residents, 2) trace locations not only of residents and staff but also contaminated areas, and 3) help focus ongoing decontamination and sanitization efforts. Featured in this surprising TechRepublic article is CarePredict, which back in March started to develop a response to COVID spread including what they dubbed the PinPoint Toolset. CarePredict already had in place a sensor-based system for residents that consolidated sensors into a wrist-worn resident ADL tracker with location and machine learning creating predictive health analytics that appear in a dashboard form. They expanded their analytics to staff and visitor contact plus locating frequently visited area by residents and staff so that decontamination efforts can be focused there. Also featured in the article are VIRI (website) and Quuppa, a real-time locating system (RTLS) repurposed from manufacturing and security. (Disclosure: Editor Donna consulted for CarePredict in 2017-18)

Ireland’s long and winding road to a national contact tracing app is the subject of an article in ZDNet. Waterford-based NearForm was called in by Ireland’s Health Services Executive (HSE) on week 1 of the lockdown and started work immediately. They had a prototype oapp running on a mobile phone by the end of the week, nonfunctioning but giving the HSE a look at the user interface. NearForm worked on a centralized model first, which was basically terminated by Apple’s insistence on blocking BTE, then in April pivoted to the decentralized Apple-Google (Gapple? AppGoo?) Exposure Notification system, once the HSE secured beta access to the new technology. By 7 July, Ireland launched and had over a million downloads in 48 hours. Germany had a similar saga and timing. Both Ireland, Germany, and other countries moved quickly to adopt Apple and Google’s APIs, when Apple blocked their original centralized app methodology. UK and NHSX did not pivot and are In The Lurch with Test and Trace [TTA 18 June, more deconstruction in VentureBeat]. Editor’s Note to Matt: go to your neighbor island, don’t be shy, and make a deal deal’ for the app. Solves that problem. 

Nanowear’s ‘smart clothing’ in NY/NJ hospital trials to monitor patients for early-stage COVID. Is it the Year of the Sensor?

Nanowear, a NYC-based developer of cloth-based nanosensors and monitoring systems, has entered a clinical trial collaboration with two major NY/NJ-area hospital systems to test for vital signs which may be predictive of an advancing case of COVID-19. 

The goal of the investigative teams at Hackensack Meridian Health, the largest health system in north and central New Jersey with 17 hospitals plus 500 patient care sites, and Maimonides Medical Center of Brooklyn, affiliated with Northwell Health, is to determine and assess patients for early signs of the ‘cytokine storm’ in the heart and lungs which indicates inflammation within the circulatory system, often leading to severe complications and death in COVID patients. The clinical trial will monitor patients with confirmed or suspected COVID-19. The release is not specific as to whether the garment will be issued to patients monitored solely in the hospital or inclusive of patients still at home.

Nanowear’s SimpleSENSE adjustable undergarment continuously captures key physiological signs related to the onset of COVID–real-time ECG, systolic and diastolic blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature. The vital signs are then transmitted via a mobile app to a physician portal for monitoring and interpretation.  

The garment test is also significant as it is a contactless monitoring system–highly applicable to contagious diseases.

Last July, SimpleSENSE launched in a heart failure management clinical trial with Penn State Hershey Medical Center in Pennsylvania and Hackensack Meridian. The patented cloth-based nanotechnology sensors can capture up to 120 million data points per patient per day. The HF management trial was designed to validate and provide a pathway to clear its own diagnostic algorithm generated from the garment. The SimpleSENSE device and mobile platform have been submitted to FDA for Class II 510(k) clearance.  Also mHealth Intelligence.

This may be the Year of the Sensor. Human contact is out, remote monitoring is in. Earlier this week, we covered Philips integrating BioIntelliSense‘s BioSticker into its RPM systems. During 2018-2019, we profiled Doncaster UK-based MediBioSense, which uses the VitalPatch from VitalConnect. They recently announced that an enhanced VitalPatch suitable for seven-day use and body temperature sensing received CE Class IIa medical certification as well as FDA clearance. We last covered them when MBS adopted the Blue Cedar app security system in 2018, but based on their website press section, much has happened since in extending their sensor-based technologies. This Editor will try to catch up with Simon Beniston of MBS.

Vote now for finalists in the Aging 2.0 Global Innovation Search (to 31 July)

Vote daily online for your favored technologies up to 31 July. Aging 2.o, the international organization that seeks to accelerate innovation around the biggest challenges and opportunities in aging, plus the Louisville Healthcare CEO Council (LHCC), are sponsoring the Global Innovation Search. 

Aging 2.0 chapters selected the companies (left) on the basis that they help keep older adults connected to their communities, families, healthcare providers, and provide vital information. In addition: 

  • The innovation should address social isolation and loneliness in older adults
  • Innovators must have a commercial-ready or commercially available product/service
  • The company’s Founder or C-level executive (or equivalent) must be the person to present if selected to advance to the Virtual Pitch Competition
  • The top ten innovators that are selected to pitch at the Virtual Pitch Competition will be required to present in English
  • The Global Innovation Search is not only open to startups. Established companies and non-profits are welcome to apply if they have recently (within the last 3 years) launched an innovative solution to improve the lives of older adults

Vote on this page. One vote per day up to 31 July is permitted. Based on the vote, the ten finalists will receive sponsorship, mentorship, and the opportunity to virtually pitch at an event in August (date TBD). 

Some familiar US names in this group are a very old friend from this Editor’s QuietCare days, GrandCare, and UnaliWear [TTA features here]. Many are from the US,  but a sample of international semifinalists are:

  • Canada–AltumView, Sirona.tv, Famli.net, Anna, Tamaduni Connect, Tochtech Technologies, Virtual Coffee House 55+
  • Spain–Oroi
  • Sweden–Camanio Care
  • Israel–BaldPhone
  • Brazil–Eu Vô, Cerebrar – Cérebro Ativo
  • UK–Joy, Buddy Hub, eargym Ltd (interesting to this Editor as it addresses age-related hearing loss and cognition through auditory training)
  • Australia–Feros Care

Hat tip to Jean Anne Booth, CEO of UnaliWear, via LinkedIn.

Can technology speed the return to office post-COVID? Is contaminated office air conditioning a COVID culprit?

Most offices in the US are still not open or only ‘essential personnel’. As this Editor noted on 19 May, a number of companies, including startups, are focusing on working with employers on return-to-work strategies. There are a raft of approaches including on-site clinics, temperature screening checkpoints, and check-in/reporting apps from Verily (Alphabet) and Fitbit’s Ready to Work. These screeners generally monitor for self-reported symptoms, but some will advise and track you to testing if you demonstrate risk, such as UnitedHealth Group and Microsoft’s ‘ProtectWell’ with a closed loop of testing recommendations that are reported to the employer. Collective Go from Collective Health goes a bit further in emphasizing up-front (molecular [PCR]) testing and continuous employee monitoring into their protocols for, apparently, every worker. OneMedical, which works with 7,000 employers, adds to their on-site management and testing additional contact tracing. FierceHealthcare

Maybe it’s in the air-conditioned air you breathe? Office building air circulation may be a culprit in the spike in Florida, Arizona, and Texas cases. The uptick in cases in Southern states where the contagion rates were initially fairly light may be due to the mostly recirculated air in office air conditioning systems. Most modern buildings don’t have windows which open. Older buildings have their own problems like mold from leaky systems and ‘soot’ (from air pollution and when people used to smoke in offices, remember when?). Newer LEED buildings are so ‘tight’ and energy efficient that air tends to be stagnant. Few buildings have good ratios of air exchange with the outside plus use HEPA filtration throughout the HVAC system. The total picture is that any virus can make its way through offices–six feet of distancing, masks, sanitization, no cafeterias, and acrylic panel separators be d****d.  (Contrast your average office building with modern commercial aircraft where about 50 percent of air is recirculated at any one time, there’s a total change about every three minutes, and HEPA filters are used! AskThePilot, a great site for all things airline)

A return-to-work readiness strategy suggested here by a Harvard Medical epidemiologist whose main area is TB spread are germicidal UV lights high in the room to catch the viruses that go up, then down. UV light for sanitization and disinfection is a technology used for several years to disinfect patient care areas (PurpleSun is one). Far-UVC, versus near-UVC, and potential uses are outlined in this Nature article from February 2018Harvard Gazette

While telehealth virtual office visits flatten, overall up 300-fold; FCC finalizes COVID-19 telehealth funding program (US)

As expected, the trend of telehealth visits versus in-person is flattening as primary care offices and urgent care clinics reopen. Yet the overall trend is up through May–a dizzying 300-fold, as tracked by the new Epic Health Research Network (EHRN–yes, that Epic). Their analysis compares 15 March-8 May 2020 to the same dates in 2019 using data from 22 health systems in 17 states which cover seven million patients. It also constructs a visit diagnosis profile comparison, which leads with hypertension, hyperlipidemia, pain, and diabetes–with the 2020 addition of — unsurprisingly — anxiety.

POLITICO Future Pulse analyzed EHRN data into July (which was not located in a cross-check by this Editor) and came up with its usual ‘the cup has a hole in it’ observation: “TELEHEALTH BOOM BUST”. But that is absolutely in line with the Commonwealth Fund/Phreesia/Harvard study which as we noted tailed off as a percentage of total visits by 46 percent [TTA 1 July]. But even POLITICO’s gloomy headline can’t conceal that telehealth in the 37 healthcare systems surveyed was a flatline up to March and leveled off to slightly below the 2 million visit peak around 15 April. 

Where POLITICO’s gloom ‘n’ doom is useful is in the caution of why telehealth has fallen off, other than the obvious of offices reopening. There’s the post-mortem experience of smaller practices which paints an unflattering picture of unreadiness, rocky starts, and unaffordability:

  • Skype and FaceTime are not permanent solutions, as not HIPAA-compliant
  • New telehealth software can cost money. However, this Editor also knows from her business experience that population health software often has a HIPAA-compliant telehealth module which is relatively simple to use and is usually free.
  • It’s the training that costs, more in time than money. If the practice is in a value-based care model, that is done by market staff either from the management services organization (MSO) or the software provider.
  • Reimbursement. Even with CMS loosening requirements and coding, it moved so quickly that providers haven’t been reimbursed properly.
  • Equipment and broadband access. Patients, especially older patients, don’t all have smartphones or tablets. Not everyone has Wi-Fi or enough data–or that patient lives in a 2-bar area. Some practices aren’t on EHRs either.
  • Without RPM, accurate device integration, and an integrated tracking platform, F2F telehealth can only be a virtual visit without monitoring data.

Perhaps not wanting to paint a totally doomy picture (advertising sponsorship, perhaps?), the interview with Ed Lee, the head of Kaiser Permanente’s telehealth program, confirmed that the past few months were extraordinary for them, even with a decent telehealth base. “We were seeing somewhere around 18 percent of telehealth [visits] pre-covid. Around the height of it, we’re seeing 80 percent.” They also have pilots in place to put technology in the homes of those who need it, and realize its limitations.

Speaking of limitations, the Federal Communications Commission (FCC) COVID-19 Telehealth Program, authorized by the CARES Act, is over and out. The final tranche consisted of 25 applications for the remaining $10.73 million, with a final total of 539 funding applications up to the authorized $200 million. Applicants came from 47 states, Washington, DC, and Guam. FCC release. To no one’s surprise, 40 Congresscritters want to extend it as a ‘bold step’ but are first demanding that Chair Ajit Pai do handsprings and provide all sorts of information on the reimbursement program which does not provide upfront money but reimburses eligible expenditures. That will take a few months. You’d think they’d read a few things on the FCC website first. mHealth Intelligence

Telehealth, virtual, and ‘omnichannel’ health winners in CVS’ ‘Path To Better Health’ study

CVS Health’s third annual ‘Path to Better Health’ study contains both cheerful (for health tech) and distressing news (for practices). While we do have to consider the source–CVS Health definitely has an entire kennel of dogs in the fractionalization of health delivery race, HealthHUB as only one–the key findings illustrate a greater acceptance of telehealth and remote visits by the surveyed consumers. Providers seem to be shifting in the same direction, albeit not that dramatically.

Percentage results are 2020 versus the (2019 study).

Consumers are much more accepting of virtual communication:

  • Telehealth interest: 32 percent (14 percent)
  • Virtual office visit interest: 29 percent (20 percent)
  • Messaging interest: 48 percent (41 percent)
  • More women (35 percent) than men (27 percent) are interested 
  • 40 percent are interested in virtual behavioral health; 38 percent in virtual advice from a pharmacist

Providers are moving more slowly in connecting virtually with patients, though telehealth had the greatest boost:

  • Telehealth: 40 percent (22 percent)
  • Virtual office visits: 24 percent (23 percent)
  • Digital messaging through email, text and patient portals: 36 percent said they are very valuable for successful interactions with their patients

While the study does not speculate on the lagging acceptance numbers for providers except for telehealth, virtual visits (by telehealth!) and digital messaging add to workload and do not necessarily at this time have clear workflows.

Predictive analytics

  • 39 percent of providers claim that they already have or are likely/somewhat likely to incorporate predictive analytics into their practices within several years
  • 31 percent of providers are somewhat likely to incorporate predictive analytics or artificial intelligence
  • Acceptance is greater among providers with very large (450+ patient) practices (48 percent)
  • Younger providers with under 15 years of experience are also more likely to incorporate predictive analytics in their practices (50 percent), versus those over 15 years of experience (35 percent)

Mental health issues. Perhaps it was the timing of the study (March), but the need for mental health support, evidenced by social connection among those 18 to 34 and 35 to 50, was drastically on the rise–unhappiness among social connections (29-30 percent), no desire to be social (44-45 percent), not knowing where to meet new people (44-51 percent).

There is also a great deal of information on concerns around affordability of medical and drug costs, convenience, the cost of chronic disease management, mental and cognitive health, and community-based resources. In reading through the executive summary, it is easy to see how delivery of care has shifted from the primary care office and hospital to urgent care clinics, but interoperability (information sharing) is a major concern. 75 percent of physicians have a high to moderate concern of a looming physician shortage.

Methodology. The US survey was taken in March. The consumer sample was 1,000 18+. CVS oversampled 12 metropolitan statistical areas (MSAs): Atlanta, Austin, Boston, Cleveland, Dallas, Houston, Los Angeles, New York City, Philadelphia, Providence, Hartford, San Francisco, Tampa plus two ethnic groups: African American and Hispanic. 400 providers were surveyed, primarily primary care physicians and specialists with at least two years’ experience, as well as nurse practitioners, physician assistants, and pharmacists.

Infographic, Executive Summary, press release. Also Fierce Healthcare. (An annoying part of the summaries is that they state changes in percentage points as percentages.)

Philips awarded by VA 10-year, $100 million remote ICU, telehealth contract; partners with BioIntelliSense for RPM

The US Department of Veterans Affairs (VA) awarded Philips a ten-year contract to build out their remote intensive care (ICU) service infrastructure to make it accessible to veterans from any location in the US. The VA currently manages 1,800 ICU beds nationwide in its approximately 1,700 sites. Based on the release, the Philips engagement in VA Tele-Critical Care will expand the VA’s current capabilities to encompass telehealth, tele-critical care (eICU), diagnostic imaging, sleep solutions, and patient monitoring. The agreement may total $100 million over the 10-year contract duration.

Philips has about 20 percent of the adult eICU market. They claim that 1 in 8 adult ICU patients are monitored 24/7 by their eICU Program, which combines audio/visual technology, predictive analytics, data visualization, and advanced reporting capabilities. Their proprietary research points to shorter ICU visits by eICU patients plus better outcomes. Healthcare IT News, Philips release (Photo: Philips)

By this Editor’s calculation, VA remains the single largest user of telehealth in the US. In their FY 2019, the first year of the ‘Anywhere to Anywhere’ initiative [TTA 24 May 2018], VA delivered more than 2.6 million telehealth episodes to 900,000 veterans. During the early part of the pandemic, they grew virtual home visits from an average of 10,000 to 120,000 per week. By the end of FY 2020, their goal is to deliver all primary care and mental health provider services, both in-person and via a mobile or web-based device. The VA release from November 2019 does not break out the different types of VA telehealth and usage.

Philips and BioIntelliSense have also inked a partnership deal to integrate BioIntelliSense’s BioSticker sensors into their post-acute remote patient monitoring (RPM) systems. The BioSticker is a wearable FDA-cleared 510(k) Class II sensor that transmits passive monitoring of key vital signs, physiological biometrics, and symptomatic events up to 30 days. The first announced user of the RPM+BioSticker systems will be Healthcare Highways of Frisco, Texas, a provider of health plans, employer self-funded health plans,  pharmacy benefit management, population health management, and benefit plan administration. Healthcare Highways is participating in seven patient monitoring programs to assess patient health status with providers: COVID-19, CHF, hypertension, diabetes, total joint replacement, cancer, and asthma. Release (Photo: Philips)