Midweek heat wave roundup: GE Healthcare’s new name, hospital-to-home health trending big, over 2 million patient records hacked

GE’s breakup into three public companies, announced last November [TTA 12 Nov 21], has been formalized with brand names. No surprise, the healthcare business has but a teeny tiny change to GE HealthCare (logo left) and after the spinoff will be trading sometime in early 2023 under GEHC on Nasdaq because “GE HealthCare will benefit from the exchange’s profile and track record as a market for innovative, technology-led public companies, particularly in the healthcare sector. The heritage ‘meatball’ (as we called it in marketing internally, but formally the Monogram) will be retained but the color will change from poison green to “compassion purple” to reflect more humanity and warmth and achieve greater distinction”. The hardest hit part of GE, the energy businesses, will be spun off as GE Vernova and key color an ‘evergreen’. What is left will be GE Aerospace, retaining its name and change its color to an ‘upper atmosphere’ blue that is almost black. Outer space, anyone? GE release, interview on YouTube

Au courant is hospital-to-home (H2H) and home health, digitally enabled mais bien sûr.

  • Mass General Brigham (MGB) is reportedly expanding its current 25-bed program to 200 in the next 2.5 years. Since 2016, MGB has treated nearly 1,800 H2H patients. By end of 2023, they plan 90 hospital-at-home beds managed across Massachusetts General Hospital, Brigham and Women’s Hospital, Newton-Wellesley Hospital, and Salem Hospital. Their new head for home-based care will be Heather O’Sullivan, who comes from EVP and chief clinical innovation officer spots at Kindred at Home, acquired by Humana in 2021. FierceHealthcare
  • Out in rural Wisconsin, Marshfield Clinic is rolling out a H2H program with DispatchHealth, to coordinate medical care for injuries and illnesses including viral infections, COPD exacerbations, congestive heart failure, and more. The goal is to reduce non-emergency ED visits. DispatchHealth can also perform services such as onsite diagnostics, mobile imaging, and CLIA-certified labs for kidney function, electrolytes, and urinalysis. In March 2021, they closed a $200 million Series D bringing their funding to unicorn level. HealthcareITNews
  • UHG’s Optum has moved closer on its $5.5 billion acquisition of LHC Group home health and hospice [TTA 31 Mar] with shareholder approval on 21 June. Once closed later this year, LHC will be integrated into Optum Health. LHC operates in 37 states and the District of Columbia, employing about 30,000 individuals. Home Health Care News, Becker’s

And what would a week with a heat wave that melts runways at RAF Brize Norton and Luton be without a couple of big data breaches to heat up things? Stolen: an iPad chock full of 75,000 Kaiser Permanente patients’ PHI from Kaiser’s Los Angeles Medical Center’s COVID-19 testing center. While the information on the iPad included first and last names, dates of birth, medical record numbers, and dates and location of service (but not SSN or financial information), Kaiser was able to remotely erase the data. At this point, there is no evidence of theft or misuse. NBC Los Angeles, Becker’s   An even larger breach of 2 million records came via a February hack attack on health provider debt collector Professional Finance Company (PFC). Hackers got into PFC’s computers and accessed patient names, addresses, SSN, health insurance, and medical treatment data. Among the 650 client companies affected were Banner Health and Nevada physician network Renown Health. Healthcare Dive

Cerner’s business now consolidated under Oracle Health

The internal memo doesn’t say so but doesn’t really have to. The sunsetting of the Cerner brand (logo left) has begun. HISTalk this evening reported on Friday 15 July’s Cerner internal announcement posted on Reddit, vetted by the Kansas City Business Journal (paywalled), and it’s not all that surprising:

  • The business unit is now called Oracle Health Global Industry Unit (GIU) or Oracle Health
  • The chairman of Oracle Health will be David Feinberg, MD, late CEO of Cerner and previously of UCLA Health, Geisinger Health, and Google’s last effort at Health. 
  • Travis Dalton is being promoted to run the Oracle Health GIU as General Manager from running Cerner Government Services as Client Services Officer
  • Cerner’s engineering and product executives will be reporting to Oracle’s Don Johnson who runs all Oracle engineering for all applications and platform services. This includes former CTO Jerome Labat who received a stay deal along with Dr. Feinberg [TTA 21 Jan, 26 Jan]. Mr. Labat has at least 11 million good reasons (and Dr. Feinberg 22 million) to stay for the next year and a day from the closing on 8 June.
  • Cerner’s corporate functions, such as IT, finance, legal, and HR, will move into Oracle’s centralized, global teams, which typically means that pink slips will be the order of the day if they haven’t already been received
  • More disclosed to employees at a town hall on that Friday 
  • No external announcement has been made as of 1845 19 July (Eastern Time)

Our Readers who have been following the acquisition and personally been through acquisitions know the stage was set by Larry Ellison’s Big Pronouncements on Healthcare Transformation at the closing [TTA 14 June]. It was all about what Oracle would be doing in building a national health record database and more, with nary a mention of Cerner. The eventual elimination of the Cerner name should thus be no surprise to industry observers. Cerner was a pearl bought at a great price ($28 billion) to make Oracle the Visionary Leader In Healthcare and provide Mr. Ellison with a Grand Finale.

How this will be received by health system and provider customers–including DOD and the ever-troublesome VA–is anyone’s guess. This Editor has previously speculated that health systems with Cerner EHRs were not going to be enthusiastic about replacing Cerner’s current third-party vendors with Oracle services and technology, especially if they worked well or if Oracle costs more. If the move to OCI–Oracle Cloud Infrastructure–doesn’t go as smooth as brand new glass, another black mark in the copybook. The other would be resentment of Oracle’s announced and completely expected hard sell on other services to make up the cost of the pearl. [TTA 15 June]

Almost an ideal scenario for Epic to sell against, one would think. As for the VA, Oracle needs to fix the Cerner Millenium rollout now under heavy scrutiny–fast and right.  

Home-based remote monitoring for Covid reduced hospitalizations, hospital length of stay: JAMA study

Activation of remote patient monitoring (RPM) in this study is associated with lower hospitalization, intensive care use, and if hospitalized, length of stay. Conducted by Froedtert & Medical College of Wisconsin Health Network with Covid-19 positive ambulatory patients who accepted RPM in the home (N=9,378), the study’s purpose was to evaluate the implementation of a large-scale daily RPM program for patients who were managing symptoms from home. They compared those who activated their RPM (N=5,364, 57%) versus those who did not (N=4,014, 43%). The mean age was 46 and 58% were women.

  • 878 patients  (16.4%) had at least one RPM alert
  • 2.4% (128) of the activated patients were hospitalized, compared to 3.9% (158) of inactivated patients

A weighted regression analysis, adjusted for demographics, comorbidities, and time period, compared RPM-activated to the tracked but inactivated patients:

  • Lower odds of hospitalization (odds ratio, 0.68; 95% CI, 0.54-0.86; P = .001)
  • Greater time between test and hospitalization for RPM-activated patients 6.67 [3.21] days vs 5.24 [3.03] days)
  • Shorter length of stay (4.44 [4.43] days vs 7.14 [8.63] days)
  • Less intensive care use (15 patients [0.3%] vs 44 patients [1.1%])

The study excluded patients younger than 18 years, those with asymptomatic tests (because these were often scheduled before procedures or other planned admissions), patients who were admitted within 24 hours of a positive test, and those who already had internal PCPs to reduce the chance of missing hospitalizations. The RPM provider was GetWellNetwork using the GetWellLoop monitored by a centralized team of Froedtert & Medical College of Wisconsin nurses. Patients used the web or a mobile app to record their symptoms, temperatures, and pulse oximetry readings. Hospitalization Outcomes Among Patients With COVID-19 Undergoing Remote Monitoring (abstract and downloadable PDF)

Weekend reading roundup: Amwell’s Schoenberg opines to Politico; Teladoc’s new CMO also opines, SPACs are done, done, done

If Teladoc’s Jason Gorevic [TTA 1 July] and new CMO Vidya Raman-Tangella (below) are suddenly available to the health press, can a Schoenberg brother be far behind? This brief Q&A with Politico is with Roy Schoenberg of Amwell and covers the state of telehealth, obstacles, abortion, consolidation, and automation. He stays pretty much on message with no surprises as the questions are short and, as is the practice, pre-submitted:

  • Telehealth is a distribution arm of healthcare, not just videoconferencing
  • The biggest war in telehealth remains state licensure–as it was pre-pandemic, past the ‘jumping in’ stage
  • Telehealth will not be a ‘pill mill’ for abortion pills (abortifacients) or controlled substances–it will be based on clinician professional judgment. (In the Editor’s opinion, this ‘hot potato’ was pre-written by the legal department.)
  • Consolidation as a question is not answered. We will see telehealth delivered by large healthcare organizations and telehealth that works with multiple brands. (What is not addressed is what telehealth services large healthcare organizations will go forward in using–the ‘high-priced spread’ of all-inclusives or the white-labels)
  • His opinion around automation is that it will be split between the camps of replacing clinicians, or augmenting them plus giving patients the opportunity to manage their health reality. (One wonders for what reality Amwell is preparing)

Teladoc’s new chief medical officer Raman-Tangella is also on the healthcare charm offensive with a Healthcare Dive interview on strategy and new products. She discusses enterprise clinical strategy and whole-person care, which echoes the Gorevic interview. There’s a diversion to ‘health equity’ which is first defined as a continuum [Editor’s term] of gathering data, taking solutions to customers, and seeking outcomes that validate the first two. She then moves on to closing care gaps through this information, especially in musculoskeletal and physical therapy, and returning to health equity, disparities and then (what we used to define as) proactive care based on all this patient information.

Forget the fork. SPACs as an IPO method are burnt and heading to the trash bin. Again [TTA 9 June] we have PrivCo’s Daily Stack addressing their demise, this time quantifying the crack of the full SPAC market (in and outside healthcare):

  • From one in 2009 to 248 in 2020
  • 2021: an estimated 50% of the total US IPO market in Q1 with 299 listings valued at $98.3 billion
  • 2022: 18 registrations this entire 2022 year and still in the process of raising $2 billion. (This Editor noted that the only healthcare SPAC apparently in progress is VSee and iDoc Telehealth with Digital Health Acquisition Corporation to close in Q3.)

As we’ve previously noted, SPACs are under attack by the SEC and by perpetual hair-on-fire for the press Senators such as  Elizabeth Warren. According to Bloomberg (sign-in needed), 30 SPACs have been called off this year. And as we’ve noted, there are healthcare SPACs like SOC Telemed which went private at a fire sale discount. Others like Owlet, Headspace, and Talkspace are struggling. Watchful eyes are on late SPACs such as Pear Therapeutics and Babylon Health. It’s a less-than-grand finale to what was touted as a low-muss way to IPO.

Weekend UK news roundup: NHS England’s growing bed shortage as backlog hits 6.6M, Inoapps software for US health vans, Data Driven Healthcare Birmingham 1 Aug, Oto raises £2.8M, WeWALK £1.7m in funding

A study by the Health Foundation’s REAL Centre is sounding the alarm over a growing shortage of hospital beds within NHS England. Their estimate is in order to maintain pre-pandemic standards of care, 23,000 to 39,000 extra beds could be needed by 2030/31–a 20–35% increase that will cost in current monetary terms between £17 and 29 billion. The study cites the factors of a larger, aging population, with more complex conditions. In the past 30 years, as in most countries, England’s hospital bed capacity has been reduced by half as care has shifted to outpatient facilities and now telehealth. Where this puts England–like the US in a different management model–is that there is little excess to meet extraordinary demand with only two beds per person, near the bottom. England’s 89.6% acute bed occupancy rate is lower only than Ireland at 90.7%, perpetually strapped Canada (which offloads to the US) at 91.7%, and Israel at 92.3%. (The US is surprisingly just above 64% though there are 2.5 beds per person.) The study does advocate solutions such as RPM and hospital-to-home, identifying four areas:

  1. Increase hospital bed supply – provide additional hospital beds that are suitably staffed to meet demand.
  2. Do things faster – continue to reduce the average time each patient spends in hospital.
  3. Do things differently – for instance, by expanding potential substitutes for hospital beds such as expanding virtual wards or nursing home beds.
  4. Do less – either by better meeting patient need, for instance by investing in primary care to reduce unnecessary emergency admissions, or by delivering less of some services, either explicitly by changing thresholds or implicitly by reducing supply.

Knocking on to all of this is the staffing shortage which REAL Centre has chronicled which is a key factor in treatment, affecting patient backlog which rose to 6.6 million at end of May. HealthcareandProtection

The REAL Centre study is available for download here. A good summary with plenty of charts to peruse is provided by the Daily Mail. Health Foundation release

Scotland and US-based Inoapps announced that it developed a guest registration application for TeleHealth Network, a Los Angeles-based (literally) mobile health provider. Over 40 5G equipped TeleHealth Vans travel to underserved areas of Los Angeles to deliver community-based virtual health services. The vans provide health services to primarily homeless, veterans, and low-income communities, and have reached 550,000 people to date. The application is based on Oracle APEX on Oracle Cloud Infrastructure (OCI) to connect people with services efficiently, using the smallest amount of personal data possible which seems to be a key driver (sic). Inoapps release.

Data Driven Healthcare is the theme of a 1 August meeting in Birmingham during the Commonwealth Games. It is sponsored by UK House: The Commonwealth Business Hub and takes place at the University of Birmingham’s Exchange Building. The meeting will address healthcare challenges faced across the world and the critical issues governments, industry and communities must work together to address, as well as how the Midlands is driving innovation in translational medicine, clinical trials, and regulatory innovation. More information and registration here.

Tinnitus management app Oto raised £2.8 ($3.3) million in seed funding from Octopus Ventures. It follows a £510,000 pre-seed round from Y Combinator in January for a total of four pre-seed rounds since 2020 (Crunchbase). The app helps sufferers (and boy, do they suffer) habituate to the incessant ringing and buzzing, better manage it, and use positive relaxation and sleep techniques. The small London-based company was founded by two doctors who developed it in their 20s. UK Tech News  Also in London, WeWALK raised £1.7 million in funding from UK Research and Innovation (UKRI) for its “smart cane”. It uses ultrasonic sensors to help those with visual impairments and can be paired with a mobile app to give voice-guided navigation. About 2 million in the UK have some form of severe visual impairment. According to their website, they are currently crowdfunding on Crowdcube and offering the app separate from the smart cane. UK Tech News

Thursday news roundup: RVO Health JV combines Optum-RV Health consumer health assets; Holmes sentencing for Theranos fraud delayed

Red Ventures, Optum combine consumer savings, digital health coaching, education assets into RVO Health. Quietly announced via Moody’s Investor Services (PDF) and appearing on LinkedIn, this offloads media holding company Red Ventures’ RV Health, consisting of Healthline health news/education media (Healthline, Medical News Today, Psych Central, Greatist, and Bezzy), plus the Healthgrades doctor rating, FindCare doctor locator and PlateJoy meal planner services. Optum contributes their Perks prescription savings card, Store shopping service, and coaching platforms Real Appeal, Wellness Coaching, and QuitForLife. For Red Ventures, this moves 20% of their company earnings into the JV, leaving media such as Bankrate.com and CNET. For Optum, this expands their coaching and consumer savings capabilities into an established digital audience–Red Ventures claims 100 million monthly users of its health media and other services. For Red Ventures, it opens up new solutions available through Optum’s parent, UnitedHealth Group.

According to Moody’s analysts, this is part of Red Ventures’ de-leveraging: “Under the terms of the JV arrangement, in exchange for the contributed assets, RV received cash proceeds, which were used to pay down the term loan. UHG will consolidate the financials of RVO Health in its future financial statements.” Based on LinkedIn, it will be located in Charlotte, North Carolina. Unannounced is who will be managing RVO Health.  FierceHealthcare, Becker’s 

Ironically, Healthline Media’ main competitor, WebMD, bought the former data analytics part of Healthgrades, Mercury Healthcare, on 29 June (release).

Elizabeth Holmes gets a three-week extension on her freedom. Her sentencing, originally scheduled for 26 September at the US District Court, Northern District of California, in San Jose has been moved to 17 October. No reason was given by the court for the extension. Judge Edward Davila will be presiding over the sentencing on four of the original 11 Theranos wire fraud charges [TTA 4 Jan]. Each one of these charges carries a penalty of up to 20 years, but generally in financial fraud, sentences are carried out concurrently. Judge Davila, known as a tough sentencer according to the Mercury News (mercifully not paywalled) may be considering factors such as that Holmes was, after all the founder and CEO but that Theranos did not start as a scam, proceeding to fraud when the technology was oversold and financially started to go under; and that she is a mother of a child not yet out of diapers. (This Editor will add the smoke around Sunny Balwani’s emotional abuse.) She will also be in a Federal facility for women likely located not far from San Jose. It is expected that she will appeal the verdicts and the sentences.

There is also the Balwani Factor. Sunny Balwani was convicted on 12 wire fraud charges and as Theranos’ president, was depicted as the ‘enforcer’. That book, when thrown after Holmes’ sentencing, will not be a paperback. Although he will want to stock up on reading for his expected long stay in Club Fed. Also CBS News.

The clunk continues: Q2 2022 digital health funding fades to $4.1B in Q2, down 50% from 2021

Digital health funding continues to take a plunge. Knocked about by the hangover from the pandemic, a grinding war between Russia and Ukraine, gasoline prices jacked up worldwide, and knock-on inflation and looming stagflation, funding continues to slide. The decline in Q2 digital health deals and funding to $4.1 billion more truly reflects the downturn than Q1’s relatively buoyant $6.1 billion, which benefited from the carryover of deals negotiated during 2021’s boom and closing then [TTA 6 April]. Year over year, it was half of 2021’s high of $8.3 billion.

  • 2022’s first half (H1) total of $10.3 billion was down 31% from 2021’s $15 billion. Despite this, it is 63% above the pandemic-stricken 2020’s H1 $6.3 billion. 
  • Average deal size has dropped to $31.2 million from 2021’s full-year $39.5 million and even 2020’s $30.6 million, accounting for inflation in the past two years. Looking at funding size by series year over year, Series A funding is flat but funding for Series B, C, and D+ have dropped substantially.
  • No startups went public but four digital health companies announced plans to go public or were reported to be planning public exits. One SPAC was announced in June to close in Q3, that of VSee and iDoc Telehealth with Digital Health Acquisition Corporation. SPACs, as this Editor has noted, have gone from Funding Hero to Zero under 2022’s economics, causing many SPACs to crack (Owlet, Talkspace) and increased scrutiny by the Feds [TTA 9 June]. SOC Telehealth, an early SPAC, went private after a 90% share price drop [TTA 8 Feb].
  • Average monthly M&A has dropped substantially. 2021’s monthly average of 23 has dropped to 20 in Q1 and 13 in Q2, for a H1 average of 16.
  • Most popular funding areas are mental health (a far ahead #1 at $1.3 billion), oncology, and cardiovascular. Diabetes dropped from #2 to #4, skewed last year by Teladoc’s acquisition of Livongo. Oncology rose to #2 from #6 in 2021. For mental health, given increased Federal scrutiny and legal problems of companies like Cerebral plus the expansion of Teladoc and Amwell into the area, this Editor does not expect telemental health companies to continue to attract this level of funding but may be attractive for M&A.
  • Disease monitoring (a/k/a RPM) as a value proposition moved from #8 to #3 in investment at $1.4 billion. R&D and on-demand healthcare remained in their #1 and #2 positions.

As TTA has noted previously, this was all to be expected. Will 2022 funding perk up like 2020’s did through Q3 and Q4, or fall off like in 2019 as money sits on the sidelines? Rock Health does try to put a rosier shine on the retrenchment in its roundup, as has venture capital–reality can be good for you. Another depressive factor is regulatory uncertainty in multiple areas and Federal involvement, which some companies can work to their advantage. The Rock Health summary discusses this at length. Also Mobihealthnews

Weekend news roundup: Teladoc adds to Primary360; Novartis, Medtronic support UK digital cardiac startups; Bluestream adds PrimaryOne Health; NoKo ransomware threatens healthcare; more Fed scrutiny on telehealth Rx, billed time may be coming

Teladoc had some positive news this week with additions to Primary360, its new primary care service for the provider/payer market. It added in-network referrals and care coordination capabilities, free, same-day prescription delivery from Capsule, and in-home, on-demand phlebotomy from Scarlet Health. The release notes that about half of patients fail to pick up their prescriptions. In addition, Priority Health, a nonprofit health benefits company serving Michigan, has added Primary360 to its fully insured virtual first plan design for employers. FierceHealthcare

Some good news from the UK in a time of government upheaval. Novartis is supporting cardiac digital health startups through the Novartis Biome UK Heart Health Catalyst 2022. This investor partnership is to identify and scale innovations for non-invasive lipid testing and at-home blood pressure testing using software as a medical device. Partners in support are Medtronic, RYSE Asset Management and Chelsea and Westminster Hospital NHS Foundation Trust and its official charity CW+. Successful applicants will receive support from partners during the competition process, the opportunity of investment up to £3 million provided by RYSE Asset Management, subject to due diligence at RYSE`s discretion, access to the Novartis Biome UK eco-system located in White City, and opportunities to work with our NHS partners to set up and deliver a pilot evaluation of the winning innovation. Applications must be in by 31 August–form is here. FierceBiotech

Bluestream Health adds PrimaryOne Health. Bluestream provides a white-labeled customized virtual care service that will be integrated into PrimaryOne’s services. This medical group of 11 community healthcare facilities across central Ohio serves 48,000 patients with primary care, OB-GYN, pediatric, vision, dental, behavioral health, nutrition, pharmacy, physical therapy, and specialty care.  Release

North Korea’s Maui Ransomware is no Hawaiian vacation. The threat has built enough since May 2021 for the Federal Bureau of Investigation (FBI), Cybersecurity and Infrastructure Security Agency (CISA), and the Department of the Treasury (Treasury) to release a joint Cybersecurity Advisory (CSA) on Thursday warning healthcare and public sector health organizations. It is state-sponsored North Korean malicious cyber activity. The CSA provides a sample of how it executes, what it targets, how it encrypts files, and how to respond. Hackermania, NoKo Style, is Running Wild with breaches piling up [TTA 7 July], and not only in healthcare. Healthcare Dive, Healthcare IT News

And in Dog Bites Man News, a former US assistant district attorney for Massachusetts predicts that Federal entities such as the Department of Justice (DOJ) may not stop with telemental prescribing. They will not only be ramping up their scrutiny of telemental health companies–but also telehealth billing. For Cerebral and Done Health that facilitate the prescribing of Schedule 2 drugs, this assumption of scrutiny has become a no-brainer. What it also is: a caution for mainstream telehealth providers such as Teladoc and Amwell charging into psychiatric telehealth.  But the former ADA, Miranda Hooker, now a health sciences area partner with Troutman Pepper in Boston, makes a broader prediction. Prosecuted telehealth fraud, as this Editor has noted, has grown in other areas, such as prescriptions for durable medical equipment (DME) billed to Medicare [TTA 6 May] and cardiologists moonlighting as Dr. Mabuse, Master Cybercriminal [TTA 19 May]. But the next frontier may be time-specified telehealth consults billed to Medicare under various CPT codes (e.g. 994XX). A 15-minute consult billed as a more lucrative 30-minute consult can be considered fraud. The Cerebral investigation, according to Hooker, marks a shift by the DOJ into investigating the actual provision of telehealth services and whether they are being billed properly. FierceHealthcare

Two telehealth case studies: St. Luke’s University Health, CommonSpirit Health

Telehealth effectiveness measured in two different US health systems. Some of our Readers are marketers like your Editor, who are always searching for references on program effectiveness. Healthcare IT News in recent days has presented two, one using Amwell and the other using Teladoc:

St. Luke’s University Health is a small health system with 14 hospitals and multiple clinics covering eastern Pennsylvania and western New Jersey. They were addressing several problems:

  • Network coverage expansion and time to consult reduction
  • Integration with EHR and multiple systems
  • Maintaining high privacy standards
  • Introducing behavioral telehealth for both patients and employees, especially during the Covid pandemic

The case study is primarily about the implementation of Amwell Psychiatric Care for 24/7 coverage and the SilverCloud Health platform, part of Amwell. This accelerated at the start of the pandemic. St. Luke’s instituted a Virtual Remote Monitoring Center (VRC) that monitored more than 6,000 patients supported by a 24/7 operations team.

With SilverCloud, they custom-built a support program for employees that included a self-paced program for stress, anxiety, and depression with support from a social worker and app-based 24/7 coaching interventions. If needed, the employee could be referred to an Employee Assistance Program or a St. Luke’s therapist. 

For the mental health programs, using the PHQ-9, comparing results between in-person and virtual visits from July 2021 to March 2022, results were close to identical in 6-point reductions in both virtual (96%) and in-person (90%) populations. In overall telehealth visits, between March 2021 and March 2022, they had over 205,000 unique patients use telehealth. Another metric that telehealth affected was outpatient care. St. Luke’s reduced no-show rates from 14% to 6%. Article

CommonSpirit Health is the largest Catholic and second-largest non-profit health system in the US.  The problem they were attempting to solve was primarily onboarding patients in crisis in the shortest possible time, well within the four hours recommended by the Joint Commission. They expanded their use of Teladoc in the CommonSpirit Telehealth Network to include behavioral health, instituting a.”round and respond” model to improve access to behavioral health specialists in several hospital emergency departments (EDs) and quickly assess patients as mild, moderate or severe based on patient risk. They also added services such as geropsychiatric and crisis intervention with medication-assisted treatment as consultation-liaison services. Results were:

  • Decrease in length of stay, cost; increased satisfaction and expectations of care met
  • 1,200 telebehavioral health consultations per month, through three states and across 25 hospitals
  • Establishing a standard of care of response within 60 minutes to all ED consult requests, have actionable recommendations within 90 minutes, and an ED disposition plan within the first four hours
    • 61% of cases seen within 30 minutes, 79% within 60 minutes with average response 42 minutes
    • 65% rate for discharge recommendations and a 35% rate for transfer at specific locations.

Article

Verdict Balwani: guilty on all 12 Theranos fraud charges

Breaking. A not-so-bright day for Sunny Balwani in the US District Court, Northern District of California, in San Jose. Today, after five days of deliberations, the jury returned verdicts on the ‘summer rerun’ of the two Theranos trials, that of former president Ramesh ‘Sunny’ Balwani. Unlike CEO Elizabeth Holmes, Balwani was found guilty of all 12 criminal fraud charges.

Each of the 10 wire fraud counts carries a maximum of 20 years imprisonment in Federal prison, plus a $250,000 fine and restitution on each count. The two additional conspiracy to commit wire fraud charges carry five years each. No date has been set yet for sentencing by Judge Edward Davila, who will be sentencing Holmes in September on her conviction on four of 11 counts and a possible 20 years as a member of Club Fed.

The trial called 24 witnesses, most of whom testified in the Holmes trial. The prosecution’s case centered on Balwani’s responsibilities in defrauding investors on the Theranos technology in order to get funding and placement in Safeway and Walgreens, as well as his knowledge that the labs didn’t work. The defense, calling only two witnesses, maintained that Balwani was a true believer in the technology, that the prosecution’s case was incomplete, he had no intent to defraud, and lost millions in direct investment and in shares. 

It is expected that Balwani will appeal the verdict. Undoubtedly, more details to come. Mercury News (mercifully, not paywalled), CNBC, KTVU2

Thursday news roundup: IBM Watson Health sale closed, now Merative; OneMedical inviting buyers–maybe; worst healthcare data breaches rounded up

It’s a post-Independence Day and early summer holiday relatively quiet week….

It’s Merative, not IBM Watson Health anymore. Francisco Partners‘ buy from IBM of Watson Health closed last Thursday (30 June) but didn’t make the news until after the holiday. The announcement of the new brand, Merative, was splashed on HLTH’s website today (not HIMSS) with the usual language about how their data connects and transforms health through pioneering “cloud, real-world data and industry-leading AI” through health systems, hospitals, health plans, life sciences, and government. Speaking of data points:

  • HQ now in Ann Arbor, MI
  • New CEO Gerry McCarthy from CEO of eSolutions, a former Francisco Partners portfolio company that exited to Waystar in October 2020
  • The former general manager, Paul Roma, will be a Senior Advisor to Francisco Partners
  • Merative will have six product families: Health Insights; MarketScan; Clinical Development; Social Program Management and Phytel; Micromedex, and Merge Imaging 
  • Other investors include True Wind Capital and Sixth Street

Since 2015, IBM had built up Watson Health through four acquisitions and over $4 billion in investment. They sold it for perhaps $1 billion to get it off their books. Once upon a time they were the leader, now they’re up against Oracle and a dozen other competitors like IQVIA that sell connectedness and ‘actionable insights’ across and in chunks of their business (example, life sciences). Given the track record of the controlling private equity partner, Merative needs to become profitable quickly. Merative will not be a long term investment for them. FierceHealthcare. Our prior coverage: 7 Jan, 22 Jan, 25 Feb (Who needs Watson Health?)

Also apparently up for sale to the right buyer is One Medical. The clinic group flirted with but ultimately sent packing CVS Health. One Medical offers concierge in-person and telehealth primary care in seven metros and has over 700,000 members. They bought Medicare value-based primary care provider group Iora Health a year ago [TTA 11 June] but since then their stock (trading under 1Life Healthcare) and valuation has cracked by 75%. Not mentioned in the Bloomberg article is whether Iora is included in the possible deal.

And for those who like their Hackermania on the Wild Side, there’s a massive list over at Wired that racks up the Greatest Hits. It’s only halfway through 2022, but the data breaching and ransomware perps have multiplied. From Russia/Ukraine to extortion gangs like Conti and Lapsus$ to cryptocurrency theft and China, the Old Reliable Healthcare continues to star. Our recent list is here but topping out the Wired list are Shields Health Care Group, Baptist Health System, Resolute Health Hospital, Kaiser Permanente, and Yuma Regional Medical Center. Also Becker’s.

Weekend news, deal roundup: Teladoc CEO’s tapdance interview, VA EHR cost reporting now law, Tunstall-Doncaster Deaf Alliance partner, Cleveland Clinic’s $33M medtech spinoff

Teladoc CEO Jason Gorevic’s curious tapdance of an interview. Teladoc has had a rough 2022 to date. Their 2022 Q1 financials [TTA 4 May] were disastrous, their share price has not recovered since it cracked in late April with a 62% year-to-date plunge, the Livongo acquisition is shaping up to be the healthcare equivalent of Eastern Airlines’ takeover by Texas Air Corporation circa 1986, and shareholders are filing class action lawsuits. Now this Editor doesn’t mean to pile on. As a professional in two fields, she does understand the value of the press and leadership being available. But FierceHealthcare’s Heather Landi cleverly got Mr. Gorevic to stake his ground for growth yet again on “holistic, integrated solutions” that combine multiple care services from primary to complex care as the ‘longitudinal’ way to go. Yet Ms. Landi does have the nerve to bring up recent history and their long-time competitors like Amwell and Doctor on Demand (now Included Health) in the same space. Then there are the slices taken by players in the direct-to-consumer and niche target players (she cites troubled Cerebral and Talkspace–I’d offer DTCs like Babylon Health and the ‘white-labels’ like Bluestream Health and Zipnosis, now owned by BrightHealth, which are directly and cost-effectively working with providers). Think of this: in an economic downturn, will providers buy the ‘premium spread’ that requires a big implementation lift, or get by a less comprehensive solution that’s easier to implement and costs less?  Surprisingly, given the ‘everyone wants everything’ strategy, he again blames the cost of paid search advertising and brushes off Microsoft and Amazon. I’m not so sure that so soon after their Q1 bad news in May, with lawsuits centering on statements to investors, and nothing new in good news, this interview was particularly good timing.

VA corralled by Congress on Cerner EHR. The Department of Veterans Affairs now, by Federal law enacted late last week, has to prepare quarterly reports on its transition to the Cerner Millenium EHR to both House and Senate Veterans committees on performance and cost, including a breakdown of program funding sources. The new bipartisan law’s title is the VA Electronic Health Record Transparency Act.  Healthcare Dive

Tunstall Healthcare is now working with a local trust, the Doncaster (UK) Deaf Trust, to provide support for deaf and hearing-impaired children and adults. With Whitley Parish Council, Tunstall is working with the specialist gardening team at Communication Specialist College, part of Doncaster Deaf Trust, to secure over 100 plants for the planters which have been grown at the Trust’s gardens. Tunstall volunteers planted them in the planters across the village. Doncaster Free Press

Cleveland Clinic’s successful spinoff, Centerline Biomedical, closed a $33 million Series B equity financing. Leading it was Cleveland Clinic with participation by GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures, and G2 Group Ventures. Centerline’s technologies improve visualization and guidance of stents, catheters, and guidewires in endovascular procedures, reducing dependence on radiation and contrast agents with the goal of improving patient outcomes. These include sensors and electromagnetic tracking that create 3-D color visualization and navigation of the human vascular system. Release, Becker’s

‘Bionic clothing’ to aid mobility tested for foot drop in MS patients

A combination of smart clothing and an exoskeleton to aid those with mobility issues. The Neural Sleeve uses functional electronic stimulation (FES) to aid walking in those with multiple sclerosis (MS) and similar conditions. In a small clinical trial, it reduced foot drop, which is the inability to dorsiflex, or raise the front part of the foot, due to weakness or paralysis of the muscles in the front of one’s lower leg. This is seen in the gait of those with MS, traumatic brain injury, stroke, spinal cord injury, and cerebral palsy. (This Editor also knew someone for whom leg drop was an initial sign of a brain aneurism.) This disturbed gate dramatically increases fall risk.

The Neural Sleeve works through sensors in the sleeve that monitor movement for muscle firing and limb position, while the analysis, connected to the device through an app, determines the FES to activate the necessary muscles precisely coordinated to the gait cycle. The developer is Cionic, located in the Bay Area of California, still in seed rounds, but marketing to both physicians and direct to consumer. 

Of 34 final participants with a mixture of causes in a small clinical trial:

  • It improved foot angle in 96% of participants, a 3.4% increase in heel-toe time, and a 5.2% increase in dorsiflexion at heel strike
  • Inversion (turning in) of the foot also was reduced by 3.6 degrees on average.
  • After eight weeks of use, mobility improved 30% on average.
  • In addition, the number of patients reporting moderate to severe pain reduced by 60%, and the number reporting moderate to severe anxiety or depression dropped by 75%.

The clinical trial is in preprint 6 June in Medrxiv as Augmenting gait in a population exhibiting foot drop with adaptive functional electrical stimulation.

The Neural Sleeve received FDA Class II medical device clearance in March. However, it is still in pre-orders, selling out 2022, with 2023 to open later this summer. Multiple Sclerosis News Today, Medium post on foot drop in the Cionic blog, other Medium posts  Hat tip to TTA founder Steve Hards

Wednesday news roundup: PicnicHealth $60M Series C, can a downturn be good for digital health, Cerebral ran wild, a tart take on HIMSS and where it’s going

PicnicHealth had a bit of one, even in this down market. This company which uses machine learning to build data sets for life sciences by working directly with patients and giving them single-source access to their data raised a $60 million Series C via new investor B Capital Group, with existing investors Felicis Ventures and Amplify Partners. The new funding will be used to build 30 new patient-centered real-world data cohorts. Adam Seabrook, Partner at B Capital Group, will be joining the PicnicHealth board of directors. Their total raise to date is $97 million since 2014 (Crunchbase). The platform was launched in 2020. FierceBiotech, release

Funding news may be a little light nowadays, and if you’re public, you’re looking at double digit share price losses, but couldn’t you guess–the downturn may be good for digital health founders! That’s the view of Big VC General Catalyst’s Hemant Taneja, said at Collision 2022, a Toronto tech conference. Now before you’ve thought the man has totally gone out of his gourd with $5+ gallon gasoline (US), 10% inflation, and rolling blackouts looming on both coasts and the UK, it is true that businesses founded in downturns tend to be tough–my father’s business was founded at the start of the Great Depression. As Mr. Taneja put it, tighter times make for more mission-driven “better founders, better investors and better executives”. Secular trends are in their favor in tech and digital transformation, but there will be another correction coming as the market is over-capitalized. Is it the dot-com boom/bust all over again? Only time will tell, but the crackups are already piling up. FierceHealthcare

Speaking of crackups, Cerebral. A report in the annoyingly paywalled Business Insider tells a tale of Telemental Health Running Wild. Former employees and ~2,000 leaked documents claim that Cerebral had no more than a nodding acquaintance with clinical standards until the Feds stepped in. For starters, they took on patients they should not have, didn’t train their nurse-practitioners and other employees, pushed prescriptions to 95% of patients, disregarded state regulations putting licenses at risk, and generally had more twists than a barrel of pretzels. And this was a company prescribing Schedule 2 drugs that had at peak 210,000 active patients and 4,500 employees.  HISTalk summarizes the article, with our thanks. But it’s par for the course, according to a new JMIR (Journal of Medical Internet Research) study also mentioned that found that “many digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online.” 

And returning to HISTalk (29 June news), there’s a group of comments from a “HIMSS insider” about how that organization is being managed that long-time observers of this organization will find interesting. Employees thought that HIMSS22 was “awkward”. New and cool conferences HLTH (which initially faltered) and ViVE (which HIMSS didn’t even bother to scout) have taken much of the ‘must attend’ and buzz away from HIMSS. Now this wasn’t supposed to happen with the buy of hipper Health 2.0, to which your Editor was connected–but H2O was HIMSS-ized and effectively killed off even before the pandemic. Regional conferences have disappeared, along with a fair number of employees. HIMSS Analytics is sold. Now this could be all one person’s opinion–but what do you think?

Theranos Summer Rerun: Sunny Balwani trial verdict countdown analysis (updated)

Our last update on the Summer Rerun of the Theranos trial, a/k/a Rock and Hard Place or Blood Out Of A Stone, was that the defense rested.  It was definitely souffle-grade–Balwani’s late entry to the company, investment of his own millions, and never selling a share. There is no breathless coverage of the trial–no sensational new revelations of cheated investors or psychological violence claims, just near-identical charges (12) mostly of wire fraud with the prosecution methodically setting up Balwani with full knowledge of the cheating with the labs and defrauding of investors. [TTA 23 Mar, 16 June], 

Now it’s up to the jury. The betting is that there will be a verdict next week. It’s expected that the jury will 1) name a foreman and 2) methodically go through the pile of evidence, sending questions to the judge for clarifications on these complex legal issues when needed. The deliberations will be over the July 4th holiday giving a small delay. Will they heap guilt on Balwani’s head with multiple or nearly all counts, or keep them to low single digits as they did with Elizabeth Holmes? We will likely know sooner rather than later. If you want some informative analysis by an attorney, you’ll have to go to YouTube for this video by “Lawyer You Know” Pete Sargos. There’s also a light update on Yahoo Finance.

Update 29 June: The jury has sent two notes back to the court so far. On Day Three, Tuesday afternoon, the jury sent a note asking if the jury cannot agree on a specific count, is there an option other than guilty or not guilty. On Wednesday morning, another note was sent, contents unknown. There are ten wire fraud charges and two counts of conspiracy to commit wire fraud.  NBC Bay Area  This part of the article will be updated as it’s reported until a verdict is reached.

US International Trade Commission initial determination: Apple infringed AliveCor’s patents (updated)

If affirmed, a David versus Goliath win. AliveCor, the developer of the KardiaMobile ECG devices, announced late today that Administrative Law Judge (ALJ) Cameron Elliot of the US International Trade Commission (ITC) issued an Initial Determination that Apple infringed certain AliveCor technology patents. If affirmed by the full ITC in a Final Determination by 26 October (!), it could lead to an exclusion order barring the importation of certain Apple devices infringing on AliveCor patents from the US.

The initial complaint was filed in May 2021 [TTA 29 April] concerning Apple’s infringement in the Apple Watch 4, 5, and 6 of three AliveCor ECG technology US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”). Last February, AliveCor successfully moved with the ITC to have the investigation terminated on certain claims on the three patents, but a considerable number remained. This is what ITC terms an “unfair import” or Section 337 investigation. These regard intellectual property rights, including “allegations of patent infringement and trademark infringement by imported goods.”

Updated for links: AliveCor press release, ITC Public Notice which details what parts of what patents have been infringed. Both the 731 and the 941 patents have been found to be infringed under Section 337. The 499 patent has not been violated. This Editor will assume we have to wait till October for any exclusion orders.