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

June 30, 2022 | by

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

June 29, 2022 | by

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)

June 28, 2022 | by

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.

Let the lawsuits begin: Meta sued by health system patient for Meta Pixel info gathering

June 23, 2022 | by

That was fast. Class action game on! Today’s reports of a class action lawsuit being filed against Meta Friday in the US District Court for the Northern District of California in San Francisco is going to be only the first. The ‘John Doe’ plaintiff, a patient of Baltimore-based Medstar Health System and a Facebook user, claims that he is filing on behalf of “millions of other Americans whose medical privacy has been violated by Facebook’s Pixel tracking tool.” Four law firms are involved in the lawsuit. It follows on last week’s investigative report by The Markup and STAT on the Meta Pixel tracker being used by 33 of the top 100 hospital systems [TTA 17 June].

The study indicates that the information gathered in the appointment booking form included IP address, doctor’s name, patient name, email address, phone number, zip code, and city of residence. When it’s put together with outside information, it can be considered a HIPAA violation.

The lawsuit alleges that the information was collected without consent. Neither Meta nor Facebook have a Business Associate Agreement (BAA) agreement in place covering them for gathering this information in any one of the 664 health systems using the Meta Pixel cited in the suit.

The suit requests compensatory and punitive damages for breach of contract, constitutional invasion of privacy, violation of the Electronic Communications Privacy Act, violation of the California Invasion of Privacy Act, and other allegations. The filing was captured by ReclaimTheNet.org. If you look at page 18, there are multiple statements from Meta/Facebook stating that advertising based on health is ‘inappropriate’, but then illustrates how Facebook goes ahead and does it anyway (!)

A small wrinkle: In a statement to HIPAA Journal, Medstar Health Systems claimed it does not use the Meta Pixel or any Facebook code on its website. It creates an issue of the plaintiff’s standing and harm.

FierceHealthcare, Becker’s, HealthITSecurity

Wednesday news roundup: March telehealth claims down to 4.6%, state telehealth waivers expiring, UnitedHealth’s Optum bids for EMIS, Talkspace reportedly rejected Amwell, Mindpath bids

June 22, 2022 | by

Telehealth usage continuing its downward trend. At 4.6%, telehealth medical claims in March were off over 6% (0.3 points) versus February’s 4.9%. Again, 65% of claims were for mental health conditions, and social workers were the leading providers of telehealth at 32% for primarily one hour of psychotherapy at 26%. FAIR Health monthly US tracker.

One possible contributing factor is states pulling back on the broad telehealth provider location and other waivers (such as platforms) that were enacted during the Covid emergency. These waivers primarily permitted out-of-state providers. The expiration of waivers thus return telehealth delivery to in-state licensed providers unless covered by other regulations, for instance Medicaid. Last year, 26 states waived in-state licensure requirements; this year, only 12 states have these waivers. California and New Jersey are due to expire soon.  NBC News with a hat tip to HISTalk.

Optum bids to buy UK health software provider EMIS. The bid of £1.24 billion ($1.5 billion) was announced last Friday. A UK affiliate of Optum, Bordeaux UK Holdings II Limited, is the actual entity for the acquisition, recommended by the EMIS board. The offer is in cash and represents a 49% premium to the current share price. EMIS is a leading provider of software and systems to the NHS, serving primary care, community care and pharmacy, acute care, and the Patient.info website. When completed, EMIS would be UnitedHealth’s largest acquisition in the UK and Europe. FierceHealthcare 

Troubled telementalhealth provider Talkspace reportedly rejected a bid from Amwell pretty much out of hand, leading to speculation that it’s up for sale but being picky-picky-picky.  According to the report in Behavioral Health Business, from Seeking Alpha, their talks did not even reach number discussions. This is after Talkspace rejected another bid in May from another telementalhealth provider Mindpath, backed by Centerbridge Partners and Leonard Green & Partners. Sources were split on whether $500 million was offered or not (Axios).

Talkspace is one of the poster children for Cracking SPACs. It hit the market in January 2021 at a valuation of $1.4 billion, opening above $8, hitting a peak of about $11 per share. Share price declined to as low as $1.06 before rising on this acquisition talk to $1.58. Current valuation is $58 million, but it is sitting on a reported $184 million in cash. Reportedly their CEO search is going nowhere. Much like Teladoc, one year after their SPAC, investor lawsuits were filed against the company for misleading investors. Look for Talkspace to be sold over the summer.

More bad news for Cerner’s VA rollout–draft report cites 150 “cases of harm” due to the ‘unknown queue’

June 21, 2022 | by

A serious revelation that may derail the Cerner Millenium rollout. A draft report by the Department of Veterans Affairs (VA) Office of Inspector General (OIG) states that a flaw in Cerner’s software caused the system to lose 11,000 orders for specialty care, lab work, and other services – without alerting health care providers the orders (also known as referrals) had been lost. This created ‘cases of harm’ to at least 150 veterans in care. Moreover, the flaw was known prior to the Mann-Grandstaff VA Medical Center rollout in October 2020, and Cerner failed to either fix or inform the VA of it prior to the implementation.

The lost orders in the quaintly termed ‘unknown queue’ resulted in delayed care at minimum. The VA patient safety team classified dozens of cases of “moderate harm” and one case of “major harm.” The major harm cited affected a homeless veteran, aged in his 60s, who was identified as at risk for suicide and had seen a psychiatrist at Mann-Grandstaff in December 2020, after the implementation. After prescribing medication to treat depression, the psychiatrist ordered a follow-up appointment one month later. That order disappeared in the EHR and not scheduled. The consequences were that the veteran, weeks after the unscheduled appointment date, called the Veterans Crisis Line. He was going to kill himself with a razor. Fortunately, he was found in time by local first responders, taken to a non-VA mental health unit, and hospitalized.

The draft report implies that the ‘unknown queue’ problem has not been fixed and continues to put veterans at risk in the VA system.

There may be as many as 60 other safety problems. Other incidents cited in the draft report include one of “catastrophic harm” and another case the VA told the OIG may be reclassified as catastrophic. Catastrophic harm is defined by the VA as “death or permanent loss of function.”

The news broke in the Spokane Spokesman-Review today (20 June). Their reporters obtained the draft report from multiple sources. Mann-Grandstaff VA Medical Center is located in Spokane. The final report is expected to be released later this summer.

Those of us who have been following the migration from warhorse EHR VistA to Cerner Millenium recall that a year ago, OIG already had criticized the Mann-Grandstaff implementation for multiple “governance and management challenges” as well as patient safety concerns and system errors, resulting in a grilling of VA Secretary Denis McDonough and Cerner executives before the Senate Veterans Affairs Committee last July. A remark by the committee’s chair, Frank Mrvan, D-Indiana. that the three-month review at the time “raises more questions than it answers,” is proving to be remarkably prescient.

According to the article, “the department did not respond to questions about the draft report, but on Friday, after The Spokesman-Review sent the questions, VA officials told Military Times they would delay the system’s planned launch in Seattle, Portland and other large facilities until 2023″. Military Times noted that the congressional committees were not informed until Friday night. The delays are as follows: Puget Sound VA Health Care System (American Lake and Seattle VA Medical Centers) from August to March 2023 and VA Portland Health Care System (Portland and Portland-Vancouver VA Medical Centers) from November to April 2023. The Central Ohio Healthcare System implementation in May has gone as planned and the VA maintains that the two delays are not indicative of other problems.

Local Representative (R-5th Congressional District, eastern Washington state) Cathy McMorris Rodgers has already had at Cerner since last year. Her press release is illustrative of her activism around Mann-Grandstaff and further rollouts of the Cerner EHR, while Mann-Grandstaff continues to have problems and outages.

Oracle has a great deal riding on a smooth implementation of Cerner Millenium at the VA. More Congressional hearings are not a good look for Oracle and its ambitions of transforming healthcare. Damage control is snapping in place. This Editor noted that Oracle’s SVP for global corporate communications was quoted in the Spokesman-Review article, not a Cerner staffer. Also EHR Intelligence.

 

Breaking: Hospitals sending sensitive patient information to Facebook through website ‘Meta Pixel’ ad tracker–study

June 17, 2022 | by | 2 Comments

Meta Pixel tracker sending appointment scheduling, patient portal information to Facebook–likely to become the Hot Story of next week. A study published jointly by The Markup and STAT examined the patient-facing areas of Newsweek’s 100 leading hospitals’ websites. It found that 33 of them permit the Meta Pixel ad tracker to send sensitive patient information back to Facebook. Ostensibly the reason is to better serve the patient with more tailored information, but what is not disclosed is what else Facebook is doing with the information. At a minimum, the information is the IP address–which HIPAA considers one of 18 identifiers that when linked to other personal information, can constitute data as protected health information.

Ad trackers like the Meta Pixel are used to target website visitors and also to track ads placed on Facebook and Instagram. Developers routinely permit these snippets of code as trackers for better performance and website tracking.

  • For 33 hospitals, the Pixel tracker is picking up and sending back to Facebook information from users of the hospital’s online appointment scheduler: the user’s IP, the text of the button, the doctor’s name, and the search term. In testing the sites using a team approach facilitated by a plug-in called Mozilla Rally, the testers found that in several cases, even more identifiable patient information was being sent: first name, last name, email address, phone number, zip code, and city of residence entered into the booking form.
  • Seven hospitals have the Pixel deep into another highly sensitive area–the password-protected patient portal. These go by various names, but a popular one is Epic’s MyChart. One surveyor found that for Piedmont Healthcare, the Pixel picked up the patient’s name, the name of their doctor, and the time of their upcoming appointment. For Novant Health, the information was even more detailed: name and dosage of medication in our health record, notes entered about the prescription about allergic reactions, and the button clicked in response to a question about sexual orientation. (Novant has since removed the Pixel.)

None of the hospitals using the Pixel have patient consent forms permitting the transmission of individual patient information, nor business associate agreements (BAAs) that permit this data’s collection.

The reaction of most of these hospitals was interesting. Some immediately removed it without comment. Others maintained that no protected information was sent using Pixel or otherwise defended its use. Houston Methodist was almost alone in providing a detailed response on how they used it, but subsequently removed it.

Facebook maintains that it does not use this information in any identifiable way and that from 2020 it has in place a sensitive health data filtering system and other safeguards. The New York Department of Financial Services, in a separate action monitoring Facebook in this area, questioned the accuracy of the filtering system. Even when the information is ‘encrypted’, it’s easy to break. Internal leaked Facebook documents indicate that engineers on the ad and business product team admitted as late as 2021 that they don’t have “an adequate level of control and explainability over how our systems use data, and thus we can’t confidently make controlled policy changes or external commitments such as ‘we will not use X data for Y purpose.” (quoted from Vice)

The study could not determine whether Facebook used the data to target advertisements, train its recommendation algorithms, or profit in other ways, but the collection alone can be in violation of US regulations. 

On the face of it, it violates patient privacy. But is it a HIPAA violation of protected health information? No expert quoted was willing to say that was 100% true, but a University of Michigan law professor who studies big data and health care said that “I think this is creepy, problematic, and potentially illegal” from the hospitals’ point of view. Some of the hospitals in their comments say that they vetted it. One wonders at this tradeoff.

To this Editor, Meta Pixel’s use in this way walks right up to the line and puts a few toes over.

If this is true of 33 major hospitals, what about the rest of them–smaller and less important than Columbia Presbyterian, Duke, Novant, and UCLA? What all of us have suspected is quite true–social media is collecting data on us and invading our privacy at every turn, and except for exposés like this, 99% of people neither know nor care that their private information is being used.

The Markup is continuing their “Pixel Hunt” series with childrens’ hospitals. A previous article is about Pixels tracking information from crisis pregnancy centers, about as sensitive as you can get. Also HISTalk.

Wednesday news roundup: Oracle scrutinizing outside vendors, cloud change coming for Cerner EHRs, audio-only telehealth can continue after PHE–HHS, Proximie connected surgery raises $80M (UK)

June 15, 2022 | by

Oracle moving quickly to change Cerner’s outside vendors to Oracle products and move their EHRs to Oracle cloud services. Will this fly with health systems and providers? An immediate change that will resonate with current Cerner EHR users is Oracle’s immediate moves to replace Cerner’s current third-party vendors with Oracle services and technology. So if your Cerner EHR has something you like but it comes from a third-party vendor, enjoy it while you can. Do expect that Oracle will be selling other products like Enterprise Resource Planning Cloud, administrative systems, and supply chain into providers and health systems–hard. From the earnings call, CEO Safra Katz: “We remain confident in our ability to grow Cerner’s top line and bottom line faster than they were able to do so on their own as these changes are implemented.”

The major and quickest move specified in yesterday’s Oracle earnings call (transcript) will be to move Cerner to OCI–Oracle Cloud Infrastructure. Further down into Mr. Katz’s remarks, Cerner is expected to account for 20 points of their cloud growth in Q1 2023 (starting 1 June 2022). When Cerner has added $15.8 billion of debt to the balance sheets, it’s to be expected.  HISTalk, Becker’s

What happens to audio-only telehealth at the end of the pandemic Public Health Emergency (PHE)? HHS has just issued guidance that will permit telehealth, including audio-only, services to continue. According to the HHS release, “HIPAA covered entities can use remote communication technologies to provide telehealth services, including audio-only services, in compliance with the HIPAA Privacy Rule. ” There are specific requirements such as how the HIPAA Security Rule applies to electronic media and electronic protected health information (ePHI). The full guidance is here.

UK surgical connectivity platform Proximie raises $80 million. London-based Proximie, a system that connects surgeries with pre-operative patient information, collaborative tools, and post-operative content distribution, completed a Series C with participation from Emerson Collective – the impact investor founded by Laurene Powell Jobs, SoftBank Vision Fund 2, British Patient Capital, Mubadala Investment Company, and the Minderoo Foundation, plus previous investors. The raise is unusually large (in this Editor’s opinion) for the UK, particularly at this uncertain time. Proximie has supported over 13,000 surgeries in 100 countries, contracts with over 35 major medical device companies such as Stryker and Abbott, and has been used in 500 hospitals across 50 countries. The company is a partner with Teladoc and Vodafone Business.  Release.  

Oracle’s Big Healthcare Transformation: it’s all about ‘better information’ (sigh) (updated)

June 14, 2022 | by

“Better information is the key to transforming healthcare,” he [Larry Ellison] said. “Better information will allow doctors to deliver better patient outcomes. Better information will allow public health officials to develop much better public health policy and it will fundamentally lower healthcare costs overall.”

Larry Ellison’s Big Vision, now that Oracle’s acquired Cerner, has a distinct and familiar ring. ‘Better information’ was also the mantra of IBM Watson Health. It’s the meme of every healthcare company, from education to data analytics, that better and more accessible information means better outcomes and lower cost of care. For those of us who’ve hung our caps in healthcare for the past decade, it’s the dawning promise that like Andrew Wyeth’s Christina’s World, is on the top of the beautiful hill, within our sight, yet out of our reach. But we keep trying.

Mr. Ellison is smarter and richer than most of us, so let’s defer to his Vision and what seem to be the most obvious obstacles to interoperability and mass scaling:

  • A national health record database, in an open standards-based system, will be built by Oracle. It will sit on top and pull information from thousands of hospital and presumably practice-based EHRs. Once completed, in the non-defined future, a hospital or practice anywhere would be able to access patient information.
    • Obstacles: data fragmentation, health records not in an EHR, cooperation in providing information, security, Federal/state privacy regulations, and buy-in from other EHRs which were at last count 500 or so with hospitals running at least 5-10 different EMRs/EHRs.
  • From the national database, disease-specific research using anonymized data from it and AI-enabled analysis
    • This is potentially a big winner, as smaller models are already in use, e.g. between Ronin, a clinical decision support solution, and MD Anderson to create a disease-specific AI model for cancer patients in treatment. 
    • Gathering, anonymizing, and securing the data are the main challenges, plus those above

Big Visions don’t thrill us the way they used to because other than the newest among us, the new Big Promises sound all too familiar. It’s not that long ago that first EHRs, then health information exchanges were supposed to be the clearinghouses to make information interoperable. 21st Century Cures, which allowed members/patients to obtain their health information from payers and providers to the individual, was supposed to fix that portability gap in its next phase. The government also has its own national data exchange framework as part of the Cures Act. So what about that?

Updated. Lest this Editor be considered an outlier, a skeptic, and a general killjoy, there are other smart people far better grounded in IT Reality who are equally skeptical. Patrick Murta, who is now with BehaVR but formerly was co-chief architect for the Office of the National Coordinator for Health IT’s FHIR at Scale Taskforce (FAST), is quoted in FierceHealthcare. “Saying that you’re going to build a national database and bringing that to fruition is a different story. This particular model is going to face the same barriers that have been there for many years and there’s no easy path to overcome those barriers quickly.” His opinion is echoed by at least three others in the article. In short, Oracle is actually behind other vendors in the data interoperability area and the goal to knit together thousands of systems that don’t talk to each other may be admirable, but is likely to be the classic Bridge Too Far.

Tony Blair and his nonprofit Tony Blair Institute for Global Change, already partners with Oracle to use its cloud technology to tackle health issues.

Oracle did not answer queries on timing, cost, and access. 

The cynics among us will need no reminder that Cerner is having interoperability issues between DOD’s MHS Genesis and VA’s Cerner Millenium, both national systems that Oracle has now inherited.

In the short term, Cerner will be updated to include a built-in voice interface, more telehealth capabilities, and disease-specific AI models. It’s nice to have the short-term needs recognized while the Big Vision is being built. Healthcare Dive, FierceHealthcare

Remote health monitoring a winning strategy…for sports?

June 9, 2022 | by | 2 Comments

Like most Americans, your Editor is utterly clueless when it comes to cricket. Bats, pitches, test matches…it sets her to wondering why the far simpler to understand polo hasn’t been popular in the US since the 1930s, because even at the club level, it’s an action sport with thrills and sometimes disastrous spills. Like most press, TTA receives releases, this one from India (published in Cricket World) promoting the use of Ultrahuman M1, a continuous blood glucose monitor (CBGM) out of Bangalore, India which with an app claims to optimize athletic metabolic fitness based on glucose biomarkers and continuous scoring. It factors in food, sleep, workouts, meditation, and daily activities. The news is the endorsement by top Indian cricket player Shreyas Iyer (at left–photo Reuters).

CBGMs such as the Dexcom G6 are not marketed this way in the US. Your Editor found one brand that is, somewhat, the pre-market Signos which also ties in weight loss, but both require a doctor’s prescription. The Apple Watch, or in fact any watch, has famously failed to factor in or have any success with blood glucose monitoring.

But actually ordering the Ultrahuman is rather opaque. You can subscribe to the app with yoga, meditation, and workouts for $25/year, but the “Cyborg” or M1 metabolic part leads you through information screens and to the realization that it’s pre-market and waitlisted. There’s no mention on the website about a prescription, either.

This resonated with your Editor because she recently read a book about 1950s F1 and sports car racing champions Phil Hill and his Ferrari teammate Wolfgang von Trips. von Trips tended to crash a lot (nicknamed Count von Crash) partly because he had a serious low blood sugar problem from childhood, and would suddenly weaken. He would eat or pop glucose tablets during a race. von Trips died at Monza in 1961. What if….

Do any Readers know if CBGMs are currently used in sports? Comment please.

Wednesday AM roundup all about money: $28B Oracle-Cerner closes today, 9 June strategy talk; Teladoc class-action lawsuits begin; Cigna’s look at loneliness

June 8, 2022 | by

As you read this, Oracle has closed on their acquisition of Cerner Corporation. According to the Oracle release, approximately 204,280,589 shares, or 69.2% for $28 billion, have been validly tendered and other conditions, such as passing antitrust approvals, have been satisfied. If there are other loose ends to tie off, they aren’t impediments to the closing.

Interested Readers can register to hear Larry Ellison, Oracle’s chairman, and other speakers outline Oracle’s strategy to “redefine the future of healthcare” (a song we’ve heard before) on 9 June at 3pm Central Time. If our UK Readers have been wondering what former PM Tony Blair’s been up to, he’ll be on this call. Other UK speakers are David Walliker, chief digital officer of Oxford University Hospitals, and Kevin Jarrold, joint CIO of Imperial College Healthcare. Another outside speaker is Meharry Medical College‘s CEO, James E.K. Hildreth, MD, PhD. Meharry, located in Nashville, is the second oldest medical school founded (1876) to educate black Americans in medicine and dentistry.  

Here we go with class-action lawsuits against Teladoc based on loss of share value and misleading statements. Teladoc, whose stock has taken a long jump off a very tall building (90% loss from the high), is being sued in US District Court for the Southern District of New York by a shareholder, Jeremy Schneider. This is a Federal securities class-action lawsuit (text here) with Mr. Schneider representing shareholders who purchased Teladoc shares between 28 October 2021 and 27 April 2022 (the date of announcing Q1 2022 results). The charges involve materially false statements that Teladoc made on its business, operations, and prospects including minimizing competition leading to increased advertising costs, unrealistic projections for revenue made in the period, and the impact of the Livongo writeoff announced Q1–a noncash goodwill impairment charge of $6.6 billion, or over $41 per share [TTA 4 May recaps Q1].

A lookup on Justia indicates that Mr. Schneider is being represented by Jeremy Alan Lieberman of Pomerantz LLP. The filing names Jason Gorevic, CEO, and Mala Murthy, CFO as individual defendants along with Teladoc. Mr. Schneider is not a large shareholder; his investment was a little over $250,000 from December 2021 to February 2022. Other shareholders may join the suit by contacting Pomerantz.

What usually happens after this is other firms file class-action suits in the same court representing other shareholders. An example of this trolling is this announcement/release from Bernstein Liebhard LLP. 

If you like risk and volatility, TDOC and AMWL shares remain relatively cheap (the latter below $5) and haven’t recovered. TTA reflected on Amwell’s equally shaky Q1 and growing losses in May 

If and when they’ll recover is anyone’s guess, with increased direct-to-consumer competition from retail (CVS, Walmart) and with providers maintaining their own telehealth systems, homegrown and whitelabeled (Bluestream Health, Zipnosis). Healthcare Dive, Mobihealthnews recap much of what led to this point.

If you feel a little lonelier after your Teladoc (or other telehealth) shares tanked, or you feel like life hasn’t gotten back to normal now that the pandemic is really over (despite the hoo-hah over monkeypox), Cigna’s latest research commissioned from Morning Consult will be on point. Isolation is a function of lower income, lower physical and mental health, and being a single parent or mother. Contrary to the usual assumption, young adults 18 to 24 feel lonelier and more left out (79%) compared to those aged 66 and over (41%). (Your Editor speculates that the office and workplace are more necessary for socialization by those starting their careers than those toward the end who’ve built their networks.) What’s also a little surprising is the increased indication of loneliness among racial lines with black/African American (68%) and Hispanics (72%) feeling significantly lonely. The impact at work is less productivity and more unhappiness with their jobs. The study recommends increases in work and community activities, work flexibility, improved benefits, and workplace inclusion. A bit more along with quotes from Cigna’s Evernorth subsidiary in FierceHealthcare. 

To white coat, or not to white coat? That is the telehealth doctor question.

May 25, 2022 | by

A light but thoughtful take on the protocols of the white coat, and how the clinical dress translates to telehealth consults. Dr. Jayne, who writes the weekly ‘Curbside Consult’ column for HISTalk, discussed how wearing a white coat on a telehealth visit may very well be passé. Some companies require it, others don’t, but what’s in those pockets anyway? And in telehealth, does this garb turn off patients? 

Dr. Jayne’s practice, based on her columns, is a mix between office and telehealth, but she has previously worked in the ER/ED. Where the white coat comes from is hospital culture, where the differentiators were short white coats for the medical students and longer white coats for the degreed physicians–except in surgery where short coats were worn by interns (remember interns?) and first-year residents. Men wore ties, and the dress was uniformly professional under those white coats. The white coats descended from laboratory coats. As everyone changed into scrubs during the pandemic and ties were ditched (long ago in the UK, along with long sleeves), who is who in a hospital became even more confusing to outsiders, thus requiring even larger nametags.

Perhaps the precedent for telehealth is psychiatry, where most of the telehealth consults occur at the present time. In my brother’s clinical practice, and at the community hospital where he admitted patients, he and his colleagues didn’t wear white coats over their jackets and ties (or dresses/suits for the women). It was offputting to patients, even if they were already in the psych ward. One concession–short sleeves in summer. He did wear a white coat as a locum tenens in a much larger hospital’s psychiatric ER, mainly to protect his clothing from ER mayhem which was prevalent on the night shift. 

As Dr. Jayne put it, it’ll be interesting to see how the protocol evolves. Curbside Consult with Dr. Jayne 5/16/22

Thursday legal news roundup: Oscar Health accused of IPO securities fraud; Venezuelan cardiologist moonlights as cybercriminal, faces slammer; Change Healthcare sues former employee now at Olive AI

May 19, 2022 | by

To use a cliché, what a difference a year makes. In March 2021, insurtech Oscar Health successfully raised $1,4 billion in its IPO with shares at $39. Heady times didn’t last long, with shares tumbling to $5.67 as of this writing. Now the shareholder lawsuits have begun, with the complaint stating that negative effects of COVID-19 on Oscar’s business were not disclosed, specifically the growing cost of the pandemic on testing and treatment costs they would cover, and “Oscar would be negatively impacted by an unfavorable prior year Risk Adjustment Data Validation (RADV) result relating to 2019 and 2020 [and] that Oscar was on track to be negatively impacted by significant SEP membership growth”. The lack of forward-looking disclosure at an IPO is a violation of the Securities Act. The initial lawsuit has been filed in the US District Court for the Southern District Court of New York by shareholder Lorin Carpenter. Multiple law firms have invited shareholders to join in the suit — example from PR Newswire. Also named in the suit are Oscar Health co-founders CEO Mario Schlosser and Vice Chairman Joshua Kushner, plus several investment banks.

Oscar started the year with a Q1 loss of $0.36 per share versus an estimate of a loss of $0.40, but this is less than half of last year’s loss of $0.98 per share. They are also exiting the Arkansas and Colorado markets in 2023. Healthcare Dive

Cardiologist, master cybercriminal, a new Dr. Mabuse? Accused of the creation, use, and sale of ransomware is one Venezuelan doctor and practicing cardiologist, Moises Luis Zagala Gonzalez, a dual citizen of Venezuela and France. The charges by the Department of Justice (DOJ) in the Eastern District of New York also detail his “extensive support of, and profit sharing arrangements with, the cybercriminals who used his ransomware programs.” SaaS can’t hold a candle to the RaaS–ransomware-as-a-service–operation he created to sell what he dubbed ‘Thanos,’ allegedly named after a fictional cartoon villain responsible for destroying half of all life in the universe. Turns out that Iranian state-sponsored hackers and fellow ransomware designers really liked it too. If convicted, he faces 10 years in Club Fed–five years for attempted computer intrusion, and five years for conspiracy to commit computer intrusions. Designing criminal software really does test the limits of moonlighting. DOJ release, TechCrunch

Change Healthcare sues former employee at competitor Olive AI. While their merger with UnitedHealthcare is tied up in the US District Court in DC [TTA 23 Mar], Change Healthcare is not letting any courtroom grass grow under their feet. They are suing a former employee, Michael Feeney, with violating the non-compete clauses of his employment contract. The suit was filed in Tennessee Chancery Court, its HQ state. Mr. Feeney has countersued in his state of residence, stating that the non-compete violates Massachusetts law. He was VP, strategy and operations at Change handling physician revenue cycle management. At Olive AI, he is currently SVP, provider market operations. Information is a bit scarce on this and the free article this Editor has found reads machine-translated. If you have access to the Nashville Post or Modern Healthcare it’s probably more decipherable.

As to the lawsuit affecting non-competes due to the tight labor market–don’t count on it. It’s a conflict between the state the company is in enforcing non-competes, versus a state which restricts (or negates) them that is the former employee’s state of residence and work. What wins out will be the interesting part and affect many of us in the US.

Perspectives: Where next for technology-enabled care after 2025?

May 17, 2022 | by | 1 Comment

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today, we have a contribution from Adrian Scaife, Global Product Manager at Tunstall Healthcare Group. Can telecare save the UK more than £14bn over the next 10 years, as FarrPoint projected–or is that an underestimate based on the past? Can we do better than this?

Interested contributors should contact Editor Donna. (We like pictures and graphs too)

FarrPoint recently published a report showing how extending telecare services to more people could save the UK more than £14bn over the next decade. While £14bn is no small sum, it is based on the evidence of hindsight and importantly through current models of reactive service provision.

In a LinkedIn post I boldly suggested that this should be an underestimate of the benefits that Technology-Enabled Care, associated with a wider transformation of care, could deliver over the next decade.

With increasing demand for care and support combined with finite resources for provision, the statutory care system is facing a perfect storm. The cracks have been appearing for some time but have become apparent to a much wider audience during the Covid pandemic. To be blunt, the current model of care provision is unsustainable in the medium term. (And many would argue today!)

By moving to more preventative, personalised, joined up and proactive service models, supported by communities as well as statutory services, the benefits are potentially much bigger across the whole care ecosystem. (The care ecosystem includes health care, social care, housing, the third sector and, the largest group of all, informal family carers.)

Source: Social Care Future  

This new vision is being discussed by many people and organisations across the care ecosystem and has been referenced, in whole or part, in a host of reports over the last couple of years. What is most encouraging is the consensus around the direction of travel.

The real challenge is the transformation of services from purely reactive, one size fits all, to a preventative and person-centred approach across housing, social care, health care, and the third sector, supported by families, friends, and communities, while still retaining a reactive safety net.

There are important questions around the how? Enabling and underpinning these new service models will be technology using data, information, and actionable insight. New technology has already created dramatic changes in many other sectors across the UK. There is a huge demand for a new set of tools that can, for example, flag everything is OK today or when an early intervention may be required. These tools will work on an individual personalised basis and all the way up to the population level. Joining up data and using insight provided by analytics will enable new high value timely personalised interventions and provide improved outcomes for all stakeholders. 

The good news is that there are a huge variety of companies already working on these challenges from start-ups to SME’s, larger companies, and even global players. The real challenge will be around people (e.g., new working practices) and processes (e.g., new models of commissioning), and of course, culture. Part of the new story will be about enabling working across all stakeholder groups and indeed recognising families as equal partners.

Finally, this is not a transformation that will take place overnight or even within a year but a journey that will take five or more years before it reaches any type of maturity. The green shoots already exist if you look for them, they may be a little tender and frost sensitive, but they are growing! It reminds me of the early telecare journey in the late 90s and early 00s when many could not see how it would scale to where we are today!

While £14bn from traditional reactive services would be welcome, the real opportunity for improved outcomes for all stakeholders across the care system is much greater and not just in an economic context. Personally, I am enormously excited to be playing a part in enabling those tender shoots to grow, thrive, and become the norm over the next few years.

Further reading:

News roundup: telehealth claims drop 9% in February; Amwell’s good news, bad news Q1; tech-enabled practice Crossover Health growing; NowRx and Hyundai test semi-self-driving delivery

May 17, 2022 | by

FAIR Health’s February monthly tracker is pointing downward again. After a brief post-holiday rise to 5.4% of claims in January, it dropped to 4.9% in February, a 9% drop. Mental health claims seized the lead again by a country mile at 64.2% of claims. COVID-19 fell off the list of top 5 claim areas, though only 3.4% in January compared to 58.9% for mental health. This month lists categories of specialists delivering telehealth, and social workers topped the list at over 31%, which fits the telemental health picture. 

Amwell’s shaky opening to 2022. It should not come as any surprise to our Readers that Amwell, the Avis to Teladoc’s Hertz, didn’t have a good Q1. Most of their key indicators around total revenue, providers, and visits grew smartly. Unfortunately, their losses did too. Comparisons are to Q1 2021 unless noted:

Revenue grew to $64.2 million [$57.6 million], up 11.5%
Gross margin: 42.8% [38.0%], up 12.6%
Total active providers grew 12% from Q4 to approximately 102,000 [91,000] Total visits also grew 20% from Q4 to 1.8 million [1.5 million]

But there’s no turning the corner on losses this quarter, despite Converge, their unified platform, shifting over telehealth visits as planned, and adding SilverCloud, Conversa, and specialty telehealth with musculoskeletal (MSK) and dermatology programs to the totals.

Net loss was ($70.3) million, compared to ($39.8) million, an increase of 77%
Adjusted EBITDA was ($47.1) million, compared to ($26.4) million, an increase of 78%

Amwell’s projected 2022 is the same–growth mixed with financial losses: revenue between $275 and $285 million, adjusted EBITDA between ($200) million and ($190) million.

Inquiring investors may very well ask when Teladoc and Amwell, now smaller by a factor of just over 9, will ever be profitable. Mr. Market had its say over the past year, from a high of $14.26 in early June 2021, to today’s close of $3.09, an enterprise valuation loss of $11.17 or 78%, just a little better than Teladoc’s 81% in the same period. It will likely be no time soon. But the shares may be an excellent opportunity at a low cost. Yahoo Finance, FierceHealthcare, Becker’s 

Crossover Health, a hybrid virtual/in-person primary care practice group, announced that they would be opening new centers in Seattle, Austin, and another one in New York this year. Their virtual care operates in all states, while their in-person footprint consists of 41 health centers in 11 states which are generally about 5,000 square feet. They have 33 on-site clinics for employers, which are a combination of exclusive to one company and shared, and in total cover 400,000 eligible employees and dependents including for 115,000 Amazon employees and dependents. In addition to corporate clinics, Crossover offers individual membership plans in a concierge, under one roof type model. FierceHealthcare

In another tech area, med delivery company NowRx is partnering with Hyundai for a limited test of their self-driving cars in the LA area. Hyundai will be using slightly modified Hyundai Ioniq 5 electric vehicles with some autonomous capability, but using a driver. The purpose of the test is to simulate and gather data on autonomous vehicle delivery, such as delivery statistics, dispatch and customer interactions, and feedback. NowRx offers free same-day prescription delivery in the San Francisco Bay area, Orange County, and Los Angeles areas. FierceHealthcare

Alertacall receives Queen’s Award For Enterprise: Innovation

May 12, 2022 | by

One of the items that whizzed by this Editor while she was in Pepper the Robot mode was the highly prestigious Queen’s Award For Enterprise: Innovation, awarded to one of the pioneering companies in UK telecare, Alertacall Ltd.  Their CEO and founder, James Batchelor, is an old friend of TTA from early days with Editor Emeritus Steve. (Editor Donna hadn’t even thought of marketing health tech at that time.)

Alertacall provides tablet touchscreen connectivity to the housing, care markets, and personal markets, from OKEachDay checkins to smart home systems controlled by the touchscreen.

Alertacall was founded in 2004 by James, the original inventor of the “I am okay” button. Like many of us in those days, he had a personal inspiration for being engaged with creating a better way to support older adults in their home–Eveline, his own staunchly independent grandmother. She was, in James’ words “a shop keeper for much of her life, and a B+B operator up until her early eighties. After the death of 2 husbands – the first of whom was detained as a Prisoner of War in WW2, she learned to drive in her late 50s, travelled the world on her own and was an inspiration to many with her grit and determination to live on her own, and under her own terms for as long as possible.”

Also, James’ gracious note from LinkedIn, posting on the Queen’s Award:

We won this Queen’s Award because of the great technology we have created for sheltered and supported housing to help independent older people, women fleeing domestic violence and people who are disabled – to feel safe, connected and informed.

This award really is testimony to that innovation, but more so to the incredible team I have the joy of working with each day. This is an award for them and their phenomenal care of our customers.

In July I’ll be attending a winners reception at Buckingham Palace with HRH The Prince Of Wales – on behalf of those team members. My grandma, Eveline, who was the inspiration for Alertacall would have been pretty excited by that I think.

A lot of you run your own businesses, and some of you might have started those from scratch. So you’ll understand that external, independent validation is rare, and a great feeling when it comes.

Many of you have also been a positive part of our journey – and if so thank you, sincerely.

Dame Esther Rantzen DBE, the well-known British journalist and TV presenter of That’s Life! on the BBC for 21 years, who was instrumental in the founding and popularization of both ChildLine and The Silver Line helplines, is a supporter of Alertacall. Her statement is attached here.

Our warmest congratulations to James and the Alertacall team!

Alertacall announcement.